Cosmetic E-Notification

System Version 2.0

 STEP 3.
NOTIFY THE COSMETIC PRODUCT
 Cosmetic E-Notification System User Interface

E-Notification System Version 1 E-Notification System Version 2

•Only FDA-CCRR can access the FDA Inventory •FDA-CCRR and its stakeholders will be using
System. the same system interface.

•FDA Inventory System can only be accessed •All end-users with user account credentials can
within the FDA Office. access the system anywhere as long as internet
connection is available
 Accessibility of E-Notification System

E-Notification System Version 1 E-Notification System Version 2

All applicant companies send their applications •All applicant companies access a
thru any free email service. centralized system. FDA e-Portal is a user-
friendly system that promotes transparency
and secures all submitted applications
specifically all the data provided by the
company.

•Each company is assigned a user account

to be able to access FDA e-Portal.
 Submission of Applications
E-Notification System Version 1 E-Notification System Version 2

All applicant companies submit their applications All applicant companies log-in to the FDA e-Portal
thru an email with two attachments (ACD form using the credentials issued by FDA-CCRR The ACD
Template, Ingredient.csv) and send it to Form including the full ingredient list is already
[email protected] incorporated into the system. The clients have to
click ‘New Case’ to start the process and fill up the
forms.
 E-Notification System Version 1 E-Notification System Version 2

After the applicant companies have sent their After the applicant companies have filled up
applications, the FDA-CCRR assesses the the forms in FDA e-Portal, an order of
submitted applications to generate the billing payment will be automatically generated.
form or the order of payment. The order of
payment is then sent to the email address
included/reflected in the ACD Form.
 Transparency
E-Notification System Version 1 E-Notification System Version 2

After paying the corresponding fee, the After paying the corresponding fee, the
applicant companies have to wait fourteen (14) applicant companies have to wait fourteen (14 )
calendar days for the acknowledged calendar days for the acknowledged
notification or disapproval letter (Based on the notification or disapproval letter (Based on the
existing FDA Citizen’s Charter). existing FDA Citizen’s Charter). With the e-
notification system version 2, the applicant
companies can check the current status of their
applications from time to time.
E-Notification System Version 1 E-Notification System Version 2

All submitted applications are saved in the

account (Participated). Applicant companies
can retrieve all their files and acknowledged
notification anytime (Inbox).
 Result

E-Notification System Version 1 E-Notification System Version 2

With the version 1, applicant companies print With the version 2, applicant companies only
out the whole acknowledged ACD Notification print out one page of notice of
template (5 or more pages). acknowledgement.
Other advantages of Cosmetic E-Notification Version 2.0

• Automatic Notice of PIF Audit upon Acknowledgement

• Revalidation
Guidelines on Issuance of Center for Cosmetics
Regulation and
Research (CCRR) User Account to Access E-
Portal
FDA Memorandum Circular No. 2015 - 010
 CCRR USER ACCOUNT REQUEST
PROCESS OVERVIEW
Email request sent to
[email protected]
• Follow e-mail format

Requirements
• QPIRA ID
• Notarized Authorization Letter

CCRR User Account

• Company-specific
• One username per account per company per product
classification
• With QPIRA ID = 2 years validity
• With Authorization Letter = 1 Year validity
Email request sent to [email protected]
• Follow e-mail format
Requirements
• QPIRA ID
• Notarized Authorization Letter
• Prior to issuance of FDA-CCRR User Account, the representative of the
applicant company shall present any proof of attendance to relevant
Qualified Person in Industry Regulatory Affairs (QPIRA) seminar.

• Any applicant who has not yet attended the relevant QPIRA seminars shall
present a notarized authorization letter (Annex A) to request for the CCRR
User Account. ANNEX A.pdf

• The issued CCRR User Account will be sent to the e-mail provided in the
request. (Annex B) ANNEX B.pdf
CCRR User Account
• Company-specific
• One username per account per company per product
classification
• With QPIRA ID = 2 years validity
• With Authorization Letter = 1 Year validity
• Account Holder with QPIRA Credentials – Valid for two (2) years

• Account Holder without QPIRA Credentials - Valid for one (1) year

• Accounts, including the username and password, are company-specific. A

representative handling multiple companies shall secure separate accounts
for each respective company.

• Only one username and password will be issued per account per company
per product classification.
 Renewal of CCRR User Account
One (1) month prior the expiration of the account, the representative of the applicant
company may request for account renewal by sending an e-mail to [email protected] following
the format below:

For applicants who have submitted their QPIRA credentials during the previous request for
user account:

(Subject of the e-mail) “CCRR – Request for Renewal of CCRR User Account”

(Body of e-mail)
Email Address:

(Attachment/s) Request Letter (Annex C) ANNEX C.pdf

For applicants who have submitted notarized authorization letter during the
previous request for user account:

(Subject of the e-mail)

“CCRR – Request for Renewal of CCRR User Account”

(Body of e-mail)
Email Address:

