Guideline On Dossier Requirement of Human Pharmaceutical Product 2

Guideline
Central Administration of Pharmaceutical Products

Central Administration of Pharmaceutical Care
GUIDELINE ON
Dossier Requirements of Human
Pharmaceutical Products for Registration &
Re-registration
Year 2023
Code: EDREX: GL.CAP.Care/CAPP.002

Version No:3
Issue Date:14/08/2023
Effective Date: 14/08/2023
GUIDELINE ON Dossier Requirements of Human

1|Page Pharmaceutical Products for Registration & Reregistration
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Guideline
Table of Contents
I. INTRODUCTION ................................................................................................................................. 3
II. SCOPE .................................................................................................................................................... 3
III. DEFINITIONS ....................................................................................................................................... 3
IV. PROCEDURES ...................................................................................................................................... 5
SECTION ONE: REQUIREMENTS FOR SUBMISSION OF REGISTRATION REQUEST …………………5
Checklist for Submission for registration request for Human pharmaceutical product…………………6
Checklist for Submission for registration request approval modification for Under-registration
Human pharmaceutical product………………………………………………………………………………………………..17
Checklist for submission for replacement of lost registration request approval for under-
registration Human pharmaceutical product ...................................................................................................... 23
Checklist for submission for Changing Applicant for Under-registration Imported Human
pharmaceutical product............................................................................................................................................. 25
Checklist for submission for Changing License Holder for Under-registration Imported Human
pharmaceutical product……………………………………………………………………………29
Checklist for Registration Request for Human Pharmaceuticals with Type of Marketing Tender &
Export or Export Only……………………………………………………………………………32
SECTION TWO: REQUIREMENTS FOR SUBMISSION OF TRADE NAME REQUESTS ....................... 34
SECTION THREE: REQUIREMENTS FOR SUBMISSION OF PHARMACEUTICAL VIGILANCE....... 38
SECTION FOUR: REQUIREMENTS FOR SUBMISSION OF QUALITY MODULE ............................... 45
Arrangement Guidance for Submission of Quality Module…………………………………………………………..45
Guidance for Submission of Quality Module…………………………………………………………………………………………49
Guidance on Submission of Quality Module Variations………………………………………………………………72
Guidance for submission of products for Evaluation of (Composition & finished product specifications)
/API specifications/S-Part ....................................................................................................................... 91
SECTION FIVE: REQUIREMENTS FOR SUBMISSION OF BIOEQUIVALENCE AND IN-VITRO
DISSOLUTION STUDIES ................................................................................................................... 104
Study Report……………………………………………………………………………………………………………………………….106
A-Format and Content of Bioequivalence Study Report……………………………………………………………………….106
B-Format and Content of Comparative In-Vitro Dissolution Study Report…………………………………….116
C-Format and Content of Dissolution Profile Study Report………………………………………………………………..119
Administrative Documents……………………………………………………………………………………………………………………122
A-Checklist for Bioequivalence and Comparative In-Vitro Dissolution study submission………122
B- Checklist for Appeals & Inquiries submission………………………………………………………………………………...125
SECTION SIX: REQUIREMENTS FOR SUBMISSION OF STABILITY STUDIES ................................ 127
SECTION SEVEN: REQUIREMENTS FOR SUBMISSION OF INSERTS ............................................. 197
SECTION EIGHT: REQUIREMENTS FOR SUBMISSION OF MOCK-UP .......................................... 201
SECTION NINE: REQUIREMENSTS FOR SUBMISSION OF FINAL REGISATRATION FILE……204
Submission guidance according to CTD format……………………………………………….205
Submission Guidance for Human Pharmaceutical Product Initial Re -Registration File
according to EDA Chairman decree 150/2022……………………………………………….217

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Guideline
I. Introduction
This guideline intended to describe how to organize file content of Human Pharmaceutical Products.
To market a Human Pharmaceutical Products in Egypt, applicants must provide adequate information
provided in each section to the Egyptian Drug Authority demonstrating that the product is safe and
effective for the conditions prescribed, recommended, or suggested in the proposed labeling for the
product.
II. Scope
The guideline primarily addresses the information required to be submitted in registration or Re-
registration applications for Human Pharmaceutical Products.
III. Definitions
Local Products - Pharmaceutical products manufactured, stored, released, distributed

and sold in the local pharmaceutical market of the same country.
Imported Products - Pharmaceutical products manufactured in their country of origin
but imported and marketed in another country.
Under-Registration - Products which have not been licensed yet, and they are proceeding
Products to get a registration license.
Registered Products - They are licensed pharmaceutical products by the Board of
Authority and have a license to manufacture, import, export,
distribute and sale the drug.
Mock-up - A virtual full-sized model of the human pharmaceutical products
that have not yet been produced showing how they will look. It also
can be defined as layout or artwork.
Pharmacovigilance - The science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other drug
related problems.
Reference Countries - An updatable list of countries approved by the technical committee
for drug control.
Non-reference product - A medicinal product that has no reference product with the same
dosage form, concentration, indication or route of administration.
Quality File (Module 3) - also referred to as ICH Module 3, includes requirements for
presenting manufacturing, characterization, drug substance controls,
stability characteristics, descriptions and compositions of
pharmaceuticals, and other essential information.

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Bioequivalence study - It is a comparative study conducted on healthy volunteers in one

of the licensed bioequivalence centers to compare between the
generic and reference products to study its conformity in terms of
the rate and extent of drug absorption, which expresses the
bioavailability of the product.
Comparative in-vitro - It is a comparative study conducted at one of the licensed
dissolution study bioequivalence centers or the companies’ plants - according to the
regulations - to compare between the generic and reference
products to study dissolution of these products in different media.
Stability study - The study that reflects the effect of temperature and humidity on
the stability of finished product in its final packaging material
during storage period to determine shelf-life and storage
conditions.
Shelf-life - The time period during which a product is expected to remain
within the approved shelf-life specifications, provided that it is
stored under the conditions defined on the container label.
Shelf-life specifications - The combination of physical, chemical, biological and
microbiological tests and acceptance criteria that determine the
suitability of active substances throughout its re-test period, or that
a product should meet throughout its shelf-life.
Stability Committee - the form, on which the committee member writes decision after
Decision assessing stability study, filled with product information which
include: serial number, type of product, type of registration, date
of receive, trade name, applicant name, manufacturer, license
holder, packager, stability performed by, active ingredients,
dosage form, proposed shelf- life, proposed storage conditions,
physical characters, pack in details, summary of the stability study
done on the product and any other remarks.

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IV. Procedures
SECTION ONE
Requirements for Submission of Registration Request

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Guideline
SECTION ONE: Registration for Submission Registration Request
This section will provide information about requirements for Submission of Registration
Request.
Checklist for Submission for registration request for Human pharmaceutical product
Requirements ‫خطوات التقديم‬ Soft Hard copy Original
copy to review
A Registration requests submitted for the products manufactured locally

)‫)فى حالة المستحضرات المصنعة محليا‬
1- The company must apply to ‫√ يجب على الشركة التقدم الدارة النظم‬
systems & Pharmaceutical ‫والمعلومات الدوائية النشاء حساب‬
information department for ‫التقدم‬ ‫خاص بالشركة حتى تتمكن من‬
creating a company profile to .‫بطلبات التسجيل على برنامج الميكنة‬
be able to submit registration
requests on the box inquiry
program.
2- Submit registration requests ‫التقدم بطلبات التسجيل على برنامج‬ √

on the box inquiry program " " ‫الميكنة‬
https://www.edaegypt.gov.eg/ https://www.edaegypt.gov.eg /
" ."
The registration request must
‫طلب التسجيل يجب ان يحتوى على‬
include the following data (1):
: (1)‫المعلومات االتية‬
▪ Generic Name
▪ Generic Strength and ‫أسم المادة الفعالة‬ ▪
strength unit ‫تركيز المادة الفعالة و الوحدة‬ ▪
▪ Salt Equivalence (if found) )‫الملح ( ان وجد‬ ▪
▪ Dosage Form ‫الشكل الصيدلي‬ ▪
▪ Case Number ‫رقم الحالة‬ ▪
▪ Track Number in case of ‫رقم المسار المقدم عليها طلبات‬ ▪
registration requests ‫التسجيل المقدمة طبقا للحالة الثالثة‬
submitted according to Case
3
▪ Receipt Number ‫رقم االيصال‬ ▪
▪ Product type (Generic, Line ‫نوع المستحضر‬ ▪
extension, Imported Generic ‫نوع الرخصة‬ ▪
or Innovator) ‫نوع المادة الفعالة‬ ▪
▪ Type of license (Local, Toll,
F-Toll, Imported or Under
license)

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▪ Generic Type (single,

combination, combo- pack,
etc)
3- Link of the approved ‫√ رابط المرجع العلمي المعتمد و صوره‬
scientific Reference and copy )‫(ان وجد‬.‫منه‬
of the leaflet (if found)
4- Submit Receipt of 1000 L.E ‫√ ارفاق ايصال الدفع قيمته ألف جنيها‬ Submit
stamped from financial ‫مختوم من االدارة المالية و مركز‬ original
department; General ‫التخطيط و السياسات الدوائية و االدارة‬ receipt with
Administration of Drug ‫المركزية للمستحضرات الصيدلية‬ 1000 LE fees
Policy & Planning & ‫ومدون عليه كافة بيانات‬ to the unit's
Central Administration of ‫المستحضروالغرض من السداد (طلب‬ administrator
Pharmaceutical Products . (2))‫تسجيل‬ after writing
written on it all generic on it
details & purpose (Generic
(Registration Request) (2). details &
Registration
request) &
Stamp the
receipt to be
uploaded to
the
automation
system after
changing the
status to
info.
required
5- Submit Receipt of 10,000 ‫√ ارفاق ايصال الدفع قيمته عشرة آالف‬ Submit
L.E stamped from Financial ‫جنيه فقط ال غير مختوم من االدارة‬ original
department, General ‫المالية و مركز التخطيط و السياسات‬ receipt with
Administration of Drug ‫الدوائية و االدارة المركزية‬ 10,000 LE
Policy & Planning & ‫للمستحضرات الصيدلية ومدون عليه‬ fees to the
Central Administration of ‫كافة بيانات المستحضر والغرض من‬ unit's
Pharmaceutical Products ‫السداد (فى حالة طلبات التسجيل المقدمة‬ administrator
written on it: written on it ‫ بخالف العدد‬Line Extension ‫ك‬ after writing
all generic details & .)3( )‫المسموح به التقدم شهريا‬ on it
purpose (Registration (Generic
Request). details &
Registration
(in case of registration
request) &
requests submitted as line

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extension above the allowed Stamp the

number per month) (3) receipt to be
uploaded to
the
automation
system after
changing the
status to
info.
required
B- Registration requests submitted for Imported & Under License products

)‫( في حالة المستحضرات المستوردة او المصنعة محليا بترخيص من شركة أجنبية‬
7- Valid & legalized CPP for the ‫شهادة تداول مستحضر صيدلي‬ √ √ √
product (4). )‫ (سارية وموثقة‬CPP
OR .(4)
‫للمستحضر‬ √
Valid Electronic Certificate of ‫أو‬

Pharmaceutical Product
‫شهادة الكترونية لتداول مستحضر‬
(eCPP) (5).
)‫ (سارية‬eCPP ‫صيدلي‬
(5).
‫للمستحضر‬
8- Valid GMP for the ‫ سارية للمصنع (سيتم‬GMP ‫شهادة‬ √ √ √

manufacturing site (will be ‫طلبها بعد دراسة طلب التسجيل‬
requested later on after )‫ويجب استيفائها في المعاد المحدد‬
reviewing the request to be
fulfilled before the due date
specified)
9- Valid & legalized Agency ‫عقد وكالة أو خطاب تفويض من‬ √ √ √
agreement or Authorization ‫الشركة األجنبية الى الشركة‬
letter between License holder ‫المستوردة بالموافقة على تسجيل‬
and Applicant Company (in ‫المستحضر (في حالة‬
case of imported products or ‫المستحضرات المستوردة‬
bulk) (will be requested later ‫والمصنعة بالخارج أو معبأة بمصر‬
on after reviewing the request ‫) (ساري و موثق) (سيتم طلبها بعد‬
to be fulfilled before the due ‫دراسة طلب التسجيل ويجب‬
date specified) )‫استيفائها في المعاد المحدد‬

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10- Valid & legalized ( ‫عقد التصنيع مع الشركة األجنبية‬ √ √ √

manufacturing agreement (in ‫في حالة المستحضرات المصنعة‬
case of under license) )‫محليا بترخيص من شركة أجنبية‬
‫(ساري و موثق) (سيتم طلبها بعد‬
(Will be requested later on
‫دراسة طلب التسجيل ويجب‬
after reviewing the request to
)‫استيفائها في المعاد المحدد‬
be fulfilled before the due date
specified)
11- Legalized Innovator letter (in ‫خطاب من الشركة صاحبة‬ √ √ √

case of Innovator) (will be ‫المستحضر يفيد أن المستحضر‬
requested later on after ‫المقدم هو المستحضر األصيل‬
reviewing the request to be ‫(موثق) (سيتم طلبها بعد دراسة‬
fulfilled before the due date ‫طلب التسجيل ويجب استيفائها في‬
specified) (Template )‫المعاد المحدد‬
attached)
12- List of countries in which the ‫خطاب من الشركة مالكة المستحضر‬ √

product is marketed (in case of ‫يوضح قائمة بالدول المتداول بها‬
CPP is from non-reference ‫المستحضر (في حالة المستحضرات‬
country) (will be requested ‫الواردة من دول غير مرجعية) (سيتم‬
later on after reviewing the ‫طلبها بعد دراسة طلب التسجيل‬
request to be fulfilled before )‫ويجب استيفائها في المعاد المحدد‬
the due date specified)
13- Permission Letter for Scientific ‫خطاب تصريح للمكتب العلمي‬ √ √ √

Office (In Case of Finished ‫بالتسجيل في حالة المستحضرات‬
Product) ‫المستوردة تامة الصنع‬
C- Registration requests submitted as Line Extension

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14- Documents showing that the ‫مايفيد أن المستحضر الخاص بالشركة‬

company's product is still valid: :‫مازال ساريا في اجراءات التسجيل‬
In case of Under Registration ‫في حالة المستحضرات تحت‬
products: ‫التسجيل السارية في إجراءات‬
▪ Naming Approval or ‫التسجيل‬
Submission √
▪ Pricing Approval or ‫▪ موافقة اإلسم التجاري‬
Submission ‫للمستحضر أو مايفيد التقدم‬
▪ Pharmacovigilance ‫في المهلة المحددة‬
‫▪ موافقة التسعيرة للمستحضر‬ √
Approval or Submission
(if found) ‫أو مايفيد التقدم في المهلة‬ √
In case of Registered ‫المحددة‬
products: ‫▪ موافقة اليقظة للمستحضر أو‬
‫مايفيد التقدم في المهلة‬
▪ Valid Initial or Final
.)‫المحددة(ان وجد‬
Registration Approval. ‫في حالة المستحضرات المسجلة‬
▪ Any other documents…. √
‫إخطار تسجيل مبدئي أو‬ ▪ √
‫نهائي‬
....‫أي مستندات أخرى‬ ▪
‫يشترط أن يكون طلب التسجيل من نفس‬

‫مجموعة األشكال الصيدلية داخل نفس‬
‫صندوق المثائل من نفس المادة الفعالة‬
‫للمستحضرات المسجلة او‬
‫المستحضرات تحت التسجيل السارية‬
.‫في إجراءات التسجيل‬
D- Permission Letter Inquiry Submitted by Scientific Office (Through E-mail)

15- Submit Receipt of 20,000 L.E ‫√ ارفاق ايصال الدفع قيمته عشرون‬
stamped from Financial ‫الف جنيها فقط ال غير مختوم من‬
department, General ‫االدارة المالية و مركز التخطيط‬
Administration of Drug Policy ‫والسياسات الدوائية و االدارة المركزية‬
& Planning & Central ‫للمستحضرات الصيدلية مدون عليه‬
Administration of ‫الغرض من السداد (فى حالة طلب‬
Pharmaceutical Products )‫اصدار خطاب تصريح لمكتب علمي‬
written on it: purpose (In Case
of issuing permission letter for
registration of Imported
products to a scientific office).

10 | P a g e Pharmaceutical Products for Registration & Reregistration
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16- Covering letter signed and ‫خطاب من المكتب العلمي معتمد‬ √

stamped to the head of Central ‫ومختوم مقدم لرئيس االدارة‬
Administration of the ‫المركزية للمستحضرات الصيدلية‬
Pharmaceutical Products ‫موضحا به طلب المكتب العلمي في‬
showing that the scientific ‫الموافقة على إصدارخطاب تصريح‬
office asking for issuing ‫للمكتب العلمي بالتسجيل‬
permission letter for ‫للمستحضرات المستوردة تامة الصنع‬
registration of Imported
products
17- Latest License of the ‫أحدث رخصة للمكتب العلمي‬ √
Scientific Office.
18- Declaration letter signed and ‫√ تعهد من المكتب العلمي معتمد‬
stamped clarifying that the ‫ومختوم يوضح بان الرخصة المقدمة‬
submitted license is the latest ‫للمكتب العلمي هى أحدث رخصة‬
license of the scientific office.
19- Valid & legalized ‫√ خطاب تفويض أو عقد اتفاق من‬
Authorization letter or ‫صاحب رخصة المستحضر ببلد المنشأ‬
Agreement letter from the ‫بالخارج أو الشركة األم موضحا به نوع‬
License holder in Country of ‫النشاط و بيانات المستحضر الذي‬
Origin or Marketing ‫سيفوض المكتب العلمي نيابة عنها القيام‬
Authorization Holder in ‫بأعمال و أنشطة التسجيل لهذا‬
Country of Origin or Mother ‫ و القيام بدور مقدم طلب‬,‫المستحضر‬
Company to the scientific ‫التسجيل أو صاحب الرخصة التسويقية‬
office in Egypt clarifying .‫في مصر‬
generic details and giving the
authorization to the scientific
office in Egypt to represent
and act on behalf of the
License holder and apply for
the registration and all
subsequent regulatory
procedures.
E- Cancellation of Registration Request Approvals (Through Google link)

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1- Covering letter signed with ‫ خطاب من الشركة معتمد ومختوم‬-1

the authenticity of a bank ‫(بصحة توقيع بنكي) موضحا به‬
signature showing that the ‫طلب الشركة في إلغاء موافقة‬
company is asking for ‫طلب التسجيل التي لم تستلمها‬
cancellation of registration ‫الشركة وموضحا بالخطاب رقم‬
request approval and will ‫موافقة طلب التسجيل وتفاصيل‬
not be received by the .‫المستحضر‬
company.
Please clarify in the letter:
Application no. & Product
details.
:‫ملحوظة‬
‫ او‬Generic ‫)*( تحتفظ الشركة بالحق في التقدم بعدد طلبات التسجيل المتاح لها شهريا طبقا (الحالة) المقدم عليه طلب التسجيل ك‬
.‫ بمقابل الخدمة المقرر لكل طلب تسجيل و هو ألف جنيها فقط ال غير‬, Line extension ‫للتسجيل الغير اعتيادى او ك‬
:‫ بخالف العدد المسموح به التقدم شهريا‬Line Extension ‫(*) بخصوص طلبات التسجيل المقدمة ك‬
‫ بخالف العدد المسموح به التقدم‬line extension ‫ طلبات تسجيل للمستحضرات البشرية ك‬١٠ ‫▪ السماح للشركات بالتقدم بعدد‬
)‫شهريا على أن يكون مقابل الخدمة المقرر لكل طلب تسجيل إضافي هو (عشرة آالف جنيه فقط ال غير‬
.‫ الحالة االولى و الثانية و الثالثة‬: ‫يطبق القرار على جميع الحاالت الساري العمل بها‬ ▪
:‫(*) بخصوص طلبات التسجيل المقدمة للتسجيل الغير اعتيادى بخالف العدد المسموح به التقدم شهريا‬
‫السماح للشركات بالتقدم بطلبات تسجيل للمستحضرات البشرية بخالف العدد المسموح به التقدم شهريا على أن يكون مقابل‬
)‫الخدمة المقرر لكل طلب تسجيل إضافي هو (عشرة آالف جنيه فقط ال غير‬
Note:
(*) The company reserves its right to submit the number of registration requests permitted to it per
month according to the Case in EDA Chairman Decree 450/ 2023 on which the registration request is
submitted as Generic or as a line extension or as Non-Routine, with service fees for each registration
request 1000LE.
(*) Regarding registration request submitted as Line Extension, other than the number allowed per
month:
▪ Companies are allowed to submit 10 registration requests for human pharmaceutical products
as a line extension other than the allowed number per month, with service fee for each
additional registration request 10,000LE.
▪ The decision applies to all Cases 1,2 & 3.

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(*) Regarding registration request submitted as Non-Routine other than the allowed number per month:
▪ Companies are allowed to submit registration requests for human pharmaceutical products as a
non-routine other than the allowed number per month, with service fee for each additional
registration request 10,000LE.
(**) General Notes:
1- In the case of applying to register a new generic that is not in the drop-down list, it can be entered by
selecting a new generic and writing the active substance and it will be reviewed and added to the drop-
down list. (If this is not possible, you can contact the Systems and Information Unit for assistance in
entering it).
2- In case any of the information required to be entered in the drop-down list when applying for
registration requests on the automation system; you can contact the Systems and Information Unit to
assist in its entry.
EX: When submitting a new registration request with new dosage form not found in the drop-down list.
3- In case there is a scratch on the receipt or the receipt is not stamped or the company has not attached
a scanned copy of the original receipt for the submitted registration request, or the company has
attached a wrong receipt, the registration request will be rejected and the company can submit the
request again after fulfilling the conditions.
4- In the case of imported products submitted according to EDA Chairman Decree 450/ 2023 Case3, a
Certificate of Pharmaceutical Product CPP for the product must be brought from a reference country.
5- In the case of products imported or manufactured locally with a license from a foreign
company:
A. Companies are allowed to apply for registration with a valid Certificate of Pharmaceutical
Product CPP in the country of origin, directed to other countries, without the condition that it is
directed to the Egypt.
B. In Case that a valid CPP for the product is not available (whether directed to Egypt or any other
country), the company is allowed to submit a registration request accompanied by the
following:
▪ A recent legalized letter from the company that owns the product abroad (License Holder)
showing the same CPP data (According to WHO Format) stating that the product is registered
and marketed in the country of origin, with the letter sent from the official email of the
company abroad to the competent department
▪ A copy of the product's registration certificate in the country of origin and it is possible to check
the accuracy of the data on the official website of the health authority of the country of origin.

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▪ In both cases, the company, after knowing the status of the registration request (Open Box), is
obligated to bring a valid, legalized CPP directed to Egypt within the due date specified by
the EDA Chairman Decree 450/ 2023 Case on which the registration request is submitted,
which is given to the company to complete the required documents before issuing the
registration request approval, otherwise it will be cancelled.
6- In the case of products imported or manufactured locally with a license from a foreign
company
The company is allowed to submit an Electronic Certificate of Pharmaceutical Product (eCPP)

without the need of legalization only under the condition that the company submit a method to
make sure the data in the submitted eCPP is correct.

Version/Year:3/2023
Guideline
WHO Letter Template

Exporting Country: ………………
Requesting Country: Egypt
Dear Egyptian Drug Authority;
- On behalf of…"License holder or MAH name"………… I am certifying that the information of the
following product is correct and identical to the information which will be submitted on the CPP.
Trade name: ………………………………………………………………..…………....
Generic Name(s), strength(s) and dosage:
………………………………………………………………..…………....
- This product is registered & actually on the market in the Exporting country.
- Product License No. and issue date:
………………………………………………………………..…………....
- The Product License Holder / Marketing Authorization Holder is:
………………………………………………………………..…………....
- The name and address of the manufacturer producing the Dosage Form:
………………………………………………………………..…………....
- The name and address of primary & Secondary Packager:
………………………………………………………………..…………....
- The name and address of Batch Release Site:
………………………………………………………………..…………....
- The manufacturer of this type of dosage form has been inspected.
- The facilities and operations conform to GMP as recommended be the WHO.
- Signature, stamp and date.
Notes: The declaration should be on the Product License Holder / Marketing authorization Holder
head letter.

Version/Year:3/2023
Guideline
Innovator Letter Template

Exporting Country: ………………………………………….………
Requesting Country: Egypt
Dear Egyptian Drug Authority;
On Behalf of………………………………………………I am Certifying here the Following information
for the Innovator Product: ………………………………………………………………..…………...
Generic Name(s), strength(s) and dosage form of the product:
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………..
This product is registered & actually on the market in the Exporting country.
The Number of product License and date of issue is the following:
Product License Number:
…………………………………………………………………………………………………….…………
Date of Issue:
………………………………………………………………………………………………………………
- The Product License Holder / Marketing Authorization Holder is (Name & Address):
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
- The name and address of the manufacturer producing the Dosage Form (Name & Address):
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
- The name and address of primary & Secondary Packager (Name & Address):
…………………..…………………………………………………………………………………………
………………………………………………………………………………………………………………
- The name and address of Batch Release Site (Name & Address):
…………………..…………………………………………………………………………………………
………………………………………………………………………………………………………………
The manufacturer of this type of dosage form has been inspected.
The facilities and operations conform to GMP as recommended be the WHO.
Notes:
- The declaration should be on the paper of Product License Holder / Marketing authorization Holder.
- Clarify in the declaration if Product License Holder or Marketing authorization holder.
- The declaration should be legalized from the exporting country.

Version/Year:3/2023
Guideline
Checklist for Submission for registration request approval modification for Under-registration
Human pharmaceutical product
Requirements ‫األوراق المطلوبة‬ Original Copy Original
to review
Covering letter signed and stamped ‫خطاب من الشركة معتمد‬ √

showing that the company asking for ‫ومختوم موضحا به طلب‬
approving registration request approval ‫الشركة في الموافقة على‬
modification and showing the ‫تعديل موافقة طلب التسجيل‬
1- modification needed. .‫مع ذكر التعديل المطلوب‬
(With the company's undertaking that ‫(مع تعهد الشركة بأن‬
the file submitted includes all approvals ‫الملف المقدم يشمل كافة‬
issued for the product to date) ‫الموافقات الصادرة‬
)‫للمستحضر حتى تاريخه‬
2- Registration request Approval ‫موافقة طلب التسجيل‬ √

Documents showing that the product is ‫مايفيد أن المستحضر‬
still valid: ‫مازال ساريا في اجراءات‬
▪ Scientific Committees approval or :‫التسجيل‬
submission (for non-referenced ‫• موافقة اللجان العلمية‬ √
products) ‫المتخصصة او مايفيد‬
‫التقدم في المهلة‬
‫المحددة‬
▪ Naming Approval or Submission ‫(للمستحضرات الغير‬ √
)‫مرجعية‬
▪ Pricing Approval or Submission ‫• موافقة اإلسم التجاري‬
‫للمستحضر أو مايفيد‬ √
3-
▪ Pharmacovigilance Approval or ‫المحددة‬
Submission (if found) ‫• موافقة التسعيرة‬ √
‫للمستحضر أو مايفيد‬
▪ Any other documents…. ‫التقدم في المهلة‬ √
‫• موافقة اليقظة‬
....‫• أي مستندات أخرى‬
Approved scientific Reference for ‫المرجع العلمي‬ √
4- modification needed. (if found) ‫المعتمد للتعديل‬
‫المطلوب‬.)‫(ان وجد‬
5- Receipt of 1000 L.E stamped from ‫ايصال قيمته ألف جنيها‬ √
Financial department, General ‫مختوم من االدارة المالية‬
Administration of Drug Policy & ‫و مركز التخطيط و‬
Planning & Central Administration of ‫السياسات الدوائية و‬
‫االدارة المركزية‬

Version/Year:3/2023
Guideline
Requirements ‫األوراق المطلوبة‬ Original Copy Original

to review
Pharmaceutical Products written on it: ‫للمستحضرات الصيدلية‬

(product name & purpose) ‫ومدون عليه اسم‬
‫المستحضروالغرض من‬
.‫السداد‬
(In case of imported or under-license products)
)‫( في حالة المستحضرات المستوردة او المصنعة محليا بترخيص من شركة أجنبية‬
6- Valid & legalized new CPP with ‫ جديدة‬CPP ‫شهادة‬ √ √
modification needed )‫(سارية وموثقة‬
OR ‫للمستحضر مذكور بها‬ √
. ‫التعديل المطلوب‬
Valid Electronic Certificate of
‫أو‬
Pharmaceutical Product (eCPP) (*).
‫شهادة الكترونية لتداول‬
‫مستحضر صيدلي‬
)‫ (سارية‬eCPP
(*)
.‫للمستحضر‬
7- Valid GMP for the new manufacturing ‫ للمصنع‬GMP ‫شهادة‬ √
site (in case of changing manufacturer ‫الجديد في حالة تغيير‬
for imported products) ‫المصنع للمستحضرات‬
‫المستوردة‬
Note:
(*) In case of the required registration request approval modification is in dosage form:
• It will be accepted in case the modification is within the same row and same box (Attached Box
Distribution table).
• Otherwise, the company must submit a new registration request as a line extension.
(*) In case of the required registration request approval is imported:
● The company is allowed to submit with Electronic Certificate of Pharmaceutical Product

(eCPP) without the need of legalization only under the condition that the company submit
a method to make sure the data in the submitted eCPP is correct.
(*) Human Pharmaceutical Products Submitted for registration prior to the enforcement of the
provisions outlined in EDA Chairman Decree 450/2023 will remain subject to the regulations
governing the registration of previous human pharmaceutical products until the expiration of their
marketing authorization license.

