KMA Application Form V2 31.10.

2013
KMA MA Form No. 1

Date Received: Protocol No:

Kosovo Medicines Agency
Agjencioni i Kosovës për Produkte Medicinale
Application processing start date :
Rrethi i Spitalit (QKU) 10000, Prishtinë, Kosovë
Tel: +381 (38) 512 066; Fax:+381 (38) 512 243
www.akpm-rks.org MA No:
MA issue date: MA exp. date:
Application for a medicinal product
marketing authorization
(KMA to fill out)
Declaration and signature

Product (invented) name: CIPERUS

Strength(s): 500 mg

Pharmaceutical form: Film-coated tablet

Active substance(s): Ciprofloxacin hydrochloride

Applicant: Istituto Chimico Internazionale Dr. Giuseppe Rende S.r.l.

Address: Via Salaria 1240, 00138 Rome, Italy

Person authorized for

communication on Adelina Lika
behalf of the applicant*:

It is hereby confirmed that all existing data which are relevant to the quality, safety and efficacy of the
medicinal products have been supplied in the dossier as appropriate and samples of the finished product,
active substance(s) and excipient(s) sufficient for analysis**.

It is hereby confirmed that the marketing authorization fees have been paid to the Kosovo Medicines
Agency***.

On behalf of the applicant

__ ________________
Signature

____ __________
Name

_____________________________________
Function

_____________________________________
Place Date (yyyy-mm-dd)

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 KMA Application Form V2 31.10.2013

* Attach letter of authorization for communication/signing on behalf of the applicant and agency
agreement as Annex 5.11  and proof of legal establishment of authorized person in Kosovo as Annex
5.21 
** Attach two samples (in final immediate packaging without final labelling) in sufficient quantity
to permit a full assay and the verification of the control methods used by the manufacturer (and
reference substances if referred to in the testing procedure if requested) as Annex 5.3 
***Attach proof of payment as Annex 5.42 

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1. Type of Product and Type of Application

1.1 Type of medicinal product 3

(i) Chemical active substance(s) (v) Dietary supplements
(ii) Biological active substance(s) (vi) Vitamins and mineral substances (ix) Orphan / Exceptional
(iii) Radiopharmaceutical (vii) Homeopathic ___________ (x) Other (Specify)
(iv) Herbal (viii) Advanced therapy

(Mark relevant box(es) with X)

1.2 Type of application

4
(i). Complete and independent (Stand alone)
 New active substance 
 Known active substance 

5
(ii). New fixed combination

(iii). Simplified procedure pursuant to:

6
(a) Well Established Medicinal Use (bibliographical)

7
(b) Essential Similarity (Informed consent)

Existing authorized product (in EU Member State, or EU-accessing state):

 Product name, strength, pharmaceutical form:

 Marketing authorization holder:
 Marketing authorization number(s):
 Attach latest SPC and package leaflet as Annex 5.5 
 Attach informed consent letter of marketing authorization holder of authorized medicinal product as Annex 5.6 

8
(c) Essential Similarity (Generic)

I. Original medicinal product (authorized for not less than 10 years in either an EU Member State or EU-accessing state):

 Product name, strength, pharmaceutical form: CIPROXIN “500 mg film coated tablet”- 6 tablets
 Marketing authorization holder: Bayer spa
 First authorization date: 1989/03/01
 State where first authorized:Italy
 Attach latest SPC and package leaflet as Annex 5.5

II. Reference medicinal product (if different from the original medicinal product, the reference medicinal product should have a
valid full non abridged dossier available and should be currently marketed in either an EU Member State, or EU-accessing
state):

 Product name, strength, pharmaceutical form:

 Marketing authorization holder:
 Marketing authorization number(s):
 State where first authorized
 Attach latest SPC and package leaflet as Annex 5.5 

III. Medicinal Product used for bioequivalence study (where applicable):

 Product name, strength, pharmaceutical form: CIPROXIN “750 mg film coated tablet”- 12 tablets
 Marketing authorization holder: Bayer Spa
 State of source: Italy

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9
(d) Essential Similarity (Generic different)