(Attachment/s) Certificate of Attendance and/or QPIRA ID

 Change of the Authorized Representative

• When there is a change of the representative of the applicant company, the

applicant shall request for a change in credentials of the CCRR User Account
by sending an e-mail to [email protected]. The following must be submitted
as attachments to the request: (1) A cover letter stating the change in
information of the User Account; and, (2) QPIRA ID or a notarized
authorization letter (Annex A) for applicants with no QPIRA ID.
(Subject of the e-mail)
“CCRR – Request for Change in Credentials of CCRR User Account”
(Body of e-mail)
• Name of Old Representative:
• Issued Username:
• Name of New Representative:
• Position:
• Email Address:
• Contact No:
• Company Name:
• Company Address:
• Product Classification(COSMETICS/HUHS/TCCA):
(Attachment/s) (1) Cover Letter, (2) Notarized Authorization Letter or QPIRA ID
What is FDA e-Portal
• This is accessible via https://www.fda.gov.ph
• Can be access also thru FDA Website (upper right corner)
• This is the portal for several types of applications filed electronically with
the FDA.

• Using this portal, tasks (i.e. steps in the procedure) are accomplished in a
simple workflow, and cases (i.e. applications) are filed using specialized
forms.

• Users of the e-portal are provided with accounts to access the processes.
 Cosmetic e-Notification version 2.0

Download
Submission Payment Revalidation
Result
Business Process Flow
 1. Submission

1.1 Access the FDA e-Portal at

https://www.fda.gov.ph

1.2. Login by entering the username and password

of the provided CCRR User account.

1.3. In the HOME tab, select New case in the

navigation pane to proceed to the notification
form.
 1.4. Accomplish the notification form as provided in
parts by the application wizard. Fill-in the fields as
completely as possible. Fields marked with a red
asterisk (*) are required to be filled-in. Mark fields
with Not applicable, if not applicable.

1.5. An assessment slip will be generated at the end of

the step.
Download the generated assessment slip by
clicking Open.
To continue with your application, click Next. The
application will then be placed in the Participated
folder in the navigation pane.
The status of the application may be checked in
the Participated folder as indicated by the Task
column.
 Guidelines in Filling the Notification Form
1. DECLARATION
Proceed with the application by selecting your
response using the drop-down list and clicking
Continue.

2. PARTICULARS OF THE PRODUCT

Validity of the notification may either be 1, 2, or 3
years at the option of the applicant.
To add variants/packaging sizes/ packaging types,
GTIN into the list, click New to add another line.
Click Delete if you wish to delete the entry.
Utilize the drop-down lists when selecting the
Product Type and Presentation. When Others is
selected, please specify using the provided space.
To continue to the next step, click Next.
 DECLARATION (found in cosmetic e-notification)
 I hereby declare on behalf of my company that the product in the notification meets all the
requirements of the ASEAN Cosmetic Directive, its Annexes and Appendices, which have
been transposed into local legislation.
 I undertake to:
 Ensure that the product’s technical and safety information is made readily available to
the regulatory authority concerned (“the Authority”) and to keep records of the
distribution of the products for product recall purposes;
 Notify the Authority of fatal or life threatening serious adverse event as soon as
possible by telephone, facsimile transmission, email or in writing, and in any case, no
later than 7 calendar days after first knowledge;
 Complete the Adverse Cosmetic Event Report Form within 8 calendar days from the
date of my notification to the Authority in para 2ii. above, and to provide any other
information as may be requested by the Authority;
 Report to the Authority of all other serious adverse events that are not fatal or life
threatening as soon as possible, and in any case, no later than 15 calendar days after
first knowledge, using the Adverse Cosmetic Event Report Form;
 Notify the Authority of any change in the particulars submitted in this notification;
 Ensure that if and when directed by the authority I will recall the product from the
market, and discontinue selling or supplying the product
 DECLARATION (found in cosmetic e-notification)
 I declare that the particulars given in this notification are true, all data, and information of
relevance in relation to the notification have been supplied and that the documents enclosed
are authentic or true copies.
 I understand that I shall be responsible for ensuring that each consignment of my product
continues to meet all the legal requirements, and conforms to all the standards and
specifications of the product that I have declared to the Authority.
 I understand that I cannot place reliance on the acceptance of my product notification by the
authority in any legal proceedings concerning my product, in the event that my product has
failed to conform to any of the standards or specifications that I had previously declared to
the Authority.
 I have examined the latest revisions of the Annexes II to VII of the ASEAN Cosmetic Ingredient
Listing as published in the latest amendment of the ASEAN Cosmetic Directive and confirmed
that the product in this notification does not contain any prohibited substances and is in
compliance with the restrictions and conditions stipulated in the Annexes.
 I undertake to respond to and cooperate fully with the regulatory authority with regard to any
subsequent post-marketing activity initiated by the authority.
3. LOCAL COMPANY RESPONSIBLE FOR PLACING THE
PRODUCT IN THE MARKET
 Place the appropriate and valid LTO number of the
company responsible for placing the cosmetic
product in the market.
 Select the activity of the company as per the
provided LTO and fill-in the additional fields provided:
 Distributor – Country of Manufacture, Supplier
Details (if applicable), Manufacturer details
 Trader – Manufacturer details
 Ensure that the provided information is consistent
with the current valid LTO of the company.
 To continue to the next step, click Next.