Version/Year:3/2023
Guideline
‫جدول دمج األشكال الصيدلية في صندوق المثائل‬
Tablets
Dragees Pilules Spansules
(Sugar - Hard Gelatin
Solid unit (Tablet in Caplets Lactabs (Pills / (Sugar coated
Film capsules
dosage form French) Capsule) Pills /Capsule)
Coated)
(traditional
1 Box I
(Conventional Lozenges
) immediate
release) Gums
Soft Gelatin capsules
Flash Tablets Oro-

Melt tablets
Quick Tablets (DISOLVE IN Oro-disintegrating Dispersible
MOUTH only) Tablets
Solid Unit Chewable Tablets

Dosage Form
2 Box II (Fast sublingual Tablets
Immediate
Buccal Mucoadhesive Tablets (Buccal Mucoadhesive Tablets (prolonged only in mouth
Release)
for local effect or systemic effect)
effervescent Tablets Disintegrating Tablets Dispersible Tablets
Powder in Bottle
Powder /
Effervescent Granules/Powders (each dose will be reconstituted at
Sachets
time of use
Enteric
SR, CR, MR, XR Capsules / Tablet Depotabs Retard Capsules / Coated
Solid unit tablets
Tablet
Dosage Form
3 Box III
(Modified Modified Release
release) Powder/Granules in Bottle (each
Modified Release Powder/Granules in Sachets
dose will be reconstituted at
time of use

Version/Year:3/2023
Guideline
Oral Sy Powders Powders/ Oral

Oral Drinking Oral
Preparation Solutions ru
drops
Elixirs
ampoules
/oral (Emulsion / Emulsion Suspension Ge
Jellys
(Liquid- ps (Solution) Susp.) ls
semisolid-
4 Box IV
Powder/
Granules for Modified Release Oral Preparations
Reconstitution
)
Oral Paste
Buccal Oromucosal Gels

5 Box V
Preparation Oromucosal Sprays
Gargles Mouth washes
Solutions Suspensions Emulsions

Sterile
6 Box VI Preparation Irrigation Solutions (LVP)
(injections)
Modified release Injections oily injections
Box
7 Implants
VII
Sterile Prefilled Syringes

Preparation
Box Pen Filled Preparations
8 (sterile
VIII
Prefilled
Injections) Cartridges
9 Box IX Topical Cream

Version/Year:3/2023
Guideline
Topical gels/Emulgel
Topical ointments
Topical solutions Topical lotions (if solution)
Topical Emulsions Topical lotions (if Emulsion)
Topical Pastes Poultices (Cataplasm)

Traditional
topical Topical Nail Preparation
Preparation
Topical Paints
Topical Shampoos
Topical Plaster
Topical Liniments
Roll on (Pack)
Non- Topical Sprays (Pressurized)

Traditional
10 Box X Topical Foams
Topical
Preparations Bag on valve (BOV)
Transdermal Patches (Transdermal Plaster)

Transdermal
11 Box XI Medicated dressings
Systems
Transdermal Semisolids
Vaginal Creams
Vaginal & Vaginal ointments

Box
12 IUD
XII Vaginal Foams
Preparations
Vaginal Ovules/Pessaries Vaginal Capsules Vaginal Tablet

Version/Year:3/2023
Guideline
Medicated IUD
Vaginal Rings (Diaphragm)
Vaginal Sponges
Vaginal Douches
Rectal suppositories Rectal Tablets Rectal Capsules

Rectal Creams
Box Rectal Rectal ointments
13
XIII Preparations Enemas
Rectal Foam
Viscous Viscous Liquids

Solutions Drops Suspensions
Liquids (Soln) (Susp)
Gels
Ointments
Box Eye/ear
14
XIV Preparations Ocular Injections
Ocuserts
Creams (Not Found)
Sprays (Not Found)
Nasal Drops Nasal Solutions
Nasal Sprays
Box Nasal Nasal Viscous Liquids Nasal Gels

15
XV Preparations Nasal Ointments
Nasal Creams (Not Found)
Nasal Powder

Version/Year:3/2023
Guideline
Rota Tabs
Capsules
Box
16 Inhaler Solutions
XVI
Powders
aerosols
Box
17 Nebules Respules
XVII
Box Oral Soluble

18 Thin Film Wafer Sublingual Wafer
XVIII Films
Checklist for submission for replacement of lost registration request approval for under-
registration Human pharmaceutical product
Original
Requirements ‫األوراق المطلوبة‬ Original Copy
to review
2- Covering letter signed and stamped ‫خطاب من الشركة معتمد‬ √

showing that the company is asking for ‫ومختوم موضحا به طلب‬
issuing replacement of lost registration ‫الشركة في الموافقة على‬
request approval & clarifying ‫إصدار بدل فاقد لموافقة طلب‬
application number, product details. ‫التسجيل وموضحا بالخطاب‬
(With the company's undertaking that ‫رقم الموافقة وتفاصيل‬
the file submitted includes all approvals .‫المستحضر‬
issued for the product to date). ‫(مع تعهد الشركة بأن الملف‬
‫المقدم يشمل كافة الموافقات‬
‫الصادرة للمستحضر حتى‬
.)‫تاريخه‬
3- Registration request approval copy (if ‫صورة موافقة طلب التسحيل‬ √
found) )‫)ان وجدت‬

Version/Year:3/2023
Guideline
Original
Requirements ‫األوراق المطلوبة‬ Original Copy
to review
4- Documents showing that the product is ‫مايفيد أن المستحضر مازال‬

still valid: :‫ساريا في اجراءات التسجيل‬
▪ Scientific Committees approval ‫موافقة اللجان العلمية‬ ▪
or submission (for non- ‫المتخصصة او مايفيد التقدم‬
referenced products) ‫في المهلة المحددة‬
▪ Naming Approval or ‫)للمستحضرات الغير‬ √
Submission )‫مرجعية‬
▪ Pricing Approval or Submission ‫▪ موافقة األسم التجاري‬
▪ Pharmacovigilance Approval or ‫للمستحضر أو مايفيد‬ √
Submission (if found) ‫التقدم في المهلة المحددة‬
▪ Or any other documents… ‫▪ موافقة التسعيرة‬
‫التقدم في المهلة المحددة‬ √
‫▪ موافقة اليقظة‬ √
‫التقدم في المهلة المحددة‬
.)‫(ان وجد‬
‫▪ أو أي مستندات‬
....‫أخرى‬
5- Police Report with product details. )‫مذكرة الفقد (محضر‬ √ √
‫مذكور به بيانات موافقة‬
.‫طلب االستعالم كاملة‬
6- Receipt of 500 L.E stamped from ‫ايصال قيمته خمسمائة‬ √
financial department, General ‫جنيها مختوم من االدارة‬
Administration of Drug Policy & ‫المالية و مركز التخطيط و‬
Planning & Central Administration of ‫السياسات الدوائية و‬
Pharmaceutical Products written on it: ‫االدارة المركزية‬
(product name & purpose) ‫للمستحضرات الصيدلية‬
‫ومدون عليه اسم‬
.‫السداد‬
Note:

Version/Year:3/2023
Guideline
Checklist for submission for Changing Applicant for Under-registration Imported

Human pharmaceutical product
Items ‫األوراق المطلوبة‬ Original Copy Origina
l to
review
1-Covering
1 letter (new applicant) signed ‫خطاب من الشركة (مقدم‬ √
1
and stamped showing that the company )‫طلب التسجيل الجديد‬
1- asking for approving changing the ‫معتمد ومختوم موضحا به‬
applicant with product name, generic ‫طلب الشركة في الموافقة‬
details, Concentration, license holder, ‫على تغيير مقدم طلب‬
manufacturer and company profile code ‫ اسم‬: ‫التسجيل مذكوربه‬
,‫ وتركيزه‬،‫المستحضر‬
(With the company's undertaking that
‫ واسم مكان‬،‫واسم المالك‬
the file submitted includes all approvals
Company ‫التصنيع وال‬
issued for the product to date)
‫ الخاص‬profile code
‫بالشركة‬
‫(مع تعهد الشركة بأن الملف‬
‫المقدم يشمل كافة الموافقات‬
‫الصادرة للمستحضر حتى‬
)‫تاريخه‬
2- Registration request Approval .‫موافقة طلب التسجيل‬ √
3- Documents showing that the product is ‫مايفيد أن المستحضر مازال‬

still valid: ‫ساريا في اجراءات‬
:‫التسجيل‬ √
▪ Scientific Committees approval or
submission (if found) ‫▪ موافقة اللجان العلمية‬
▪ Naming Approval or Submission ‫المتخصصة او مايفيد‬
▪ Pricing Approval or Submission ‫التقدم في المهلة المحددة‬ √
▪ Pharmacovigilance Approval or ‫▪ موافقة األسم التجاري‬
Submission (if found) ‫للمستحضر أو مايفيد‬
▪ Or any other documents… ‫التقدم في المهلة المحددة‬
‫▪ موافقة التسعيرة‬ √
‫للمستحضر أو مايفيد‬ √
‫التقدم في المهلة المحددة‬
‫▪ موافقة اليقظة‬
‫التقدم في المهلة‬ √
.‫المحددة‬
‫▪ أو أي مستندات‬
....‫أخرى‬

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Guideline

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4- CPP showing that the product is ‫شهادة مستحضر صيدلي‬ √ √
registered and actually in the market of ‫) موضح بها أن‬CPP(
the exporting country. (Valid and ‫المستحضر مسجل ومتداول‬
signed from ministry of health and . ‫في البلد الوارد منها‬
legalized from the chamber of ‫(سارية ومختومة من‬
commerce and Egyptian embassy) ‫وزارة الصحة وموثقة من‬
‫الغرفة التحارية والسفارة‬
‫المصرية بالخارج من البلد‬
) ‫المسنخرج منها‬
5- Authorization letter for the new ‫خطاب تفويض من الشركة‬ √ √
applicant. (Valid and legalized from the ‫صاحبة المستحضرلمقدم‬
chamber of commerce and Egyptian .‫طلب التسجيل الجديد‬
embassy) ‫(ساري وموثق من الغرفة‬
‫التجارية والسفارة المصرية‬
(A translated letter from an ‫بالخارج من البلد المسنخرج‬
accredited translation center must be ) ‫منها‬
submitted)
‫(مع إحضار ترجمة‬
‫للخطاب من مركز ترجمة‬
)‫معتمد‬
6- Termination letter for the old applicant ‫خطاب انهاء التفويض بين‬ √ √
(legalized from the chamber of ‫الشركة صاحبة المستحضر‬
commerce and Egyptian embassy) ‫ومقدم طلب التسجيل القديم‬ √ √
‫( موثق من الغرفة التجارية‬
(A translated letter from an ‫والسفارة المصرية بالخارج‬
accredited translation center must be )‫من البلد المسنخرج منها‬
submitted) ‫(مع إحضار ترجمة للخطاب‬
)‫من مركز ترجمة معتمد‬
‫أو‬
‫التنازل عن حقوق مقدم‬
‫طلب التسجيل الى مقدم‬
( ‫طلب التسجيل الجديد‬
‫موثق من الغرفة التجارية‬
‫والسفارة المصرية بالخارج‬
)‫من البلد المسنخرج منها‬

Version/Year:3/2023
Guideline

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7- Submit Receipt of 1000 L.E stamped ‫ايصال قيمته ألف جنيها‬ √
from financial department, General ‫مختوم من االدارة المالية و‬
Administration of Drug Policy & ‫مركز التخطيط و السياسات‬
Planning & Central Administration of ‫الدوائية و االدارة المركزية‬
Pharmaceutical Products written on it ‫للمستحضرات الصيدلية‬
all generic details & purpose ‫ومدون عليه كافة بيانات‬
‫السداد‬
8- Submit Receipt of 1000 L.E and ‫ارفاق ايصال الدفع قيمته‬ √
10000LE stamped from financial ‫ألف جنيها و عشرة االف‬
department, General Administration of ‫جنيها مختوم من االدارة‬
Drug Policy & Planning & Central ‫المالية و مركز التخطيط و‬
Administration of Pharmaceutical ‫السياسات الدوائية و االدارة‬
Products written on it all generic details ‫المركزية للمستحضرات‬
& purpose (In case changing applicant ‫الصيدلية ومدون عليه كافة‬
from Scientific Office to Scientific
‫بيانات المستحضروالغرض‬
Office)
‫من السداد (في حالة تغيير‬
‫مقدم طلب التسجيل‬
‫لمستحضر طبي مستورد‬
‫من مكتب علمي الى مكتب‬
)‫علمي اخر‬
5000LE stamped from financial ‫ألف جنيها و خمسة االف‬
department, General Administration of ‫جنيها مختوم من االدارة‬
Drug Policy & Planning & Central ‫المالية و مركز التخطيط و‬
Administration of Pharmaceutical ‫السياسات الدوائية و االدارة‬
Products written on it all generic details ‫المركزية للمستحضرات‬
& purpose (In case changing applicant ‫الصيدلية ومدون عليه كافة‬
from Scientific Office to Company)
‫بيانات المستحضروالغرض‬
‫من السداد (في حالة تغيير‬
‫مقدم طلب التسجيل‬
‫لمستحضر طبي مستورد‬
)‫من مكتب علمي الى شركة‬

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Guideline

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15000LE stamped from Financial ‫ألف جنيها و خمسة عشر‬
department, General Administration of ‫االف جنيها مختوم من‬
Drug Policy & Planning & Central ‫االدارة المالية و مركز‬
Administration of Pharmaceutical ‫التخطيط و السياسات‬
Products written on it all generic details ‫الدوائية و االدارة المركزية‬
& purpose (In case changing applicant ‫للمستحضرات الصيدلية‬
from Company to Scientific Office)
‫ومدون عليه كافة بيانات‬
‫السداد (في حالة تغيير مقدم‬
‫طلب التسجيل لمستحضر‬
‫طبي مستورد من شركة الى‬
)‫مكتب علمي‬
11- A copy of the importer's register of the ‫صورة من قيد سجل‬ √
new applicant. ‫المستوردين لمقدم طلب‬
.‫التسجيل الجديد‬
Note:

Version/Year:3/2023
Guideline
Checklist for Submission for Changing License Holder for Under-Registration

Imported Human pharmaceutical product
Items ‫األوراق المطلوبة‬ Original Copy Original

to
review
1- Covering letter signed and ‫ خطاب من الشركة معتمد‬-1 √
stamped showing that the ‫ومختوم موضحا به طلب الشركة‬
company asking for approving ‫في الموافقة على تغيير الشركة‬
changing license holder with : ‫المالكة للمستحضر مذكور به‬
product name, generic details, ‫ واسم‬,‫ وتركيزه‬،‫اسم المستحضر‬
Concentration, old license ‫ واسم‬، ‫الشركة المالكة القديمة‬
holder, new license holder, ‫واسم‬، ‫الشركة المالكة الجديدة‬
manufacturer and Company ‫مكان التصنيع وال‬
Company profile code. ‫ الخاص بالشركة‬profile code
(With the company’s ‫(مع تعهد الشركة بأن الملف‬
undertaking that the file ‫المقدم يشمل كافة الموافقات‬
submitted includes all ‫الصادرة للمستحضر حتى‬
Approvals issued for the product )‫تاريخه‬
to date).
2- Latest Permission letter in case ‫ أحدث خطاب تصريح في حالة‬-2 √ √
the applicant is a scientific .‫أن مقدم الطلب مكتب علمي‬
office.
3- Registration request Approval ‫ موافقة طلب التسجيل‬-3 √
4- Documents showing that the ‫ مايفيد أن المستحضر مازال ساريا‬-4
product is still valid: :‫في اجراءات التسجيل‬
▪ Scientific Committees ‫▪ موافقة اللجان العلمية‬ √
approval or submission (for ‫المتخصصة او مايفيد التقدم‬
non-referenced products) ‫في المهلة المحددة‬
‫(للمستحضرات الغير‬
)‫مرجعية‬
▪ Naming Approval or ‫▪ موافقة اإلسم التجاري‬ √
Submission ‫للمستحضر أو مايفيد التقدم‬
‫في المهلة المحددة‬
▪ Pricing Approval or ‫▪ موافقة التسعيرة للمستحضر‬ √
Submission ‫أو مايفيد التقدم في المهلة‬
▪ Pharmacovigilance Approval ‫▪ موافقة اليقظة للمستحضر‬ √
or Submission (if found) ‫أو مايفيد التقدم في المهلة‬
▪ Any other documents…. ....‫▪ أي مستندات أخرى‬ √
5- Valid new CPP with )CPP( ‫ شهادة مستحضر صيدلي‬-5 √ √
modification needed showing ‫جديدة موضح بها التعديل‬
that the product is registered and ‫المطلوب و أن المستحضر مسجل‬
actually in the market of the . ‫ومتداول في البلد الوارد منها‬
exporting country. (Valid and ‫(سارية ومختومة من وزارة‬
signed from ministry of health ‫الصحة وموثقة من الغرفة‬

Version/Year:3/2023
Guideline
Items ‫األوراق المطلوبة‬ Original Copy Original

to
review
and legalized from the chamber ‫التحارية والسفارة المصرية‬
of commerce and Egyptian ‫بالخارج من البلد المسنخرج منها‬
embassy) )
Or ‫أو‬
Valid Electronic Certificate of ‫شهادة الكترونية لتداول مستحضر‬
Pharmaceutical Product (eCPP) )‫ (سارية‬eCPP ‫صيدلي‬
(*)
.
(*)
.‫للمستحضر‬
6- Authorization letter from the ‫ خطاب تفويض من الشركة‬-6 √ √
new license holder stating that ‫صاحبة المستحضرالجديدة‬
it’s the new owner and clarifying ‫يوضح أنه صاحب المستحضر‬
the product trade name and ‫الجديد مع توضيح االسم التجاري‬
concentration. .‫للمنتج والتركيز‬
(Valid and legalized from the ‫(ساري وموثق من الغرفة‬
chamber of commerce and ‫التجارية والسفارة المصرية‬
Egyptian embassy) ‫بالخارج من البلد المسنخرج منها‬
)
7- Declaration letter from the new ‫ تعهد من الشركة المالكة الجديدة‬-7 √ √
License holder clarifying that ‫أنه ال يوجد تغيير في تركيبة و‬
there is no change in product ‫ طريقة‬،‫مواصفات المستحضر‬
composition, specification, ‫ و طريقة التعبئة و‬،‫التصنيع‬
manufacturing process and .‫العبوة‬
container/closure system. ‫(ساري وموثق من الغرفة‬
(Valid and legalized from the ‫التجارية والسفارة المصرية‬
chamber of commerce and ‫بالخارج من البلد المسنخرج منها‬
Egyptian embassy) )
8- Receipt of 5000 L.E stamped ‫ ايصال قيمته خمسة االف جنيها‬-8 √
from stamped from Financial ‫مختوم من االدارة المالية و مركز‬
department, General ‫التخطيط و السياسات الدوائية و‬
Administration of Drug Policy & ‫االدارة المركزية للمستحضرات‬
Planning & Central ‫الصيدلية ومدون عليه اسم‬
Administration of ‫المستحضروالغرض من السداد‬
Pharmaceutical Products written ‫في حالة تغيير الشركة المالكة‬
on it: (product name & purpose) .‫للمستحضر‬
in case of changing License
Holder.

Version/Year:3/2023
Guideline
Note:
(*) The company is allowed to submit with Electronic Certificate of Pharmaceutical Product (eCPP)
without the need of legalization only under the condition that the company submit a method to make
sure the data in the submitted eCPP is correct.

Version/Year:3/2023
Guideline
Checklist for submission for Registration Request for Human Pharmaceuticals with
Type of Marketing Tender & Export or Export Only
Soft Hard Original
Items ‫األوراق‬
Copy copy to review
‫المطلوبة‬
1. Registration request form ‫ نموذج طلب التسجيل) كما هو‬.1 √
stamped by company stamp ( ‫مرفق في اللينك الخاص بالتقديم‬
(according to the form ‫ويراعى أن يكون على ورق‬
attached ‫الشركة ومختوما بختم الشركة‬
in the submission link)
2. Submit Receipt of 1000 L.E ‫ ارفاق ايصال الدفع قيمته ألف‬.2 √ ‫تسليم أصل‬
stamped from financial ‫جنيها مختوم من االدارة المالية و‬ ‫ايصال الدفع‬
department written on it: ‫مركز التخطيط و السياسات‬ ‫الخاص‬
‫الدوائية و االدارة المركزية‬ ‫بالمقابل‬
(product generic name, ‫للمستحضرات الصيدلية ومدون‬
concentration & dosage form ‫المادي لخدمة‬
‫عليه كافة بيانات‬
with type of marketing tender ‫المستحضروالغرض من السداد‬ ‫طلب التسجيل‬
& export or export only) ‫(طلب تسجيل) ) ونوع التداول‬ ‫بقيمة ال‬
‫تصديرومناقصات أم تصدير فقط‬ ‫ جنيه‬1000
‫لالداري‬
‫الخاص‬
‫بالوحدة وتسلم‬
‫صورة موقعة‬
‫منه تفيد تسليم‬
‫االصل‬
3. Receipt of 15000 L.E stamped ‫ ايصال قيمته خمسة عشر ألف‬.3 √
from financial department written ‫جنيه مختوم من االدارة المالية و‬
on it: (product generic name, ‫مركز التخطيط و السياسات الدوائية‬
‫و االدارة المركزية للمستحضرات‬
concentration & dosage form with ‫الصيدلية ومدون عليه كافة بيانات‬
type of marketing tender & export ‫المستحضروالغرض من السداد‬
or export only) ‫(طلب تسجيل) ونوع التداول‬
‫تصديرومناقصات أم تصدير فقط‬
4. Link of the approved scientific ‫ رابط المرجع العلمي المعتمد و‬.4 √
Reference and copy of the leaflet (if )‫(ان وجد‬.‫صوره منه‬
found)
Note:

Version/Year:3/2023
Guideline
SECTION TWO
Requirements for Submission of Trade Name

Requests

Version/Year:3/2023
Guideline
SECTION TWO: Requirements for submission of Trade Name Requests

This section will provide information about Requirements for Submissions of Trade
Name Request for Under-registration Human pharmaceutical product
No. Documents Notes

Trade name approval for local marketing products
A- Trade name approval for export or Export & Tender
1 Registration request Scan of original
2 Trade name application form (Attached)
3 Reference leaflet In case of Reference Products.
4 Trade name approval letter or In case of already approved trade name for the same
registration license. generic
5 Monograph of the product according to In case of Compendial Products

latest edition of pharmacopeia
6 Scientific committee approval In case of Non-Reference Products
7 Valid legalized CPP In case of imported products or under- license products.
B- Name Change
1 Cover letter On company letter head signed, stamped and dated.
2 Trade name approval letter For Under Reg Products
3 Registration License In case of Registered Products
4 Trade name application form (Attached)

5 Fees payment receipt. According to the published submission link
C- Name Change for Export
1 Registration License
2 Cover letter On company letterhead signed, stamped and dated,

Specifies the requested trade name for export and names
of the countries where the product will be exported.

Version/Year:3/2023
Guideline
3 Fees payment receipt According to the published submission link
D- Naming Letter Correction
1 Registration request
2 Trade name approval letter Specifies data to be corrected
3 Cover letter On company letterhead signed, stamped and dated,

specifies data to be corrected
4 Fees payment receipt According to the published submission link
E- Replacement Certificate
1 Registration request Scan of original
2 Trade name approval letter If available
3 Police report
4 Fees payment receipt. According to the published submission link

Version/Year:3/2023
Guideline
Trade Name Application Form

Application No: …………… box ID: ………
Innovator Name:………………
Generic Name & Strength: …………………………..
Dosage Form:……………….
Company Name:……………………………………
No To be filled by Company Similarity To be Filled by EDA

English Name Arabic Name Score (%) Reason for Refusal
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
The final Name after Revision:…………………………

N.B. Names are reviewed according to the sequencing.
Declaration: The Company acknowledges that the chosen name from the names provided above
is the final name and not subject to amendment.
Stamp Applicant Signature

Version/Year:3/2023
Guideline
SECTION THREE
Requirements for Submission of Pharmacovigilance

Version/Year:3/2023
Guideline
SECTION THREE: Requirements of Submissions of Pharmacovigilance File

‫الملفات المطلوبة المقدمة على نوافذ االستقبال االلكترونى لإلدارة العامة لليقظة الصيدلية‬
:‫برجاء التأكد من إستيفاء االتي مع كل عملية تسليم على نوافذ االستقبال االلكترونى لإلدارة العامة لليقظة الصيدلية‬
❖ Cover letter
✓ Date (maximum two days before date of submission)
✓ Signed QPPV (actual original signature not print screen)

✓ Signed CEO (only in the contexts mentioned below)
✓ Stamped (‫(مختوم بختم الشركة‬
✓ In context of ……
NB: The context of submission mentioned in the cover letter should be matched with the submitted
documents attached on the link.
✓ Company paper
✓ PDF
✓ Type of document/Name of the product
❖ Delegation letter (‫)صورة من التفويض‬
❖ In case of amendments:
MAH is required to attach EPVC amendment letter along with the submitted documents.
.‫ يتعين على الشركة إرفاق الخطاب الصادر من إدارة اليقظة الصيدلية مع المستندات المقدمة‬، ‫يرجى مالحظة أنه في حالة تقديم اإلستكماالت‬

Version/Year:3/2023
‫‪Guideline‬‬
‫‪Central Administration of Pharmaceutical Products‬‬
‫‪Central Administration of Pharmaceutical Care‬‬
‫المستندات المطلوبة الخاصة بكل إطار‬

‫‪Reg/Re-Reg Reception‬‬
‫متطلبات إدارة اليقظة‬ ‫اإلطار‬
‫‪ ‬موافقة صندوق المثائل )‪)Box approval‬‬ ‫تسجيل المستحضرات المحلية‬ ‫‪1‬‬
‫‪ ‬موافقة اللجان المختصة بالنسبة للمستحضرات غير المرجعية )‪(Non-Reference‬‬ ‫(الخاصة بالشركات المحلية)‬
‫‪ ‬إيصااااااال بالقيمة المالية المدرجة بقرار الساااااايد األسااااااتاذ الدكتور رئيس هيئة الدواء‬ ‫)‪(New Registration‬‬
‫المصاارية رقم (‪ )6‬لسنننة ‪ 2021‬و رقم (‪ )99‬لسنننة ‪ 2022‬مع مراعاة ما اسننتحد‬
‫على مقابل الخدمات‪.‬‬
‫‪(Receipts stamped by Pharmacovigilance department‬‬
‫‪(including‬‬ ‫‪the‬‬ ‫‪handwritten‬‬ ‫‪details‬‬ ‫‪of‬‬ ‫‪the‬‬
‫)‪product/submission as mentioned below‬‬
‫‪ ‬خطة إدارة المخاطر‪.‬‬
‫)‪Risk Management Plan (RMP‬‬
‫‪ ‬أحدث خطاب صادر من إدارة اليقظة بخصوص مستندات وصف نظام اليقظة الدوائية‬
‫للشركة أو البريد االلكترونى الصادر من نافذة االستقبال االلكترونى الخاص بأنظمة‬
‫اليقظة باستالم أحدث مستندات وصف نظام اليقظة الدوائية (أيهما أحدث)‪.‬‬
‫‪ ‬في حالة وجود كيانات‪/‬أطراف مختلفة‬
‫ارفاق صورة من اإليميل الصادر من وحدة أنظمة اليقظة بالموافقة على استالم عقود‬
‫اليقظة (الموقعة‪-‬المختومة‪-‬الموثقة) من كل األطراف المعنية وتشمل احد قائمة‬
‫المستحضرات المعنية‪.‬‬
‫‪ ‬موافقة صندوق المثائل )‪)Box approval‬‬ ‫تسجيل المستحضرات المستوردة ‪/‬‬ ‫‪2‬‬
‫‪ ‬موافقة اللجان المختصة بالنسبة للمستحضرات غير المرجعية (‪)Non reference‬‬ ‫المستحضرات المصنعة محليا‬
‫‪ ‬إيصااااااال بالقيمة المالية المدرجة بقرار الساااااايد األسااااااتاذ الدكتور رئيس هيئة الدواء‬ ‫بترخيص من شركة أجنبية ‪/‬‬
‫المصاارية رقم (‪ )6‬لسنننة ‪ 2021‬و رقم (‪ )99‬لسنننة ‪ 2022‬مع مراعاة ما اسننتحد‬ ‫المستحضرات المحلية الخاصة‬
‫على مقابل الخدمات‪.‬‬ ‫بالشركات الدولية‬
‫‪(Receipts stamped by Pharmacovigilance department‬‬ ‫)‪(New Registration‬‬
‫‪ ‬خطة إدارة المخاطر العالمية ‪/‬الدولية‬

‫)‪EU/Global Risk Management Plan (RMP‬‬
‫أو شهادة من الشركة موقعة و مسببة بعدم وجود هذا المستند‬
‫‪(Globally signed declaration letter for not submitting EU /Global‬‬
‫)‪RMP‬‬
‫‪ ‬الملحق المصري الخاص بخطة إدارة المخاطر‪.‬‬
‫‪Egyptian Display of Risk Management Plan.‬‬
‫‪ ‬التقرير الدوري لتقييم المنافع و المخاطر أو شهادة من ال شركة موقعة و م سببة بعدم‬
‫وجود هذا المستند‪.‬‬
‫‪GUIDELINE ON Dossier Requirements of Human‬‬

‫‪39 | P a g e‬‬ ‫‪Pharmaceutical Products for Registration & Reregistration‬‬
‫‪Code: EDREX: GL.CAP.Care/CAPP.002‬‬
‫‪Version/Year:3/2023‬‬
‫‪Global Periodic Benefit Risk Evaluation Report (PBRER) (OR‬‬

‫)‪Globally signed justification letter for not submitting PBRER‬‬
‫للشركة (في الخارج ومكتب الشركة في مصر‪ /‬الوكيل المحلي) أو البريد االلكترونى‬
‫الصادر من نافذة االستقبال االلكترونى الخاص بأنظمة اليقظة باستالم أحدث مستندات‬
‫وصف نظام اليقظة الدوائية (أيهما أحدث)‪.‬‬
‫‪ ‬في حالة وجود كيانات‪/‬أطراف مختلفة‪ :‬ارفاق صورة من اإليميل الصادر من وحدة‬
‫أنظمة اليقظة بالموافقة على استالم عقود اليقظة (الموقعة‪-‬المختومة‪-‬الموثقة) من‬
‫كل األطراف المعنية وتشمل احد قائمة المستحضرات المعنية‪.‬‬
‫تسجيل المستحضرات المحلية ‪ ‬إخطار التسجيل النهائى‬ ‫‪3‬‬
‫‪Final Registration License‬‬ ‫(الخاصة بالشركات المحلية) طبقا ً‬
‫لتأشيرة رئيس هيئة الدواء ‪ ‬إيصااااااال بالقيمة المالية المدرجة بقرار الساااااايد األسااااااتاذ الدكتور رئيس هيئة الدواء‬
‫المصاارية رقم (‪ )6‬لسنننة ‪ 2021‬و رقم (‪ )99‬لسنننة ‪ 2022‬مع مراعاة ما اسننتحد‬ ‫المصرية بتاريخ ‪2/3/2021‬‬
‫‪ ‬خطة إدارة المخاطر‪.‬‬

‫في حالة وجود كيانات‪/‬أطراف مختلفة‪ :‬ارفاق صورة من اإليميل الصادر من وحدة‬ ‫‪‬‬
‫إخطار التسجيل النهائى‬ ‫تسجيل المستحضرات المستوردة ‪ /‬‬ ‫‪4‬‬
‫‪Final Registration License‬‬ ‫المستحضرات المصنعة محليا ً‬
‫إيصااااااال بالقيمة المالية المدرجة بقرار الساااااايد األسااااااتاذ الدكتور رئيس هيئة الدواء‬ ‫بترخيص من شركة أجنبية ‪ /‬‬
‫المصاارية رقم (‪ )6‬لسنننة ‪ 2021‬و رقم (‪ )99‬لسنننة ‪ 2022‬مع مراعاة ما اسننتحد‬ ‫المستحضرات المحلية الخاصة‬
‫على مقابل الخدمات‪.‬‬ ‫بالشركات الدولية‬
‫‪(Receipts stamped by Pharmacovigilance department‬‬ ‫طبقا ً لتأشيرة رئيس هيئة الدواء‬
‫‪(including‬‬ ‫‪the‬‬ ‫‪handwritten‬‬ ‫‪details‬‬ ‫‪of‬‬ ‫‪the‬‬ ‫المصرية بتاريخ ‪2/3/2021‬‬
‫خطة إدارة المخاطر العالمية ‪/‬الدولية‬ ‫‪‬‬
‫)‪RMP‬‬
‫الملحق المصري الخاص بخطة إدارة المخاطر‪.‬‬ ‫‪‬‬
‫التقرير الدوري لتقييم المنافع و المخاطر أو شهادة من ال شركة موقعة و م سببة بعدم‬ ‫‪‬‬


‫)‪Globally signed justification letter for not submitting PBRER‬‬
‫موافقة السااير)‪ + (Action letter‬موافقة اللجان المختصااة بالنساابة للمسااتحضاارات‬ ‫إعادة تسجيل المستحضرات ‪‬‬ ‫‪5‬‬
‫غير مرجعية (‪)Non reference‬‬ ‫المحلية (الخاصة بالشركات‬
‫إخطار التسجيل السابق‬ ‫‪‬‬ ‫المحلية)‬
‫‪Previous Registration License‬‬
‫إيصااااااال بالقيمة المالية المدرجة بقرار الساااااايد األسااااااتاذ الدكتور رئيس هيئة الدواء‬ ‫‪‬‬
‫‪ ‬خطة إدارة المخاطر‬

‫‪ ‬ملحق المعلومات اإلكلينيكية‬
‫)‪Addendum to Clinical Overview (ACO‬‬
‫(تبااادأ الفترة التي يغطيهاااا المسااااااتناااد من تااااري اإلخطاااار المبااادئي ‪(Initial‬‬
‫)‪ marketing authorization‬أو من تااااري آخر إخطاااار إعاااادة تسااااااجيااال‬
‫للمسااااااتحضاااااار (‪ )Last Renewal‬وتنتهي الفترة التي يغطيها حتى ‪ 90‬يوم قبل‬
‫التقديم)‬
‫موافقة السااير)‪ + (Action letter‬موافقة اللجان المختصااة بالنساابة للمسااتحضاارات‬ ‫إعادة تسجيل المستحضرات ‪‬‬ ‫‪6‬‬
‫غير مرجعية (‪)Non reference‬‬ ‫المستوردة ‪ /‬المستحضرات‬
‫إخطار التسجيل السابق‬ ‫المصنعة محليا بترخيص من شركة ‪‬‬
‫‪Previous Registration License‬‬ ‫أجنبية ‪ /‬المستحضرات المحلية‬
‫إيصااااااال بالقيمة المالية المدرجة بقرار الساااااايد األسااااااتاذ الدكتور رئيس هيئة الدواء‬ ‫‪‬‬ ‫الخاصة بالشركات الدولية‬


‫‪ ‬خطة إدارة المخاطر العالمية ‪/‬الدولية‬
‫‪(Globally signed declaration letter for not submitting EU/Global‬‬
‫)‪RMP‬‬
‫‪ ‬ملحق المعلومات اإلكلينيكية‬
‫)‪Global Addendum to Clinical Overview (ACO‬‬
‫(تبااادأ الفترة التي يغطيهاااا المسااااااتناااد من تااااري اإلخطاااار المبااادئي ‪(Initial‬‬
‫)‪ marketing authorization‬أو من تااااري آخر إخطاااار إعاااادة تسااااااجيااال‬
‫للمسااااااتحضاااااار (‪ )Last Renewal‬وتنتهي الفترة التي يغطيها حتى ‪ 90‬يوم قبل‬
‫التقديم)‬
‫إخطار التسجيل الذي يحتوي على شرط تقديم متطلبات اليقظة‬ ‫ا لمسننننننتنننندات المطلوب تقنننديم نننا ‪‬‬ ‫‪7‬‬
‫‪Registration License‬‬ ‫السننننتيفاء شننننرط اإلخطار المتعل‬
‫إيصااااااال بالقيمة المالية المدرجة بقرار الساااااايد األسااااااتاذ الدكتور رئيس هيئة الدواء‬ ‫‪‬‬ ‫بنننالمسننننننتحضننننننرات التى تحتو‬
‫المصاارية رقم (‪ )6‬لسنننة ‪ 2021‬و رقم (‪ )99‬لسنننة ‪ 2022‬مع مراعاة ما اسننتحد‬ ‫نشرات ا على ‪Inverted black‬‬
‫على مقابل الخدمات‪.‬‬ ‫‪ triangle‬والننتنننى تننحنننتنننا إلننى‬
‫‪(Receipts stamped by Pharmacovigilance department‬‬ ‫‪Additional Monitoring‬‬
‫‪(including‬‬ ‫‪the‬‬ ‫‪handwritten‬‬ ‫‪details‬‬ ‫‪of‬‬ ‫‪the‬‬ ‫بالنسننننبة للمسننننتحضننننرات المحلية‬
‫)‪product/submission as mentioned below‬‬ ‫(الخاصة بالشركات المحلية)‬
‫خطة إدارة المخاطر‪.‬‬ ‫‪‬‬
‫في حالة وجود كيانات‪/‬أطراف مختلفة‪ :‬ارفاق صااااااورة من اإليميل الصااااااادر من‬ ‫‪‬‬
‫وحدة أنظمة اليقظة بالموافقة على اسااااااتالم عقود اليقظة (الموقعة‪-‬المختومة‪-‬‬
‫الموثقة) من كل األطراف المعنية وتشمل احد قائمة المستحضرات المعنية‪.‬‬
‫إخطار التسجيل الذي يحتوي على شرط تقديم متطلبات اليقظة‬ ‫المسننننننتنننندات المطلوب تقنننديم نننا ‪‬‬ ‫‪8‬‬
‫‪Registration License‬‬ ‫السننننتيفاء شننننرط اإلخطار المتعل‬
‫بنننالمسننننننتحضننننننرات التى تحتو‬
‫نشرات ا على ‪Inverted black‬‬