I. Original medicinal product (authorized for not less than 10 years in either an EU Member State or EU-accessing state):

 Product name, strength, pharmaceutical form:

 Marketing authorization holder:
 First authorization date (yyyy-mm-dd):
 State where first authorized:
 Attach latest SPC and package leaflet as Annex 5.5 

II. Reference medicinal product (if different from the original medicinal product) (marketed in EU Member State or EU-
accessing state):

 Product name, strength, pharmaceutical form:

 Marketing authorization holder:
 Marketing authorization number(s):
 State where first authorized:
 Attach latest SPC and package leaflet as Annex 5.5 

III. Medicinal Product used for bioequivalence study (where applicable):

 Product name, strength, pharmaceutical form:

 Marketing authorization holder:
 State of source:

IV. Differences compared to the original/reference medicinal product:

 Different pharmaceutical form 

 Different strength(s) (quantitative change to the active substance(s)) 
 Different route of administration 
 Different pharmacokinetics (including different bioavailability) 
 Different therapeutic use 
 Other difference(s) (specify):

10
(e) Vitamins / mineral substances

(g) EU- Centralized / EMA- CPP 11

 Submit documentation specified in note 11 as Annex 5.6 

12
(h) EU –Decentralized
 Submit documentation specified in note 12 as Annex 5.6 

(i) Unilateral/Mutual recognition 13

 Reference EU Member State /
 Product name, strength, pharmaceutical form:
 Marketing authorization holder:
 Marketing authorization number(s):
 Submit other documentation specified in note 13 as Annex 5.6 

14
(iv). Line extension
 Reference strength and form ________________________________

15
(v). Herbal (traditional) medicinal product

16
(vi). Homeopathic medicinal product

17
(viii) Simplified procedure pursuant to Article 11 of the AI Nr.17/2013

2. Application particulars

2.1 Trade (invented) name of the medicinal product

CIPERUS

2.2 Name of the active substance18

Ciprofloxacin hydrochloride

2.3 Proposed therapeutic indications19

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(for main indication)
Quinolone antibacterial, fluoroquinolone

CIPERUS 250 mg, 500 mg, 750 mg film-coated tablets is recommended against the infections listed below (see paragraphs 4.4
and 5.1). Before commencing the treatment, please pay attention to the information available about ciprofloxacin resistance.
Adults

 Lower respiratory tract infections, sustained by Gram-negative bacteria

- Acute exacerbation of obstructive and chronic pulmonary disease. During an acute exacerbation of the
obstructive and chronic pulmonary disease, CIPERUS shall be used only in case other antibacterial
medicines, which are most commonly recommended against these infections, should prove to be inadequate.
Pulmonary infections in the course of a cystic fibrosis or bronchiectasis
- pneumonitis

 Festering chronic otitis media

 Acute exacerbation of chronic sinusitis, especially if cause by Gram-negative bacteria

Non-complex acute cystitis. During a non-complex acute cystitis, CIPERUS shall be used only in case other
antibacterial medicines, which are most commonly recommended against these infections, should prove to be
inadequate
 Acute pyelonephritis

 Complex urinary infections

 Bacterial prostatitis

 Gonococcal urethritis and cervicitis caused by susceptible strains of Neisseria gonorrhoeae

 Epididymal-orchitis, including those caused by Neisseria gonorrhoeae

 Pelvic inflammatory diseases, including those by Neisseria gonorrhoeae

During infections of the reproductive systems, in case sustained by Neisseria gonorrhoeae or deemed to be as such, it is
extremely important to obtain local information about the prevalence of the resistance to ciprofloxacin and to verify the
susceptibility through laboratory tests.

 Inter-abdominal infections

 Acute skin and soft-tissue infections caused by Gram-negative bacteria

 Infection of bone and joint infections

 Treatment of neutropenic patients with flu, possibly caused by a bacterium

 Prevention of infections in neutropenic patients

 Prevention of invasive infections caused Neisseria gonorrhoeae

 Inhalation anthrax (prevention and after-exposition) treatment

Children and adolescents

 Pulmonary infections caused by Pseudomonas aeruginosa in patients affected by cystic fibrosis

 Complex urinary infections Acute pyelonephritis
 Inhalation anthrax (prevention and after-exposition) treatment

Ciprofloxacin may also be used to treat serious infections in children and adolescents, in case it is deemed necessary.

