Medicines Registration Guideline-English

Islamic Republic of Afghanistan
Ministry of Public Health

General Directorate of Pharmaceutical Affairs
Medicines Registration Guideline
2014
Contents
ABBREVIATIONS AND ACRONYMS.......................................................................................iv
FOREWORD...................................................................................................................................v
ACKNOWLEDGEMENTS............................................................................................................vi
INTRODUCTION...........................................................................................................................1
Objectives....................................................................................................................................1
SCOPE.............................................................................................................................................1
SECTION ONE...............................................................................................................................2
GENERAL INFORMATION..........................................................................................................2
1. GENERAL REGISTRATION PROVISIONS..........................................................................2
2. APPLICATION PROCEDURE FOR PRODUCT REGISTRATION......................................2
2.1. Application Types...............................................................................................................2
2.2. Application Submission......................................................................................................2
2.3. Application Screening........................................................................................................3
2.4. Application Evaluation.......................................................................................................3
2.5. Cost of Registration............................................................................................................3
3. MINISTRY OF PUBLIC HEALTH-GDPA DECISION..........................................................4
3.1. Product Registration Number.............................................................................................4
3.2. Product Registration Certificate.........................................................................................4
3.3. Rejection, Cancellation, and Suspension of an Application...............................................4
3.4. Appeal Against the MoPH– GDPA Decision.....................................................................4
3.5. Reapplication for Rejected Products..................................................................................4
4. MAINTENANCE OF REGISTRATION..................................................................................4
4.1. General Registration Conditions.........................................................................................4
4.2. Validity Period of Product Registration.............................................................................6
4.3. Product Registration Renewals...........................................................................................6
5. CHANGE IN PARTICULARS OF REGISTERED PRODUCTS............................................6
6. CHANGE IN IMPORTER OF A REGISTERED PRODUCT.................................................6
SECTION TWO..............................................................................................................................7
ADMINISTRATIVE DATA AND PRODUCT INFORMATION.................................................7
1. Cover Letter.........................................................................................................................7
2. Completed and Signed Application Form...........................................................................7
3. Letter of Authorization........................................................................................................7
4. Certifications........................................................................................................................7
5. Product Labeling Requirement............................................................................................8
6. Product Information.............................................................................................................8
SECTION THREE...........................................................................................................................9
ACTIVE PHARMACEUTICAL INGREDIENT(S).......................................................................9
1. Nomenclature.......................................................................................................................9
2. Properties of Active Pharmaceutical Ingredient(s)..............................................................9
2.1. API Described in a Recognized Pharmacopeia (BP, USP, EP, IP)................................9
2.2. API NOT Described in a Recognized Pharmacopeia (BP, USP, EP, IP).......................9
3. Site(s) of Manufacture–Active Pharmaceutical Ingredient(s).............................................9
4. Route(s) of Synthesis of Active Pharmaceutical Ingredient(s)............................................9
4.1. API Described in a Recognized Pharmacopeia (BP, USP, EP, IP)................................9
4.2. API NOT Described in a Recognized Pharmacopeia (BP, USP, EP, IP).....................10
5. Specification for the Active Pharmaceutical Ingredient(s)................................................10
5.1. API Described in a Recognized Pharmacopeia (BP, USP, EP, IP)..............................10
5.2. API NOT Described in a Recognized Pharmacopeia (BP, USP, EP, IP).....................10
6. Batch Analysis...................................................................................................................10
7. Container Closure System.................................................................................................11
8. Stability Testing of the Active Pharmaceutical Ingredient(s)............................................11
SECTION FOUR...........................................................................................................................12
FINISHED PHARMACEUTICAL PRODUCTS.........................................................................12
1. Description of the Finished Pharmaceutical Product.........................................................12