‫‪ ‬إيصااااااال بالقيمة المالية المدرجة بقرار الساااااايد األسااااااتاذ الدكتور رئيس هيئة الدواء‬ ‫‪ triangle‬والننتنننى تننحنننتنننا إلننى‬
‫المصاارية رقم (‪ )6‬لسنننة ‪ 2021‬و رقم (‪ )99‬لسنننة ‪ 2022‬مع مراعاة ما اسننتحد‬ ‫‪Additional Monitoring‬‬
‫على مقابل الخدمات‪.‬‬ ‫(بالنسبة للمستحضرات المستوردة‬
‫‪(Receipts stamped by Pharmacovigilance department‬‬ ‫‪ /‬المستحضرات المصنعة محليا ً‬
‫‪(including‬‬ ‫‪the‬‬ ‫‪handwritten‬‬ ‫‪details‬‬ ‫‪of‬‬ ‫‪the‬‬ ‫بترخيص من شركة أجنبية ‪/‬‬
‫)‪product/submission as mentioned below‬‬ ‫المستحضرات المحلية الخاصة‬
‫‪ ‬خطة إدارة المخاطر العالمية ‪/‬الدولية‬ ‫بالشركات الدولية)‬
‫)‪RMP‬‬
‫‪ ‬التقرير الدوري لتقييم المنافع و المخاطر أو شهادة من ال شركة موقعة و م سببة بعدم‬
‫‪Globally signed justification letter for not submitting PBRER‬‬
‫‪ ‬في حالة وجود كيانات‪/‬أطراف مختلفة‪ :‬ارفاق صااااااورة من اإليميل الصااااااادر من‬
‫وحدة أنظمة اليقظة بالموافقة على اسااااااتالم عقود اليقظة (الموقعة‪-‬المختومة‪-‬‬
‫الموثقة) من كل األطراف المعنية وتشمل احد قائمة المستحضرات المعنية‪.‬‬
‫‪ ‬موافقة القسم المعني داخل هيئة الدواء المصرية على إلغاء المستحضر‪.‬‬ ‫إلغاء مستحضر‬ ‫‪9‬‬
‫‪ ‬خطاب يقدم على ورق الشركة و يوضح تفاصيل إلغاء المستحضر‪.‬‬ ‫‪Product cancellation‬‬
‫))‪(Company official paper (MAH‬‬
‫‪ ‬إخطار التسجيل‬
‫‪Registration License (if available).‬‬
‫‪ ‬صااورة من اسااتالم المركز للمسااتحضاار (إذا تم تقديمة سااابقا في إطار التسااجيل أو‬
‫إعادة التسجيل)‪.‬‬
‫‪ ‬موافقة القسم المعني داخل هيئة الدواء المصرية على نقل ملكية المستحضر‪.‬‬ ‫‪ 10‬نقل ملكية المستحضر‬
‫‪  Product ownership‬خطاب يقدم على ورق الشركة و يوضح تفاصيل نقل ملكية المستحضر‬
‫))‪(Company official paper (MAH‬‬ ‫‪transfer‬‬
‫‪ ‬إخطار التسجيل‬
‫‪Registration License (if available).‬‬

Guideline
SECTION FOUR
Requirements for Submission of Quality Module

Version/Year:3/2023
Guideline
SECTION FOUR: Requirements for Submission of Quality Module
Arrangement Guidance for Submission of Quality Module

This section will provide information about Requirements for Submission of Quality
Module for Human pharmaceutical product
The Quality Module soft file should be arranged to contain two folders according to the following:
I- Folder Name:
Administrative Documents (Product name, Strength & Dosage form)
To contain the application form and administrative documents, as separate PDFs for each
document according to the Quality Module Submission Guidance.
II- Folder Name:

Quality Module (Product name, Strength & Dosage form)
To contain the following folders, subfolders & files, as follows:
MODULE 3 Item Type of Document

3.1 TABLE OF REQUIREMENTS OF MODULE 3
Separate PDF
3.2 BODY OF DATA Folder
"S-Part"
3.2.S Drug substance (or active pharmaceutical ingredient (API) Sub Folder of BODY OF
(S part) DATA
3.2.S.1 General information (Name- Manufacturer) (S) Sub Folder of Drug substance
3.2.S.1.1 Nomenclature (name, manufacturer) (S) Separate PDF
3.2.S.1.2 Structure (name, manufacturer) (S) Separate PDF
3.2.S.1.3 General Properties (name, manufacturer) (S) Separate PDF
3.2.S.2 Manufacture (name, manufacturer) (S) Sub Folder of Drug substance
3.2.S.2.1 Manufacturer(s) (name, manufacturer) (S)
Separate PDF
Description of Manufacturing Process and Process Controls
3.2.S.2.2
(name, manufacturer) (S) Separate PDF
3.2.S.2.3 Control of Materials (name, manufacturer) (S) Separate PDF
Controls of Critical Steps and Intermediates (name,
3.2.S.2.4
manufacturer) (S) Separate PDF
3.2.S.2.5
Process Validation and/or Evaluation (name, manufacturer) (S) Separate PDF
3.2.S.2.6 Manufacturing Process Development (name, manufacturer) (S) Separate PDF
3.2.S.3 Characterization (name, manufacturer) (S) Sub Folder of Drug substance

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Guideline
Elucidation of Structure and other Characteristics (name,

3.2.S.3.1
manufacturer) (S) Separate PDF
3.2.S.3.2 Impurities (name, manufacturer) (S) Separate PDF
3.2.S.4 Control of Drug Substance (name, manufacturer) (S) Sub Folder of Drug substance
3.2.S.4.1 Specification (name, manufacturer) (S) Separate PDF
3.2.S.4.2 Analytical Procedures (name, manufacturer) (S) Separate PDF
3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer) (S) Separate PDF
3.2.S.4.4 Batch Analyses (name, manufacturer) (S) Separate PDF
3.2.S.4.5 Justification of Specification (name, manufacturer) (S) Separate PDF
Reference Standards or Materials (name, manufacturer)
3.2.S.5
(S) Sub Folder of Drug substance
3.2.S.6 Container Closure System (name, manufacturer) (S) Sub Folder of Drug substance
3.2.S.7 Stability (name, manufacturer) (S) Sub Folder of Drug substance
3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer) (S) Separate PDF
Post-approval Stability Protocol and Stability Commitment Separate PDF
3.2.S.7.2
(name, manufacturer) (S)
3.2.S.7.3 Stability Data (name, manufacturer) (S) Separate PDF
3.2.P: Drug product "P-Part"
3.2.P Drug product (P part) Sub Folder of Body of Data
3.2.P.1 Description and Composition of the Drug Product Sub Folder of Drug product
(name, dosage form)
& contains separate DPF
3.2.P.2 Pharmaceutical Development (name, dosage form) Sub Folder of Drug product
3.2.P.2.1 Components of the Drug Product (name, dosage form)
3.2.P.2.1.1 Drug Substance (name, dosage form)
3.2.P.2.1.2 Excipients (name, dosage form)
3.2.P.2.2 Drug Product (name, dosage form)
3.2.P.2.2.1 Formulation Development (name, dosage form).

One PDF or multiple documents
3.2.P.2.2.2 Overages (name, dosage form)
can be submitted in this section
3.2.P.2.2.3 Physicochemical and Biological Properties (name, dosage
form)
3.2.P.2.3 Manufacturing Process Development (name, dosage form)
3.2.P.2.4 Container Closure System (name, dosage form).

3.2.P.2.5 Microbiological Attributes (name, dosage form)

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Guideline
3.2.P.2.6 Compatibility (name, dosage form)
3.2.P.3 Manufacture (name, dosage form) Sub Folder of Drug product
3.2.P.3.1 Manufacturer(s) (name, dosage form) Separate PDF
3.2.P.3.2 Batch Formula (name, dosage form) Separate PDF
Description of Manufacturing Process and Process Controls Separate PDF

3.2.P.3.3
(name, dosage form)
Controls of Critical Steps and Intermediates (name, dosage Separate PDF

3.2.P.3.4
form)
3.2.P.3.5 Process Validation and/or Evaluation (name, dosage form). Separate PDF
3.2.P.4 Control of Excipients (name, dosage form) Sub Folder of Drug product
3.2.P.4.1 Specifications (name dosage form) Separate PDF
3.2.P.4.2 Analytical Procedures (name, dosage form) Separate PDF

3.2.P.4.3 Validation of Analytical Procedures (name, dosage form) Separate PDF
3.2.P.4.4 Justification of Specifications (name, dosage form) Separate PDF

3.2.P.4.5 Excipients of Human or Animal Origin (name, dosage form) Separate PDF
3.2.P.4.6 Novel Excipients (name, dosage form Separate PDF
3.2.P.5 Control of Drug Product (name, dosage form). Sub Folder of Drug product
3.2.P.5.1 Specification(s) (name, dosage form) Separate PDF
3.2.P.5.2 Analytical Procedures (name, dosage form) Separate PDF

3.2.P.5.3 Validation of Analytical Procedures (name, dosage form) Separate PDF
3.2.P.5.4 Batch Analyses (name, dosage form Separate PDF
3.2.P.5.5 Characterization of Impurities (name, dosage form) Separate PDF
3.2.P.5.6 Justification of Specification(s) (name, dosage form) Separate PDF
3.2.P.6 Reference Standards or Materials (name, dosage form) Sub Folder of Drug product
3.2.P.7 Container Closure System (name, dosage form) Sub Folder of Drug product
3.2.P.8 Stability (name, dosage form) Sub Folder of Drug product
3.2.P.8.1 Stability Summary and Conclusion (name, dosage form) Separate PDF

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Guideline
Post-approval Stability Protocol and Stability Commitment Separate PDF

3.2.P.8.2
(name, dosage form)
3.2.P.8.3 Stability Data (name, dosage form) Separate PDF
3.2.A APPENDECIES Sub Folder of Body of Data
3.2.A.1 Facilities and Equipment Separate PDF
3.2.A.2 Adventitious Agents Safety Evaluation Separate PDF
3.2.A.3 Excipients Separate PDF
3.2.R Regional Information Sub Folder of Body of Data
3.2.R.1 Production documents Sub Folder of Regional Information
3.2.R.1.1 Executed production documents Separate PDF
3.2.R.1.2 Master production documents Separate PDF
3.2.R.2 Analytical Procedures and Validation information Sub Folder of Regional Information
3.3 Literature References Separate PDF
▪ General notes:
1. Folders and documents name should include section number and section name.
(e.g.: 3.2.P.8.1 Stability Summary and Conclusion)
2. Searchable PDFs are preferred.
3. Bookmarking is preferred.
4. For “S-Part”: separate PDFs are preferred, if available by the API manufacturer.
5. All documents of the Quality module should be submitted in English language.

Version/Year:3/2023
Guideline
▪ Guidance on Content of the Quality Module
I- Quality Module
General notice regarding submission of Quality Module
3.1 : Table of contents of Module 3:

A table of content for the filed product dossier should be provided
3.2 : Body of data
3.2.S: Drug Substance "S-Part"
The applicant should clearly indicate at the beginning of the API section how the information on the API
for each API manufacturer is being submitted:
▪ Option 1: Confirmation of API prequalification document
▪ Option 2: Certificate of suitability of the European Pharmacopoeia (CEP)
▪ Option 3: API master file (APIMF/DMF)
▪ Option 4: Full details in the Product Dossier
▪ Copy of the latest version of the CEP (including any

annexes) should be provided.
-CEP data should be consistent with that available online on

EDQM certification Database.
In case of Option 2: ▪ The declaration of access, should be duly filled out by the
CEP holder in order to authorize the applicant company to
Certificate of Suitability of the use the CEP in support of its marketing authorization
application (MAA).
European Pharmacopoeia (CEP)
-And should include the name of pharmaceutical company
(FPP MAH/Manufacturer), the name of the medicinal
product(s).
▪ Written commitment that the applicant will inform EDA in

the event that the CEP is revised, renewed or withdrawn by
EDQM should be submitted.
▪ Copy of the most recent European Monograph for the API is

required.

Version/Year:3/2023
Guideline
▪ A copy of the letter of access/authorization from the DMF

In case of Option 3: holder should be provided in the Product Dossier.
API master file (APIMF) /(DMF) [details on Page .19]
procedure
▪ Restricted Part should be submitted from API Manufacturer.
Clause Item General Notice
3.2.S.1 General Information
▪ Information on the nomenclature of the API should be

provided. For example:
▪ (recommended) International Non-proprietary
Name (INN);
▪ compendial name, if relevant;
3.2.S.1.1 Nomenclature ▪ chemical name(s);
▪ company or laboratory code;
▪ Other non-proprietary name(s) (e.g. national name,
United States
▪ Chemical Abstracts Service (CAS) registry
number.
▪ The structural formula, including relative and absolute
3.2.S.1.2 Structure stereochemistry, the molecular formula and the relative
molecular mass should be provided.
▪ The physical and chemical properties of the API should be

discussed, including the physical description, solubilities in
common solvents (e.g. water, alcohols, dichloromethane,
acetone), quantitative aqueous pH solubility profile (e.g.
3.2.S.1.3 General properties
pH 1.2 to 6.8, dose/solubility volume), polymorphism, pH
and pKa values, UV absorption maxima and molar
absorptivity, melting point, refractive index (for a liquid),
hygroscopicity, partition coefficient.
3.2.S.2 Manufacture
▪ The name, address and responsibility of each manufacturer,

including contractors, and each proposed production site or
3.2.S.2.1 Manufacturer(s)
facility involved in manufacturing and testing should be
provided.
▪ Information should be provided to adequately describe the

Description of
manufacturing process and process controls. including:
manufacturing
3.2.S.2.2
process and process ▪ a flow diagram of the synthetic process(es) should
controls be provided that includes molecular formulae,
weights, yield ranges, chemical structures of

Version/Year:3/2023
Guideline
starting materials, intermediates, reagents and API

reflecting stereochemistry, and identifies operating
conditions and solvents.
▪ A sequential procedural narrative of the
manufacturing process should be submitted.
▪ Alternate processes should be explained and
described with the same level of detail as the
primary process.
▪ Reprocessing steps should be identified and
justified.
Note: Where the APIMF (DMF) procedure is used, a cross-
reference to the Restricted part of the APIMF may be indicated
for confidential information. In this case, if detailed
information is presented in the Restricted part, the information
to be provided for this section includes a flow chart (including
molecular structures and all reagents and solvents) and a brief
outline of the manufacturing process, with special emphasis on
the final steps including purification procedures.
▪ Materials used in the manufacture of the API (e.g. raw

materials, starting materials, solvents, reagents, catalysts)
* Control of should be listed identifying where each material is used in
3.2. S.2.3 the process.
materials
▪ Information on the quality and control of these materials
should be provided.
▪ Critical steps: Tests and acceptance criteria (with

justification including experimental data) performed at
critical steps identified in 3.2.S.2.2 of the manufacturing
* Controls of process to ensure that the process is controlled should be
3.2. S.2.4 critical steps and provided
intermediates
▪ Intermediates: Information on the quality and control of
intermediates isolated during the process should be
provided.
* Process
3.2.S.2.5 validation and/or ▪ Process validation and/or evaluation studies for aseptic
evaluation processing and sterilization should be included.
* Manufacturing
3.2. S.2.6 process
▪ A description and discussion should be provided of the
significant changes made to the manufacturing process
development
and/or manufacturing site of the API used in producing

Version/Year:3/2023
Guideline
comparative bioavailability or biowaiver, scale-up, pilot

and, if available, production-scale batches.
Note: * Where the APIMF procedure is used, a cross-reference to the Restricted part of the APIMF is
considered sufficient for this section.
3.2.S.3 Characterization
▪ Confirmation of structure based on e.g. synthetic route and

Elucidation of spectral analyses should be provided. Information such as
3.2.S.3.1 structure and other the potential for isomerism, the identification of
characteristics stereochemistry, or the potential for forming polymorphs
should also be included.
▪ Details on the principles for the control of impurities (e.g.

reporting, identification and qualification) are outlined in
the ICH Q3A, Q3B and Q3C impurity guidelines.
▪ A discussion should be provided of the potential and actual

impurities arising from the synthesis, manufacture, or
3.2.S.3.2 Impurities degradation of the API “This should cover starting
materials, by-products, intermediates, chiral impurities and
degradation products and should include the chemical
names, structures and origins.”.
▪ Residual solvents, elemental risk assessment and Genotoxic
risk assessment should be provided.
3.2.S.4 Control of the API
▪ Copies of the API specifications, dated and signed by

authorized personnel should be provided, including
specifications from each API manufacturer as well as those
of the FPP manufacturer.
▪ Specifications should be presented in a tabular form

contains a list of tests, references to analytical procedures
3.2.S.4.1 Specification (updated version) and appropriate acceptance criteria,
▪ Copy of the recent Monograph for the API should be

submitted “if applicable”.
▪ In case where there is more than one API manufacturer, the

FPP manufacturer’s API specifications should be one single
compiled set of specifications that apply to the API from all
manufacturers.

Version/Year:3/2023
Guideline
▪ The analytical procedures used for testing the API should

be provided.
Analytical ▪ Copies of the in-house analytical procedures used to
3.2.S.4.2
procedures generate testing results provided in the PD, as well as those
proposed for routine testing of the API by the FPP
manufacturer, should be provided.
▪ Analytical validation information, including experimental

data for the analytical procedures used for testing the API,
should be provided.
▪ Copies of the validation reports for the analytical

Validation of
procedures used to generate test results provided in the PD,
3.2.S.4.3 analytical
as well as those proposed for routine testing of the API by
procedures
the FPP manufacturer, should be provided.
▪ As recognized by regulatory authorities and

pharmacopoeias themselves, verification of compendial
methods can be necessary.
▪ Description of batches and results of batch analyses should

be provided.
▪ Batches analysis should be recent.

▪ The information provided should include batch number,
batch size, date, production site of relevant API batches &
the use of the batch (comparative bioavailability or
biowaiver studies, preclinical and clinical data (if relevant),
3.2.S.4.4 Batch Analyses
stability, pilot-scale, production-scale batches).
▪ Results should be provided from at least two batches of at
least pilot-scale from each proposed manufacturing site of
the API.
▪ Copies of the certificates of analysis, both from the API

manufacturer(s) and the FPP manufacturer should be
provided.
Justification of ▪ The justification for certain tests, analytical procedures and

3.2.S.4.5
specification acceptance criteria should be provided
3.2.S.5 Reference standards or materials
Reference
3.2.S.5 standards or ▪ Information on the reference standards or reference
materials materials used for testing of the API should be provided.

Version/Year:3/2023
Guideline
▪ The source(s) of the reference standards or materials used

in the testing of the API should be provided (e.g. those used
for the identification, purity, and assay tests).
3.2.S.6 Container-closure system
▪ A description of the container-closure system(s) should be

provided, including the identity of materials of construction
of each primary packaging component and their
specifications. The specifications should include
description and identification (and critical dimensions with
drawings, where appropriate). Non-compendial methods
(with validation) should be included, where appropriate.
▪ For non-functional secondary packaging components (e.g.

Container-closure
3.2.S.6 those that do not provide additional protection), only a brief
system
description should be provided. For functional secondary
packaging components, additional information should be
provided.
▪ The suitability should be discussed with respect to, for
example, choice of materials, protection from moisture and
light, compatibility of the materials of construction with the
API, including sorption to container and leaching, and/or
safety of materials of construction.
3.2.S.7 Stability
▪ The types of studies conducted, protocols used and the

results of the studies should be summarized. The summary
Stability Summary should include results, for example, from forced
3.2.S.7.1
and Conclusions degradation studies and stress conditions, as well as
conclusions with respect to storage conditions and retest
date or shelf-life, as appropriate.
▪ Primary stability study commitment:

In case of the available long-term data on the stability of
primary batches do not cover the proposed retest period,
Post-approval
Stability Protocol a written commitment (signed and dated) to continue long-
3.2.S.7.2 term testing over the retest period should be included in the
and Stability
Commitment dossier when relevant.
▪ Commitment stability studies:

In case of stability data were not provided for three
production batches, written commitment (signed and dated)

Version/Year:3/2023
Guideline
should be included in the dossier and the stability protocol

for the commitment batches should be provided.
▪ Ongoing stability studies:

A written commitment (signed and dated) for ongoing
stability studies should be included in the dossier.
▪ The actual stability results used to support the proposed

retest period should be included in the dossier.
3.2.S.7.3 Stability Data ▪ The Data should be submitted in a tabular form including:
(Manufacturing date, manufacturer name & site, stability
loading date, batch number, storage condition & container
closure system).
3.2.P: Drug product (or finished pharmaceutical product (FPP))

"P-Part"
3.2.P.1 Description and Composition of the Drug Product
▪ A description of the FPP and its composition should be

provided. The information provided should include, for
example:
▪ Description of the dosage form
▪ Composition: list of all components of the dosage
form and their amount on a per unit basis (including
Description and overages, if any), the function of the components and
3.2.P.1 Composition of a reference to their quality standards (e.g.
the Drug Product compendial monographs or manufacturer’s
specifications).
▪ Description of accompanying reconstitution
diluent(s)
▪ Type of container and closure used for the dosage
form and accompanying reconstitution diluent, if
applicable.
3.2.P.2 Pharmaceutical Development
▪ The Pharmaceutical Development section should contain information on the development studies
conducted to establish that the dosage form, the formulation, manufacturing process, container-

Version/Year:3/2023
Guideline
closure system, microbiological attributes and usage instructions are appropriate for the purpose
specified in the product dossier.
▪ Pharmaceutical development information should include, at a minimum:

- The definition of the quality target product profile (QTPP) as it relates to quality, safety and
efficacy, considering for example the route of administration, dosage form, bioavailability, strength
and stability;
- Identification of the potential critical quality attributes (CQAs) of the FPP so as to adequately
control the product characteristics that could have an impact on quality;
- Discussion of the potential CQAs of the API(s), excipients and container-closure system(s)
including the selection of the type, grade and amount to deliver pharmaceutical product of the
desired quality;
- Discussion of the selection criteria for the manufacturing process and the control strategy required
to manufacture commercial lots meeting the QTPP in a consistent manner.
▪ 3.2.P.2.1.1 Active pharmaceutical ingredient:

▪ The compatibility of the API with excipients listed
in 3.2.P.1 should be discussed. Additionally, key
physicochemical characteristics of the API that can
influence the performance of the FPP should be
discussed.
Components of the
3.2.P.2.1 ▪ For fixed-dose combinations, the compatibility of
FPP
APIs with each other should be discussed.
▪ 3.2.P.2.1.2 Excipients:
▪ The choice of excipients listed in 3.2.P.1, their
concentration, their characteristics that can
influence the FPP performance should be discussed
relative to their respective functions
▪ 3.2.P.2.2.1 Formulation Development:

▪ A brief summary describing the development of the
FPP should be provided, taking into consideration
Finished the proposed route of administration and usage.
3.2.P.2.2 pharmaceutical ▪ In case of generic products, results from
product comparative in vitro studies (e.g. dissolution) or
comparative in vivo studies (e.g. bioequivalence)
should be discussed.
▪ 3.2.P.2.2.2 Overages:

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Guideline
▪ Any overages in the formulation(s) described in

3.2.P.1 should be justified.
▪ 3.2.P.2.2.3 Physicochemical and biological properties:

▪ Parameters relevant to the performance of the FPP, such as
pH, ionic strength, dissolution, redispersion, reconstitution,
particle size distribution, aggregation, polymorphism,
rheological properties, biological activity or potency,
and/or immunological activity, should be addressed.
▪ The selection and optimization of the manufacturing

Manufacturing
process described in 3.2.P.3.3, in particular its critical
3.2.P.2.3 process
aspects, should be explained. Where relevant, the method
development
of sterilization should be explained and justified.
▪ The suitability of the container closure system (described in

3.2.P.7) used for the storage, transportation (shipping) and
use of the FPP should be discussed.
▪ This discussion should consider, e.g. choice of materials,

Container-closure protection from moisture and light, compatibility of the
3.2.P.2.4
system materials of construction with the dosage form (including
sorption to container and leaching) safety of materials of
construction and performance (such as reproducibility of
the dose delivery from the device when presented as part of
the FPP).
▪ Where appropriate, the microbiological attributes of the

dosage form should be discussed, including, for example,
the rationale for not performing microbial limits testing for
non-sterile products and the selection and effectiveness of
Microbiological preservative systems in products containing antimicrobial
3.2.P.2.5
attributes preservatives.
▪ For sterile products, the integrity of the container-closure

system to prevent microbial contamination should be
addressed.
▪ The compatibility of the FPP with reconstitution diluent(s)

or dosage devices (e.g. precipitation of API in solution,
3.2.P.2.6 Compatibility sorption on injection vessels, stability) should be addressed
to provide appropriate and supportive information for the
labelling.
3.2.P.3 Manufacture

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Guideline
▪ The name, address and responsibility of each manufacturer,

including contractors, and each proposed production site or
3.2.P.3.1 Manufacturer(s)
facility involved in manufacturing and testing should be
provided.
▪ A batch formula should be provided that includes a list of

all components of the dosage form to be used in the
3.2.P.3.2 Batch formula manufacturing process, their amounts on a per batch basis,
including overages, and a reference to their quality
standards.
▪ A flow diagram should be presented giving the steps of the

process and showing where materials enter the process. The
critical steps and points at which process controls,
intermediate tests or final product controls are conducted
should be identified.
▪ A narrative description of the manufacturing process,

including packaging that represents the sequence of steps
undertaken and the scale of production should also be
provided. Novel processes or technologies and packaging
operations that directly affect product quality should be
described with a greater level of detail. Equipment should,
at least, be identified by type (e.g. tumble blender, in-line
Description of homogenizer) and working capacity, where relevant.
Manufacturing
3.2.P.3.3
Process and
Process Controls ▪ Steps in the process should have the appropriate process
parameters identified, such as time, temperature or pH.
Associated numeric values can be presented as an expected
range. Numeric ranges for critical steps should be justified
in Section 3.2.P.3.4. In certain cases, environmental
conditions (e.g. low humidity for an effervescent product)
should be stated.
▪ The maximum holding time for bulk FPP (product prior to

final packaging, e.g. tablets in HDPE drums) should be
stated. The holding time should be supported by the
submission of stability data, if longer than 30 days.

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Guideline
▪ For the manufacture of sterile products, the class (e.g. A, B,

C, etc.) of the areas should be stated for each activity (e.g.
compounding, filling, sealing, etc.), as well as the
sterilization parameters for equipment, container/closure,
terminal sterilization, etc.
▪ Critical steps: Tests and acceptance criteria should be

provided (with justification, including experimental data)
performed at the critical steps identified in 3.2.P.3.3 of the
Controls of critical manufacturing process, to ensure that the process is
3.2.P.3.4 steps and controlled.
intermediate
provided.
▪ Description, documentation, and results of the validation

and/or evaluation studies should be provided for critical
steps or critical assays used in the manufacturing process
(e.g. validation of the sterilization process or aseptic
processing or filling). Viral safety evaluation should be
provided in 3.2A.2, if necessary.
▪ The following information should be provided for all

products:
▪ a copy of the process validation protocol, specific
Process Validation to the FPP
3.2.P.3.5
and/or Evaluation
▪ a commitment that three consecutive, production-
scale batches of this FPP will be subjected to
prospective validation in accordance with the
above protocol; the applicant should submit a
written commitment that information from these
studies will be available for verification after
approval.
▪ if the process validation studies have already been
conducted (e.g. for sterile products), a copy of the
process validation report should be provided
3.2.P.4 Control of excipients
▪ COA of excipients (If Applicable).
3.2.P.4.1 Specifications ▪ The specifications for excipients should be provided.

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Guideline
▪ If the standard claimed for an excipient is an officially-

recognized compendial standard, it is sufficient to state that
the excipient is tested according to the requirements of that
standard, rather than reproducing the specifications found
in the officially-recognized compendial monograph.
▪ If the standard claimed for an excipient is a non-

compendial standard (e.g. in-house standard) or includes
tests that are supplementary to those appearing in the
officially-recognized compendial monograph, a copy of the
specification for the excipient should be provided.
▪ The analytical procedures used for testing the excipients

Analytical should be provided, where appropriate.
3.2.P.4.2
procedures ▪ Copies of analytical procedures from officially-recognized
compendial monographs do not need to be submitted.
Validation of ▪ Analytical validation information, including experimental

3.2.P.4.3 analytical data, for the analytical procedures used for testing the
procedures excipients should be provided, where appropriate.
▪ Justification for the proposed excipient specifications

should be provided, where appropriate.
Justification of
3.2.P.4.4 ▪ A discussion of the tests that are supplementary to those
specifications
appearing in the officially-recognized compendial
monograph should be provided.
Excipients of
▪ For excipients of animal origin, certificate of TSE
3.2.P.4.5 Human or Animal
compliance should be provided.
Origin
▪ For excipient(s) used for the first time in an FPP or by a

new route of administration, full details of manufacture,
characterization, and controls, with cross-references to
3.2.P.4.6 Novel excipients
supporting safety data (nonclinical and/or clinical) should
be provided according to the API and/or FPP format
(details in 3.2.A.3).
3.2.P.5 Control of FPP
▪ A copy of the FPP specification(s) from the applicant (as

well as the company responsible for the batch release of the
3.2.P.5.1 Specification(s)
FPP, if different from the applicant), dated and signed by
authorized personnel should be provided in the PD.

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Guideline
▪ Two separate sets of specifications may be set out: after

packaging of the FPP (release) and at the end of shelf-life.

(updated version) and appropriate acceptance criteria,
▪ The analytical procedures used for testing the FPP should

be provided.
▪ Copies of the in-house analytical procedures used during

Analytical pharmaceutical development (if used to generate testing
3.2.P.5.2
procedures results provided in the PD) as well as those proposed for
routine testing should be provided.
▪ For pharmacopeial products: Copy of the recent

Monograph should be submitted.
▪ Analytical validation information, including experimental

data, for the analytical procedures used for testing the FPP,
Validation of should be provided.
3.2.P.5.3 analytical
procedures ▪ Copies of the validation reports for the in-house analytical
procedures used as well as those proposed for routine
testing should be provided.
▪ A description of batches and results of batch analyses

should be provided.
▪ Information should include strength and batch number, batch

size, date and site of production and use (e.g. used in
comparative bioavailability or biowaiver studies, preclinical
3.2.P.5.4 Batch Analyses
and clinical studies (if relevant), stability, pilot, scale-up
and, if available, production-scale batches).
▪ Analytical results tested by the company responsible for the

batch release of the FPP should be provided for not less than
two batches of at least pilot scale.
▪ Information on the characterization of impurities should be

provided.
3.2.P.5.5
Characterization ▪ A discussion should be provided of all impurities that are
of impurities potential degradation products (including any of the
impurities identified in 3.2.S.3.2 as well as potential
degradation products resulting from interaction of the API
with other APIs (FDCs), excipients or the container-closure

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Guideline
system) and FPP process-related impurities (e.g. residual

solvents in the manufacturing process for the FPP).
▪ Justification for the proposed FPP specification(s) should

be provided.
▪ A discussion should be provided on the omission or
Justification of inclusion of particular tests, evolution of tests, analytical
3.2.P.5.6
specification(s) procedures and acceptance criteria, differences from the
officially-recognized compendial standard(s).
▪ If the officially-recognized compendial methods have been
modified or replaced, a discussion should be included.
3.2.P.6 Reference standards or materials
▪ Information on the reference standards or reference

Reference materials used for testing of the FPP should be provided.
3.2.P.6 standards or ▪ The source(s) of the reference standards or materials used in
materials the testing of the FPP should be provided (e.g. those used for
the identification, purity, and assay tests).
3.2.P.7 Container-closure system
▪ A description of the container-closure systems should be

provided, including the identity of materials of construction
of each primary packaging component and its specification.
The specifications should include description and
identification (and critical dimensions, with drawings
where appropriate). Non-compendial methods (with
validation) should be included, where appropriate.
Container-closure
3.2.P.7
system ▪ For non-functional secondary packaging components (e.g.
those that neither provide additional protection nor serve to
deliver the product), only a brief description should be
provided.
▪ For functional secondary packaging components, additional
information should be provided.
▪ Suitability information should be located in 3.2.P.2.
3.2.P.8 Stability
▪ The types of studies conducted, protocols used, and the

Stability results of the studies should be summarized. The summary
3.2.P.8.1 Summary and should include, for example, conclusions with respect to
Conclusion storage conditions and shelf-life, and, if applicable, in-use
storage conditions and shelf-life.

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Guideline

In case of the available long-term data on the stability of
primary batches do not cover the proposed shelf life, a
written commitment (signed and dated) to continue long-
term testing over the shelf life period should be included in
the dossier.
Post-approval ▪ Commitment stability studies:
3.2.P.8.2 Stability Protocol
and Stability Where stability data were not provided for three production
Commitment batches of each strength, a written commitment (signed and
dated) should be included in the dossier.