The treatment shall only initiate by doctors who have experience in cystic fibrosis therapy and/or in serious infections in
children and adolescents (see paragraphs 4.4 and 5.1).

ATC Code: J01MA02

2.4 Pharmaceutical form and strength20

Film-coated tablets/500 mg

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2.5 Route(s) of administration21
Oral use

2.6 Packaging and package size(s)22 (attach list of Mock-ups or Samples/specimens as Annex 5.7 )
(i) Immediate packaging: (ii) Outer packaging: Carton box (iii) Package size(s): 6 tablets
PVC/PE/PVDC/ALU blister

(v) Shelf life (after first opening (vi) Shelf life (after reconstitution or dilution):
(iv) Shelf life (as specified in the container): NA NA
SPC proposal): 5 years

(vii) Storage conditions:

(as specified in the SPC proposal)
(viii) Storage conditions after first opening:
This medicinal product does not require any special
(as specified in the SPC proposal)
storage conditions.

2.7 Summary of Product Characteristics (SPC) proposal 23 (attach as Annex 5.8 )

English Other languages (optional) (Specify):

2.8 Package Leaflet proposal 24 (attach as Annex 5.9 )

Albanian Serbian English Other (Specify):

2.9 Description of the medicinal product25

2.10 Proposed dispensing classification (legal status) (Tick appropriate box(es) with X)
Subject to medicinal prescription Not subject to medicinal prescription
If subject to medicinal prescription:
(i) prescription which may be automatically renewed (iv) product on restricted prescription
(ii) prescription which may not be automatically renewed (v) product for use only in in-patient health facilities
(iii) product on special prescription
Promotion of products not subject to medicinal prescription:
Promotion to health care professionals only Promotion to the general public and health care professionals

2.11 “Birth date” of the product for pharmacovigilance purposes26

EU International
Active substance contained in a medicinal product registered in the world more than 5 years Yes No

2.12 Qualitative and quantitative composition

(i) Qualitative and quantitative composition in terms of the active substance(s) and the excipient(s):
Dosage type (e.g. capsule):
Name Quantity Unit Reference/Monograph standard
Active substance (s)
Ciprofloxacin hydrochloride 582.00 mg Ph. Eur
equivalent to Ciprofloxacin 500.00

Excipient (s) ampoules

96.00 mg Ph. Eur
Cellulose microcrystalline

Sodium starch glycolate 25.00 mg Ph. Eur

Crospovidone 25.00 mg Ph. Eur
Maize starch 14.00 mg Ph. Eur
Silica colloidal anhydrous 4.00 mg Ph. Eur
Magnesium stearate 4.00 mg Ph. Eur
Titanium dioxide 4.00 mg Ph. Eur
Hydromellose 6cP 12.00 mg Ph. Eur
Macrogol 4000 4.00 mg Ph. Eur
Details of any overages should not be included in the formulation columns but stated below:
 active substance(s): _______________________
 excipient(s): _______________________

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(ii) Are materials of animal and / or human origin contained or used in the manufacturing process of the medicinal product?

No

Yes (if yes, please fill out the separate form attached to this application form and attach as Annex 5.10 ; attach Ph. Eur.
Certificate of Suitability for TSE if available as Annex 5.11 ; if not available include appropriate data in the dossier)

(iii) Does the medicinal product contain or consist of Genetically Modified Organisms (GMOs)?