2. Formulation........................................................................................................................12
3. Pharmaceutics Development.............................................................................................13
4. In Vitro Dissolution or Drug Release................................................................................14
5. Sites of Manufacture - Finished Product...........................................................................14
5.1. Imported Products.........................................................................................................15
5.2. Domestically Manufactured Products...........................................................................15
6. Detailed Description and Validation of the Manufacturing Procedure for the Finished Product. .15
7. Specifications for Excipients.............................................................................................15
7.1. Excipients Described in a Recognized Pharmacopeia (BP, USP, EP, IP)....................15
7.2. Excipients NOT Described in a Recognized Pharmacopeia (BP, USP, EP, IP)..........15
8. Control of the Finished Pharmaceutical Products.............................................................16
8.1. Specifications for the Finished Pharmaceutical Product..............................................16
8.2. Analytical Procedures...................................................................................................16
8.3. Validation of Analytical Procedures.............................................................................16
8.4. Batch Analysis..............................................................................................................16
9. Container Closure System(s) and Other Packaging...........................................................16
10. Stability Testing of the Finished Product..........................................................................17
10.1. Stability-Indicating Quality Parameters.......................................................................17
10.2. Selection of Batches.....................................................................................................17
10.3. Container Closure System............................................................................................18
10.4. Testing Frequency........................................................................................................18
10.5. Storage Conditions........................................................................................................18
10.6. Stability Result..............................................................................................................18
10.7. Stability Commitment...................................................................................................19
SECTION FIVE.............................................................................................................................21
SUMMARY OF PHARMACOLOGY, TOXICOLOGY AND EFFICACY................................21
ANNEXES.....................................................................................................................................22
Annex I: Application Form for the Registration of a Product...................................................22
Annex II. Guide on How to Complete the Application Form for the Registration of a Product............26
Annex III. Checklist for Submission of Documents for the Registration of a Product.............31
Annex IV: Flowchart for the Application Procedure for the Registration of a Product............37
Annex V: Appeal Form.............................................................................................................38
Annex VI. Recommendations for Conducting and Assessing Comparative Dissolution Profiles..........39
GLOSSARY..................................................................................................................................40
ABBREVIATIONS AND ACRONYMS
API Active Pharmaceutical Ingredient
ATC Anatomical Therapeutic Chemical (Classification System)
BP British Pharmacopoeia
CAS Chemical Abstracts Service
CoA Certificate of ANALYSIS
CoPP Certificate of Pharmaceutical Product
EP European Pharmacopoeia
FDA US Food and Drug Administration
FPP Finished Pharmaceutical Product
GDPA General Directorate of Pharmaceutical Affairs
GMP Good Manufacturing Practices
ICH International Conference on Harmonization
INN International Nonproprietary Name
IP International Pharmacopoeia
LDPE Low-Density Polyethylene
MAH Marketing Authorization Holder
MoPH Ministry of Public Health
NA Not Applicable
NMFB National Medicines and Food Board
NMR Nuclear Magnetic Resonance
OTC Over-The-Counter
PIL Patient Information Leaflet
SMA Site Master File
SPS Strengthening Pharmaceutical Systems
SRA Stringent Regulatory Authority
USAID US Agency for International Development
USP United States Pharmacopoeia
WHO World Health Organization
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FOREWORD
The General Directorate of Pharmaceutical Affairs (GDPA) in Afghanistan was established under
the Ministry of Public Health (MoPH) in 2006, with the mission of leading, initiating, and managing
all programs and systems relevant to pharmaceuticals at the country level. I have the pleasure to
introduce the FIRST-ever guidelines produced for the registration of medicines with the Afghanistan
MoPH–GDPA.
The Regulation on Manufacturing and Importing Medicine and Medical Appliances, issue number
916, dated February 24, 2007, requires that all medicinal products intended to be marketed in
Afghanistan meet acceptable standards of quality, safety, and efficacy. The first step in ensuring that
medicinal products meet the required standards of quality, safety, and efficacy is to evaluate the
products before they are allowed into the market. This is a fundamental requirement for
authorization of pharmaceutical products in Afghanistan.
This document was developed by the GDPA to provide direction to applicants on the format and
contents required in a product dossier, and other general requirements to be submitted to the GDPA
when applying for the registration of a medicinal product.
Adherence to these guidelines by submitting all required data in the correct format will facilitate
efficient and effective evaluation as well as expedite the approval process. This will enable the
prospective license holders to market their products in a timely manner and give the public improved
access to medicines of examined quality, safety, and efficacy.