A written commitment (signed and dated) to monitor the
product over its shelf-life and to determine that the product
remains within specifications should be included in the
dossier.
▪ The actual stability results/reports used to support the

proposed shelf-life should be provided
3.2.P.8.3 ▪ The Data should be submitted in a tabular form including:
Stability Data (Product Name, strength, dosage form, manufacturing date,
manufacturer name & site, stability loading date, batch
number, storage condition & container closure system) &
also API batch number, manufacturer name & site.
3.2.A Appendices
3.2.A.1 Facilities and equipment
▪ Not applicable
3.2.A.2 Adventitious agents safety evaluation
3.2.A.3 Novel excipients
▪ If novel excipients are accepted, full information should be provided in the format of the sections in
3.2.P.
3.2.R Regional information
3.2.R.1 Production documentation

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Guideline
▪ Copies of the executed production documents should be

3.2.R.1.1 Executed provided.
production
documents ▪ English translations of executed records should be provided,
where relevant.
3.2.R.1.2 ▪ Copies of the FPP master production documents should be

Master production
provided for each proposed strength, commercial batch size
documents
and manufacturing site.
3.2.R.2 Analytical procedures and validation information
▪ The tables presented in section 2.3.R.2 in the QOS-PD template may be used to summarize the
analytical procedures and validation information from sections 3.2.S.4.2, 3.2.S.4.3, 2.3.S.4.4 (c),
2.3.S.7.3 (b), 3.2.P.5.2 and 3.2.P.5.3, where relevant.
3.3 Literature references
▪ References to the scientific literature relating to both the API and FPP should be included in this
section of the PD when appropriate.
General Notes:
Note 1: For a drug product containing more than one drug substance, the information requested for “S-
part” should be provided in its entirety for each drug substance.
Note 2: For a drug product supplied with reconstitution solvent(s), the information on the solvent(s)
should be provided in a separate “P-part” as appropriate. (Not applicable for solvents with registration
license)
Abbreviations:
▪ “drug substance” is replaced with “active pharmaceutical ingredient” or “API”;
▪ “drug product” is replaced with “finished pharmaceutical product” or “FPP”;
▪ “application” is replaced with “product dossier” or “PD”;
▪ “combination product” is replaced with “fixed-dose combination” or “FDC”;
For More Detailed information about Quality module documentation and submission, kindly
refer to: “WHO: Annex 6 Guidelines on submission of documentation for a multisource
(generic) finished pharmaceutical product: quality part”
Link: https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex6.pdf?ua=1

Version/Year:3/2023
Guideline
II- Administrative Documents
Required documents for under-registration products
▪ Application form (Template Attached) (On company letterhead signed, stamped and dated)
▪ Action Letter & Name Approval
▪ Any other approvals (e.g. Fast track, Technical committee approval,…….)
▪ Declaration (On company letterhead signed, stamped and dated )
To state the product's status concerning Pricing, Pharmacovigilance, EDA labs analysis,
Stability and Bioequivalence approvals release.
▪ EDA Labs API certificate ((for local products, When Available)

▪ EDA Labs FPP certificate & composition (When Available)
▪ Stability approval (When Available)
▪ Bioequivalence approval "If applicable" (When Available)
▪ Pharmacovigilance approval and Pricing license (for products submitted for registration
according to ministerial decrees 425/2015, 645/2018, EDA chairman Decree 450/ 2023
▪ For locally manufactured products:
- Pilot batch samples withdrawal record /
primary batches’ reports (Attendance and samples withdrawal)
(by EDA Inspection), with the product composition attached
(signed or stamped by EDA inspector).
+ Importation approval for each API
+ Manufacturing site factory license
▪ For Imported/Imported Bulk and Under license Products:

Certificate of Pharmaceutical Product (CPP) issued by the Competent Authority in the
Country of Origin (Valid, Legalized & Including product's composition and Smpc.)
▪ For non-reference products: Specialized committee approval

▪ Copy of certificate(s) of suitability of the European Pharmacopoeia (CEP) (including any
annexes) "If applicable"
▪ Letters of access for active pharmaceutical ingredient master files (APIMFs)
(Template Attached) "If applicable"

Version/Year:3/2023
Guideline
Required documents for registered and re-registration products
▪ Application form (Template Attached)

(On company letterhead signed, stamped and dated)
▪ Registration license
▪ Preliminary approval for the re-registration (for re-registration products)
▪ Any Pre-approved letters from EDA concerning the product during previous registration
period (e.g. Variation approval, Technical committee decisions, …….)
▪ Declaration (On company letterhead signed, stamped and dated)
To state all the variations done to the product through its last registration period.
▪ EDA Labs API certificate (for local products)

▪ EDA Labs FPP certificate & composition
▪ Stability approval
▪ Bioequivalence approval "If applicable"
Certificate of Pharmaceutical Product (CPP) issued by the Competent Authority in the
Country of Origin (Valid, Legalized & Including product's composition and Smpc.)
▪ For non-reference products: Specialized committee approval (Previously, Non-Reference

committee and pharmacology committee approvals)
▪ Copy of certificate(s) of suitability of the European Pharmacopoeia (CEP) (including any
annexes) "If applicable"
(Template Attached) "If applicable"

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Guideline
Application form for Quality module file submission

Trade Name:
Active Ingredient(s) & Strength

(s):
(Including salts, hydrate forms and
equivalence to free base)
Pharmaceutical dosage form:
Route of administration:
Product's Status: 󠇤 Submitted for registration according to ministerial decree

…………….
󠇤 Submitted for re-registration according to ministerial decree
…………….
󠇤 Have a valid license and submitted for variation
󠇤 Registered and still not marketed
Therapeutic Group:
Applicant:
License Holder/ Marketing

Authorization Holder:
Manufacturer:
-Manufacturer of Solvent/
Accessories (If Applicable):
-Registration status of solvent:
Packaging site:
Batch release site:
Proposed Pack:

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Guideline
Type of registration: 󠇤Local 󠇤Toll/F-Toll

󠇤Under-license 󠇤 Toll /F-Toll Under-License
󠇤 Imported 󠇤Imported Bulk
API(s) Manufacturer name,

Address and Country of origin:
API information submitted as: 󠇤Prequalification 󠇤 DMF

󠇤 CEP 󠇤 Full details in the PD
CEP number and issue date:

"If applicable"
Reference Drug Product (Note: According to bioequivalence approval)
Reference name:
Name of reference Product

(RLD, RS, … )
Name of MAH, Manufacturer and

Country of origin
Applicant Company Representative
Name:
Telephone number:
E-mail:
• Company Stamp Registration Manager
• Name:
• Signature:
Date:

Version/Year:3/2023
Guideline
Link for editable application template:

https://docs.google.com/document/d/1EzXgA5KEvs8RJPT15ZEu5_ETLYAhxXJ8/edit?usp=sharing&
ouid=111862349084529780102&rtpof=true&sd=true
Letter of Authorization (Access) to EDA TO REFER TO A DRUG MASTER

FILE
Before EDA can review DMF information in support of an application, the DMF holder must submit in
duplicate to the DMF a letter of authorization permitting EDA to reference the DMF.
The letter of authorization should include the following:
1. The date.
2. Name of DMF holder.
3. DMF version number.
4. Name of person(s) authorized to incorporate information in the DMF by reference.
5. Specific product(s) covered by the DMF.
6. Statement of commitment that the DMF is current and that the DMF holder will comply with
the statements made in it.
7. Signature of authorizing official.
8. Typed name and title of official authorizing reference to the DMF.
Link for editable Letter of authorization (access) Template:

https://docs.google.com/document/d/16OKC9Qcd1LByiJm1dQy97KZx3k1DwZmg/edit?usp=sharing&
ouid=111862349084529780102&rtpof=true&sd=true
To be submitted on the API supplier letterhead.

Version/Year:3/2023
Guideline

FILE
Date: [Enter the date of this submission]
DMF No.: [Enter the DMF version number (Applicant and Restricted part version number)]
Holder: [Enter the DMF holder’s name]
Subject (Title): [Enter the subject (title) of the DMF]
Submission Type: Letter of Authorization
To, Egyptian Drug Authority [EDA]

21-Abdulaziz Al Saud Al Manial, Cairo – Egypt
[email protected]
Dear EDA,
[DMF HOLDER] authorizes [Authorized party] to incorporate by reference information in [DMF

VERSION NUMBER] into any application filed by [Authorized party].
[DMF HOLDER] also authorizes EDA to review this information in [DMF VERSION NUMBER]
when considering any application filed by [Authorized party].
Provide the name of [Authorized party] (one per LOA).

Provide information of the product (trade name, strength and dosage form)
Sincerely,
[Signature of responsible official]
[Name of responsible official]
[Responsible official’s title]
[Responsible official’s company (i.e., DMF holder or agent)]
[Responsible official’s telephone number]
[Responsible official’s fax number]
[Responsible official’s email address]

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Guideline
Date: [Enter the date of this submission]

DMF No.: [Enter the DMF version number (Applicant and Restricted part version number)]
Holder: [Enter the DMF holder’s name]
Subject (Title): [Enter the subject (title) of the DMF]
Submission Type: Letter of Authorization
To, Egyptian Drug Authority EDA

21-Abdulaziz Al Saud Al Manial, Cairo – Egypt
[email protected]
Statement of Commitment: [The following statement of commitment, signed by the DMF holder,
should be included in this letter.]
[DMF HOLDER] states that [DMF VERSION NUMBER] is current and [DMF HOLDER] will
comply with the statements made within it.
[DMF HOLDER] will notify Egyptian Drug Authority through an amendment to [DMF
VERSION NUMBER] of any addition, change, or deletion of information in the DMF.
[DMF HOLDER] will also notify Egyptian Drug Authority in writing that an addition, change,
or deletion of information has been made to the DMF.
__________________________
Signature of DMF holder
*Information to be filled in, including notes about that information, is in brackets.

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Guideline
Guidance on Submission of Quality Module Variations

▪ Scope:
This guidance applies for any registered human pharmaceutical product submitted for Quality
Module variations on the previously approved Quality Module.
▪ Objective:
This guidance aims to provide applicants with the documents and information required for
preparation and submission of the quality module variations for human pharmaceutical products
submitted according to different Ministerial decrees and technical committee decisions.
Applicants should submit the relevant/ updated CTD quality module sections in accordance to the
type of variations.
It should be noted that Egyptian Drug Authority has the right to request any further information or
documents, with a commitment that such requests are justifiable, and will be for the purpose of
ensuring quality, safety and efficacy of the submitted product.
▪ Guidance on format:
I- Quality Module
General notice regarding submission of CTD Quality Module

3.1: Table of contents of Module 3:
A table of content for the filed product dossier should be provided
3.2: Body of data
3.2.S: Drug Substance "S-Part"
The applicant should clearly indicate at the beginning of the API section how the information on
the API for each API manufacturer is being submitted:
▪ Option 1: Confirmation of API prequalification document
▪ Option 2: Certificate of suitability of the European Pharmacopoeia (CEP)
▪ Option 3: API master file (APIMF/DMF)
▪ Option 4: Full details in the Product Dossier
▪ Copy of the latest version of the CEP (including
any annexes) should be provided.
In case of Option 2: -CEP data should be consistent with that
Certificate of Suitability of the European available online on EDQM certification
Pharmacopoeia (CEP) Database.
▪ The declaration of access, should be duly filled
out by the CEP holder in order to authorize the
applicant company to use the CEP in support of
its marketing authorization application (MAA).

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Guideline
-And should include the name of pharmaceutical

company (FPP MAH/Manufacturer), the name
of the medicinal product(s).
▪ Written commitment that the applicant will
inform EDA in the event that the CEP is revised,
renewed or withdrawn by EDQM should be
submitted.
▪ Copy of the most recent European Monograph
for the API is required.
▪ A copy of the letter of access/authorization from
the DMF holder should be provided in the
In case of Option 3:
Product Dossier.
API master file (APIMF) /(DMF)
[details on Page .19]
procedure
▪ Restricted Part should be submitted from API
Manufacturer.
Clause
Item General Notice
3.2.S.1 General Information
▪ Information on the nomenclature of the API should
be provided. For example:
▪ (recommended) International Nonproprietary
Name (INN);
▪ compendial name, if relevant;
3.2.S.1.1 Nomenclature ▪ chemical name(s);
▪ company or laboratory code;
▪ Other nonproprietary name(s) (e.g. national name,
United States
▪ Chemical Abstracts Service (CAS) registry
number.
▪ The structural formula, including relative and
3.2.S.1.2 Structure absolute stereochemistry, the molecular formula and
the relative molecular mass should be provided.
▪ The physical and chemical properties of the API
should be discussed, including the physical
description, solubilities in common solvents (e.g.
water, alcohols, dichloromethane, acetone),
3.2.S.1.3 General properties quantitative aqueous pH solubility profile (e.g. pH
1.2 to 6.8, dose/solubility volume), polymorphism,
pH and pKa values, UV absorption maxima and
molar absorptivity, melting point, refractive index
(for a liquid), hygroscopicity, partition coefficient.
3.2.S.2 Manufacture
▪ The name, address and responsibility of each
manufacturer, including contractors, and each
3.2.S.2.1 Manufacturer(s)
proposed production site or facility involved in
manufacturing and testing should be provided.

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Guideline
▪ Information should be provided to adequately

describe the manufacturing process and process
controls. including:
▪ a flow diagram of the synthetic process(es)
should be provided that includes molecular
formulae, weights, yield ranges, chemical
structures of starting materials, intermediates,
reagents and API reflecting stereochemistry,
and identifies operating conditions and
solvents.
▪ A sequential procedural narrative of the
manufacturing process should be submitted.
Description of ▪ Alternate processes should be explained and
manufacturing described with the same level of detail as the
3.2.S.2.2
process and process primary process.
controls ▪ Reprocessing steps should be identified and
justified.
Note: Where the APIMF (DMF) procedure is used,
a cross-reference to the Restricted part of the
APIMF may be indicated for confidential
information. In this case, if detailed information is
presented in the Restricted part, the information to
be provided for this section includes a flow chart
(including molecular structures and all reagents and
solvents) and a brief outline of the manufacturing
process, with special emphasis on the final steps
including purification procedures.
▪ Materials used in the manufacture of the API

(e.g. raw materials, starting materials, solvents,
* Control of reagents, catalysts) should be listed identifying
3.2.S.2.3
materials where each material is used in the process.
▪ Information on the quality and control of these
materials should be provided.
▪ Critical steps: Tests and acceptance criteria
(with justification including experimental data)
performed at critical steps identified in
3.2.S.2.2 of the manufacturing process to
* Controls of
ensure that the process is controlled should be
3.2.S.2.4 critical steps and
provided
intermediates
▪ Intermediates: Information on the quality and
control of intermediates isolated during the
process should be provided.
* Process ▪ Process validation and/or evaluation studies for
3.2.S.2.5 validation and/or aseptic processing and sterilization should be
evaluation included.

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Guideline
▪ A description and discussion should be

provided of the significant changes made to the
* Manufacturing
manufacturing process and/or manufacturing
3.2.S.2.6 process
site of the API used in producing comparative
development
bioavailability or biowaiver, scale-up, pilot
and, if available, production-scale batches.
Note: * Where the APIMF procedure is used, a cross-reference to the Restricted part of the
APIMF is considered sufficient for this section.
3.2.S.3 Characterization
▪ Confirmation of structure based on e.g.
synthetic route and spectral analyses should be
Elucidation of
provided. Information such as the potential for
3.2.S.3.1 structure and other
isomerism, the identification of
characteristics
stereochemistry, or the potential for forming
polymorphs should also be included.
▪ Details on the principles for the control of
impurities (e.g. reporting, identification and
qualification) are outlined in the ICH Q3A,
Q3B and Q3C impurity guidelines.
▪ A discussion should be provided of the
potential and actual impurities arising from the
synthesis, manufacture, or degradation of the
3.2.S.3.2 Impurities
API “This should cover starting materials, by-
products, intermediates, chiral impurities and
degradation products and should include the
chemical names, structures and origins.”.
▪ Residual solvents, elemental risk assessment
and Genotoxic risk assessment should be
provided.
3.2.S.4 Control of the API
▪ Copies of the API specifications, dated and
signed by authorized personnel should be
provided, including specifications from each
API manufacturer as well as those of the FPP
manufacturer.
▪ Specifications should be presented in a tabular
form contains a list of tests, references to
3.2.S.4.1 Specification
analytical procedures (updated version) and
appropriate acceptance criteria,
▪ Copy of the recent Monograph for the API
should be submitted “if applicable”.
▪ In case where there is more than one API
manufacturer, the FPP manufacturer’s API
specifications should be one single compiled

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Guideline
set of specifications that apply to the API from

all manufacturers.
▪ The analytical procedures used for testing the
API should be provided.
Analytical
▪ Copies of the in-house analytical procedures
3.2.S.4.2 used to generate testing results provided in the
procedures
PD, as well as those proposed for routine
testing of the API by the FPP manufacturer,
should be provided.
▪ Analytical validation information, including
experimental data for the analytical procedures
used for testing the API, should be provided.
▪ Copies of the validation reports for the
Validation of analytical procedures used to generate test
3.2.S.4.3 analytical results provided in the PD, as well as those
procedures proposed for routine testing of the API by the
FPP manufacturer, should be provided.
▪ As recognized by regulatory authorities and
pharmacopoeias themselves, verification of
compendial methods can be necessary.
▪ Description of batches and results of batch
analyses should be provided.
▪ Batches analysis should be recent.
▪ The information provided should include batch
number, batch size, date, production site of
relevant API batches & the use of the batch
(comparative bioavailability or biowaiver
studies, preclinical and clinical data (if
3.2.S.4.4 Batch Analyses
relevant), stability, pilot-scale, production-scale
batches).
▪ Results should be provided from at least two
batches of at least pilot-scale from each
proposed manufacturing site of the API.
▪ Copies of the certificates of analysis, both from
the API manufacturer(s) and the FPP
manufacturer should be provided.
▪ The justification for certain tests, analytical
Justification of
3.2.S.4.5 procedures and acceptance criteria should be
specification
provided
3.2.S.5 Reference standards or materials
▪ Information on the reference standards or
Reference reference materials used for testing of the API
3.2.S.5 standards or should be provided.
materials ▪ The source(s) of the reference standards or
materials used in the testing of the API should

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Guideline
be provided (e.g. those used for the

identification, purity, and assay tests).
3.2.S.6 Container-closure system

▪ A description of the container-closure
system(s) should be provided, including the
identity of materials of construction of each
primary packaging component and their
specifications. The specifications should
include description and identification (and
critical dimensions with drawings, where
appropriate). Non-compendial methods (with
validation) should be included, where
appropriate.
Container-closure ▪ For non-functional secondary packaging

3.2.S.6
system components (e.g. those that do not provide
additional protection), only a brief description
should be provided. For functional secondary
packaging components, additional information
should be provided.
▪ The suitability should be discussed with respect

to, for example, choice of materials, protection
from moisture and light, compatibility of the
materials of construction with the API,
including sorption to container and leaching,
and/or safety of materials of construction.
3.2.S.7 Stability
▪ The types of studies conducted, protocols used
and the results of the studies should be
summarized. The summary should include
Stability Summary
3.2.S.7.1 results, for example, from forced degradation
and Conclusions
studies and stress conditions, as well as
conclusions with respect to storage conditions
and retest date or shelf-life, as appropriate.
In case of the available long-term data on the
stability of primary batches do not cover the
Post-approval proposed retest period,
Stability Protocol a written commitment (signed and dated) to
3.2.S.7.2
and Stability continue long-term testing over the retest
Commitment period should be included in the dossier when
relevant.

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Guideline
In case of stability data were not provided for

three production batches, written commitment
(signed and dated) should be included in the
dossier and the stability protocol for the
commitment batches should be provided.
A written commitment (signed and dated) for
ongoing stability studies should be included
in the dossier.
▪ The actual stability results used to support the
proposed retest period should be included in the
dossier.
3.2.S.7.3 Stability Data
▪ The Data should be submitted in a tabular form
including: (Manufacturing date, manufacturer
name & site, stability loading date, batch
number, storage condition & container closure
system).
3.2.P: Drug product (or finished pharmaceutical product (FPP)) "P-Part"

3.2.P.1 Description and Composition of the Drug Product
▪ A description of the FPP and its composition
should be provided. The information provided
should include, for example:
▪ Description of the dosage form
▪ Composition: list of all components of the
dosage form and their amount on a per unit
basis (including overages, if any), the function
Description and
of the components and a reference to their
3.2.P.1 Composition of
quality standards (e.g. compendial
the Drug Product
monographs or manufacturer’s
specifications).
▪ Description of accompanying reconstitution
diluent(s)
▪ Type of container and closure used for the
dosage form and accompanying reconstitution
diluent, if applicable.
3.2.P.2 Pharmaceutical Development
▪ The Pharmaceutical Development section should contain information on the development
studies conducted to establish that the dosage form, the formulation, manufacturing process,
container-closure system, microbiological attributes and usage instructions are appropriate for
the purpose specified in the product dossier.
▪ Pharmaceutical development information should include, at a minimum:
- The definition of the quality target product profile (QTPP) as it relates to quality, safety and
efficacy, considering for example the route of administration, dosage form, bioavailability,
strength and stability;

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Guideline
- Identification of the potential critical quality attributes (CQAs) of the FPP so as to

adequately control the product characteristics that could have an impact on quality;
- Discussion of the potential CQAs of the API(s), excipients and container-closure system(s)
including the selection of the type, grade and amount to deliver pharmaceutical product of the
desired quality;
- Discussion of the selection criteria for the manufacturing process and the control strategy
required to manufacture commercial lots meeting the QTPP in a consistent manner.
▪ 3.2.P.2.1.1 Active pharmaceutical
ingredient:
▪ The compatibility of the API with
excipients listed in 3.2.P.1 should be
discussed. Additionally, key
physicochemical characteristics of the
API that can influence the performance
of the FPP should be discussed.
Components of the
3.2.P.2.1 ▪ For fixed-dose combinations, the
FPP
compatibility of APIs with each other
▪ 3.2.P.2.1.2 Excipients:
▪ The choice of excipients listed in
3.2.P.1, their concentration, their
characteristics that can influence the
FPP performance should be discussed
relative to their respective functions
▪ 3.2.P.2.2.1 Formulation Development:
▪ A brief summary describing the
development of the FPP should be
provided, taking into consideration the
proposed route of administration and
usage.
▪ In case of generic products, results
from comparative in vitro studies (e.g.
dissolution) or comparative in vivo
studies (e.g. bioequivalence) should be
Finished discussed.
3.2.P.2.2 pharmaceutical ▪ 3.2.P.2.2.2 Overages:
product ▪ Any overages in the formulation(s)
described in 3.2.P.1 should be justified.
▪ 3.2.P.2.2.3 Physicochemical and biological
properties:
▪ Parameters relevant to the performance of the
FPP, such as pH, ionic strength, dissolution,
redispersion, reconstitution, particle size
distribution, aggregation, polymorphism,
rheological properties, biological activity or
potency, and/or immunological activity, should
be addressed.

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▪ The selection and optimization of the

Manufacturing manufacturing process described in 3.2.P.3.3,
3.2.P.2.3 process in particular its critical aspects, should be
development explained. Where relevant, the method of
sterilization should be explained and justified.
▪ The suitability of the container closure system
(described in 3.2.P.7) used for the storage,
transportation (shipping) and use of the FPP
▪ This discussion should consider, e.g. choice of
Container-closure materials, protection from moisture and light,
3.2.P.2.4
system compatibility of the materials of construction
with the dosage form (including sorption to
container and leaching) safety of materials of
construction and performance (such as
reproducibility of the dose delivery from the
device when presented as part of the FPP).
▪ Where appropriate, the microbiological
attributes of the dosage form should be
discussed, including, for example, the rationale
for not performing microbial limits testing for
non-sterile products and the selection and
Microbiological
3.2.P.2.5 effectiveness of preservative systems in
attributes
products containing antimicrobial
preservatives.
▪ For sterile products, the integrity of the
container-closure system to prevent microbial
contamination should be addressed.
▪ The compatibility of the FPP with
reconstitution diluent(s) or dosage devices (e.g.
precipitation of API in solution, sorption on
3.2.P.2.6 Compatibility
injection vessels, stability) should be addressed
to provide appropriate and supportive
information for the labelling.
3.2.P.3 Manufacture
▪ The name, address and responsibility of each
manufacturer, including contractors, and each proposed
3.2.P.3.1 Manufacturer(s)
production site or facility involved in manufacturing and
testing should be provided.
▪ A batch formula should be provided that includes a list
of all components of the dosage form to be used in the
3.2.P.3.2 Batch formula manufacturing process, their amounts on a per batch
basis, including overages, and a reference to their quality
standards.
▪ A flow diagram should be presented giving the steps of
Description of
3.2.P.3.3 the process and showing where materials enter the
Manufacturing
process. The critical steps and points at which process

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Guideline
Process and controls, intermediate tests or final product controls are

Process Controls conducted should be identified.
▪ A narrative description of the manufacturing process,

including packaging that represents the sequence of steps
undertaken and the scale of production should also be
provided. Novel processes or technologies and packaging
operations that directly affect product quality should be
described with a greater level of detail. Equipment
should, at least, be identified by type (e.g. tumble
blender, in-line homogenizer) and working capacity,
where relevant.
▪ Steps in the process should have the appropriate process

parameters identified, such as time, temperature or pH.
Associated numeric values can be presented as an
expected range. Numeric ranges for critical steps should
be justified in Section 3.2.P.3.4. In certain cases,
environmental conditions (e.g. low humidity for an
effervescent product) should be stated.
▪ The maximum holding time for bulk FPP (product prior

to final packaging, e.g. tablets in HDPE drums) should
be stated. The holding time should be supported by the
submission of stability data, if longer than 30 days.
▪ For the manufacture of sterile products, the class (e.g. A,

B, C, etc.) of the areas should be stated for each activity
(e.g. compounding, filling, sealing, etc.), as well as the
sterilization parameters for equipment, container/closure,
terminal sterilization, etc.
▪ Critical steps: Tests and acceptance criteria should be
provided (with justification, including experimental data)
performed at the critical steps identified in 3.2.P.3.3 of
Controls of critical
the manufacturing process, to ensure that the process is
3.2.P.3.4 steps and
controlled.
intermediate
provided.
▪ Description, documentation, and results of the validation
and/or evaluation studies should be provided for critical
steps or critical assays used in the manufacturing process
Process Validation (e.g. validation of the sterilization process or aseptic
3.2.P.3.5
and/or Evaluation processing or filling). Viral safety evaluation should be
provided in 3.2A.2, if necessary.
▪ The following information should be provided for all
products:

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Guideline
▪ a copy of the process validation protocol, specific to the

FPP
▪ a commitment that three consecutive, production-scale
batches of this FPP will be subjected to prospective
validation in accordance with the above protocol; the
applicant should submit a written commitment that
information from these studies will be available for
verification after approval.
▪ if the process validation studies have already been
conducted (e.g. for sterile products), a copy of the
process validation report should be provided
3.2.P.4 Control of excipients
▪ COA of excipients (If Applicable).

▪ The specifications for excipients should be provided.
▪ If the standard claimed for an excipient is an officially-
recognized compendial standard, it is sufficient to state
that the excipient is tested according to the requirements
of that standard, rather than reproducing the
specifications found in the officially-recognized
3.2.P.4.1 Specifications
compendial monograph.
▪ If the standard claimed for an excipient is a non-
compendial standard (e.g. in-house standard) or includes
tests that are supplementary to those appearing in the
officially-recognized compendial monograph, a copy of
the specification for the excipient should be provided.
▪ The analytical procedures used for testing the excipients
Analytical
3.2.P.4.2
procedures
▪ Copies of analytical procedures from officially-
recognized compendial monographs do not need to be
submitted.
Validation of
experimental data, for the analytical procedures used for
testing the excipients should be provided, where
procedures
appropriate.
▪ Justification for the proposed excipient specifications
Justification of
3.2.P.4.4
specifications
▪ A discussion of the tests that are supplementary to those
appearing in the officially-recognized compendial
monograph should be provided.
Excipients of
▪ For excipients of animal origin, certificate of TSE
3.2.P.4.5 Human or Animal
compliance should be provided.
Origin
▪ For excipient(s) used for the first time in an FPP or by a
3.2.P.4.6 Novel excipients new route of administration, full details of manufacture,
characterization, and controls, with cross-references to

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Guideline
supporting safety data (nonclinical and/or clinical)

should be provided according to the API and/or FPP
format (details in 3.2.A.3).
3.2.P.5 Control of FPP
▪ A copy of the FPP specification(s) from the applicant (as
well as the company responsible for the batch release of
the FPP, if different from the applicant), dated and
signed by authorized personnel should be provided in the
PD.
3.2.P.5.1 Specification(s) ▪ Two separate sets of specifications may be set out: after
packaging of the FPP (release) and at the end of shelf-
life.
(updated version) and appropriate acceptance criteria,
▪ The analytical procedures used for testing the FPP
should be provided.
▪ Copies of the in-house analytical procedures used during
Analytical pharmaceutical development (if used to generate testing
3.2.P.5.2
procedures results provided in the PD) as well as those proposed for
▪ For pharmacopeial products: Copy of the recent
Monograph should be submitted.
experimental data, for the analytical procedures used for
Validation of
testing the FPP, should be provided.
procedures
▪ Copies of the validation reports for the in-house
analytical procedures used as well as those proposed for
▪ A description of batches and results of batch analyses
should be provided.
▪ Information should include strength and batch number,
batch size, date and site of production and use (e.g. used
in comparative bioavailability or biowaiver studies,
3.2.P.5.4 Batch Analyses
preclinical and clinical studies (if relevant), stability, pilot,
scale-up and, if available, production-scale batches).
▪ Analytical results tested by the company responsible for
the batch release of the FPP should be provided for not
less than two batches of at least pilot scale.
▪ Information on the characterization of impurities should
be provided.
Characterization of
▪ A discussion should be provided of all impurities that are
3.2.P.5.5 potential degradation products (including any of the
impurities
impurities identified in 3.2.S.3.2 as well as potential
degradation products resulting from interaction of the
API with other APIs (FDCs), excipients or the container-

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Guideline
closure system) and FPP process-related impurities (e.g.

residual solvents in the manufacturing process for the
FPP).
▪
▪ Justification for the proposed FPP specification(s) should
be provided.
▪ A discussion should be provided on the omission or
inclusion of particular tests, evolution of tests, analytical
Justification of
3.2.P.5.6 procedures and acceptance criteria, differences from the
specification(s)
officially-recognized compendial standard(s).
▪ If the officially-recognized compendial methods have
been modified or replaced, a discussion should
be included.
3.2.P.6 Reference standards or materials
▪ Information on the reference standards or reference
Reference materials used for testing of the FPP should be provided.
3.2.P.6 standards or ▪ The source(s) of the reference standards or materials used
materials in the testing of the FPP should be provided (e.g. those
used for the identification, purity, and assay tests).
3.2.P.7 Container-closure system
▪ A description of the container-closure systems should be
provided, including the identity of materials of
construction of each primary packaging component and
its specification. The specifications should include
description and identification (and critical dimensions,
with drawings where appropriate). Non-compendial
methods (with validation) should be included, where
Container-closure
3.2.P.7 appropriate.
system
▪ For non-functional secondary packaging components
(e.g. those that neither provide additional protection nor
serve to deliver the product), only a brief description
should be provided.
▪ For functional secondary packaging components,
additional information should be provided.
▪ Suitability information should be located in 3.2.P.2.
3.2.P.8 Stability
▪ The types of studies conducted, protocols used, and the
results of the studies should be summarized. The
Stability Summary
3.2.P.8.1 summary should include, for example, conclusions with
and Conclusion
respect to storage conditions and shelf-life, and, if
applicable, in-use storage conditions and shelf-life.
Post-approval ▪ Primary stability study commitment:
3.2.P.8.2 Stability Protocol In case of the available long-term data on the stability of
and Stability primary batches do not cover the proposed shelf life, a
Commitment written commitment (signed and dated) to continue long-

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Guideline
term testing over the shelf life period should be included

in the dossier.

Where stability data were not provided for three
production batches of each strength, a written
commitment (signed and dated) should be included in the
dossier.