No

Yes (if yes, complete relevant section of Annex to CTD Module 1/EU Part I)

2.13 Marketing authorization holder / contact persons / company

(i) Applicant :
Company name. Istituto chimico internazionale dr. Giuseppe rende s.r.l.
Address:Via Salaria 1240,00138 Rome
Country: Italy
Tel. +39 06/8889655
Fax : N/A
Contact person at this address: Dr. Gabriele Paradisi

(ii) Authorized person in Kosovo27:

Name: Adelina Lika
Company nameN.SH.T.”PHCI”
AddressL.e Prizrenit 159/A Prishtine
Tel: 044117257
Fax:
E-mail: [email protected]
 Attach power of attorney, copy of contract with MAH and, proof of establishment of authorized person as Annex 5.2 
(iii) Qualified person for Pharmacovigilance28:
Name: Mirjeta Kadriu Zymeri
Company name: N.SH.T.”PHCI”
Address: AddressL.e Prizrenit 159/A Prishtine
Tel044117257
Fax:
E-mail: [email protected]

 Attach CV and copy of contract of qualified person for pharmacovigilance with MAH ,as Annex 5.12 

2.14 Manufacturer(s)
(i) Authorized manufacturer(s) (or importer) responsible for batch release (as shown in the package leaflet and where
applicable in the labeling):
Company name: Laboratorio Farmacologico Milanese S.r.l.,
Address: via Monterosso 273, 21042 Caronno Pertusella (VA)
Country: Italy
Tel. +39 02 964 50181
Fax : NA
E-mail: [email protected]

Contact person at this address: NA

Manufacturing Authorization number: aM17/2022

 Attach original /copy of valid manufacturing authorization (Annex 5.13 )

 Attach latest GMP certificate (Annex 5.16)

For Blood Products and Vaccines:

Details of the state laboratory or laboratory designated for that purpose (OMCL) where the official batch release takes place:
Name:
Address:
Country:
Tel:
Fax:
E-mail:

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(ii) Manufacturer(s) of the medicinal product and site(s) of manufacture ) 29:
Company name: Laboratorio Farmacologico Milanese S.r.l.,
Address: via Monterosso 273, 21042 Caronno Pertusella (VA)
Country: Italy
Tel. +39 02 964 50181
Fax : NA
E-mail: [email protected]

Contact person at this address: NA

Manufacturing Authorization number: aM17/2022

 Attach original /copy of valid manufacturing authorization (Annex 5.15 )
 Attach latest GMP certificate (Annex 5.16)

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(iii) Manufacturer of the active substance(s)30:

1.Substance: Ciprofloxacin Hydrochloride

Company name. Aarti Drugs Limited
Address: Plot No E-22, M.I.D.C Tarapur Tal. Palghar, District Thane India- 401 506 Tarapur Maharashtra
Tel: ++91 22 2401 9025
Fax: ++91 22 2407 3462
(a) Has a Ph. Eur. Certificate of Suitability been issued for the active substance(s): No Yes
If yes,
 substance: Ciprofloxacin Hydrochloride
 manufacturer name: Aarti Drugs Limited
 reference number: R1- CEP 2005-119-Rev04
 date of last update (yyyy-mm-dd): 2019-10-23
 provide copy of Certificate of Suitability as Annex 5.18 

(b) Is a European Drug Master File to be used for the active substance(s) reference / original? No Yes
If yes,
 substance:
 manufacturer name:
 reference number:
 date of last update (yyyy-mm-dd):
 attach letter of access for the Kosovo Medicines Agency
 attach copy of written confirmation from the manufacturer of the active substance to inform the applicant in case of
modification of the manufacturing process or specifications as Annex 5.19 

Provide statement from competent authority that conducted last GMP inspection that site is GMP compliant (for each site) as Annex
5.16 
or
For each active substance, attach a copy of Qualified Person declaration that the active substance is manufactured in compliance
with the detailed guidelines on good manufacturing practice for starting materials (Annex 5.16)

 attach copy of written confirmation from the manufacturer of the active substance to inform the applicant in case of
modification of the manufacturing process or specifications as Annex 5.19 

(iv) Contract companies used for bioavailability / bioequivalence or used for the validation of blood product manufacturing
processes
Manufacturer name:
Address:
Tel:
Fax:
E-mail:
Duty performed according to contract:

Location of performance of analytical tests and clinical data collection:

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3. Marketing authorizations of the same medicinal product in other countries31 (i.e. from applicants/MAHs
belonging to the same mother company or group of companies OR which are ‘licensees’) Provide information in accordance with
the following scheme and attach as 5.21 in the list of Annexed documents