4. DETAILS OF THE PERSON REPRESENTING

THE COMPANY
 The name and designation of the
person representing the company will
automatically reflect the current user.
 To continue to the next step, click Next.
5. PRODUCT INGREDIENT LIST
 Indicate the full ingredient list of the cosmetic
product indicated in the application. The
function and percentage of restricted ingredients
in the formulation are required to be provided.
 To continue to the next step, click Next
INFORMATION TO BE DECLARED IN THE PRODUCT
NOTIFICATION
BRAND NAME The complete name of the product should be given, in the
PRODUCT NAME following sequence: brand name, line name (if applicable),
PRODUCT VARIANTS product name, if a single shade is notified, the shade
name/number (e.g. BRAND ABC PRODUCT XYZ EYSHADOW
SHADE 1).If there are different shades, the shade name/number
for each shade shall be declared.
PRODUCT TYPES The illustrative list (ACD Annex I) is not exhaustive and you can
include other types of cosmetic products not in the list by
selecting others and specifying what it is.
INTENDED USE This refers to the function or use of the product and not the
directions for use e.g. to moisturize the face, hand, etc.
PRODUCT A SINGLE PRODUCT exists in a single presentation form.
PRESENTATIONS A RANGE OF VARIANTS SIMILAR IN COMPOSITION FOR THE
SAME USE BUT DIFFERS IN COLOURS, FLAVORS ETC. is a
range of cosmetic products, which are similar in composition and
produced by the same manufacturer, and are intended for the
same use but are available in different shades of colour (e.g.
lipsticks, eye shadows or nail polish but not composite packs of
different types).
 INFORMATION TO BE DECLARED IN THE PRODUCT
NOTIFICATION
PRODUCT PALETTE(S) IN A RANGE OF ONE PRODUCT TYPE
PRESENTATIONS refers to a range of colours as defined above, which may be
presented in a series of palettes.
COMBINATION PRODUCTS IN A SINGLE KIT refer to
similar and/ or different product types packed and sold in a
single kit. They cannot be sold separately (e.g. a make-up kit
of eye and lip colours; a set of skin-care products sold in a
single kit). Please note that components of such kits must be
notified separately.

LOCAL COMPANY It refers to the local company responsible for placing the
RESPONSIBLE FOR cosmetic products in the market, which may be a local
PLACING THE COSMETIC manufacturer or an agent appointed by a manufacturer to
PRODUCT IN THE market the product or the company that is responsible for
MARKET bringing in the product for sale in the country, etc.
ESTABLISHMENT It refers to the particulars of the manufacturer and/or supplier
INFORMATION of the notified cosmetic product.
PERSON REPRESENTING It refers to the person representing the local company
THE LOCAL COMPANY responsible. The e-notification program automatically reflects
the account details of the applicant in this portion.
INFORMATION TO BE DECLARED IN
THE PRODUCT NOTIFICATION
PRODUCT All the ingredients in the product must
INGREDIENT be specified by using the nomenclature
LIST from the latest edition of standard
references (International Cosmetic
Ingredient Dictionary, British
Pharmacopoeia, United States
Pharmacopoeia, Chemical Abstract
Services). Botanicals and extract of
botanicals should be identified by its
genus and species. The genus may be
abbreviated.
The functions and percentages of
ingredients must be declared if they are
substances with restrictions for use as
specified in the annexes of the ASEAN
Cosmetic Directive.
 2. Payment

1. Download the generated assessment form

and print copies as needed. Note the
Reference Number for the payment option/s
to be availed.

2. Clients may pay for their applications

through the bank facilities made available by
FDA. The current payment options available
are through BancNet online payment (FDA
Advisory No. 2015-021) and the LandBank
OnColl Payment Facility (FDA Memorandum
Circular No. 2013-015).
 3. Download Result
RESULT OF APPLICATION
A cosmetic e-notification application may either be
acknowledged or disapproved and correspondingly issued with an acknowledged
notification form or letter of disapproval, respectively.

1.Download the result of application by clicking Open.

2.Click Next Step to proceed with the next task.
ACKNOWLEDGED COSMETIC LETTER OF DISAPPROVAL
PRODUCT NOTIFICATION
 4. Revalidation
• Acknowledged cosmetic notifications may be
revalidated for a new validity date, where the new
validity date will be based on the date of
submission of the revalidation application.

• In the e-portal, the previously acknowledged case

must be selected to continue with the task for
Revalidation Application.

• There must be no modifications from the

information provided during the previous
application to avail of revalidation. Hence, any
changes to the information will constitute a new
notification application.

•In the event that the notification is desired to be

cancelled, the applicant may choose to cancel the
application. This option is available in the
Revalidation Application Task.
Q&A
Thank You!!!

Virgilio C. Marquinez Jr.

Administrative Assistant I, LRD,CCRR
[email protected]
857-1984