A written commitment (signed and dated) to monitor the
product over its shelf-life and to determine that the
product remains within specifications should be included
in the dossier.
▪ The actual stability results/reports used to support the
proposed shelf-life should be provided
▪ The Data should be submitted in a tabular form including:
3.2.P.8.3 (Product Name, strength, dosage form, manufacturing
Stability Data
date, manufacturer name & site, stability loading date,
batch number, storage condition & container closure
system) & also API batch number, manufacturer name &
site.
3.2.A Appendices
3.2.A.1 Facilities and equipment
▪ Not applicable
3.2.A.2 Adventitious agents safety evaluation
3.2.A.3 Novel excipients
▪ If novel excipients are accepted, full information should be provided in the format of the
sections in 3.2.P.
3.2.R Regional information

3.2.R.1 Production documentation
▪ Copies of the executed production documents
3.2.R.1.1 Executed production should be provided.
documents ▪ English translations of executed records should be
provided, where relevant.
▪ Copies of the FPP master production documents
3.2.R.1.2 Master production
should be provided for each proposed strength,
documents
commercial batch size and manufacturing site.
3.2.R.2 Analytical procedures and validation information

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Guideline
▪ The tables presented in section 2.3.R.2 in the QOS-PD template may be used to summarize the
analytical procedures and validation information from sections 3.2.S.4.2, 3.2.S.4.3, 2.3.S.4.4
(c), 2.3.S.7.3 (b), 3.2.P.5.2 and 3.2.P.5.3, where relevant.
3.3 Literature references
▪ References to the scientific literature relating to both the API and FPP should be included in
this section of the PD when appropriate.
General Notes:
Note 1: For a drug product containing more than one drug substance, the information requested for “S-
part” should be provided in its entirety for each drug substance.
Note 2: For a drug product supplied with reconstitution solvent(s), the information on the solvent(s)
should be provided in a separate “P-part” as appropriate. (Not applicable for solvents with registration
license).
Note 3:
The above CTD Structure illustrates the whole Quality Module (Module 3 of the CTD File), In case of
Variations the applicant has to submit the relevant sections in accordance to the variation type.
Abbreviations:
▪ “drug substance” is replaced with “active pharmaceutical ingredient” or “API”;
▪ “drug product” is replaced with “finished pharmaceutical product” or “FPP”;
▪ “application” is replaced with “product dossier” or “PD”;
▪ “combination product” is replaced with “fixed-dose combination” or “FDC”;
For More Detailed information about CTD sections of Quality module documentation and
submission, kindly refer to:
“WHO: Annex 6 Guidelines on submission of documentation for a multisource (generic) finished
pharmaceutical product: quality part”
Link: https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex6.pdf?ua=1

Version/Year:3/2023
Guideline
II- Administrative Documents

▪ Application form (Template Attached) (On company letterhead signed, stamped and dated)
▪ Cover letter on brief description of variation type (along with comparison table with the current and
proposed statues).
▪ Previous Approval of the quality file.
▪ Primary variation approval from Administration of Human Pharmaceuticals Variation.
▪ Registration license
▪ Preliminary approval for the re-registration (for re-registration products)
▪ Any Pre-approved letters from EDA concerning the product during previous registration period (e.g.
Technical committee decisions, …….)
▪ Declaration (On company letterhead signed, stamped and dated)
To state all the variations done to the product through its registration period.
▪ EDA Labs API certificate (for local products) (if required/available; in case of variations related to the
API supplier)
▪ EDA Labs FPP certificate & composition (if required/available; supporting new variation application)
▪ Stability approval (if required/available; supporting new variation application)
▪ Bioequivalence approval "If applicable" (if required/available; supporting new variation application)
Certificate of Pharmaceutical Product (CPP) issued by the Competent Authority in the Country of
Origin (Valid, Legalized & Including product's composition and Smpc.)
(if required/available; supporting new variation application)
▪ Copy of certificate(s) of suitability of the European Pharmacopoeia (CEP) (including any annexes) "If
applicable"(if required/available; in case of variation related to the API supplier)
(Template Attached) "If applicable"(if required/available; in case of variation related to the API supplier)

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Guideline
#Application form Template#

Application Form for variations on Quality Module File
Trade Name:
Active Ingredient(s) & Strength (s):

Registration information Registration date:
Registration number:
Previous approval date of Quality file:
Primary approval of Administration of Approval date:

Human Pharmaceuticals Variation
Type of variation Change or addition or deletion of ………………………
Applicant:
License Holder/MAH:
Manufacturer: (Current and proposed status to be fulfilled)
Note: if the variation is concerning to the change in the one of the

manufacturing sites; current and proposed status should be
illustrated.
Packaging site: (Current and proposed status to be fulfilled)
Batch release site: (Current and proposed status to be fulfilled)
Proposed Pack: (Current and proposed status to be fulfilled)
Type of registration: 󠇤Local 󠇤Toll/F-Toll

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Guideline
󠇤Under-license 󠇤󠇤Toll /F-Toll Under-

License
󠇤󠇤Imported
󠇤Imported Bulk
API(s) Manufacturer name, Address and (Current and proposed status to be fulfilled)
Country of origin:
Note: if the variation is concerning to change in the API
manufacturing site; current and proposed status to be illustrated.
API information submitted as: 󠇤Prequalification 󠇤 DMF

󠇤 CEP 󠇤 Full details in the PD
(if required/available; in case of variations related to the API
supplier).
CEP number and issue date:
"If applicable"
Reference Drug Product (Note: According to bioequivalence approval)
Reference name:
Name of reference Product
(RLD, RS, … )
Name of MAH, Manufacturer and

Country of origin
Applicant Company Representative
Name:
Telephone number:
E-mail:
Registration Manager •
Company Stamp
• Name:
• Signature:
Date:

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Guideline
Link for editable application template:

https://docs.google.com/document/d/1eFvinqJDChdrJiPAwdWMOFnRxmGM4fec/edit?usp=sharing&o
uid=111862349084529780102&rtpof=true&sd=true

FILE
Before EDA can review DMF information in support of an application, the DMF holder must
submit in duplicate to the DMF a letter of authorization permitting EDA to reference the
DMF.
The letter of authorization should include the following:
1. The date.
2. Name of DMF holder.
3. DMF version number.
4. Name of person(s) authorized to incorporate information in the DMF by reference.
5. Specific product(s) covered by the DMF.
6. Statement of commitment that the DMF is current and that the DMF holder will comply
with the statements made in it.
7. Signature of authorizing official.
8. Typed name and title of official authorizing reference to the DMF.
Link for editable Letter of authorization (access) Template:

https://docs.google.com/document/d/16OKC9Qcd1LByiJm1dQy97KZx3k1DwZmg/edit?usp=sharing&o
To be submitted on the API supplier letterhead.

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Guideline
Guidance for submission of products for Evaluation of (Composition & finished

product specifications) / API specifications/ S-Part
Scope:
This guidance applies for any human pharmaceutical product submitted for registration according to
the Ministerial decree 645/2018, 425/2015,820/2016 or EDA Chairman Decree 450/ 2023 case 1,
2& 3 or according to Emergency Use Authorization procedures.
Objective:
This guidance aims to provide applicants with the documents and information required for preparing
and submitting the files for evaluation of (Composition & finished product specifications) /API
specifications/S-Part (Submitted for evaluation prior to file submission).
It should be noted that Egyptian Drug Authority has the right to request any further information or
documents, with a commitment that such requests are justifiable, and will be for the purpose of
ensuring quality, safety and efficacy of the submitted product.
Item No. EUA Products submitted

Products according to Ministerial
Decree425/2015 645/2018
Required Documents
and EDA Chairman
Decree (450/2023) Case
1,2&3 for evaluation of
FPP AP s-part
Comp. specs
&
specs
1 Application Form (Attached: Template #1) R R R R

On company letterhead signed, stamped and dated
2 Action Letter R R R R
3 Name approval R R R R
4 Fees Payment Receipt N.A R R R
5 Declaration states reference drug product used in the N.R R N.R N.R
developmental studies.
On Applicant Co. letterhead signed, dated and stamped
(Attached: Template #2)
6 Bioequivalence Unit approval for reference drug product N.R R N.R N.R
which will be used in bioequivalence or in-vitro study (If
applicable).

Version/Year:3/2023
Guideline
7 Proposed API/ Semi-Finished or Intermediate product R N.R R I

specifications
8 CoA of API/ Semi-Finished or Intermediate product R F.I R I
On API manufacturer letterhead signed, dated and stamped
9 Detailed description of container closure system of API/ Semi- R N.R R I
Finished or Intermediate product
On API manufacturer letterhead signed, dated and stamped
10 Proposed composition certificate R R N.R N.R
11 Declaration for calculation of equivalent base of API/ Semi- R R N.R N.R
Finished or Intermediate product (If applicable).
12 CoA of all excipient(s) R R N.R N.R
On excipient`s manufacturer letterhead signed, dated and
stamped.
13 Proposed FPP specification R R N.R N.R
14 Detailed description of container closure system of FPP R F.I N.R N.R
15 Data certificate license for pharmaceutical plant R R N.R N.R
(manufacturer of FPP)
Including the suitable production area and line for the FPP
16 Description of manufacturing process (flow diagram) F.I F.I N.R N.R
On FPP manufacturer letterhead signed, dated and stamped
17 Drug Master File (Including the Restricted Part) N.R N.R N.R R
From the API Manufacturer (For Each API).
Attached with:
1-letter of access from the supplier.
2- Summary Sheet of stability file
(On the Applicant letterhead and according to the template on
following link:
https://docs.google.com/document/d/1jolSqWNMskUdTU9Tr
-
6D1hO6zoF1CdEG/edit?usp=sharing&ouid=1118623490845
29780102&rtpof=true&sd=true
▪ For details, please refer to this section in the quality module
submission guidance, on the following link:
https://drive.google.com/file/d/1M_ew9dDDgdyod61r7Md3w
rppEftC7S4Y/view?usp=sharing

Version/Year:3/2023
Guideline
18 Scientific committee approval (in case of non-reference R R R R

products)
Notes:
▪ Semi-Finished or Intermediate product: Partially processed products that undergo further
manufacturing process before it becomes a bulk product.
▪ Fees Payment Receipt: 7,000 L.E. for each type of evaluation for products submitted
according to Ministerial Decree 645/2018 and EDA Chairman Decree (450/2023) case 3.
N.B.:
-Different Strengths of the FPP and different API Suppliers are considered separate
applications.
-The following data should be specified on the receipt: Trade Name, Dosage Form, Strength
&Type of evaluation required.
▪ For EUA Products Evaluation:

In case of registered products submitted for evaluation of new API manufacturer:
Document #2 should be replaced with: Registration License.
Document #3 should be REed with: Variation Approval.
▪ Abbreviations
R : The Document is required.
N.R : The Document is Not Required.
F.I : The Document is required for information & will not be a subject for evaluation.
N.A : Not Applicable.
I : Included within the S-Part.

Version/Year:3/2023
Guideline
Documents naming, file preparation and arrangement

1- All Templates: to be filled by the Applicant company on the Applicant’s letter head signed and stamped
by the applicant company, then attached as an Adobe Acrobat Document (.pdf)
-Link for editable copies of the templates:
https://docs.google.com/document/d/1kwzhfT2uCJLGVYATAlDeYvK9CkssUXJ4/edit?usp=sharing&o
2- All items from ( 1 to 17): documents should be submitted in form of separate Adobe Acrobat Document
(.pdf) under File names ;
Item Adobe Acrobat Document (.pdf)

No. File Name:
1 Application Form (Trade Name-Concentration-Dosage form)
2 Action letter (Trade Name-Concentration-Dosage form) (In case of Under-Registration products)

Or Registration License (Trade Name-Concentration-Dosage form) (In case of Registered products)
3 Name approval - (Trade Name-Concentration-Dosage form) (In case of Under-Registration products)
Or Variation approval (Trade Name-Concentration-Dosage form) (In case of Registered products)
4 Fees Payment Receipt (Trade Name-Concentration-Dosage form)
5 BE- (Trade Name-Concentration-Dosage form)
6 Ref- (Trade Name-Concentration-Dosage form)
7 API Specs- (Trade Name-Concentration-Dosage form) (API name-API manuf.name)
8 CoA API- (Trade Name-Concentration-Dosage form) (API name-API manuf.name)
9 CCS API- (Trade Name-Concentration-Dosage form) (API name-API manuf.name)
10 Composition- (Trade Name-Concentration-Dosage form)
11 Equivalence- (Trade Name-Concentration-Dosage form)
12 CoA Inactive- (Trade Name-Concentration-Dosage form)
13 FPP Specs- (Trade Name-Concentration-Dosage form)
14 CCS FPP- (Trade Name-Concentration-Dosage form)
15 Data Certificate- (FPP Manufacturer Plant Name)
16 Mfr process- (Trade Name-Concentration-Dosage form)
17 DMF- (Trade Name-Concentration-Dosage form) (API name-API manuf.name)
18 Scientific committee approval - (Trade Name-Concentration-Dosage form)
3- All (.pdf) files should be uploaded in one Compressed folder named and dated:
(Trade name-generic –Concentration-Dosage form) (dd-mm-yy)

Version/Year:3/2023
Guideline
Template #1
Application Form
Trade Name: This section to be filled by the Applicant company
Generic Name(s) + Strength(s): This section to be filled by the Applicant company
Dosage Form: This section to be filled by the Applicant company
Box Approval /Registration No: This section to be filled by the Applicant company
Applicant Company: This section to be filled by the Applicant company
Manufacturer of FPP: This section to be filled by the Applicant company
Packaging & Batch release site: This section to be filled by the Applicant company
Manufacturer(s) of API: This section to be filled by the Applicant company
Reference of Quality Standards of API: (USP, Ph. Eur., B.P..) This section to be filled by the Applicant company
Solvent’s Registration status & supplier (If applicable): This section to be filled by the Applicant company
Type of Evaluation required: This section to be filled by the Applicant company
Notes: This section to be filled by the Applicant company
Contact Information:
Applicant Company regulatory FPP Manufacturer (R&D department)

Representative.
Representative.
- Title: This section to be filled by the Applicant company This section to be filled by the Applicant company
- Name: This section to be filled by the Applicant company This section to be filled by the Applicant company
- Mobile: This section to be filled by the Applicant company This section to be filled by the Applicant company
- E-mail: This section to be filled by the Applicant company This section to be filled by the Applicant company
- - Registration Manager
-
- - - Name :
- Signature:
- Date:
-
Company Stamp
Notes on submission of Template #1: (To be deleted)

1- This template should be copied and submitted on Applicant Company letterhead.

Version/Year:3/2023
Guideline
Template #2
Title: Declaration states reference drug product used in developmental
studies
Reference Product Details:
Reference Drug Product
Name, strength and dosage This section to be filled by the Applicant company
form of reference Product
Name of MAH, Manufacturer This section to be filled by the Applicant company

and Country of origin
Applicant Company Signature, Date & Stamp:
Notes on submission of Template # 2: (To be deleted)

1-This template should be copied and submitted on Applicant Company letterhead.

Version/Year:3/2023
Guideline
Template #3
Title: Proposed API/ Semi-Finished or Intermediate product specifications
Generic Name(s) + This section to be filled by the Applicant company

Strength(s):
Test / Analytical Method Acceptance Criteria Reference

2- Universal tests are mandatory (Description, Identification, Assay, Impurities).
3- The Analytical method should be specified under the name of the test in case of:
-Instrumental Methods used: (for example: Identification by (IR, UV, HPLC, TLC), Assay by
(HPLC), Residual Solvents by (GC), Polymorphism by (XRPD, DSC)).
-Specific Analytical Method used: (for example: Water Content by (Karl Fischer or Loss on
Drying), Particulate Matter by (Light Obscuration or Microscopic), and Uniformity of Dosage
Unit by (Content Uniformity or Weight Variation).
4- Reference: (for example: BP, USP, JP, Ph. Eur., ICH, In-house), with detailed data (current
edition of pharmacopeia, General chapter number, ICH guidelines number … etc)

Version/Year:3/2023
Guideline
Template #4
Title: Proposed composition certificate
Ingredient(s) Amount/ Unit Percentage Function Reference

% w/w or (Compendial
% w/v or In-house)
API
Excipient
Total weight / Volume

2- API (s), it’s (their) hydrate(s) and salt form(s) with its (their) quantity (ies) per unit dose is (are)
specified.
3- Grades of excipient should be mentioned beside excipient name.
4- Coat or Capsule Shell should be mentioned separate from the core or capsule content.
5- Weight of core tablet or content of capsule should be mentioned separately from total weight.
6- Solvents and Nitrogen Gas used during manufacturing process: to be mentioned as manufacturing
auxiliary agent.
7- Composition of all components used as mixtures should be mentioned in details and submitted on
supplier’s Letterhead (e.g. Pellets, premixes, colorants, coatings, capsule shells and imprinting inks).
8- The Overage should be mentioned, and justification should be submitted on a separate document.
9- Reconstitution Solvents should be mentioned if present. (Not applicable for solvents with
registration license).
10- In case of Pellets & Premix: composition on supplier letterhead should be attached.

Version/Year:3/2023
Guideline
Template #5
Title: Declaration for calculation of

-Equivalent base of API/ Semi-Finished or Intermediate product
-Quantity of pellets / Premix

Strength(s):
Calculations:

2- Detailed calculation steps should be provided.

Version/Year:3/2023
Guideline
Template # 6
Title: Proposed FPP specifications.

Strength(s):
Test / Analytical Method Acceptance Criteria Reference

2- Universal tests are mandatory (Description, Identification, Assay, Impurities).
3- The Analytical method should be specified under the name of the test in case of:
-Instrumental Methods used: (for example: Identification by (IR, UV, HPLC, TLC), Assay by
(HPLC), Residual Solvents by (GC), Polymorphism by (XRPD, DSC)).
-Specific Analytical Method used: (for example: Water Content by (Karl Fischer or Loss on
Drying), Particulate Matter by (Light Obscuration or Microscopic), and Uniformity of Dosage
Unit by (Content Uniformity or Weight Variation).
4- Reference: (for example: BP, USP, JP, Ph. Eur., ICH, In-house), with detailed data (current
edition of pharmacopeia, General chapter number, ICH guidelines number … etc)

Version/Year:3/2023
Guideline
Template # 7
Title: Description of container closure system for FPP

Strength(s):
FPP Container Closure System:

2- Detailed description of container closure system: (1ry, 2ry packaging components, unit count,
fill size, container volume, dispensing or administration device … etc.)

Version/Year:3/2023
Guideline
Template # 8
Title: Description of manufacturing process of FPP (flow diagram)

Strength(s):
Flow Diagram:
FPP manufacturer Signature(s), Date & Stamp:

Applicant Company Stamp:

1- This template should be copied and submitted on FPP manufacturer letterhead.
2- Flow diagram illustrating manufacturing process including (input materials, order of addition,
manufacturing steps, equipment used with parameters, in-process control… etc.).

Version/Year:3/2023
Guideline
Application Form for Preliminary Evaluation of Intermediate Product
Trade Name:
Active Ingredient(s) & Strength

(s):
Applicant Company:
Manufacturer of FPP:
Packaging & Batch release site of

FPP
Intermediate Name:
API(s) Manufacturer name,

Address and Country of origin:
Reference of Quality Standards of

API: (USP, Ph. Eur., B.P….)
Date of submission of DMF of the
API for Evaluation.
Reviewer Pharmacist:

Version/Year:3/2023
Guideline
SECTION FIVE
Requirements for Submission of Bioequivalence and

In-vitro dissolution studies

Version/Year:3/2023
Guideline
SECTION FIVE: Requirements for Submission of Bioequivalence and In-vitro

dissolution studies
This section will provide information about Requirements for Submission of Bioequivalence and
In-vitro dissolution studies for Human pharmaceutical product
The files to be submitted should be arranged as the following:
For Studies Submission
Submit a link with one compressed folder named after the ‘Product Name – Concentration
– Company abbreviation’ through the Google form contains:
1- Study report: One Searchable pdf file named after ‘Product Name – Concentration –
Study Report’ to be done and arranged according to the Format and Content of Studies.
2- Administrative Documents: One Folder contains separate pdf files named after the
type of document required (ex. Registration License, Composition... etc.) done and
arranged according to the Studies Checklist.
For Appeals and Inquires Submission
Submit a link with one folder named with Product Name – Concentration – Company abbreviation
through the Google form contains:
The administrative documents contain separate pdf files named after the type of document required
(ex. Registration License, Composition …etc.) done and arranged according to theAppeals and requests
Checklist.

Version/Year:3/2023
Guideline
Study Reports
A- Format and Content of Bioequivalence Study Report
1. Title page
1.1 Study title
1.2 Name of the test drug & dosage form
1.3 Name of active ingredient(s) & conc.
1.4 Name of manufacturer & sponsor
1.5 Name of the reference drug & dosage form
1.7 Name of manufacturer, sponsor & country of origin
1.9 Name, affiliation and signature of: (dated)
1.9.1 Chairman of the board
1.9.2 Center manager
1.9.3 Technical manager
1.9.4 Chief analyst
1.9.5 Quality assurance manager
1.9.6 Sponsor representative
2. Study Synopsis
2.1 Study Title
2.2 Project No.:
2.3 study center:
2.4 Dates of:
2.4.1 Contract with sponsor
2.4.2 Protocol approval
2.4.3 In-vitro phase
2.4.4 IRB or ethics committee approval
2.4.5 Screening of volunteers
2.4.6 Phase I
2.4.7 Phase II
2.4.8 Start of analysis
2.4.9 End of analysis
2.4.10 Report issue
2.5 Objective
2.6 study design:
2.7 Subjects:
2.7.1 Disposition of volunteers
No. of screened volunteers
No. of withdrawn volunteers
No. of enrolled volunteers
No. of excluded volunteers
Final no. of volunteers participated in the study

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Guideline
2.8 Diagnosis and Main Criteria for Inclusion:

2.9 Treatment
Treatment Identification: Test Product Reference Product
1. Product name
2. API(S)
3. Molecular and structural formula
4. Dosage form
5. Type of the product (Immediate or
modified release)
6. Dosage regimen
7. Strength
8. Batch number
9. Manufacture date
10. Expiry date
11. Storage conditions
12. Manufacturer & Sponsor
2.10 Duration of Treatment:
2.11 Blood Sampling Points:
2.12 Summary of analytical procedure (method of analysis)
2.13 Pharmacokinetic parameters & Statistical methods
2.14 Figures & Summary of Results
2.14.1 Figure of mean plasma concentration - time profile (linear - semilog)
with standard deviation bars
Figure of mean cumulative urinary excretion (if applicable)
Figure of mean urinary excretion rates (if applicable)
2.14.2 Results and conclusion (tables of mean parameters Cmax, AUC0→∞,
AUC0→t, Ke & T1/2) "untransformed - transformed" including the
mean of Tmax "untransformed"
90% confidence interval "C.I"& Point estimate for Pharmacokinetic
parameters (AUC0→t, AUC0→∞, Cmax)
2.15 Conclusion
2.15.1 Efficacy Results
2.15.2 Safety Results
3 Table of Contents
4 Glossary of Abbreviations and Definition of Terms
5 Ethics
5.1 Independent Ethics Committee (IEC) or Institutional Review Board (IRB).
5.2 Ethical Conduct of the Study
5.3 Subject Information and Consent
6 Investigators and Study Administrative Structure

Version/Year:3/2023
Guideline
7 Introduction
7.1 Drug Review
7.1.1 Pharmacokinetic characteristics
7.1.2 Pharmacodynamics, indications
7.1.3 Side effects & contraindications
7.1.4 Other information
8 Study Objectives
9 Investigational Plan
9.1 Overall Study Design & Plan Description
9.2 Discussion of Study Design
9.3 Selection of Study Subject
9.3.1 Inclusion Criteria
9.3.2 Exclusion Criteria
9.3.3 Removal of Subjects
9.4 Treatments
9.4.1 Treatments Administered
9.4.2 Identity of Investigational Product(s)
9.4.3 Method of assigning subjects to treatment groups
9.4.4 Selection of doses in the study
9.4.5 Selection and timing of dose for each subject
9.4.6 Blinding
9.4.7 Prior and concomitant therapy (if needed)
9.4.8 Treatment compliance
9.5 Efficacy and Safety Variables
9.5.1 Efficacy and Safety Measurements
9.5.2 Appropriateness of Measurements
9.5.3 Primary efficacy variable(s)
9.5.4 Drug Concentration Measurements
9.6 Data Quality Assurance
9.7 Statistical Methods
9.7.1 Statistical Analysis
9.7.2 Determination of Sample Size
9.8 Changes in the Conduct of the Study or Planned Analyses
10 Study Subjects
10.1 Disposition of Subjects
10.1.1 Summary of Subject Discontinuation
10.2 Protocol Deviations
11 Efficacy Evaluation (Pharmacokinetics and Statistics)

11.1 Data Set Analyzed
11.2 Demographics & other Baseline Characteristics
11.3 Measurements of Treatment Compliance
11.4 Efficacy Results and Tabulations of Individual Patient Data

Version/Year:3/2023
Guideline
11.4.1 Analysis of efficacy

11.4.2 Statistical/analytical issues
11.4.2.1 Adjustments for Covariates NA
11.4.2.2 Handling of Dropouts or Missing Data NA
11.4.2.3 Interim Analyses and Data Monitoring NA
11.4.2.4 Multicenter Studies NA

11.4.2.5 Multiple Comparisons/Multiplicity NA
11.4.2.6 Use of an "Efficacy Subset" of Subjects NA
11.4.2.7 Active-Control Studies Intended to Show Equivalence NA
11.4.2.8 Examination of Subgroups NA
11.4.3 Tabulation of individual response data NA
11.4.4 Drug dose, drug concentration, and relationships to response NA
11.4.5 Drug-drug and drug-disease interactions NA
11.4.6 By-patient displays NA
11.4.7 Efficacy conclusions
12 Safety
12.1 Extent of Exposure
12.2 Adverse Events (AEs)
12.2.1 Summary of Adverse Events
12.2.2 Display of Adverse Events
12.2.3 Analysis of Adverse Events
12.2.4 Listing of adverse events by subject
12.3 Serious Adverse Events, and Other Significant Adverse Events
12.4 Clinical Laboratory Evaluations
12.4.1 Listing of individual laboratory measurements by subject (16.2.8)
and each abnormal laboratory value (14.3.4)
12.4.2 Evaluation of each laboratory parameter
12.4.2.1 Laboratory Values Over Time
12.4.2.2 Individual subject Changes
12.4.2.3 Individual Clinically Significant Abnormalities
12.5 Vital Signs, Physical Findings, and Other Observations Related to Safety
12.6 Safety Conclusions
13 Discussion and Overall Conclusions
14 Tables, Figures, and Graphs Referred to, but Not Included in the Text
14.1 Demographic Data
14.2 Efficacy Data (Pharmacokinetic and Statistical Results)
14.2.1 Tabulated plasma concentration for each volunteer at each actual
sampling time & regression equation used and mark terminal plasma
conc. used for calculating Ke, T1/2 including statistical analysis (mean
- SD - CV %"RSD")
* If urine data is obtained, tabulated cumulative urinary excretion &
urinary excretion rates for each volunteer & regression equation used
should be submitted.

Version/Year:3/2023
Guideline
14.2.2 Tabulated pharmacokinetic parameters for each volunteer (AUC0→t,

AUC0→∞, AUC0→t / AUC0→∞ Ratio, AUCExtra "AUCt→∞",
AUCExtra / AUC0→∞ Ratio, Cmax, Tmax, Ke, T1/2,) including
statistical analysis (mean - SD - CV %"RSD")
14.2.3 Figure of mean plasma concentration - time profile with standard
deviation bars
14.2.4 Figures of individual subjects’ plasma concentration-time profile
(linear & semi log)
14.2.5 Figure of mean cumulative urinary excretion (if applicable)
14.2.6 Figures of individual subject cumulative urinary excretion

(if applicable)
14.2.7 Figure of mean urinary excretion rates (if applicable)

14.2.8 Figures of individual subject urinary excretion rates
(if applicable)
14.2.9 Statistical analysis
14.2.9.1 Type of statistical program that was used
ANOVA tables "for pharmacokinetic parameters (AUC0→t,
AUC0→∞, Cmax)" should include (df, SS, MS, F, P) for each of
the following parameters:
Treatments (drugs or formulations)
Periods (phases)
Sequence (group or order)
Subjects within sequence
Error
Total
14.2.9.2 Logarithmic transformation of the pharmacokinetic parameters:
Cmax, AUC0→t and AUC0→∞, should be performed before
data analysis
14.2.9.3 The pharmacokinetic parameter, Tmax, should be expressed as
median values and analyzed on untransformed data; also
Wilcoxon test for Tmax should be performed.
14.2.9.4 The two one-sided hypotheses at the alpha error = 0.05 level of
significance should be performed for AUC(s) and Cmax by
constructing the 90% confidence interval for the ratio between
the test and the reference averages based on transformed data
(90% C.I. should be based on the error value from the ANOVA
tables).
14.2.12.5 Point estimate and 90% C.I. should be stated under each
transformed ANOVA Table for pharmacokinetic parameters
(Cmax, AUC0→t, AUC0→∞)
14.3 Safety Data
14.3.1 Displays of adverse events
14.3.2 Listings of deaths, other serious and significant adverse events

Version/Year:3/2023
Guideline
14.3.3 Narratives of deaths, other serious and certain other significant adverse
events
14.3.4 Abnormal laboratory value listing (each subject)
15 References List
16 Appendices
16.1 Study Information
16.1.1 Protocol and protocol amendments (as illustrated at protocol section)
16.1.2 Sample case report form (unique pages only)
16.1.3 List of IECs or IRBs (plus the name of the committee Chair
if required by the regulatory authority) - representative written
information for patient and sample consent forms
16.1.4 List and description of investigators and other important participants
in the study, including brief (1 page) CVs or equivalent summaries of
training and experience relevant to the performance of the clinical
study.
16.1.5 Signatures of principal or coordinating investigator(s) or sponsor’s
responsible medical officer, depending on the regulatory authority’s
requirement.
16.1.6 Listing of subjects receiving test drug(s)/investigational product(s)
from specific batches, where more than one batch was used
16.1.7 Randomization scheme and codes (subjects identification and
treatment assigned)
16.1.8 Audit certificates (if available)
16.1.9 Documentation of statistical methods
16.1.10 Documentation of inter-laboratory standardization methods
and quality assurance procedures if used
16.1.11 Publications based on the study
16.1.12 Important publications referenced in the report
16.2 Subject Data Listings
16.2.1 Discontinued subjects
16.2.2 Protocol deviations

16.2.3 Patients excluded from the efficacy analysis
16.2.4 Demographic data
16.2.5 Compliance and/or Drug Concentration Data (if available)
16.2.6 Individual Efficacy Response data

16.2.7 Adverse event listings (each subject)
16.2.8 Listing of individual laboratory measurements by subject,
when required by regulatory authorities
16.3 Case Report Forms
16.3.1 Other serious adverse events and withdrawals for AE
16.3.2 Other CRFs submitted

Version/Year:3/2023
Guideline
16.4 Analytical & Clinical facilities' description

16.5 "Bioequivalence Summary Tables" present in the Egyptian Guidelines for
Bioequivalence Studies for Marketing Authorization of Generic Products
Attached Sections
Section I
1 Bio-analytical method and validation
1.1 Bio-analytical method description (with reference(s) if applicable)
1.1.1 Equipment, materials, solvents and their sources
1.1.2 Internal standard (name, concentration, and molecular formula)
1.1.3 Preparation of stock and standard solutions (in details)
1.1.4 Sample extraction scheme
1.2 Validation report in terms of:
1.2.1 Calibration curve: (done on spiked plasma and not less than three
curves)
1.2.1.1 Data & figures of individual calibration curves
1.2.1.2 Regression equation
1.2.1.3 Sample back calculation
1.2.2 Linearity, range & lower limit of quantitation (LLOQ)
1.2.3 Accuracy
1.2.4 Precision
1.2.5 Recovery
1.2.6 QC samples (3 Levels LQC-MQC-HQC)
1.2.7 Selectivity / Specificity / Matrix effect
1.2.8 Robustness
1.2.9 System suitability
1.2.10 Stability
1.2.10.1 Stability of the matrix
1.2.10.1.1 Short term stability
1.2.10.1.2 Freeze and thaw stability
1.2.10.1.3 Long term stability
1.2.10.1.4 Post preparative stability & Processed sample integrity (Auto
sampler stability)
1.2.10.2 Stability of the standard solution
1.2.10.3 Dilution integrity
1.3 Chromatograms of at least 20% of subjects (all chromatograms should reveal
the peak areas of the drug and internal standard used including peak area
ratio & calculation equation for each) "dated"
Section Π
1. In Vitro testing
1.1 Summary of in-vitro dissolution testing including mean of % dissolved for
both test and reference products at all media including similarity factor "f2"
values

Version/Year:3/2023
Guideline
1.2 Potency determination (done for both test and reference products, on at least
ten dosage forms and taking three determinations then statistically analyzed)
1.2.1 Assay methodology
1.2.2 Tabulated results & acceptance values
1.2.3 HPLC chromatograms or UV absorbance values (and UV charts "if
applicable") (dated)
1.3 Uniformity of dosage unit (weight variation and / or content uniformity)
"according to the official compendia" (Reference is to be attached)
1.3.1 Description of method used
1.3.2 Tabulated results & acceptance values
1.3.3 HPLC chromatograms or UV absorbance values (and UV charts
"if applicable") (dated)
1.4 Dissolution testing "on 12 dosage units"
1.4.1 Dissolution testing method (with reference attached)
1.4.2 Dissolution media used
1.4.2.1 pH 1.2
1.4.2.2 pH 4.5
1.4.2.3 pH 6.8
1.4.2.4 The most suitable medium (done only if there is a reference
method in FDA or USP or ……….etc)
1.4.3 Equations & tabulated % dissolved results including (mean - SD - CV%
"RSD"….) for the 12 dosage units for all pH
1.4.4 Tabulated similarity factor "f2" calculation for each pH
1.4.5 Tabulated dissimilarity factor "f1" calculation for each pH
1.4.6 Comparative dissolution profile for each pH
1.4.7 Clarification of method of calculation adopted (illustrative example of
calculation)
1.4.8 Representative HPLC chromatograms (including peak areas) or UV
absorbance values (and UV charts "if applicable") of at least 25% of the
test and reference products for each pH (dated)
1.5 Dissolution method validation
1.5.1 Full validation report for the most suitable medium (if there is no
reference for the most suitable medium, full validation will be done for
only one of the three media "1.2, 4.5, 6.8" at which the drug is most
soluble) as follows:
* If the most suitable medium is pharmacopoeial, verification report in
terms of (Accuracy, Precision & Specificity) is needed
1.5.1.1 Calibration curve (with regression equation)
1.5.1.2 Linearity
1.5.1.3 Selectivity / Specificity
1.5.1.4 Accuracy
1.5.1.5 Precision
1.5.1.6 Recovery
1.5.2 Verification report for the other media as follows:
1.5.2.1 Accuracy
1.5.2.2 Precision

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Section III
Study protocol
1.1 Protocol approval (signed & dated)
1.2 Study design & Protocol illustration and justification
1.3 Deviation from protocol with justification (if present)
1.4 Letter of IRB or ethics committee approval (dated, signed & including study
title)
1.5 Subjects assignment in the study
1.5.1 Disposition of volunteers
No. of screened volunteers
No. of withdrawn volunteers
No. of enrolled volunteers
No. of excluded volunteers
Final no. of volunteers participated in the study
1.5.2 Exclusion and inclusion criteria
1.6 Number of periods
1.7 Sequence (randomization plan) for final no. of volunteers participated in the
study
1.8 Treatments (test and reference)
1.9 Half-life for each active ingredient
1.10 Washout period
1.11 Dosage form administration (fasting, with food, fluid intake with product,
time, type of food and fluids,…etc)
1.12 Procedures to minimize risk
1.13 Type of obtained biological samples
1.14 Time and frequency of sampling
1.14.1 Sufficient number of biological samples should be collected during the
absorption phase (not less than 3 points)
1.14.2 Intensive sampling should be carried out around the time of the
expected peak concentration
1.14.3 Sufficient number of samples should be collected in the Log-linear
elimination phase of the drug (A sampling period extending to at least
three to four half-lives of the drug is usually sufficient)
1.15 Storage conditions of biological samples
1.16 Data analysis (pharmacokinetic& statistical analysis)
1.17 Template of informed consent form
1.18 Template of case report
Section IV
Original certificate of sameness or equivalence including: (dated & signed)
1.1 Test product (as stated in registration documents)
1.1.1 Trade name
1.1.2 Dosage form
1.1.3 Strength
1.1.4 Manufacturer & sponsor

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1.1.5 Batch number

1.1.6 Manufacture date & expiry date
1.2 Reference Product (as on the pack)
1.2.1 Trade name
1.2.2 Dosage form
1.2.3 Strength
1.2.4 Manufacturer, sponsor & country of origin
1.2.5 Batch number
1.3 Conclusion (90% confidence interval "C.I" & point estimate) for pharmacokinetic
parameters (AUC0→t, AUC0→∞, Cmax)
The study report should be submitted as follows:

1. According to the above-mentioned sequence.
2. On the official papers of the bioequivalence center.
3. All the pages should be numbered.
4. Containing an index (a table of contents).
5. Separators should be used between each of the previously mentioned items.
6. All required chromatograms are submitted in a separate file, mentioning the title for each part
(Volunteers, In-vitro, etc).