(i) Authorization in country of origin

Country: Italy
Date of authorization: 2007-12-20
Invented name: CIPERUS
Authorization number: AIFA decree 2955
Attach copy of marketing authorization in Annex 5.20

(ii) Authorization in third countries

Country: ALBANIA
Date of authorization:2018-03-21
Invented name: CIPERUS
Authorization number:254/21.03.2018
 Attach copy of marketing authorization in Annex 5.20

(iii) Pending
Country:
Date of submission (yyyy-mm-dd):

(iv) Refused
Country:
Date of refusal (yyyy-mm-dd):
Reason for refusal:

(v) Withdrawn (by applicant before authorization)

Country:
Date of withdrawal (yyyy-mm-dd):
Reason for withdrawal:

(vi) Withdrawn (by applicant after authorization)

Country:
Date of withdrawal (yyyy-mm-dd):
Invented name:
Authorization number:
Reason for withdrawal:

(vii) Suspended/revoked (by competent authority)

Country:
Date of suspension/revocation (yyyy-mm-dd):
Invented name:
Reason for suspension/revocation:

4. Other information

(i) EAN code32:

(iii) Intellectual property protection to be applied for in Kosovo33:

 Product composition No Yes (if applicable, attach declaration of originality as Annex 5.21)
 Trade name No Yes (if applicable, attach declaration of originality as Annex 5.21 )

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5. Annexed documents

Yes N/A
Letter of authorization for communication on behalf of the applicant(MAH) and agency agreement
5.1
(original or legally attested copy)
5.2 Proof of legal establishment of authorized person in Kosovo
Samples of the finished medicinal product.
5.3 Active substance(s), excipient(s) and reference substances (if requested from Control Laboratory of
KMA)
5.4 Evidence of fee payment
5.5 Packaging mock-ups or samples/specimens attached to the application
5.6 SPC proposal (in English language)
5.7 Package leaflet / PIL / Package insert proposal (in Albanian & Serbian languages)
5.8 Materials of animal/human origin form completed
5.9 Ph.Eur. Certificate of Suitability for TSE
5.10 Attach CV and copy of contract of qualified person for pharmacovigilance with MAH ,as Annex 5.12 
5.11 Manufacturing authorization for manufacturer releasing batches (original or copy)
5.12 Manufacturing authorization for all manufacturing sites mentioned in the application (original or copy)
Statement from competent authority that conducted last GMP inspection that site is GMP compliant (for
each site including manufacturer of the active substance(s), or Declaration from Qualified Person from
5.13
batch release that the active substance is manufactured in compliance with the detailed guidelines on good
manufacturing practice for starting materials .
5.14 CPP (original)
5.15 Ph. Eur. Certificate of Suitability or Drug Master File(s)
Copy of marketing authorization(s) in country of origin and third countries (a photocopy of the pages
5.16 which give the marketing authorization number, the date of authorization and the page which has been
signed by the authorizing competent authority)
5.17 Declaration of originality (copy od property protection) if applicable
5.18 CTD Module 1: Administrative information
5.19 CTD Module 2: CTD Summaries
5.20 CTD Module 3: Chemical, pharmaceutical and biological information
5.21 CTD Module 4: Non clinical reports
5.22 CTD Module 5: Clinical study reports
CD Rom of full dossier / pharmbridge-DAMOS format / PDF / HTML / XML (in addition to the paper
5.23
documentation of identical content)
5.24 SPC, package leaflet (PIL) and mock-up in the required languages on a CD in Word format

Number of pages added by the applicant because of lack of space in any part of the application form:

All documentation: submitted / not submitted

All pages and volumes present and marked: yes / no

Documentation: accepted / not accepted

Documentation not accepted for reasons :

Signature of KMA officer:

Date: (KMA to fill out)

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 KMA Application Form V2 31.10.2013
Instructions for the applicant

The application form may be completed by typewriter or computer. If there is insufficient space to complete any part
of the application form, please use additional pages, which then will become an integral part of the application. In the
appropriate part, specify that there is an additional appendix. References to already submitted documentation are not
permitted. The application should be completed in compliance with valid KMA guidelines or other documents that
are referred to. All guidelines can be found on the KMA web site (www.k-ma.org) or are obtainable directly from the
KMA premises.