I wish to commend the Strengthening Pharmaceutical Systems (SPS) Project funded by the US
Agency for International Development (USAID) and implemented by Management Sciences for
Health for their tremendous technical support. I also thank the Medicines Registration Guidelines
Development Task Force members and all those who contributed to the development of this
document.
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ACKNOWLEDGEMENTS
The GDPA in the MoPH wishes to acknowledge the contributions of the individuals who comprised
the Taskforce for the development of these guidelines. Acknowledgement is given to the following
people in particular:
1. Ph. Mohammad Omar Mansory, GDPA Registration and License Issuing Manager
2. Ph. Nematullah Nawrozian, GDPA, Medicine Information Center Manager
3. Ph. Latefa Qaomi, GDPA, Pharmaceutical Products & Companies Registration Manager
4. Ph. Abdul Hadi Mana, GDPA, Foreign Companies Registration Officer
5. Ph. Khan Aqa Osmani, GDPA,
6. Ph. Mohammad Basir, SPS Regulation/Legal Officer
7. Ph. Wahidullah Karwar, SPS Supply Chain Systems Advisor in Afghanistan
8. Ph. Mohammad Zafar Omari, SPS/Afghanistan Chief of Party
9. Mr. Mahmod Azimi, SPS PMIS Officer in Afghanistan
I would also like to acknowledge comments received from the Medicines Committee and the
National Medicines and Food Board (NMFB) members.
The GDPA further expresses its gratitude to the SPS Project for providing technical support in the
development of this guidance document, with the financial assistance of USAID.
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INTRODUCTION
The Ministry of Public Health (MoPH) of the Islamic Republic of Afghanistan, through the General
Directorate of Pharmaceutical Affairs (GDPA), implements the registration system for all medicinal
products for human use prior to their use in Afghanistan. Medicines in Afghanistan are governed by the
Provisions of the Afghanistan Medicine Law, article number 16 (clause 2) (issue number 963), and
article number 16 (clause 3) of the Regulation on Manufacturing and Importing Medicine and Medical
Appliances dated February 24, 2007, issue number 916.
These guidelines prescribe the data that should be submitted to the GDPA on the active
pharmaceutical ingredients (API) and finished pharmaceutical products (FPP) to support applications
for the registration of medicines in Afghanistan. Alternate approaches to the principles and practices
described in these guidelines may be acceptable provided that they are supported by adequate
scientific justification. It is also important to note that the MoPH may request additional information
or materials, or define conditions not specifically described in these guidelines, to adequately assess
the quality of a pharmaceutical product.
The contents of this document should be read in conjunction with relevant information described in
other existing MoPH, World Health Organization (WHO), or International Conference on
Harmonization (ICH) reference documents and guidelines. Scientific literature may be appropriate to
fulfill the requirements for some of the information or parameters outlined in these guidelines (e.g.,
qualification of specified identified impurities).
The GDPA in the MoPH is responsible for compliance and enforcement of these guidelines.
This document replaces all previous guidelines on medicines registration distributed by the GDPA.
The guidelines consist of five sections—
1. Section One: General Information
2. Section Two: Administrative Data and Product Information
3. Section Three: Active Pharmaceutical Ingredients
4. Section Four: Finished Pharmaceutical Products
5. Section Five: Summary of Pharmacology, Toxicology, and Efficacy
Objectives
These guidelines are intended to:
1. Ensure that medicines marketed in Afghanistan are safe, efficacious, and of good quality.
2. Assist applicants with the preparation of applications for the registration of multisource (generic)
products by providing clear general guidance on the format of the dossiers.
3. Provide guidance on technical and other general data requirements.
SCOPE
The guidelines are intended to promote effective and efficient processes for the development and
submission of applications for registration of a product by applicants and the subsequent evaluation
process of the GDPA.
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SECTION ONE
GENERAL INFORMATION
This section describes the application procedures and provides useful information for applicants.
Applicants are advised to read this section carefully before preparing dossiers and assembling the
application for submission to the GDPA.