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B-Format and Content of Comparative In-Vitro Dissolution Study Report
1. Title page
1.1 Study title
1.7 Name of manufacturer, sponsor & country of origin
1.8 Name and address of bioequivalence center / company
1.9.1 Chairman of the board (center)
1.9.2 Center manager (center)
1.9.3 Technical manager (center)
1.9.4 Chief analyst (center)
1.9.5 Quality assurance manager (center)
1.9.6 Registration manager (company)
1.9.7 Other responsible members in the company
2. Reason for dissolution submission (EDA approval is to be submitted)

2.1 Bio-waiver of one strength based on approved bioequivalence study of the other strength
2.2 Bio-waived active ingredient
2.3 Variation in
2.3.1 Change in inactive ingredients
2.3.2 Change in raw materials' suppliers
2.4 Re-registration
3. Original certificate of sameness or equivalence including: (dated & signed)

3.1.1 Trade name
3.1.2 Dosage form
3.1.3 Strength
3.1.4 Manufacturer, sponsor
3.1.5 Batch number
3.2 Reference product (as on the pack)
3.2.1 Trade name
3.2.2 Dosage form
3.2.3 Strength
3.2.4 Manufacturer & sponsor & country of origin
3.2.5 Batch number
3.3 Conclusion (similarity factor "f2") for all pH

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4. Dates of:
4.1 Contract with sponsor
4.2 Start of analysis
4.3 End of analysis
4.4 Report issue
5. Product Information (presented as follows)

Item Test Product Reference Product
1.Product name
2. API(S)
3.Molecular & structural formula
4.Dosage form
5.Type of the product
(Immediate or modified release)
6.Dosage regimen
7.Strength
8.Batch number
9.Manufacture date
10.Expiry date
11.Storage conditions
6. Potency determination (done for both test and reference products, on at least ten dosage forms and
taking three determinations then statistically analyzed)
6.1 Assay methodology
6.2 Tabulated results & acceptance values
6.3 HPLC chromatograms or UV absorbance values (and UV charts "if applicable") (dated)
7. Uniformity of dosage unit (weight variation and / or content uniformity) "according to the official
compendia" (Reference is to be attached)
7.1 Description of method used
8. Dissolution testing "on 12 dosage units"

8.1 Dissolution testing method (with reference attached)
8.2 Dissolution media used
8.2.1 pH 1.2
8.2.2 pH 4.5
8.2.3 pH 6.8
8.2.4 The most suitable medium (done only if there is a reference method in FDA or USP
or ……….etc)

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8.3 Equations & tabulated % dissolved results including (mean - SD - CV% "RSD"….) for
the 12 dosage units for all pH
8.4 Tabulated similarity factor "f2" calculation for each pH
8.5 Tabulated dissimilarity factor "f1" calculation for each pH
8.6 Comparative dissolution profile for each pH
8.7 Clarification of method of calculation adopted (illustrative example of calculation)
8.8 HPLC chromatograms (including peak areas) or UV absorbance values (and UV charts
"if applicable") of the test and reference products for each pH (dated)
9. Dissolution method validation

9.1 Full validation report for the most suitable medium (if there is no reference for the most suitable
medium, full validation will be done for only one of the three media "1.2, 4.5, 6.8" at which the drug is
most soluble) as follows:
* If the most suitable medium is pharmacopoeial, verification report in terms of (Accuracy, Precision &
Specificity) is needed
9.1.1 Calibration curve (with regression equation)
9.1.2 Linearity
9.1.3 Selectivity / Specificity
9.1.4 Accuracy
9.1.5 Precision
9.1.6 Recovery
9.2 Verification report for the other media as follows:
9.2.1 Accuracy
9.2.2 Precision
9.3 Data of the previously mentioned parameters
9.4 Representative HPLC chromatograms or UV absorbance values (and UV charts "if
10. Extra items can be submitted (if any)
11. References

2. On the official papers of the bioequivalence center / company.
6. All required chromatograms are submitted in a separate file.

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C-Format and Content of Dissolution Profile Study Report

1. Title page
1.1 Study title
1.5 Name and address of bioequivalence center / company
1.6.1 Chairman of the board (center)
1.6.2 Center manager (center)
1.6.3 Technical manager (center)
1.6.4 Chief analyst (center)
1.6.5 Quality assurance manager (center)
1.6.6 Registration manager (company)
1.6.7 Other responsible members in the company
2. Reason for dissolution profile submission

(EDA Approval is to be attached)
3. Dates of:
3.1 Contract with sponsor
3.2 Start of analysis
3.3 End of analysis
3.4 Report issue
4. Product Information (presented as follows)

Item Test Product
1.Product name
2. API(S)
3.Molecular & Structural formula
4.Dosage form
5.Type of the product (Immediate or modified release)
6.Dosage regimen
7.Strength
8.Batch number
9.Manufacture date
10.Expiry date
11.Storage conditions
5. Potency determination (done on at least ten dosage forms and taking three determinations then statistically
analyzed)

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6. Uniformity of dosage unit (weight variation and / or content uniformity) "according to the official
compendia" (Reference is to be attached)
6.3 HPLC chromatograms or UV absorbance values (and UV charts "if applicable")
(dated)
7. Dissolution testing "on 12 dosage units"

7.1 Dissolution testing method (with reference attached)
7.2 Dissolution media used
7.2.1 pH 1.2
7.2.2 pH 4.5
7.2.3 pH 6.8
7.2.4 The most suitable medium (done only if there is a reference method in FDA or USP
or ……….etc)
7.3 Equations & tabulated % dissolved results including (mean - SD - CV% "RSD"….)
for the 12 dosage units for all pH
7.6 Dissolution profile for each pH
7.7 Clarification of method of calculation adopted (illustrative example of calculation)
7.8 HPLC chromatograms (including peak areas) or UV absorbance values (and UV
charts "if applicable") of the test and reference products for each pH (dated)
8. Dissolution method validation

8.1 Full validation report for the most suitable medium (if there is no reference for the most suitable medium,
full validation will be done for only one of the three media "1.2, 4.5, 6.8" at which the drug is most soluble)
as follows:
* If the most suitable medium is pharmacopoeial, verification report in terms of (Accuracy, Precision &
Specificity) is needed
8.1.1 Calibration curve (with regression equation)
8.1.2 Linearity
8.1.3 Selectivity / Specificity
8.1.4 Accuracy
8.1.5 Precision
8.1.6 Recovery
8.2 Verification report for the other media as follows:
8.2.1 Accuracy
8.2.2 Precision
8.3 Data of the previously mentioned parameters
8.4 Representative HPLC chromatograms or UV absorbance values (and UV charts "if
9. Certificate of Compliance (dated & signed)

9.1.1 Trade name
9.1.2 Dosage form

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9.1.3 Strength
9.1.4 Manufacturer, sponsor
9.1.5 Batch number
9.2 Conclusion (mean % dissolved of the drug for each pH meet or dosen't meet the
requirements)
10. Extra items can be submitted (if any)
11. References

2. On the official papers of the bioequivalence center / company.
6. All required chromatograms are submitted in a separate file.

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Guideline
Administrative Documents
A- Checklist for Bioequivalence and Comparative In-Vitro Dissolution study
S.N. Required Documents

1 Application form (Attached) clarifying the reason of performing the study
On company letter head signed, stamped and dated
Documents required for Under-Registration Products
2 Registration request approval (Action letter)
3 Trade Name approval
4 Pricing & Pharmacovigilance approval (if any)
5 Composition certificate approved by EDA (for the batch on which the study will be performed on)
6 The importation approval for the active raw materials of the drug product or the production plan for the
sources of the active raw materials for the to prove the name of the supplier of the raw material.
7 Evaluation unit of Scientific data and drug development for drug control approval regarding the reference of
the product (if the product does not have a scientific reference).
8 Fulfilling the previous required documents from 1 to 7 in addition to the documents related to local/imported
products according to the type of pharmaceutical products
Documents required for Registered Products
2 Registration license (the latest) (in case of Preliminary Registration License has been expired, an approval for
its renewal must be submitted)
3 Preliminary approval for the re-registration (in case of expired RL)
4 Composition Certificate (approved from EDA)
5 Variation approval for Registered Pharmaceutical Products on any change occurred (valid) – if any
6 Certificate of analysis from EDA labs
7 Fulfilling the previous required documents from 1 to 5 in addition to the documents related to local/
imported / under-license/ bulk pharmaceutical products

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Additional documents required for the ‘imported / bulk pharmaceutical products

1 Composition attached to CPP
2 Valid Certificate of Pharmaceutical Product (CPP) issued by Competent Authorities in Country of Origin
(In Case of Imported or Imported Bulk or Under-license Products)
3 Bioequivalence unit decision for the type of study required – if any
4 Bioequivalence center license (where the study performed) – in case of the study is performed at Center
5 The approval of the Ministry of Health or the regulatory authority for this study (if possible).
6 Declaration letter regarding batch type, batch number and manufacturer of API
7 Inner and Outer packages and inner leaflet of the reference drug product
8 A copy of one of the scientific references such as the website of the American Food and Drug Organization
(FDA) or the US Pharmacopoeia (USP) ... etc. (if any), explaining the method of conducting a dissolution
study (The most suitable medium)
Documents required for local / under-license pharmaceutical products
1 Bioequivalence unit decision for the type of study required – if any
2 Sample withdrawing report issued by the EDA inspectors mentioning the following:
-Trade name, concentration and dosage form
-The factory name.
- The name of the bioavailability and Bioequivalence Center in which the study will be conducted.
- Type of batch (first production batch - Pilot Batch - production batch ...........).
- Batch number.
- Production date and expiration date.
- Names of raw materials suppliers on which the batch was produced.
- The composition on which the batch was produced.
3 The agreement between the marketing authorization holder and the bioequivalence center or the manufacturer
that conducted the study.
4 Valid Certificate of Pharmaceutical Product (CPP) issued by Competent Authorities in Country of Origin
(In Case of Under-License Products).
5 Inner and Outer packages and inner leaflet of the reference drug product
6 A copy of one of the scientific references such as the website of the American Food and Drug Organization
(FDA) or the US Pharmacopoeia (USP) ... etc. (if any), explaining the method of conducting a dissolution
study (The most suitable medium)
7 Scientific references (such as FDA Orange Book, ANSM, etc. websites). (In case of inquiring about the
reference product)
- All documents must be ‘Scanned Original’
- In case of any other document is required after receiving the request; An email will be sent to the applicant

Version/Year:3/2023
Guideline
Application form
Egyptian Drug Authority
Central Administration for Pharmaceutical Products
General Administration Human Pharmaceuticals Registration
Evaluation unit of bioavailability and bioequivalence studies for human Pharmaceuticals
Regarding the following product:
Product Information
Trade Name
Generic Name & Strength
Dosage Form
Other concentration(s)
Applicant Company
Manufacturer
Ministerial Decree
󠅹 Local 󠅹 Under-License 󠇤 Imported
Registration Type 󠅹New 󠅹 Re-Registration 󠅹 Variation
Reference Product Information
Trade Name
Dosage Form
Manufacturer
Country of origin
Selection of product
according to
Study Information
Reason of Study 󠅹 according to Bioequivalence unit decision
󠅹 according to decision stated in the registration license
󠅹 according to the variation decision committee
󠅹 Other (clarify)
pH(s ) used
Kindly……………………………………………………………………………………………………………
…………………………………………………………………………………………
Thanks and Regards,
Signature Stamp
Name:
Signature:
Date:

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Guideline
B- Checklist for Appeals & Inquiries submission

S.N. Required Documents
1 Application form (Attached)
*Clarify if there are any other concentrations; registered or under-registration
Documents required for Under-Registration Products
2 Registration request approval (Action letter)
3 Trade Name approval
4 Pricing & Pharmacovigilance approval (if any)
5 Composition certificate approved by EDA (for the batch on which the study will be performed on)
6 Fulfilling the previous required documents from 1 to 5 in addition to the documents related to
pharmaceutical products
Documents required for Registered Products
2 Registration license (the latest) (in case of Preliminary Registration License has been expired, an
approval for its renewal must be submitted)
3 Preliminary approval for the re-registration (in case of expired RL)
4 Composition Certificate (approved from EDA)
5 Variation approval (valid) – if any
6 Fulfilling the previous required documents from 1 to 5 in addition to the documents related to
pharmaceutical products
Additional documents required for all pharmaceutical products
1 Valid Certificate of Pharmaceutical Product (CPP) issued by Competent Authorities in Country of
Origin
(In Case of Imported or Imported Bulk or Under-license Products)
2 Evaluation unit of Scientific data and drug development for drug control approval regarding the
reference of the product (if the product does not have a scientific reference).
3 Composition Certificate for all concentrations (approved from EDA) – if any.
reference product)
5 Inner and Outer packages of the reference drug product – if present (In case of inquiring about the
reference product)
Documents required regarding reference product inquires
2 Type of study required for the product submitted (the decision of the bioequivalence unit / registration
license / variation approval).
3 Inner and Outer packages of the reference drug product – if present (In case of inquiring about the
reference product)
reference product)
- All documents must be ‘Scanned Original’
- In case of any other document is required after receiving the request; An email will be sent to the applicant

Version/Year:3/2023
Guideline
Application form
Egyptian Drug Authority

Central Administration for Pharmaceutical Products
General Administration Human Pharmaceuticals Registration
Evaluation unit of bioavailability and bioequivalence studies for human Pharmaceuticals
Regarding the following product:

Product Information
Trade Name
Dosage Form
Other concentration(s)
Applicant Company
Manufacturer
Ministerial Decree
󠅹 Local 󠅹 Under-License 󠅹 Imported
Registration Type 󠅹New 󠅹 Re-Registration 󠅹 Variation
Reference Product Information

Trade Name
Dosage Form
Manufacturer
Country of origin
Selection of product according to
Kindly…………………………………………………………………………………………………………………
……………………………………………………………………………………
Thanks, and Regards,
Signature Stamp
Name:
Signature:
Date:

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Guideline
SECTION SIX
Requirements for Submissions of Stability Studies

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Guideline
SECTION SIX: Requirements for Submission of Stability Studies

This section will provide information about requirements for any human pharmaceutical
product submitted for Stability Studies
Dossier requirements for stability study submitted for locally manufactured human
pharmaceutical products (New registration)
Folder 1 Box Approval

Naming Approval
Composition of Central Administration of When available
Drug Control
Certificate of analysis of When available
Central Administration of Drug
Control
Stability summary sheet (Template 1)
Shall be presented by Applicant company in two formats:
• Word format
• PDF format (signed and stamped)
Composition • Shall be presented by Applicant company
(signed and stamped) in tabular form listing all
components of finished product and their
amounts in unified units, the function of each
component and its reference (e.g.:
pharmacopoeia or manufacturer’s specifications)
• Shall state equivalence weight of salt in case of
using active moiety
• Shall include all finished product components
(e.g.: components of capsule shell, components
of ink ........................................ )
• Shall include all components used in the
manufacturing process, including those that
may not be added to every batch (e.g.: acid and
alkali…), those that may be removed during
processing (e.g.: solvents….) and any others
(e.g.: nitrogen….) and any note to be reflected
in footnote
• Shall separate active ingredients from inactive
ingredients
• Shall separate core and coat in case of film coated
tablet
• Shall separate cap and body in case of capsule

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Guideline
shell
• Shall include solvent for reconstitution if it
is co-packaged with finished product
• Shall indicate the use of an over-fill or
overage when applicable and its rationale
• Shall state total weight or total volume
• Shall state grade of any component (when
applicable) and color index of any coloring
agent
Shall state composition statement for purchased mixture as
flavor or capsule shell
or pellets (when applicable)
Commitment for storage (in case of (Template 3)
proposed storage conditions at Shall be presented by Applicant company signed and
temperature not exceeding 25ᵒC stamped
Certificate of responsibility (Template 4)

Shall be presented by Stability testing site (signed and
stamped)
Declaration letter for manufacturer of (Template 5)
active pharmaceutical ingredient(s) Shall be presented by Applicant company (signed and
entering in the manufacture of finished stamped)
product
Finished product specification • Shall be presented by stability testing site signed

and stamped
• Shall include list of tests, specifications and
reference to analytical procedures and acceptance
criteria
• Shall include the following:
Physical analysis
Chemical analysis
Shall include assay of active ingredient(s),
quantitation of impurities and related substances,
and content of preservative(s) and/or
antioxidant(s) (when applicable)
Microbiological analysis
Biological analysis (when applicable)
Report from Central Administration of Shall state batch type (e.g.: pilot, production…), batch
Operations order (e.g.: 1st,2nd…)
Certificate of analysis • Shall be presented by stability testing site
Folder 2 signed and stamped
• For the batch of finished product on which
stability study was done
• Shall state product name, batch number,

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manufacturing and expiry date

▪ Physical analysis
▪ Chemical analysis
Shall include assay of active ingredient(s),
quantitation of impurities
and related substances, and content of
preservative(s) and/or antioxidant(s) (when
applicable)
▪ Microbiological analysis
▪ Biological analysis (when applicable)
• Shall include results within release specifications
Method of analysis • Shall be presented by stability testing site
signed and stamped
• Shall include stability-indicating analytical
procedure used for physical, chemical and
microbiological analysis
• Shall submit reference if analytical procedure
used found in a pharmacopoeia
Stability study table(s) • Shall be presented by stability testing site signed
and stamped
• Shall clearly state product name, batch number
on which stability study was done,
manufacturing and expiry date, date of starting
stability study in case of being different than
manufacturing date, storage conditions, testing
intervals and product pack in details
▪ Shall include assay of active ingredient(s),
quantitation of impurities and related
substances, and content of preservative(s)
and/or antioxidant(s) (when applicable)
• Any skipped test shall by scientifically
justified by the site responsible for stability
testing
• May include (when applicable):
• In-use stability study
• Shall include results within shelf-life
specifications
Stability study contract • Required when stability testing site is different
(when )‫) عقد دراسة الثبات‬ from applicant company or manufacturer of

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Guideline
applicable) finished product

• Shall include annex in which product name,
strength and dosage form are stated
Both contract and annex shall be legalized by
bank and EDA legal affairs
Folder 3 Assay chromatograms annex • Shall state product name, batch number and
injection date
• Shall include chromatograms of assay of active
ingredient(s), quantitation of impurities and
related substances, and content of
applicable)
• Shall include 3 injections for standard and test
at each time interval
• Shall be stamped by stability testing site
Validation of analytical procedure Shall include validation of analytical procedures
for assay of active ingredient(s), quantitation of
impurities and related substances, and content of
applicable)
Complete validation of analytical procedures
shall be conducted in which the following
validation characteristics should be considered
including: specificity, precision, linearity,
accuracy, ruggedness and robustness
In case of analytical procedure used found in a
pharmacopoeia, verification of analytical
procedures shall be conducted in which the
following validation characteristics should be
considered including: specificity, precision and
accuracy
Validation chromatograms annex • Shall include chromatograms of validation of
analytical procedures for assay of active
related substances, and content of preservative(s)
• For specificity: injections for samples stored
under relevant stress conditions: light, heat,
humidity, acid/base hydrolysis and oxidation
are required in addition to placebo and blank
injections
• For precision: 6 injections are required
• For linearity: 5 concentrations are
recommended with 1 injection required
for each concentration

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Guideline
• For accuracy: 3 concentrations are

recommended with 3 injections required
• For ruggedness: 3 injections are required
for each random variation
• For robustness: 3injections are
required for each small variation in method
parameters

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Guideline
Dossier Requirements for stability study submitted for locally manufactured human
pharmaceutical products (Re- registration)
Folder 1 Registration License and attached
composition (if applicable)
Preliminary Re-registration Approval
Central Administration of Drug Control Required if ministerial decree 150/2022

Composition (in case composition is not In case the composition is not inferred by EDA
attached to registration license or variation Labs, Stability General Administration accredits
approval for changing composition) the composition
Any other EDA approvals and/or decisions In case of any approvals or decisions issued for
(e.g.: variation approval…) the product and not reflected in the last released
registration license
Shall be presented by Applicant company in two
formats:
Word format
PDF format (signed and stamped)
Composition • Shall be presented by Applicant company
(signed and stamped) in tabular form listing
all components of finished product and their
amounts in unified units, the function of each
component and its reference (e.g.:
pharmacopoeia or
• manufacturer’s specifications)
• Shall state equivalence weight of salt in case
of using active moiety
• Shall include all finished product
components (e.g.: components of capsule
shell, components of ink… )
manufacturing process, including those that
may not be added to every batch (e.g.: acid
and alkali…), those that may be

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Guideline
removed during processing (e.g.:

solvents….) and any others (e.g.:
nitrogen….) and any note to be reflected
in footnote
• Shall separate active ingredients from
inactive ingredients
• Shall separate core and coat in case of film
coated tablet
• Shall separate cap and body in case of
capsule shell
• Shall include solvent for reconstitution if it
is co-packaged with finished product
• Shall indicate the use of an over-fill or
overage when applicable and its rationale
• Shall state grade of any component
(when applicable) and color index of
any coloring agent
• Shall state composition statement for
purchased mixture as flavor or capsule
shell or pellets (when applicable)
Commitment for storage (in case of proposed (Template 3)
storage conditions at temperature not Shall be presented by Applicant company signed and
exceeding 25ᵒC stamped

Shall be presented by Stability testing site (signed
and stamped)
Declaration letter for manufacturer of active (Template 5)
pharmaceutical ingredient(s) entering in the Shall be presented by Applicant company (signed
manufacture of finished product and stamped)
Finished product specification • Shall be presented by stability testing site

signed and stamped
• Shall include list of tests, specifications
and reference to analytical procedures and
acceptance criteria
Shall include assay of active
ingredient(s), quantitation of
impurities and related

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substances, and content of

preservative(s) and/or
antioxidant(s)
(When applicable)
• Microbiological analysis biological
analysis (when applicable)
Report from Central Administration of Shall state batch type (e.g.: pilot, production…),
Operations (in case of any batch order (e.g.: 1st,2nd…) and type of variation
variations) (when applicable)

substances, and content of
▪ Biological analysis (when
applicable)
• Shall include results within release
specifications
signed and stamped
• Shall submit reference if analytical procedure
used found in a pharmacopoeia

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Guideline
Stability study table(s) • Shall be presented by stability testing site

signed and stamped
• Shall clearly state product name, batch
number on which stability study was done,
manufacturing and expiry date, date of
starting stability study in case of being
different than manufacturing date, storage
conditions, testing intervals and product pack
in details
▪ Shall include assay of active
impurities and related substances,
and content of preservative(s) and/or
applicable)
• Any skipped test shall by
scientifically justified by the site
responsible for stability testing
specifications
Stability study contract • Required when stability testing
(when applicable) )‫) عقد دراسة اثبات‬ site is different from applicant
company or manufacturer of
finished product
• Shall include annex in which
product name, strength and
dosage form are stated
• Both contract and annex shall be
legalized by bank and EDA legal
affairs
Folder 3 Assay chromatograms annex • Shall state product name, batch
number and injection date
• Shall include chromatograms of
assay of active ingredient(s),
quantitation of impurities and

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Guideline
• Shall include 3 injections for

standard and test at each time
interval Shall be stamped by
stability testing site
Validation of analytical procedure • Shall include validation of analytical

procedures for assay of active
ingredient(s), quantitation of impurities
preservative(s) and/or antioxidant(s)
(when applicable)
• Complete validation of analytical
procedures shall be conducted in which
the following validation characteristics
should be considered including:
specificity, precision, linearity,
considered including: specificity, precision
and accuracy
Validation chromatograms annex • Shall include chromatograms of validation
of analytical procedures for assay of active
and related substances, and content
of preservative(s) and/or antioxidant(s)
(when applicable)
• For specificity: injections
for samples stored under
relevant stress conditions: light,
heat, humidity, acid/base
hydrolysis and oxidation are
required in addition to placebo
and blank injections
• For precision: 6 injections are
required
• For ruggedness: 3 injections are

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Guideline
required for each random variation

• For robustness: 3injections are
required for each small variation in
method parameters
Shall be stamped by stability testing site

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Guideline
Dossier Requirements for stability study for locally manufactured pharmaceutical

products submitted for fulfillment of variation committee or registration
license requirements
Folder 1 Registration License and attached
composition
or
Is a must in case of shelf-life extension or storage
Valid Registration License and attached condition change
composition
Stability general administration technical When needed

report for approval of Accelerated study
Evidence for submission of product for re- In case of product submitted for variation
registration (in case of invalid Registration
License)
Any other EDA approvals and/or decisions In case of any approvals or decisions issued for
(e.g.: variation approval…) the product and not reflected in the last released
Stability general administration technical
reports approval for other variations in
submitted product
Certificate of analysis of Central When available
Administration of Drug Control
Certificate of analysis of Central When available

Administration of Drug Control
Shall be presented by Applicant company in two
formats:
Word format
proposed storage conditions at Shall be presented by Applicant company
temperature not exceeding 25ᵒC signed and stamped

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Guideline

Shall be presented by Stability testing site
(signed and stamped)
Declaration letter for manufacturer of (Template 5)

active pharmaceutical Shall be presented by Applicant company (signed and
stamped)
ingredient(s) entering in the manufacture of
finished product
Finished product specification • Shall be presented by stability testing site
signed and stamped
• Shall include list of tests, specifications and
reference to analytical procedures and
acceptance criteria
▪ Shall include assay of active ingredient(s),
▪ Microbiological analysis Biological
Report from Central Administration Shall state batch type (e.g.: pilot, production…),
of Operations batch order (e.g.: 1st,2nd…) and type of variation
Payment receipt Required when stability study is submitted for the

purpose of change of storage conditions or shelf life
extension
(when applicable)

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▪ Shall include results within release

specifications
signed and stamped
procedure used for physical, chemical
and microbiological analysis
Shall submit reference if analytical procedure used
found in a pharmacopoeia
Stability study table(s) • Shall be presented by stability testing site
signed and stamped
• Shall clearly state product name, batch
number on which stability study was done,
manufacturing and expiry date, date of
starting stability study in case of being
different than manufacturing date, storage
conditions, testing intervals and product
pack in details
(when applicable)
justified by the site responsible for stability
testing
specifications
Stability study contract • Required when stability testing site
(when applicable) )‫) عقد دراسة الثبات‬ is different from applicant company
or manufacturer of finished product
• Shall include annex in which product name,
strength and dosage form are stated
• Both contract and annex shall be
legalized by bank and EDA legal
affairs

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Guideline
Folder 3 Assay chromatograms annex • Shall state product name, batch number and
injection date
• Shall include chromatograms of assay of
active ingredient(s), quantitation of
impurities and related substances, and
content of preservative(s) and/or
• Shall include 3 injections for standard and
test at each time interval
Validation of analytical procedure • Shall include validation of analytical
procedures for assay of active ingredient(s),
following validation characteristics should
be considered including: specificity,
precision, linearity, accuracy, ruggedness
and robustness
considered including: specificity, precision and
accuracy
Validation chromatograms annex • Shall include chromatograms of validation of
analytical procedures for assay of active
applicable)
• For specificity: injections for samples
stored under relevant stress conditions:
light, heat, humidity, acid/base hydrolysis
and oxidation are required in addition to
placebo and blank injections
• For precision: 6 injections are required

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Guideline

• For ruggedness: 3 injections are required for
each random variation
• For robustness: 3injections are required for
each small variation in method parameters
Shall be stamped by stability testing site

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Guideline
Common Technical Dossier Requirements for stability study submitted for locally
manufactured human pharmaceutical products (New registration) where CTD is a
condition for registration)
EDA Approvals Box Approval Shall state that the dossier shall be submitted as full
Common Technical Dossier CTD (i.e.: Both drug
substance and drug product)
Naming Approval
Quality Approval including When needed

approved composition
Product Composition • Shall be presented by Applicant company (signed

Documents and stamped) in tabular form listing all components
of finished product and their amounts in unified
units, the function of each component and its
reference (e.g.: pharmacopoeia or manufacturer’s
specifications)
• Shall state equivalence weight of salt in case of
using active moiety
• Shall include all finished product components (e.g.:
components of capsule shell, components of ink…
)
manufacturing process, including those that may
not be added to every batch (e.g.: acid and
alkali…), those that may be removed during
processing (e.g.: solvents….) and any others (e.g.:
nitrogen….) and any note to be reflected in
footnote
• Shall separate active ingredients from inactive
ingredients
• Shall separate core and coat in case of film coated
tablet
• Shall separate cap and body in case of capsule shell
• Shall include solvent for reconstitution if it is co-
packaged with finished product
• Shall indicate the use of an over-fill or overage
when applicable and its rationale
• Shall state grade of any component (when
applicable) and color index of any coloring agent
Shall state composition statement for purchased mixture as
flavor or capsule shell or pellets (when applicable)

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Guideline

Shall be presented by Stability testing site (signed and
stamped)
Declaration letter for (Template 5)

manufacturer of active Shall be presented by Applicant company (signed
pharmaceutical ingredient(s) and stamped)
entering in the manufacture of
finished product
Report from Central • Shall state batch type (e.g.: pilot, production…),
Administration of Operations batch order (e.g.: 1st,2nd…)
Applicant Stability summary sheet (Template 1)

Commitments Shall be presented by applicant company in two formats:
• Word format
Commitment for authenticity of (Template 2)
data submitted Shall be presented by applicant company signed and
stamped
Commitment for storage (in (Template 3)
case of proposed storage Shall be presented by applicant company signed and
conditions at temperature not stamped
exceeding 25ᵒC)
Required CTD Section 3.2.P.1: Description and

Sections for Drug Composition of the Drug
Product Product
Section 3.2.P.3.1:
Manufacturer(s)
Section 3.2.P.5.1: • Shall include test, specification and

Specification(s) reference for specification
Physical analysis
Chemical analysis
Shall include identification and assay of active
ingredient(s), quantitation of impurities and related
substances, and identification and assay of
applicable)
Biological analysis (when applicable)

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Section 3.2.P.5.2: • Shall include stability-indicating analytical

Analytical Procedures procedure used for physical, chemical and
Section 3.2.P.5.3: • Shall include validation of analytical

Validation of Analytical procedures for assay of active
Procedures ingredient(s), quantitation of impurities
and related substances, and assay of
applicable)
and robustness
• In case of analytical procedure used found
in a pharmacopoeia, verification of
analytical procedures shall be conducted in
which the following validation
characteristics should be considered

including: specificity, precision and
accuracy
Section 3.2.P.5.4: Batch • For any batch of finished product
Analyses
• Shall state product name, batch
number, manufacturing and expiry
date
Shall include identification and assay of
identification and assay of preservative(s)
Shall include results within release specifications
Section 3.2.P.5.6: Justification
of Specification(s)

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Guideline
Section 3.2.P.7: Container

Closure System
Section 3.2.P.8.1: Stability

Summary and Conclusion
Section 3.2.P.8.2: Post-
approval Stability Protocol
and Stability Commitment
Section 3.2.P.8.3: Stability • Shall include the following:

Data • Physical analysis
• Chemical analysis
Shall include assay of active ingredient(s), quantitation
of impurities and related substances,
and assay of preservative(s) and/or antioxidant(s)
(when applicable)
▪ Any skipped test shall by scientifically justified
▪ May include (when applicable):
▪ In-use stability study
▪ Photo stability study
▪ Hold time stability study (for Bulk Products)
▪ Shall include results within shelf-life specifications
Assay chromatograms annex ▪ Shall include chromatograms of assay of active
substances, and assay of preservative(s) and/or
antioxidant(s) (when applicable) at each time
interval
▪ Shall include 3 injections for standard and test at
each time interval

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Guideline
Validation chromatograms ▪ Shall include chromatograms of validation of

annex analytical procedures for assay of active
substances, and assay of preservative(s) and/or
▪ Shall include the following:
▪ For specificity: injections for samples stored
humidity, acid/base hydrolysis and oxidation
aren required in addition to placebo and blank
injections
▪ For precision: 6 injections are required
▪ For linearity: 5 concentrations are
recommended with 3 injections required for
each concentration
▪ For accuracy: 3 concentrations are
each concentration
▪ For ruggedness: 3 injections are required for
▪ For robustness: 3 injections are required for
Required CTD In case of availability of valid Certificate of Suitability of the European Pharmacopoeia
Sections for Drug (CEP):
Substance *CEP specifying a retest period that is the same as or longer than that proposed by the
applicant, and storage conditions are the same or at a higher temperature and humidity than
those proposed by the applicant, the applicant is waived from submission of CTD Sections
for Drug Substance OR
*CEP stating a container closure system while not stating a retest period and storage
condition, the applicant is waived from submission of analytical procedure and validation of
analytical procedure
Section 3.2.S.2.1: In case of more than one manufacturer for an active
Manufacturer(s) ingredient(s), declaration letter from License Holder
mentioning manufacturer(s) of active pharmaceutical
ingredient(s) for each batch submitted
Section 3.2.S.3.2: Impurities
Section 3.2.S.4.1: ▪ Shall include test, specification and
Shall include identification and
assay of active ingredient(s) and
related substances
▪ Microbiological analysis (when applicable)