1. Any legal or physical entity, authorized by the applicant to communicate with KMA is considered as the authorized person. This
person submits to KMA the officially verified authorization by the applicant. Each applicant without a permanent residence or a
registered office in Kosovo has a duty to authorize an authorized person with an address in Kosovo to submit the application and to
communicate with KMA. The following documents should be provided:
* a letter of authorization to communicate on behalf of the applicant (MAH) and original of agency agreement or a legally attested
copy of the agency agreement between the applicant/MAH and the authorized person (attach as Annex 5.1 to the application);
* proof of the legal establishment of the authorized person in Kosovo, e.g. certificate of registration of a legal entity with the
relevant competent authority in Kosovo (attach to the application as Annex 5.2).
2. Marketing authorization fee payment. The schedule of fees is set out as KMA guideline KMAG20 to the MA Regulation.
Payment method: this should be paid to KMA Account: Pay to:

Raiffeisen Zentralbank Österreich AG SWIFT/BIC-Code: RZBAATWW Bank Sort Code: 31000

Account: Central Bank of the Republic of Kosovo
Account no: 55044937
IBAN: AT263100000055044937
For further credit to: ...please insert here the final beneficiary’s account details (name + number) in this
case Agjensioni i Produkteve Medicvinale and account number 1000400070002508

The fee shall be paid before submission of the application. Evidence of fee payment: a copy of the bank transfer statement should
be provided as a part of the application documentation. The marketing authorization procedure can only proceed when the fee is
paid.
3. A product can fall into more than one category simultaneously. Biological active substance(s) includes medicinal products
derived from blood and plasma and immunological products. Advanced therapy medicinal products means any medicinal product
based on processes focused on various gene transfer-produced bio-molecules, and biologically advanced therapeutic modified cells
and tissues as active substances or part of active substances. Orphan applies to medicinal products defined by the EMEA as
possessing orphan status and exceptional applies to medicinal products for which a MA may be granted under exceptional
circumstances.
4. A complete and independent application (stand alone) requires a complete dossier with administrative, quality, pre-clinical and
clinical data. A new active substance refers to a constitutent of a product not yet authorized by a competent authority; a known
active substance refers to a constituent of a product already authorized by a competent authority whether by the same or a different
marketing authorization holder.
5. For a new product containing known active substances not used previously in combination (so called new fixed combination),
complete administrative, quality, preclinical and clinical data on the combination only should be provided. For line extensions of
new fixed combination applications, cross references can only be made to pre-clinical and clinical data.
6. For applications under the well established medicinal use simplified procedure, refer to guidelines set out in Annex 3 to the
Kosovo marketing authorization Administrative Instruction.
7. An application under the essential similarity (informed consent) procedure requires consent being by the existing marketing
authorization holder to use their data in support of this application. Complete administrative and quality data should be provided
with consent to pre-clinical and clinical data. The authorized product and the informed consent application can have the same or
different MAH.
8. For an application under the essential similarity (generic) procedure, refer to guidelines set out in Annex 3 to the Kosovo
marketing authorization Administrative Instruction.
9. An application under the essential similarity (generic different) procedure concerns essentially similar generic medicinal
products that have a different therapeutic use, route of administration, dosage or pharmacological presentation to the
original/reference medicinal product. The results of appropriate toxicological and pharmacological tests and/or of appropriate
clinical trials must be provided concerning the indicated differences and refer also to KMA guideline KMAG9.V110/05 to the
Kosovo marketing authorization Administrative Instruction concerning demonstration of bioavailability and bioequivalence.
10. A MA application for a vitamin/mineral substance must include complete administrative and quality data. If necessary, the
Kosovo Medicines Agency may request that the applicant provide information concerning the combinations of vitamins and
minerals and the efficacy and safety of the quantities of vitamins and minerals used in the combinations.
11. Marketing authorization following EU centralised procedure. If the applicant is following this procedure for marketing
authorization of its product(s) in Kosovo, then it is necessary for the applicant to submit the documentation set out in AI
Nr.17/2013 , Article 11 on the marketing authorization procedure .
12. Marketing authorization following EU decentralised procedure. If the applicant is following this procedure for marketing
authorization of its product(s) in Kosovo, then it is necessary for the applicant to submit the documentation set out in KMA
guideline KMAG11.V1 10/05 on the simplified marketing authorization procedure pursuant to the EU decentralised procedure to
the marketing authorization regulation.
13. Unilateral /Mutual recognation procedure for medicinal products. If the applicant is following this procedure for marketing
authorization of its product(s) in Kosovo, then it is necessary for the applicant to submit documentation (in addition to the required
documents of the dossier) set out in MH –AI Nr.03/2011 (Recognation by the Kosovo Medicines Agency-KMA of Marketing
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 KMA Application Form V2 31.10.2013
Authorization for medicinal Products for human use issued by the German Federal Instituite for drugs and Medical Devices-
BfArM) -accessing states as Annex 5.6 to this application.
14. Line extensions. Refer to the strength and form of the product to which a line extension is referenced. For line extensions of
both stand alone and simplified applications, cross references can only be made to pre-clinical (safety) and clinical data.
15. Herbal (traditional) medicinal products. Refer to the KMA guideline KMAG16.V1 10/05 on 'Special provisions for herbal
medicinal products'.
16. Homeopathic medicinal products. Refer to the KMA guideline KMAG15.V1 10/05 on 'Special provisions for homeopathic
medicinal products'.
17.Simplified procedure for the Marketing Authorization of medicinal products approved nationally in Schengen States of the EU
countries, USA, Canada, Switzerland, Turkey**, Israel*, Japan, UK and Australia according to the Article 10 of AI Nr.17/2013
on the marketing authorization procedure .
18. Only one name should be given in the following order of priority: INN*, Ph.Eur., National Pharmacopoeia, common name,
scientific name.
* the active substance should be declared by its recommended INN, accompanied by its salt or hydrate form if relevant (for further
details consult WHO Cumulative List No. 10 of International Nonproprietary Names (INN) for pharmaceutical substances).