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Guideline

Section 3.2.S.4.2: Analytical ▪ Shall include stability-indicating analytical
Procedures procedure used for physical, chemical and
▪ Shall submit reference if analytical
procedure used found in a pharmacopoeia
Section 3.2.S.4.3: Validation of • Shall include validation of analytical
Analytical Procedures procedures for assay of active ingredient(s) and
substances
• Complete validation of analytical procedures
validation characteristics should be considered
including: specificity, precision, linearity,
• In case of analytical procedure used found in a
following validation
accuracy
Section 3.2.S.4.4: Batch
analyses
Section 3.2.S.4.5: Justification
of Specification(s)
Section 3.2.S.6: Container
Closure System
Section 3.2.S.7.1: Stability
Summary and Conclusions
Section 3.2.S.7.2: Post-
approval Stability Protocol
Commitment
Section 3.2.S.7.3: Stability • Shall include the following:
Data ▪ Physical analysis
Shall include assay of active ingredient(s) and
substances
▪ Microbiological analysis (when
applicable)
justified

Version/Year:3/2023
Guideline
specifications
Assay chromatograms • Shall include chromatograms of assay of

annexes active ingredient(s) and quantitation of
impurities and related substances at least
last time interval of accelerated and long-
term conditions
• Shall include 3 injections for standard and test
Validation chromatograms • Shall include chromatograms of validation of
annex analytical procedures for assay of active
ingredient(s) and quantitation of impurities and
related substances at least specificity and forced
degradation chromatograms
▪ For specificity: injections for samples stored
humidity, acid/base hydrolysis and
oxidation are required in addition to placebo
each concentration
each concentration
▪ For ruggedness: 3 injections are required for
• For robustness: 3 injections are required for

Version/Year:3/2023
Guideline
Common Technical Dossier Requirements for stability study submitted for human
pharmaceutical products imported
(New registration) where CTD is a condition for registration
EDA Approvals Box Approval Shall state that the dossier shall be submitted as
full Common Technical Dossier CTD (i.e.: Both
drug substance and drug product)
Naming Approval
Product Certificate of Pharmaceutical Product The certificate shall establish up to date status and
Documents (CPP) and attached Summary of data of the product in the exporting country or
Product Characteristics (SmPC) or region at the time of issuing of certificate. This
Product Information Leaflet (PIL) (if data may include (when applicable):
applicable) • Product Trade name in Egypt, its strength
and dosage form
• Complete composition of the product
• License Holder, Manufacturer and
Packager of the product
• Summary of Product
Characteristics (SmPC) or Product
Information Leaflet (PIL)
• Shelf life, storage conditions, in-use
shelf life (when applicable) and in-use
storage conditions (when applicable)
• Container closure system in details
The certificate shall be legalized by Health
Authority in country of License Holder,
Chamber of Commerce, and Egyptian
Embassy or Consulate
Legalized declaration letter stating • Declaration letter for the product shall
shelf life, storage conditions, in- use be presented from License Holder and
shelf life (if applicable), in-use legalized by Health Authority in
storage conditions (if applicable) country of License Holder, Chamber
and/or container closure system (in of Commerce, and Egyptian Embassy
details) (if not stated in CPP or or Consulate
attached SmPC or PIL or if • Original legalized declaration letter
updated than those mentioned in shall be submitted by the applicant
registration license) company to Stability General
Administration once stability dossier
is accepted
• In case of legalization is not available
at time of submission due to current
situation, applicant company shall
submit commitment for legalization of
declaration letter within 6 months
according to EDA Chairman decision

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Guideline
Legalized composition (if not stated • Composition for the product shall be
in CPP or free sale) presented from License Holder and
legalized by Health Authority in country
of License Holder, Chamber of
Commerce, and Egyptian Embassy or
Consulate
• Original legalized composition shall be
submitted by the applicant company to
Stability General Administration once
stability dossier is accepted
• In case of legalization is not available at
time of submission due to current
situation, applicant company shall submit
commitment for legalization of
declaration letter within 6 months
Certificate of analysis • For any batch of finished product
Shall include identification and assay
of active ingredient(s), quantitation of
identification and assay of
(when applicable)
specifications
Commitments Shall be presented by applicant company in two
formats:
• Word format
Commitment for authenticity of data (Template 2)
submitted Shall be presented by applicant company signed
and stamped
proposed storage conditions at Shall be presented by applicant company signed
temperature not exceeding 25ᵒC) and stamped
Sections for Composition of the Drug Product

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Guideline
Drug Product Section 3.2.P.3.1: Manufacturer(s)

Section 3.2.P.5.1: Specification(s) • Shall include test, specification and
reference for specification
Physical analysis
Chemical analysis
related substances, and
(when applicable)
Biological analysis (when
applicable)
Section 3.2.P.5.2: Analytical Procedures • Shall include stability-indicating
analytical procedure used for physical,
chemical and microbiological analysis
Section 3.2.P.5.3: Validation of Analytical • Shall include validation of analytical

Procedures procedures for assay of active
(when applicable)
• In case of analytical procedure used
found in a pharmacopoeia, verification
of analytical procedures shall be
conducted in which the following
validation characteristics should be
considered including:
• specificity, precision and accuracy
Section 3.2.P.5.4: Batch Analyses
Section 3.2.P.5.6: Justification of
Specification(s)
Section 3.2.P.7: Container Closure System


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Guideline
Section 3.2.P.8.2: post-approval

Stability Protocol and Stability
Commitment
Section 3.2.P.8.3: Stability Data • Shall include the following:
(when applicable)
justified
▪ Hold time stability study (for Bulk
Products)
specifications
Assay chromatograms annex • Shall include chromatograms of assay of
assay of preservative(s) and/or
antioxidant(s) (when applicable) at least
term conditions
test
Validation chromatograms • Shall include chromatograms of validation
annex of analytical procedures for assay of active
applicable) at least specificity and forced
degradation chromatograms

Version/Year:3/2023
Guideline
▪ For specificity: injections for

samples stored under relevant stress
conditions: light, heat, humidity,
acid/base hydrolysis and oxidation
are required in addition to placebo
recommended with 3 injections
required for each concentration
▪ For ruggedness: 3 injections are
▪ For robustness: 3 injections are
method parameters
Required In case of availability of valid Certificate of Suitability of the European
CTD Sections Pharmacopoeia (CEP):
for Drug *CEP specifying a retest period that is the same as or longer than that proposed by
Substance the applicant, and storage conditions are the same or at a higher temperature and
humidity than those proposed by the applicant, the applicant is waived from
submission of CTD Sections for Drug Substance OR
*CEP stating a container closure system while not stating a retest period and storage
condition, the applicant is waived from submission of analytical procedure and
validation of analytical procedure
Section 3.2.S.2.1: In case of more than one manufacturer
Manufacturer(s) for an active ingredient(s), declaration
letter from License Holder mentioning
manufacturer(s) of active
pharmaceutical ingredient(s) for each
batch submitted
Section 3.2.S.4.1: • Shall include test, specification
Specification(s) and reference for specification
• Shall include identification and
related substances
(when applicable)

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Guideline
Section 3.2.S.4.2: Analytical • Shall include stability-indicating

Procedures analytical procedure used for physical,
• Shall submit reference if analytical
procedure used found in a
pharmacopoeia
Analytical Procedures procedures for assay of active
ingredient(s) and quantitation of
impurities and related substances
specificity, precision, linearity, accuracy,
ruggedness and robustness
found in a pharmacopoeia, verification of
analytical procedures shall be conducted
in which the following validation
accuracy
Section 3.2.S.4.4: Batch analyses
Section 3.2.S.4.5: Justification of
Specification(s)
Section 3.2.S.6: Container Closure
System
Section 3.2.S.7.2: Post-approval
Stability Protocol Commitment
Section 3.2.S.7.3: Stability Data • Shall include the following:
Shall include assay of active ingredient(s)
and quantitation of impurities and related
substances
applicable)
justified

Version/Year:3/2023
Guideline

specifications
Assay chromatograms annexes • Shall include chromatograms of assay of
active ingredient(s) and quantitation of
term conditions
test
Validation chromatograms annex • Shall include chromatograms of validation
of analytical procedures for assay of
specificity and forced degradation
chromatograms
▪ For specificity: injections for samples
light, heat, humidity, acid/base
hydrolysis and oxidation are required
in addition to placebo and blank
injections
method parameters

Version/Year:3/2023
Guideline
Dossier Requirements for stability study submitted for human pharmaceutical products
imported from non-reference countries non-CTD (New registration)
EDA Approvals Box Approval

Naming Approval
Product Certificate of Pharmaceutical Product The certificate establishes up to date status and
applicable) • Product Trade name in Egypt, its
strength and dosage form
• Summary of Product Characteristics
(SmPC) or Product Information Leaflet
(PIL)
• Shelf life, storage conditions, in-use shelf
life (if applicable), in-use storage
conditions (if applicable)
Container closure system in details
Authority in country of License Holder, Chamber
of Commerce, and Egyptian Embassy or Consulate
shelf life, storage conditions, in-use be presented from License Holder and
shelf life (if applicable), in-use storage legalized by Health Authority in country
conditions (if applicable) and/or of License Holder, Chamber of
container closure system (in details) (if Commerce, and Egyptian Embassy or
not stated in CPP or attached SmPC or Consulate
PIL • Original legalized declaration letter shall
be submitted by the applicant company
to Stability General Administration once
situation,
Commitment for legalization of declaration
letter within 6 months according to EDA
Chairman decision

Version/Year:3/2023
Guideline
in CPP or free sale) presented from License Holder and
Consulate
• Original composition letter shall be
situation, Applicant Commitment for
legalization of declaration letter within 6
months according to EDA Chairman
decision shall be submitted
Declaration letter stating • Declaration letter shall be presented
manufacturer of active from License Holder
pharmaceutical ingredient(s) • Shall state product name, its strength,
formulation, batches number on which
stability study was performed, name of
active pharmaceutical ingredient(s) and
its/their manufacturer

number, manufacturing and
expiry date
quantitation of
impurities and related substances,
and identification and assay of
applicable) Shall include results within
release specifications

Version/Year:3/2023
Guideline
Applicant (Template 1)
Commitments Stability summary sheet Shall be presented by applicant company in two
formats:
Word format
Submitted Shall be presented by Applicant company
signed and stamped
temperature not exceeding 25ᵒC) signed and stamped
Stability data Finished Product Specification • Shall include test, specification and
Stability study summary and protocol Shall include batch(es) number, batch(es) scale,
manufacturing and expiry date(s), storage
conditions, duration, and testing frequency
Stability study table(s) • Shall include the following:
• Shall include assay of active ingredient(s),
substances, and assay of preservative(s)
justified
▪ Hold time stability study
(for BulkProducts)
Shall include results within shelf-life specifications

Version/Year:3/2023
Guideline
Analytical Procedures • Required only for imported products from

non- reference countries or when stability
testing site is in non-reference country
Validation of Analytical Procedures • Required only for imported products from
• Shall include validation of analytical
related substances, and assay of
applicable)
following
considered including: specificity,
precision, linearity, accuracy,
precision and
Accuracy
Assay chromatograms annexes • Required only for imported products
from non- reference countries or when
stability testing site is in non-reference
country
• Shall include chromatograms of assay
Shall include 3 injections for standard and test
Validation chromatograms annex • Required only for imported products
countries

Version/Year:3/2023
Guideline
validation of analytical procedures for

For precision: 6 injections are required
For linearity: 5 concentrations are
For accuracy: 3 concentrations are
For ruggedness: 3 injections are
For robustness: 3 injections are
method parameters

Version/Year:3/2023
Guideline
imported from non-reference countries non-CTD (re-registration)
EDA Approvals -Transfer Letter and attached

composition (When needed)
-Preliminary Re-registration Approval
Registration License and attached
composition
EDA Labs composition (in case In case the composition is not inferred by
composition is not attached to EDA Labs, Stability General Administration
Registration License or variation accredits the composition
approval for changing composition)
In case of any approvals or decisions issued for
Any other EDA approvals and/or
decisions (e.g.: variation approval…) the product and not reflected in the last released
(PIL)
conditions (if applicable), Container
closure system in details
of Commerce, and Egyptian Embassy or
Consulate

Version/Year:3/2023
Guideline
shelf life, storage conditions, in- be presented from License Holder and
use shelf life (if applicable), in- legalized by Health Authority in
use storage conditions (if country of License Holder, Chamber
applicable) and/or container of Commerce, and Egyptian Embassy
closure system (in details) (if not or Consulate
stated in CPP or attached SmPC • Original legalized declaration letter
or PIL or if updated than those shall be submitted by the applicant
mentioned in registration license) company to Stability General
Administration once stability dossier
is accepted
situation, Commitment for
legalization of declaration letter
within 6 months according to EDA
Chairman decision
Legalized composition (if not • Composition for the product shall be
stated in CPP, free sale or if not presented from License Holder and
attached registration license, no legalized by Health Authority in
EDA Labs composition or country of License Holder, Chamber
variation approval for changing of Commerce, and Egyptian Embassy
composition) or Consulate
submitted by the applicant company
to Stability General Administration
once stability dossier is accepted
legalization of declaration letter
within 6 months according to EDA
Chairman decision shall be submitted
Declaration letter stating • Declaration letter shall be presented
manufacturer of active from License Holder
pharmaceutical ingredient(s) Shall state product name, its strength,
formulation, batches number on which
stability study was performed, name of active
pharmaceutical ingredient(s) and its/their
manufacturer

Version/Year:3/2023
Guideline

number, manufacturing and expiry
date
(when applicable)
applicable) Shall include
results within release
specifications
Commitments Stability summary sheet Shall be presented by applicant
company in two formats:
▪ Word format
▪ PDF format (signed and stamped)
data Submitted Shall be presented by Applicant company
signed and stamped
Commitment for storage (in case (Template 3)
of proposed storage conditions at Shall be presented by Applicant company
Stability Finished product specification(s) ▪ Shall include test, specification and
data reference for specification
▪ Shall include identification and
assay of active ingredient(s), quantitation
of impurities and related substances, and
▪ Microbiological analysis biological
Stability study summary and protocol Shall include batch(es) number, batch(es)
scale, manufacturing and expiry date(s),
storage conditions, duration, and testing
frequency

Version/Year:3/2023
Guideline

applicable)
scientifically justified
Products)
Shall include results within shelf-life
specifications
Analytical Procedures • Shall include stability-indicating
analytical procedure used for
physical, chemical and
Validation of Analytical Procedures • Shall include validation of analytical
applicable)
and robustness
following validation
characteristics should be considered including:
specificity, precision and accuracy

Version/Year:3/2023
Guideline

Shall include 3 injections for standard and
Validation chromatograms annex • Shall include chromatograms of
▪ For precision: 6 injections are
required
method parameters

Version/Year:3/2023
Guideline
imported from non-reference countries non-CTD (submitted for variation)
EDA Approvals Variation Committee Approval (if

applicable)
Valid Registration License and attached
composition
Evidence for submission of product for
re-registration (in case of invalid
Registration License)
EDA Labs composition (if not attached
to Registration License or
variation approval for changing
composition)
Documents (CPP) or Free sale and attached data of the product in the exporting country or
Summary of Product Characteristics region at the time of issuing of certificate. This
(SmPC) or Product Information Leaflet data may include (when applicable):
(PIL) (if applicable) • Product Trade name in Egypt, its
(PIL)
Chamber of Commerce, and Egyptian Embassy
or Consulate
legalized by

Version/Year:3/2023
Guideline
shelf life (if applicable), in-use Health Authority in country of License

storage conditions (if applicable) Holder, Chamber of Commerce, and
and/or container closure system Egyptian Embassy or Consulate
(in details) (if not stated in CPP or • Original legalized declaration letter
attached SmPC or PIL or if shall be submitted by the applicant
updated than those mentioned in company to Stability General
registration license) Administration once stability dossier is
accepted
situation, Commitment for legalization
of declaration letter within 6 months
(when applicable)
applicable)
specifications
Commitments Stability summary sheet Shall be presented by applicant
company in two formats:
• Word format
data Submitted Shall be presented by Applicant company
signed and stamped
Cover Letter for scope of variation
(in case of variation)

Version/Year:3/2023
Guideline
Payment Receipt (in case of

variation of shelf-life, storage
conditions, in- use shelf-life or
in-use storage conditions)
Stability data Finished Product Specification • Shall include test, specification and
(when applicable)
applicable)
Stability study summary and Shall include batch(es) number, batch(es)
protocol scale, manufacturing and expiry date(s),
storage conditions, duration, and testing
frequency
substances, and assay of
applicable)
scientifically justified
▪ Hold time stability study (for
Bulk Products)
specifications

Version/Year:3/2023
Guideline
Analytical Procedures • Shall include stability-indicating

Validation of Analytical Procedures • Shall include validation of analytical
procedures shall be conducted in
including: specificity, precision,
linearity, accuracy, ruggedness and
robustness
In case of analytical procedure used found
in a pharmacopoeia, verification of
analytical procedures shall be conducted in
accuracy
Assay chromatograms annexes • Shall include chromatograms of
applicable)
Shall include 3 injections for standard and

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Guideline

validation of analytical procedures
for assay of active ingredient(s),
samples stored under relevant
stress conditions: light, heat,
humidity, acid/base hydrolysis
and oxidation are required in
addition to placebo and blank
injections
required
▪ For linearity: 5 concentrations
are recommended with 3
injections required for each
concentration
▪ For accuracy: 3 concentrations
are recommended with 3
injections required for each
concentration
required for each random
variation
For robustness: 3 injections are required for

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Guideline
Common Technical Dossier content for stability study submitted for Human
pharmaceutical products imported (New registration)
EDA Approvals Box Approval Shall state that the dossier shall be submitted as
full Common Technical Dossier CTD (i.e.:
Both drug substance and drug product) When
needed
Naming Approval
Product Certificate of Pharmaceutical Product The certificate shall establish up to date status and
• Summary of Product
Characteristics (SmPC) or
Product Information Leaflet (PIL)
shelf life (when applicable) and in-use
storage conditions (when applicable)
Chamber of Commerce, and Egyptian
Embassy or Consulate
shelf life, storage conditions, in- use be presented from License Holder and
shelf life (if applicable), in-use storage legalized by Health Authority in
conditions (if applicable) and/or country of License Holder, Chamber of
container closure system (in Commerce, and Egyptian Embassy or
details) (if not stated in CPP or Consulate
attached SmPC or PIL or if • Original legalized declaration
letter shall be submitted by the
applicant company to Stability
updated than those mentioned in • General Administration once stability
registration license) dossier is accepted
• declaration letter within 6 months

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Guideline
Legalized composition (if not • Composition for the product shall be

stated in CPP or free sale) presented from License Holder and
Consulate
• Original legalized composition shall be
• declaration letter within 6 months
(when applicable)
• Biological analysis (when applicable)
specifications
formats:
• Word format

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Guideline

data submitted Shall be presented by applicant company signed
and stamped
Commitment for storage (in case (Template 3)
of proposed storage conditions at Shall be presented by applicant company signed

Sections for Drug Composition of the Drug
Product Product
Section 3.2.P.3.1:
Manufacturer(s)
Section 3.2.P.5.1: • Shall include test, specification and

Physical analysis
Chemical analysis
• Shall include identification and assay of
(when applicable)
Biological analysis (when
applicable)
Section 3.2.P.5.2: Analytical • Required only for imported products
Procedures from non- reference countries or when
country
• Shall include stability-indicating

analytical procedure
used for physical, chemical and
Section 3.2.P.5.3: Validation of • Required only for imported products
Analytical Procedures from non- reference countries or when
country

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Guideline

validation
characteristics should be
precision and accuracy
Specification(s)
Section 3.2.P.7: Container Closure
System
Section 3.2.P.8.1: Stability Summary
and Conclusion
Section 3.2.P.8.2: Post-approval
Commitment

applicable)
justified
▪ Hold time stability study (for
Bulk Products)

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Guideline
specifications
Assay chromatograms annex • Required only for imported products

country
• Shall include 3 injections for standard
and test at each time interval
countries
substances, and assay of

(when applicable)
samples stored under relevant
stress conditions: light, heat,
humidity, acid/base hydrolysis and
oxidation are required in addition
to placebo and blank injections

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Guideline
required
method parameters
Required CTD In case of availability of valid Certificate of Suitability of the European Pharmacopoeia
Sections for (CEP):
Drug Substance
(When needed) • *CEP specifying a retest period that is the same as or longer than that proposed by
the applicant, and storage conditions are the same or at a higher temperature and
humidity than those proposed by the applicant, the applicant is waived from
submission of CTD Sections for Drug Substance OR
• *CEP stating a container closure system while not stating a retest period and
storage condition, the applicant is waived from submission of analytical procedure
and validation of analytical procedure
Section 3.2.S.2.1: Manufacturer(s) In case of more than one manufacturer for an
active ingredient(s), declaration letter from
License Holder
mentioning manufacturer(s) of active
pharmaceutical ingredient(s) for each
batch submitted
Section 3.2.S.4.1: Specification(s) • Shall include test, specification and
related substances
applicable)
applicable)
Section 3.2.S.4.2: Analytical Procedures • Shall include stability-indicating
• Shall submit reference if analytical
procedure used found in a

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Guideline
pharmacopoeia

Analytical Procedures procedures for assay of active
specificity, precision, linearity, accuracy,
accuracy
Section 3.2.S.4.4: Batch analyses
Section 3.2.S.4.5: Justification of
Specification(s)
Section 3.2.S.6: Container Closure
System
Section 3.2.S.7.2: Post-approval
Stability Protocol Commitment
Section 3.2.S.7.3: Stability Data • Shall include the following:
applicable)
justified
specifications

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Guideline

• Shall include 3 injections for standard
and test at each time interval
substances
stored under relevant stress
acid/base hydrolysis and oxidation are
required in addition to placebo and
blank injections
required
recommendedwith 3 injections
method parameters

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Guideline
in CTD format Imported (re-registration)
EDA -Transfer Letter and attached

Approvals composition (When needed)
-Preliminary Re-registration
Approval (When needed)
Registration License and
attached composition
EDA Labs composition (in case In case the composition is not inferred by EDA
composition is not attached to Labs, Stability General Administration
registration license or variation accredits the composition
approval for changing
composition)
Any other EDA approvals and/or In case of any approvals or decisions issued for
decisions (e.g.: variation the product and not reflected in the last
approval…) released registration license
Product Certificate of Pharmaceutical The certificate establishes up to date status and
Documents Product (CPP) or free sale and data of the product in the exporting country or
attached Summary of Product region at the time of issuing of certificate. This
Characteristics (SmPC) or data may include (when applicable):
Product Information Leaflet • Product Trade name in Egypt, its
(PIL) (if applicable) strength and dosage form
(PIL)
shelf life (if applicable), in-use storage

of Commerce, and Egyptian Embassy or Consulate
shall be submitted.

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Guideline
shelf life (if applicable), in-use legalized by Health Authority in country
storage conditions (if applicable) of License Holder, Chamber of
and/or container closure system (in Commerce, and Egyptian Embassy or
details) (if not stated in CPP or free Consulate
sale or attached SmPC or PIL or if • Original legalized declaration letter shall
updated than those mentioned in be submitted by the applicant company
registration license) to Stability General Administration once
situation, Commitment for legalization
of declaration letter within 6 months
shall be submitted
in CPP, free sale or if not attached presented from License Holder and
registration license, no EDA Labs legalized by Health Authority in country
composition or variation approval of License Holder, Chamber of
for changing composition) Commerce, and Egyptian Embassy or
Consulate

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Guideline

number, manufacturing and
expiry date
▪ Shall include identification and assay of
(when applicable)
specifications
Commitments Stability summary sheet Shall be presented by applicant company in two
formats:
• Word format
Submitted Shall be presented by Applicant company signed
and stamped
proposed storage conditions at Shall be presented by Applicant company signed

Sections Composition of the Drug Product
Section 3.2.P.3.1: Drug Product
Manufacturer(s)
Section 3.2.S.2.1: Drug Substance In case of more than one manufacturer for an
Manufacturer(s) active ingredient(s), declaration letter from License
Holder mentioning manufacturer(s) of active
pharmaceutical ingredient(s) for each batch
submitted

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Guideline
Section 3.2.P.5.1: Drug • Shall include test, specification and

Product Specification(s) reference for specification
▪ Shall include identification and assay of
(when applicable)
Section 3.2.P.5.2 Analytical • Required only for imported products from
Procedure non- reference countries or when stability
Section 3.2.P.5.3 Validation • Required only for imported products from
of analytical procedure non- reference countries or when stability

and robustness
In case of analytical procedure used
Accuracy
Section 3.2.P.5.6: Justification
of Specification(s)

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Guideline
Section 3.2.P.7: Container

Closure System
preservative(s) and/orantioxidant(s)
(when applicable)
justified
Products)
specifications
Assay chromatograms annex • Required only for imported products from
• Shall include chromatograms of assay of
impurities and related substances, and assay
of preservative(s) and/or antioxidant(s)
(when applicable)

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Guideline
Validation chromatograms annex • Required only for imported products from

testing site is in non-reference countries
• Shall include chromatograms of validation
of analytical procedures for assay of active
applicable)
hydrolysis and oxidation are required in
addition to placebo and blank injections
▪ For robustness: 3 injections are required
for each small variation in method
parameters

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Guideline
in CTD format imported (variation)
EDA Approvals Variation Committee Approval (if

applicable)
Valid Registration License and attached Is a must in case of shelf-life extension or storage
composition condition change
Evidence for submission of product for

re-registration (in case of invalid
Registration License)
EDA Labs composition (if not attached

to Registration License or variation
approval for changing composition)
Product Information Leaflet (PIL) data may include (when applicable):
(when applicable) • Product Trade name in Egypt, its strength
and dosage form
(PIL)
Chamber of Commerce, and Egyptian Embassy
or Consulate
Legalized declaration letter stating • Is a must in case of shelf-life extension or
shelf life, storage conditions, in-use storage condition change
shelf life (if applicable), in-use
storage

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Guideline
conditions (if applicable) and/or • Declaration letter for the product shall be
container closure system (in details) (if presented from License Holder and
not stated in CPP or attached SmPC or legalized by Health Authority in country
PIL or if updated than those mentioned
in registration license) of License Holder, Chamber of
Consulate
• Original legalized declaration letter shall
be submitted by the applicant company to
of active ingredient(s), quantitation
of impurities and related substances,
and identification and assay of
(when applicable)
applicable)
▪ Shall include results within release
specifications

formats:
• Word format

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Guideline

Submitted Shall be presented by Applicant company signed
and stamped
proposed storage conditions at Shall be presented by Applicant company signed
Cover Letter for scope of variation (in
case of variation)
Payment Receipt (in case of variation

of shelf-life, storage conditions, in-use
shelf-life or in-use storage conditions)

Sections Composition of the Drug
Product
Section 3.2.P.3.1: Drug Product
Manufacturer(s)
Section 3.2.S.2.1: Drug Substance In case of more than one manufacturer for an
Manufacturer(s) active ingredient(s), declaration letter from
License Holder mentioning manufacturer(s) of
active pharmaceutical ingredient(s) for each
batch submitted
Section 3.2.P.5.1: Drug • Shall include test, specification and

Product Specification(s) reference for specification
▪ Shall include identification and assay
(when applicable)

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Guideline
Section 3.2.P.5.2 Analytical Procedure • Required only for imported products from
Section 3.2.P.5.3 Validation • Required only for imported products from
of analytical procedure non- reference countries or when stability
• Complete validation of analytical procedures
considered including: specificity, precision,
linearity, accuracy, ruggedness and
robustness
• In case of analytical procedure used found in
a pharmacopoeia, verification of analytical
considered including: specificity, precision
and
• Accuracy
Specification(s)
Section 3.2.P.7: Container Closure
System
Section 3.2.P.8.1: Stability Summary
and Conclusion
Section 3.2.P.8.2: post-approval
Commitment

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Guideline
Section 3.2.P.8.3: Stability Data Shall include the following:

• Physical analysis
• Chemical analysis
• Shall include assay of active
• Microbiological analysis
Any skipped test shall by scientifically
justified
May include (when applicable):
• Photo stability study
• Hold time stability study (for Bulk
Products)
specifications
Assay chromatograms annex • Required only for imported products
country
Shall include 3 injections for standard and test

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Guideline

countries
hydrolysis and oxidation are required
in addition to placebo and blank
injections
For robustness: 3 injections are required for each
small variation in method parameters

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Guideline
Template 1
Stability Summary sheet
Note: All items of the sheet should be fulfilled
Summary of Stability Study:

(Type of study, duration, conditions and batches number)

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Guideline
Template 2
Commitment for authenticity of data submitted

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Guideline
Template 3
Commitment for storage conditions

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Guideline
Template 4
Certificate of responsibility

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Guideline
SECTION SEVEN
Requirements for Submission of Inserts

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Guideline
SECTION SEVEN: Requirements for Submission of Inserts

This section will provide information about Requirements for Inserts
Checklist of requirements for medical insert submission
General Requirements for leaflet submission
1 Cover letter
2 Proposed Leaflet (in Word format (SmPC & PIL), *For cases of exceptions of Arabic leaflet, see
technical committee decisions in 12/3/2009 &25/8/2022.
3 The most Updated reference for both SmPc & PIL
4 EDA approved product composition (stability/CADC) (Excluded for 820, EDA chairman decree
(450/2023) case 2 track A, B&C (for imported products), and to be submitted immediately after
releasing from responsible department.
5 Naming approval, layout or art work.
6 Checking for Technical & Pharmacology warnings
7 In case of imported and innovator products: CPP
In case of imported and innovator products with PIL only: A Legalized letter from the country of
origin stamped from Egyptian Embassy comprising a warrant that the attached leaflet (Patient
information leaflet) with the specified Trade Name, generic name, concentration, version date and
version number is marketed and registered in the country of origin, and is to be translated to Arabic
language as the patient information leaflet. (Template attached in annexes in submission guidance)
And for non-English inserts,
✓ A Declaration Letter from License Holder commit that the leaflet is translated
according to authorized medical translation on their responsibility in accordance with the
translation attached. (Signature & Stamp)
Or
✓ Legalized letter from the head office stating that the scientific office is responsible for
the translation and the insert is translated medical translation through their scientific office,
the medical translation submitted (2 languages: English and Non-English)) should be signed
and stamped by the scientific office.
A declaration letter from the scientific office declares that the letter is to be legalized within 6 months
8 In case of Non -referenced product: Committee approval (s)
9 In case of non-English reference: Authorized Translation of the Reference
For products under registration:
1 Box approval.
2 Naming approval.
3 Accelerated stability (excluded for 820& EDA Chairman Decree (450/2023) case 2) and to be
submitted immediately after releasing from responsible department.
4 Pricing (not required in case of: 820, EDA chairman decree (450/2023) case 2, export only, tender &
export)
5 PV for approval (requested for 425, 645, EDA Chairman Decree (450/2023) case 1&3 & excluded
for export, EDA Chairman Decree (450/2023) case 2)

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Guideline
6 Receipt (1000 LE)
For re-registration products:

If the insert approval date is within 5 years and no updates &/ warnings are required, it is permissible NOT
to submit to insert administration, but if it exceeds 5 years the following should be submitted.
1 Last approved insert
3 Re-registration action letter
4 Re-Reg stability (depending on the requirements stated in the ministerial decree that the
product follows), and in case of safety update may not be submitted.
5 Naming or Layout approval (in case Arabic name is not written in the registration license)
6 PV approval required for products following 150 decision.
7 Receipt (1000 LE)
Requirements for leaflet update:
1 Receipt: 500 LE
2 Tracked Change
3 Last approved inserts
4 Tracked Change between proposed updated leaflet and previously approved
5 Valid EDA documents (ex., registration approval, re-registration approval)
For warning addition:
1 Warning to be added highlighted inside the insert

3 Most updated version of reference leaflet for both (SmPC & PIL)
For variation:
1 Variation approval
2 Receipt (500 LE)
4 Most updated version of Reference leaflet for both (SmPC & PIL)
For appeals:
1 Receipt:1000 LE
2 Cover letter in Word format

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Guideline
3 Where applicable, a comparison table (in Word format) between the two inserts the appeal is
submitted for.
4 Relevant documents to the raised issue.
In case of Replacement insert:
1 Receipt: (500.l.E)
2 Copy of last approved leaflet

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Guideline
SECTION EIGHT
Requirements for Submission of Mock-Up Requests

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Guideline
SECTION EIGHT: Requirements for Submission of Mock-up Requests

This section will provide information about requirements for any human pharmaceutical product
submitted for Mock-up approval.
Type of Request No. Documents Notes

1 Cover letter On company letterhead signed, stamped and dated.
2 Registration request
3 Scientific committee approval In case of Non-reference products.
1 4 Trade name approval letter
Mock-up approval for
5 Stability approval
new registration
License. 6 Price certificate
7 Valid Legalized CPP In case of imported or under license products
8 Original Pack In case of imported or under license products
9 Monograph of the product according In case of Compendial Products
to latest edition of pharmacopeia
10 Coloured stamped outer and inner Editable PDF form is preferable.
mock-ups
1 Cover letter On company letterhead signed, stamped and dated.
2 3 Registration license Extension If registration license is not valid.
4 Stability approval for Accelerated
stability study and Long-Term
stability study (if present)
Mock-up approval for 5 Price certificate
Re-Registration
6 Valid Approved Leaflet
License.
7 Latest Approved Mock-up
8 Approved variation letters. If relevant.
9 Valid legalized CPP In case of imported products.
10 Monograph of the product according In case of Compendial Products
to latest edition of pharmacopeia
mock-ups
3 1 Cover letter On company letterhead signed, stamped
and dated, specifies changes requested.
3 Valid Approved Leaflet
3 Approved variation letters. If relevant.
Mock-up change
5 Fees payment receipt According to the published submission
link
mock-ups

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Guideline
1 Cover letter On company letterhead signed, specifies

4 products names, strengths, dosage forms
and registration numbers.
Logo Change
2 Coloured copy of new Logo
3 Fees payment receipt According to the published submission
link
1 Cover
1 letter On company letterhead signed, specifies
5 products names, strengths, dosage forms,
Telephone & Fax registration numbers and new Telephone
Number Change & Fax Number.
2 Fees payment receipt. According to the published submission
link
Appeal for marketing 1 Cover letter On company letterhead signed, stamped
of unapproved or and dated.
invalid Mock up 2 Registration License
6 3 Coloured copy of required mock-up
5 Fees payment receipt. According to the published submission
link