19. Specify a broad therapeutic indication group (e.g. antihypertensives, diuretics) and indicate the ATC code for the main
therapeutic indication. If the ATC code is not assigned, propose it and state that it is a proposal. The ATC code will be assigned
during the marketing authorization procedure according to the latest WHO ATC classification code valid for the authorization
period. This item is for information purposes only and does not affect the outcome of the authorization decision-making process.

20. An application for authorization of one dosage form and one strength of the medicinal product should be made on each
application form except for homeopathics, where more dilution degrees can be included in an application. If the active substance is
present as a salt, hydrate etc, it must be clearly and unambiguously stated whether the strength refers to the molecular substance or
the active entity of the molecule. Use the list of standard Ph.Eur. terms.

21. In the case of parenteral products specify all proposed routes of administration, e.g. intravenous, intraarterial, intramuscular,
subcutaneous and as specified in the SPC proposal.
22. This table should be completed in such a way, that it is clear which immediate and outer packaging belong to a single package
size, and should be unambiguous how many product presentations are included in this application. I nclude administration devices
where applicable. A list of mock-ups* or samples/specimens** sent with the application should be attached.
* A ‘mock up’ is a copy of the flat artwork design in full colour, providing a replica of both the outer and immediate packaging,
providing a two dimensional presentation of the packaging / labelling of the medicinal product. It is generally referred to as a
‘paper copy’ or ‘computer generated version’.
** A ‘specimen’ should be interpreted as referring to a sample of the actual printed inner and outer packaging and package insert.
23. Summary of Product Characteristics (SPC). The SPC should be submitted in English and follow the structure set out in KMA
guideline KMAG2.1.V1 10/05 on CTD Module 1 – Administrative information or KMA guideline KMAG2.2.V1 10/05 on Part I –
Summary of the dossier.
24. Package leaflet. The package leaflet proposal shall be provided in Albanian and Serbian languages and in conformance with
KMA guideline KMAG2.1.V1 10/05 on CTD Module 1 – Administrative information or KMA guideline KMAG2.2.V1 10/05 on
Part I – Summary of the dossier.
25. Provide a detailed description of the dosage form appearance (color, shape, dimensions, imprint, markings, consistency, flavour
etc.).
26. To specify the “birth date” KMA applies rules given in the European Notice to Marketing Authorization Holders,
Pharmacovigilance Guidelines (CPMP/PhVWP/108/99 corr.). Most frequently the birth date is considered to be the date of first
granting a marketing authorization in the EU (or in the world) to the relevant marketing authorization holder or his contract
partners for a medicinal product with that active substance. On this date the sequence of Periodic Safety Update Reports
submissions is based also for all further marketing authorization holders, i.e. generic manufacturers. The KMA prefers
specification of the “EU birth date”, if it does not exist, the “international birth date” should be specified. The birth date is
significant in those cases where the first marketing authorization has been granted less than 5 years ago. Therefore it is not
necessary to indicate the date in cases of active substances contained in a medicinal product registered in the world for more than 5
years as of the date of application for a marketing authorization in Kosovo.
27. The responsible person is the person making the application on behalf of the applicant and is the same person as described in
Note 1 above.
28. The qualified person responsible for pharmacovigilance should hold a university degree in pharmacy or human medicine.
29. All manufacturing steps and the site of manufacture must be indicated.
30. Only the final manufacturer of the active substance(s) should be mentioned.
31. Marketing Authorization of the same medicinal product in other countries.
32. Specify the EAN bar code, if available. This item is for information purposes only and does not affect the marketing
authorization decision- making process.
33. If the medicinal product is currently protected by intellectual property rights conventions in terms of either its trade name or
composition and the applicant wishes to apply these rights in the territory of Kosovo this has to be clearly stated. The existing rights
should be clearly stated in Annex 5.17 to this application at the discretion of the applicant. The Annex should state the nature of the
patent(s), under which jurisdiction(s) and when the patent(s) were issued, expiry dates of patent(s) and registration and expiry of
registered trade names.

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 KMA Application Form V2 31.10.2013
List of materials of animal and/or human origin contained
or used in the manufacturing process of the medicinal product
Name of medicinal product

Active substance(s)

Applicant

Date of completion of table

1. Materials of animal origin

Name of material
Source of material (tissue,
plasma etc.)
Country of origin of the
source animal for the material
cited
Is the material a derivative of
SRM*?
Category of the tissue of
which the material is a
derivative**
As active substance
As reagent/culture
medium component
Use of material

Starting material
used in manufacture
of active substance
As excipient
Starting material
used in manufacture
of excipient
Other, give details
2. Materials of human origin
Name of material
Source of material (tissue,
plasma etc.)
Country/ies where donation
took place
Is the material contained in a
product authorized for
marketing?
If yes, specify states
including MA numbers
As active substance
material
Use of

As excipient
Other, give details

Notes:

* Specified risk material = SRM = materials defined in Commission Decision 97/534/EC

(a) the skull, including the brain and eyes, tonsils and spinal cord of
 bovine animals aged over 12 months
 ovine and caprine animals which are aged over 12 months or have a permanent incisor tooth erupted through the gum
(b) the spleens of ovine and caprine animals

** Categories - specification according to the guideline CPMP/BWP/1230/98

I High infectivity: brain, spinal cord, (eye)
II Medium infectivity: ileum, lymph nodes, proximal colon, spleen, tonsil, (dura mater, pineal gland, placenta), cerebrospinal fluid,
pituitary, adrenal
III Low infectivity: distal colon, nasal mucosa, peripheral nerves, bone marrow, liver, lung, pancreas, thymus
IV No detectable infectivity: blood clot, faeces, heart, kidney, mammary gland, milk, ovary, saliva, salivary gland, seminal vesicle,
serum, skeletal muscle, testis, thyroid, uterus, foetal tissue, (bile, bone, cartilaginous tissue, connective tissue, hair, skin, urine)

If a Ph. Eur. Certificate of Suitability for TSE is available please attach as part of the application.

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