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Guideline
SECTION NINE
Requirements for Submission of Final Registration

File

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Guideline
SECTION NINE: Requirements for Submission of Final Registration File
This section will provide information about Requirements for human pharmaceutical products
submitted for final registration/Re-registration
Submission guidance according to CTD format
Module 1 Original Copy Original

Administrative Information and Prescribing Information to review
1.1. Company commitments
1.1.1. Application form & Commitment (Attached) R

:‫فى حالة التوقيع من قبل‬
‫ برجاء إرفاق نموذ توقيع رئيس مجلس اإلدارة مصدقا ً بصحة توقيع‬:‫رئيس مجلس اإلدارة‬
(‫من البنك أو الش ر العقاري (األصل لالطالع‬
‫ برجاء إرفاق تفويض بإنابة التوقيع عن رئيس مجلس‬:‫من ينوب عن رئيس مجلس اإلدارة‬
(‫اإلدارة مصدقا ً بصحة توقيع من البنك أو الش ر العقاري (األصل لالطالع‬
1.1.2. Letter of Attorney for Company representative R R
‫تفويض الشركة للمندوب مصدقا ً بصحة توقيع من البنك‬
1.1.3. Declaration for other concentrations (Attached) R

1.1.4. Production / Importation status declaration (For Re- Registration R

Products)
‫ االستيراد متضمنًا رقم آخر تشغيلة إنتاجية تم إنتاج ا أو‬/ ‫إقرار بموقف المستحضر من اإلنتا‬
.‫استيرادها وتاريخ اإلنتا وتاريخ انت اء صالحية التشغيلة‬
1.1.5. Fees payment receipt (Total fees For Re- Registration Products) R
‫ تعديل المقابل الماد إلعادة‬2021/5/17 ‫طبقا ً لتأشيرة رئيس هيئة الدواء المصرية فى‬
:‫ ليصبح‬2018/600 ‫تسجيل المستحضرات الصيدلية البشرية الوارد بالقرار الوزار رقم‬
.( ‫*مستحضر محلى‬10000 L.E.)
( ‫*مستحضر مستورد‬15000 L.E..)
1.1.6. Fast Track Fees Payment receipt (According to EDA chairman R
decision on 27/9/2021)

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Guideline
‫ تطبي الية نظام التسجيل السريع‬2021/9/27 ‫طبقا ً لتأشيرة رئيس هيئة الدواء المصرية فى‬
.)15000 L.E.( ‫لملفات تسجيل المستحضرات البشرية نظير مقابل ماد قدره‬
:‫ملحوظة‬
.)15000 L.E.( ‫*قيمة االيصال الخاص بنظام التسجيل السريع‬
‫*يتم كتابة اسم الشركة واسم المستحضر على أصل ايصال الدفع الخاص بنظام التسجيل‬
.‫السريع‬
‫*يتم تسليم أصل ايصال الدفع مدونا ً به البيانات لالدار المختص والحصول على صورة‬
.‫االستالم‬
‫*تلتزم الشركة برفع ملف التسجيل كامالً مرف به صورة االستالم الخاصة بايصال نظام‬
.‫التسجيل السريع‬
1.2. EDA Approvals

1.2.1. Action Letter & Name Approval (For New Products)
Registration license & Preliminary approval for the re-registration (For Re-
Registration Products)
1.2.2. Pricing License R R
1.2.3. Pharmacovigilance approval R R
1.2.4. Any other approvals (e.g. Fast track, Technical committee approval…….) (For R R
New Products)
Any Pre-approved letters from EDA concerning product during previous
registration period (e.g. Variation approval, Technical committee decisions,
…….) (For Re- Registration Products)
1.2.5. Pilot batch samples withdrawal record (by inspection department), R
with the product composition attached (signed or stamped by EDA inspector)
(For New Products)
1.2.6. Production / Importation status report (For Re- Registration Products)
‫) لإلفادة عن وجود تشغيلة سارية‬....... ‫ إفرا‬،‫إفادة من اإلدارة العامة للتفتيش على المصانع (محضر سحب‬ R
‫الصالحية من المستحضر‬
R R
:‫* في حالة عدم توفر تشغيلة انتاجية سارية الصالحية‬
)2018/600 ‫تقديم موافقة اللجنة الفنية على االستثناء من م لة االنتا واإلستيراد طبقا لقرار‬
1.2.7. Importation approval for each API (For New Products) R

Importation approval / plan for each API (For Re- Registration Products)
1.3. Imported / Under license documents
1.3.1. Certificate of Pharmaceutical Product (CPP) issued by Competent Authorities R
in Country of Origin
(In Case of Imported Or Imported Bulk Or Under license Products)
▪ Valid
▪ From the country of origin

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Guideline
▪ Issued and authenticated by the competent authority

▪ Signed and stamped by:
Chamber of Commerce or Notary Public or Foreign Affairs (If applicable)
▪ Legalized by the Egyptian Embassy
▪ The Arab Republic of Egypt is mentioned as Importing Country
▪ Date of issue is specified
▪ Trade name of the Product is specified
▪ Dosage form (s) and Strength (s) are specified.
▪ License Holder (address, city, country) is specified
▪ Role of License Holder is specified
▪ Product must be marketed in the COO for not less than one year
(if not marketed, explain why marketing is lacking)
▪ Manufacturing, packing & batch release site(s) involved in the
manufacturing process of the product is/are specified.
▪ Good Manufacturing Practice (GMP) of the manufacturer & Primary
Packager is specified.
▪ Pack Presentation and pack size(s) of the Product is (are) specified (could be
as attachment) (If available)
▪ Inner leaflet (could be as attachment) (If available)
▪ Complete product composition
- Active Ingredient(s) by its salt or hydrate form (if any) with its (their)
quantity (ies) per unit dose is (are) specified
- Inactive Ingredient(s) with its (their) quantity (ies) per unit dose is (are)
specified (could be as attachment)
Note:
▪ Capsule shell composition should be included in case of capsules.
▪ Shelf-life of the Product is specified (could be as attachment) (If available)
▪ Storage Conditions of the Product is specified (could be as attachment) (If
available)
▪ Summary of Products Characteristics or package insert of the product (could
be as attachment) (If available)
▪ If the Name of the product is different in Egypt, it must be noted
(If not stated, a separate legalized declaration on the license holder letter head
is required).
1.3.2. Certificate of the Good Manufacturing Practice (GMP) R R
(In Case Of Imported Or Imported Bulk)
▪ Legalized
▪ valid
▪ The name of the plant by its address should be specified
▪ The date of the last inspection should be specified.
▪ The invalidation date should be mentioned.
▪ The production lines are specified.
Note:

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Guideline
It should be submitted for manufacturer &Primary Packager involved in the

manufacturing steps of the product.
1.3.3. Technical Committee approval on Inspection Report R R

(In case of products imported from non-reference countries & not marketed in any
reference country)
1.3.4. List of Countries in which the product is registered & marketed R
1.4. Committees' approvals, Leaflet and Layout
1.4.1. Stability Approval R R
1.4.2. Bioequivalence Approval "if applicable" R R
1.4.3. Quality committee approval (module 3 S&P part) (If Required) R R
1.4.4. Approved leaflet (Original + 2 Copies) R

+ original leaflet (In case of Under license, Imported or Imported bulk products)
+ original leaflet marketed in Egypt (For Re- Registration Products)
1.4.5. Approved layout R
Outer & Inner label of the Product
3 Colored Copies approved by Naming & Labeling Department
1.4.6. Original pack (outer &inner) (In case of Under license, Imported products or R
Imported bulk products).
Original pack marketed in Egypt (For Re- Registration Products)
1.5. Reference
1.5.1. The reference (on-line or text book) R
The reference product should be identical to the submitted product in terms of the
active ingredient, concentration & dosage form.
Latest Edition of the reference text book (eg. BNF)
Recent on-line reference:
FDA, MHRA, EMA, ANSM, Swissmedic, TGA, Pmda, etc.
(Note: The Reference product should be registered and marketed)
OR
Non-Reference Approval from Evaluation unit of scientific data & drug
development for Human Pharmaceuticals
1.5.2. Leaflet of the reference product R
1.6. Product certificates

1.6.1. CADAC certificate + CADAC composition R R
+

Version/Year:3/2023
Guideline
Renewal certificate of the analysis file for a registered pharmaceutical product

(for re-reg product)
1.6.2. Declaration to state if product had been analyzed / Undergoing analysis / will be R
analyzed after registration license in EDA Labs
(For New Imported/ Imported Bulk Products from reference Country)
On company letter head signed & stamped
1.6.3. Composition Certificate (5 Copies) R
Kindly submit as the composition attached with stability approval & Update
Specifications
On company letter head Signed and Stamped
Trade name of the Product is specified.
Dosage form of the Product is specified.
Active Ingredient(s), it’s (their) hydrate(s) and salt form(s) with its (their) quantity
(ies) per unit dose is (are) specified.
N.B:
1-Active Ingredient(s) must be identical to that in C.O.A. of supplier
(if not: please submit the synonyms)
2-Attach the equivalence calculation on the company letter head signed and
stamped, with reference for the molecular weight.
3- Attach the calculation of dose of Parabens for oral liquid dosage forms on the
company letter head signed and stamped
Inactive Ingredient(s) with its (their) quantity (ies) per unit dose is (are) specified.
Active & Inactive specifications should be specified (the In house Specification,

USP, EU, JP, British pharmacopoeia)
• Specify only one specification for each ingredient.

• Specifications should be recent
Active & Inactive ingredients should be separated in composition.
Any Overage should be mentioned.
N.B
Please write the Composition Per:

Version/Year:3/2023
Guideline
1gm 1ml 5ml Dosage Form
A. Cream A. Drops1 A. Syrup A. Tablet2

B. Ointment B. Vial contains B. Suspension5 B. Capsule3
C. Powder for solution (After Re- C. Patch
external use constitution) D. Sachet4
D. Gel C. Emulsion E. Suppository 4
E. Paste D. Elixir F. Vial contains
E. Lotion powder5
F. Topical Solution G. Prefilled Syringe
H. Cartridge
I. Ampoule
1. Coated tablets:
*Write the core and coat composition separated & mention the weight of tablet.
*Coating composition (e.g. Opadry coat) on the supplier head letter should be
attached.
2. Hard gelatin capsules:
* write the body and cap. composition separated & mention the size of capsule.
*Composition of the capsule shell on the supplier head letter should be attached.
3. Write the total Weight
4. Write the composition & volume for the solvent.
5. Please attach calibration for the drop volume on the company letter head signed and
stamped. i.e.(each 1 ml contains …… drop)
Note:
*In case of pellets: composition on supplier letter head should be attached &
attach the calculation of pellets (weight /capsule) on company letter head
*Premix Composition on supplier letter head should be attached
*For the Local manufactured products, the composition should be submitted on the
manufacturer and applicant head letter.
*For Imported / Imported Bulk /Under license products:
If the composition is attached with the CPP, it could be written on the applicant head
letter.
If the Composition is not attached in the CPP, a legalized composition should be
submitted on the license holder or the manufacturer head letter.
1.6.4. Certificate of Analysis of Finished Product R

Signed and Stamped by the Company or the concerned center or laboratory that held
the analysis

Version/Year:3/2023
Guideline
Product name, strength and dosage form are specified
Manufacturing date is specified
Expiry date is specified
Batch number is specified
Note:
- All the Physical, Chemical and Microbiological tests should be mentioned.
- Physical properties before and after reconstitution should be mentioned (In case of vial
containing powder, sachet, powder for suspension & granules)
1.7. API Documents & Specifications
1.7.1. Certificate of Analysis of Active Substance R
Signed and Stamped
Active Substance is specified
Manufacturing date, Expiry date are specified

Batch number is specified
1.7.2. GMP of the manufacturer R

1.7.3. Specification
Recent edition of specifications (pharmacopeias) and/or in-house specifications R

of all active ingredients.
In house specification of all inactive ingredients. R
On the company letter head signed and stamped
1.8. Company Documents & Agreements
1.8.1. Factory License & GMP of Factory / Manufacturer& IDA License R
1.8.2. The register of trade R
1.8.3. Toll Manufacturer License (For Toll Products)
1.8.4. License of Scientific Office & Scientific Office permit Letter. (if the Scientific
office is the applicant) (For Imported / Imported Bulk Products)
1.8.5. Importers register license (For Imported / Imported Bulk Products)
1.8.6. Company profile screenshot

1.8.7. Store License (If different from factory)
1.8.8. Agreements

Version/Year:3/2023
Guideline
▪ Manufacturing and storage agreement between the applicant and the

manufacturer. ( For Toll & F-Toll Products) (Authenticated by the bank
Or Legal department of EDA )
▪ License agreement (For Under License Products) Legalized by the
chamber of commerce & the Egyptian embassy
▪ Agency Agreement or Authorization letter (Legalized by the chamber of
commerce & the Egyptian embassy)
▪ Packaging agreement (In case of Bulk Imported) (Authenticated by the
bank & Legal department of EDA)
1.8.9. Declaration letter stating the list of (Registered & Under-Registration)

products owned by the toll company. (For Toll Products)
1.8.10. Declaration letter from the license holder specifying the API manufacturers. R
(should be legalized if different entity) (For Under License Products)
1.8.11. Declaration letter from the supplier stating the form of bulk (strips, Capsules,
etc……) (In case of bulk products) (For Imported / Imported Bulk Products)
▪ Legalized by the chamber of commerce & the Egyptian embassy
▪ In case of same entity or affiliate it might be on the applicant letter head
1.9. Special requirements
1.9.1. Scored products R
If the product (according to the physical description in the stability approval) is not
identical to the reference product, Declaration letter with the reason of scoring
should be submitted.
1.9.2. Generics for a patent product R
If the active ingredient has a patency, please submit the following commitment on
company letter head signed, stamped and dated:
‫تتعهد الشركة بعدم تداول المستحضر للجمهور طوال مدة سريان براءة إختراع المادة الفعالة‬
‫) وأن تتحمل الشركة جميع العواقب التى تخالف قانون براءة اإلختراع وعدم وجود‬.......................(
.‫مسئولية قانونية على هيئة الدواء المصرية فى هذا الشأن‬
1.9.3. Solvents R
If a solvent is attached with the product, kindly submit the Registration license for
the solvent.
1.9.4. Devices R
If a device is attached with the product, kindly submit a Declaration of conformity
of the device

Version/Year:3/2023
Guideline
Application form & Commitment

‫ رئيس هيئة الدواء المصرية‬/‫السيد الدكتور‬
،،،،‫تحية طيبة وبعد‬
:‫نتقدم لسيادتكم بملف التسجيل للحصول على رخصة تسويق المستحضر اآلتي‬
Trade Name:
English and Arabic
Active Ingredient(s) & Strength (s):
Physical Characters:
Shelf Life:
Storage Condition:
Approved Price Pack: Note: Kindly Specify No. of Units according

to the Pricing Certificate & Packaging
Material according to the Stability Approval.
Price:
Reference:
Therapeutic Group:
Applicant:
License Holder:
Manufacturer:
Manufacturer of Solvent/ Accessories (If

Applicable):
Packager:
Batch releaser:
Storage Site & Address:
Type of registration:

Version/Year:3/2023
‫‪Market status:‬‬
‫‪Name of API:‬‬
‫‪Name of Manufacturer & country of‬‬

‫‪origin:‬‬
‫‪"Address as in the manufacturer's‬‬
‫‪GMP":‬‬
‫‪Name of Supplier &country of origin:‬‬
‫‪Note: The above box can be repeated according to No. of APIs in Product‬‬
‫‪Contact person:‬‬
‫‪Telephone number:‬‬
‫‪E-mail:‬‬
‫رئيس مجلس إدارة (أو ‪/‬العضو المنتدب‪ /‬المفوض باإلمضاء) شركة ‪..................................‬وأتعهد أنا الموقع أدناه‬
‫‪ ........................‬باآلتي‪:‬‬
‫● بأن كافة البيانات المذكورة أعاله صحيحة ودقيقة وكاملة‪.‬‬

‫● االلتزام بأحكام قانون حماية حقوق الملكية الفكرية رقم ‪ 82‬لسنة ‪ 2002‬والئحته التنفيذية دون أدنى مسؤولية على هيئة الدواء‬
‫المصرية‪.‬‬
‫● االلتزام بطباعة اسم المصنع وعنوانه والشركة مالكة المستحضر (أو اسم الشركة مالكة الحق في التسويق للمستحضرات‬
‫المستوردة بدال من الشركة مالكة المستحضر وذلك طبقا لشهادة ‪ CPP‬المقدمة) وتاري اإلنتاج وتاري انتهاء الصالحية ورقم‬
‫التشغيلة ورقم التسجيل والسعر على العبوة الخارجية وعدم إحداث أي تغيير في المستحضر إال بعد الحصول على موافقة هيئة‬
‫الدواء المصرية‪.‬‬
‫● إخطار هيئة الدواء المصرية بأسماء جميع الموزعين المعتمدين وبأي تغيير يطرأ على البيانات الخاصة بهم والتأكد من أن‬
‫الموزع المعتمد يطبق قواعد التخزين والتوزيع الجيد (‪ )GDP & GSP‬ومتابعتها من قبل اإلدارة العامة للتفتيش على المصانع‪.‬‬
‫● عدم تغيير مصادر المادة الخام الفعالة إال بعد موافقة اإلدارة العامة لتسجيل المستحضرات البشرية‪ ،‬وإال يلغى إخطار التسجيل‪.‬‬
‫● تحمل المسئولية الكاملة عن تخزين المواد الخام‪ ،‬وعن جميع مراحل تصنيع المستحضر‪ ،‬وعن مطابقة المستحضر للمواصفات‬
‫الفنية وتخزين المنتج حتى تمام التوزيع وفى حالة التصنيع لدى الغير يشترط أن يكون المصنع مرخصا وأن يلتزم بجميع‬
‫االلتزامات الواردة بهذا القرار بقواعد التصنيع الجيد وما ورد بالقرار الوزاري ‪ 539‬لسنة ‪ 2007‬بشأن اعتماد المدونة المصرية‬
‫ألساليب التصنيع الجيد للمستحضرات الصيدلية‪.‬‬
‫● ال يتم نقل مكان التصنيع أو نقل الملكية إال بعد موافقة اإلدارة العامة لتسجيل المستحضرات البشرية‪ ،‬وإال يلغى إخطار‬
‫التسجيل‪.‬‬
‫● ال يتم نقل ملكية المستحضرات المحلية االبعد مرور ثالث سنوات من التداول المحلي وموافقة اإلدارة العامة لتسجيل‬
‫المستحضرات البشرية‪،‬وإال يلغى إخطار التسجيل‪.‬‬
‫● أن جميع البيانات المقدمة بملف التحليل باإلدارة المركزية للرقابة الدوائية للمستحضر مطابقة لما تم تقديمة بملف التسجيل‬
‫بهيئة الدواء المصرية وأن جميع المستندات والبيانات صحيحة وعلى مسئوليتي الخاصة‪.‬‬

‫● إنتاج المستحضر بنفس مصدر المادة الخام التي تم عمل التشغيلة بها وأجريت جميع الدراسات المطلوبة عليها وذلك‬
‫للمستحضرات المصنعة محليا ومقدمة للتداول المحلي أو التصدير والمناقصات‪.‬‬
‫● تقديم دراسات الثبات المعجلة وطويلة المدى عن أول ثالث تشغيالت إنتاجية خالل خمس سنوات من تاري إصدار إخطار‬
‫التسجيل‪ ،‬وإال يلغى إخطار التسجيل‪.‬‬
‫● اإلنتاج (االستيراد للمستحضرات المستوردة) خالل ثمانية عشر شهرا من تاري إصدارإخطار التسجيل وذلك طبقا‬
‫للتقريرالمقدم من اإلدارة العامة للتفتيش على المصانع‪ ،‬وإال يلغى إخطار التسجيل‪.‬‬
‫● اإلنتاج (االستيراد للمستحضرات المستوردة) قبل انتهاء تاري صالحية أخر تشغيله إنتاجية‪ ،‬وذلك طبقا للتقرير المقدم من‬
‫اإلدارة العامة للتفتيش على المصانع‪ ،‬وإال يلغى إخطار التسجيل‪.‬‬
‫● تقديم شهادة ال ‪ GMP‬وشهادة التحليل الخاصة بالمادة الخام‪ ،‬وذلك عند التقدم إلستيراد المادة الخام بهيئة الدواء المصرية‪.‬‬
‫● إبالغ اإلدارة العامة لليقظة الصيدلية عن أى آثار عكسية خطيرة يتم رصدها عن هذا المستحضرو تقديم تقرير ‪Periodic‬‬
‫‪ ،Safety Update Report‬متابعة مأمونية مستحضراتها وتنفيذ جميع أنشطة اليقظة الدوائية وذلك وفقا للمهل المحددة‬
‫والقواعد الواردة بأسس الممارسة الجيدة لليقظة الدوائية الصادرة والمفعلة من اإلدارة‪.‬‬
‫● سوف يتم توزيع المستحضر عن طريق الشركات اآلتية‪:‬‬
‫‪.......................................................................................................‬‬
‫● تم إجراء دراسات إعادة التسجيل (تحليل باإلدارة المركزية للرقابة الدوائية ‪ /‬دراسة الثبات ‪ /‬دراسة التكافؤ الحيوى ‪ /‬معدل‬
‫الذوبان) على تشغيالت إنتاجية باستخدام مصدر المادة الخام‪........................:‬‬
‫● تم عمل الـمتغيرات (‪ )Variations‬اآلتية ‪( /‬لم يتم عمل أى متغيرات (‪ )Variations‬للمستحضر عن آخر إخطار تسجيل‬
‫للمستحضر‬
‫(إلعادة التسجيل) ‪ /‬موافقة طلب االستعالم (للمستحضرات الجديدة)‪:‬‬
‫‪Type of Variation‬‬ ‫‪From‬‬ ‫‪To‬‬
‫رئيس مجلس اإلدارة او المفوض إليه باإلمضاء‬ ‫ختم الشركة‬
‫‪:‬االسم‬
‫‪:‬التوقيع‬
‫‪:‬التاريخ‬

‫‪Declaration of other concentrations‬‬

‫السيد الدكتور‪ /‬رئيس هيئة الدواء المصرية‬
‫تحية طيبة وبعد‪،،،،‬‬
‫أتعهد أنا (رئيس مجلس إدارة ‪ /‬العضو المنتدب) لشركة ‪ .........................‬والثابت شخصيتى بموجب ‪ ................‬بأن‬
‫المستحضر الصيدلى اآلتي‪:‬‬
‫‪Product Name:‬‬
‫)‪Active Ingredient (s) & Strength: (s‬‬
‫‪Dosage Form:‬‬
‫‪Type of Registration:‬‬
‫‪Applicant:‬‬
‫‪Manufacturer:‬‬
‫والمقدم إلدارة الشئون التنظيمية للمستحضرات البشرية طبقا للقرار الوزاري‪ /‬قرار رئيس الهيئة رقم‬
‫‪……………………….‬‬
‫لنفس الشكل الصيدلي وهى كاآلتي‪ :‬يوجد ‪ /‬ال يوجد له تركيزات أخرى (مسجلة ‪ /‬تحت التسجيل)‬
‫‪---- .1‬‬
‫‪---- .2‬‬
‫مرفق صورة من ‪:‬‬

‫إخطارات تسجيل المستحضرات (للتركيزات األخري المسجلة)‬ ‫‪-‬‬
‫موافقة طلب االستعالم وموافقة االسم التجاري للمستحضرات (للتركيزات األخري تحت التسجيل)‬ ‫‪-‬‬
‫رئيس مجلس اإلدارة أو المفوض إليه باإلمضاء‬ ‫ختم الشركة‬
‫االسم‪:‬‬
‫التوقيع‪:‬‬
‫التاريخ‪:‬‬

Guideline
Submission Guidance for Human Pharmaceutical Product Initial Re -Registration File

according to EDA Chairman decree 150/2022
Submission guidance for preliminary approval first release

Required Documents
Section I
Company commitments
1. Application form (Attached)
On applicant letter head signed, stamped and dated
2. Letter of Attorney for Company representative
‫تفويض الشركة للمندوب مصدقا ً بصحة توقيع من البنك‬
3. Production/Importation status declaration
‫ االستيراد متضمنًا رقم آخر تشغيلة إنتاجية تم إنتاج ا أو استيرادها وتاريخ اإلنتا وتاريخ‬/ ‫إقرار بموقف المستحضر من اإلنتا‬
‫انت اء صالحية التشغيلة‬.
4. Total Fees payment receipt (Product Name, Strength, Dosage form Should be written)
For Local: 10000L.E
For Imported: 15000L.E
Section II
(EDA Approvals)
1. Registration Final license
)‫(أن وجدت‬.‫ توضيح موقف الدراسات المذكورة في إخطار التسجيل‬.1
‫ تقديم مايفيد استيفاء هذة الدراسات‬.2
‫ فى حالة عدم استيفاء الدراسات برجاء ارفاق تع د باستيفاء هذة الشروط قبل التقدم الصدار إخطار إعادة التسجيل‬.3
‫الن ائى‬
2. Any Pre-approved letters from EDA concerning product during previous registration period
(e.g. Variation Approval, Technical Committee approval, …….)
3. Production/Importation status report
‫) لإلفادة عن وجود تشغيلة سارية الصالحية من المستحضر‬....... ‫ افرا‬،‫إفادة من اإلدارة العامة للتفتيش (محضر سحب‬
‫تقديم موافقة اللجنة الفنية على االستثناء من م لة اإلنتا واالستيراد‬
Section III
(Imported / Under license documents)
1. Certificate of Pharmaceutical Product (CPP) issued by Competent Authorities in Country of
Origin (In Case of Imported Or Imported Bulk Or Under license Products)
• Valid
• From the country of origin
• Issued and authenticated by the competent authority
• Signed and stamped by:
Chamber of Commerce or Notary Public or Foreign Affairs (If applicable)
• Legalized by the Egyptian Embassy
• The Arab Republic of Egypt is mentioned as Importing Country
• Date of issue is specified
• Trade name of the Product is specified
• Dosage form (s) and Strength (s) are specified.
• License Holder (address, city, country) is specified

Version/Year:3/2023
Guideline
• Role of License Holder is specified

• Product must be marketed in the COO for not less than one year
(if not marketed, explain why marketing is lacking)
• Manufacturing, packing & batch release site(s) involved in the manufacturing process of the
product is/are specified.
• Good Manufacturing Practice (GMP) of the manufacturer & Primary Packager is specified.
• Pack Presentation and pack size(s) of the Product is (are) specified (could be as attachment)
(If available)
• Inner leaflet (could be as attachment) (If available)
• Complete product composition
- Active Ingredient(s) by its salt or hydrate form (if any) with its (their) quantity (ies) per unit
dose is (are) specified
- Inactive Ingredient(s) with its (their) quantity (ies) per unit dose is (are) specified (could be
as attachment)
Note: Capsule shell composition should be included in case of capsules.
• Shelf-life of the Product is specified (could be as attachment) (If available)
• Storage Conditions of the Product is specified (could be as attachment) (If available)
• Summary of Products Characteristics or package insert of the product (could be as
attachment) (If available)
• If the Name of the product is different in Egypt, it must be noted
(If not stated, a separate legalized declaration on the license holder letter head is required).
Section IV
(Reference)
1. The reference (on-line or text book)
The reference product should be identical to the submitted product in terms of the active ingredient,
concentration, dosage form & Rout of administration.
2. Latest Edition of the reference text book (eg. BNF)
Recent on-line reference:
FDA, MHRA, EMA, ANSM, Swissmedic, TGA, Pmda, etc.
(Note: The Reference product should be registered and marketed)
3. Leaflet of the reference product
Section V
(Company documents & agreements)
1. For Under License Products
License and manufacturing agreement
▪ Valid
▪ The manufactured products mentioned (Trade name / Dosage form & strength)
Legalized Letter For Any relation stated in the final license (Affiliate, subsidiary, etc……)
2. For Imported / Imported Bulk Products
Declaration letter from the supplier stating the form of bulk (strips, Capsules, etc……) (In case
of bulk products)
▪ In case of same entity or affiliate it might be on the applicant letter head
Agency Agreement or Authorization letter

Version/Year:3/2023
Guideline
▪ Valid
▪ The manufactured products mentioned (Trade name / Dosage form & strength)
Legalized Letter For Any relation stated in the final license (Affiliate, subsidiary, etc……)
License of Scientific Office (if the Scientific office is the applicant)
Special requirements
▪ The latest recent pharmacopeia for the finished product. (If the submitted product is a
pharmacopeial product).
Submission guidance for preliminary approval renewal
Required Documents
1. Application form (Attached)
On applicant letter head signed, stamped and dated
2. Renewal Fees payment receipt (Product Name, Strength, Dosage form Should be written)
according to ministerial Decree 150/2022
1000L.E
3. Total Fees payment receipt
For Local: 10000L.E
For Imported: 15000L.E
4. Old license +Old preliminary approval or stability referral letter
5. Production/Importation status report
‫) لإلفادة عن وجود تشغيلة سارية الصالحية من المستحضر‬....... ‫ افراج‬،‫إفادة من اإلدارة العامة للتفتيش (محضر سحب‬
‫تقديم موافقة اللجنة الفنية على االستثناء من مهلة اإلنتاج واالستيراد‬

Version/Year:3/2023
Guideline
Application Form
)‫ (االسم بالكامل للشخص المسئول عن المؤسسة‬/ ‫أتعهد أنا الموقع ادناه‬
.‫بأن المعلومات التالي ذكرها صحيحة و دقيقة و كاملة‬ ●
Type of request: ▪ First release

▪ Renewal
Registration number:
Trade Name:
Active Ingredient(s) &
Strength(s):
Applicant:
License Holder:
Marketing Authorization Holder:
Manufacturer:
Primary Packager:
Secondary Packager:
Batch Releaser:
Type of Registration:
Reference:
Therapeutic Group &Indication:
Fees payment receipt No.:
Person authorized for
communication on behalf of the
applicant Company
Applicant Mail & Phone
number:
On Company letter head
‫رئيس مجلس اإلدارة‬ ‫ختم الشركة‬ ‫مدير التسجيل‬
:‫االسم‬ :‫االسم‬
:‫التوقيع‬ :‫التوقيع‬
: ‫التاري‬ : ‫التاري‬

Version/Year:3/2023

Guideline On Dossier Requirement of Human Pharmaceutical Product 2

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Guideline On Dossier Requirement of Human Pharmaceutical Product 2

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Guideline

Central Administration of Pharmaceutical Products

Code: EDREX: GL.CAP.Care/CAPP.002

GUIDELINE ON Dossier Requirements of Human

GUIDELINE ON Dossier Requirements of Human

Local Products - Pharmaceutical products manufactured, stored, released, distributed

GUIDELINE ON Dossier Requirements of Human

Bioequivalence study - It is a comparative study conducted on healthy volunteers in one

GUIDELINE ON Dossier Requirements of Human

Requirements for Submission of Registration Request

GUIDELINE ON Dossier Requirements of Human

SECTION ONE: Registration for Submission Registration Request

A Registration requests submitted for the products manufactured locally

2- Submit registration requests ‫التقدم بطلبات التسجيل على برنامج‬ √

GUIDELINE ON Dossier Requirements of Human

Requirements ‫خطوات التقديم‬ Soft Hard copy Original

▪ Generic Type (single,

GUIDELINE ON Dossier Requirements of Human

Requirements ‫خطوات التقديم‬ Soft Hard copy Original

extension above the allowed Stamp the

B- Registration requests submitted for Imported & Under License products

Valid Electronic Certificate of ‫أو‬

8- Valid GMP for the ‫ سارية للمصنع (سيتم‬GMP ‫شهادة‬ √ √ √

GUIDELINE ON Dossier Requirements of Human

Requirements ‫خطوات التقديم‬ Soft Hard copy Original

10- Valid & legalized ( ‫عقد التصنيع مع الشركة األجنبية‬ √ √ √

11- Legalized Innovator letter (in ‫خطاب من الشركة صاحبة‬ √ √ √

12- List of countries in which the ‫خطاب من الشركة مالكة المستحضر‬ √

13- Permission Letter for Scientific ‫خطاب تصريح للمكتب العلمي‬ √ √ √

C- Registration requests submitted as Line Extension

GUIDELINE ON Dossier Requirements of Human

Requirements ‫خطوات التقديم‬ Soft Hard copy Original

14- Documents showing that the ‫مايفيد أن المستحضر الخاص بالشركة‬

‫يشترط أن يكون طلب التسجيل من نفس‬

D- Permission Letter Inquiry Submitted by Scientific Office (Through E-mail)

GUIDELINE ON Dossier Requirements of Human

Requirements ‫خطوات التقديم‬ Soft Hard copy Original

16- Covering letter signed and ‫خطاب من المكتب العلمي معتمد‬ √

GUIDELINE ON Dossier Requirements of Human

Requirements ‫خطوات التقديم‬ Soft Hard copy Original

1- Covering letter signed with ‫ خطاب من الشركة معتمد ومختوم‬-1

GUIDELINE ON Dossier Requirements of Human

(**) General Notes:

GUIDELINE ON Dossier Requirements of Human

The company is allowed to submit an Electronic Certificate of Pharmaceutical Product (eCPP)

GUIDELINE ON Dossier Requirements of Human

WHO Letter Template

GUIDELINE ON Dossier Requirements of Human

Innovator Letter Template

GUIDELINE ON Dossier Requirements of Human

Covering letter signed and stamped ‫خطاب من الشركة معتمد‬ √

2- Registration request Approval ‫موافقة طلب التسجيل‬ √

GUIDELINE ON Dossier Requirements of Human

Requirements ‫األوراق المطلوبة‬ Original Copy Original

Pharmaceutical Products written on it: ‫للمستحضرات الصيدلية‬

(*) In case of the required registration request approval is imported:

● The company is allowed to submit with Electronic Certificate of Pharmaceutical Product

GUIDELINE ON Dossier Requirements of Human

‫جدول دمج األشكال الصيدلية في صندوق المثائل‬