1. GENERAL REGISTRATION PROVISIONS

1. Any pharmaceutical product of any dosage form intended to be used in Afghanistan must be
registered with the GDPA.
2. To be registered, the product must be on the Afghanistan Licensed Medicines List and the
manufacturing company must be registered with the GDPA.
3. The application and supporting documents should be in English or Dari/Pashto.
4. All information/data should be printed on A4 paper with legible lettering of at least font size
12. Every page should be numbered in the style of page X of Y.
5. Applications for product registration should be made using the prescribed forms issued by
the GDPA.
6. A separate application is required for each product, i.e., products containing the same
ingredient(s) but made in different dosage forms (strength/content of ingredient(s), dosage
form, description, etc.) or by a different manufacturer.
7. The manufacturing company must inform the GDPA by official letter if production and/or
licensing (marketing authorization) of the product is suspended/cancelled or withdrawn in
the country of origin.
8. No change in the product name, product specifications, packing, indications, content of the
product label, patient information leaflet (PIL), or any relevant particulars of the registered
product should be made without prior approval of the GDPA.
9. The registration of a product may be cancelled if changes are made to a registered product
without prior approval of the GDPA.
10. A product that is packed together with diluent(s) is NOT considered a combination pack
medicinal product.
11. All registration data submitted to the GDPA will be considered confidential and will be kept
in safe manner.
2. APPLICATION PROCEDURE FOR PRODUCT REGISTRATION

2.1. Application Types
Applications are classified into three categories for the purposes of submission to the GDPA, as
follows:
1. New Application: This is an application for the registration of a product that is intended to
be placed on the Afghanistan market for the first time.
2. Application for Variation of a Registered Product: All applications for variation of a
registered product will be made according to requirements stipulated in the “Variation
Guidelines” (To be developed later).
3. Applications for Renewal of Registration: All applications for renewal of a registered
product should be made at least six months before the expiry of the existing registration,
according to requirements stipulated in the “Variation Guidelines”.
2.2. Application Submission
1. Applications for product registration should be made using the prescribed forms issued by
the GDPA. (Refer to “Annex 1: Application Form for the Registration of a Product” and
“Annex 2: Guide on How to Complete the Application Form for the Registration of a
Product”). A copy of the Application Form can be obtained from the GDPA website
(www.gdpa.gov.af).
8
2. An application consists of documentation in hard and electronic copies in PDF format and in
Microsoft Word on DVDs/CDs.
3. The applicant should submit the application for registration in duplicate to the GDPA.
4. Applications should be duly completed and supported by all the required documents. To
ensure that the submitted documents are complete, an application checklist is provided in
Annex 3. The completed checklist should be attached at the front of each application
submitted to the GDPA.
5. The application may be physically delivered to the GDPA office located at:
Registration and License Issuing Department
Shah-e-Do Shamshera
Kabul, Afghanistan
6. Submission of the application should be made by appointment with the concerned office at
the above address.
2.3. Application Screening
1. The submitted application will be screened and validated for completeness within fifteen (15)
working days. The GDPA may request further information and additional supporting
documents from the applicant through a query letter. The applicant should make any
additional information or documentation requested for each application available within sixty
(60) calendar days from the date the query letter is received. Once the additional information
has been received by the GDPA, it will be reviewed for completeness. The application will
not proceed for evaluation if no response is received from the applicant within the allotted
sixty (60) calendar days. In this case, the GDPA will issue a non-acceptance letter and the
documents will be returned to the applicant. A new application will have to be submitted if
the applicant wishes to pursue registration of the product.
2. The application will be accepted once the required documents are complete. An
acknowledgement of receipt of the application will be issued to the applicant.
3. Any application that is incomplete, submitted in the wrong format, or illegible will be
rejected.
4. A flowchart on the application procedure for the registration of a product is provided

in Annex 4.
2.4. Application Evaluation
1. Evaluation of the application will be done on a first in, first out basis.
2. Review of the application for the registration of a product will adhere to the appropriate
evaluation queue.
3. During product evaluation, the GDPA may request further information and additional
supporting documents from the applicant. The applicant should make information or
documentation required available within sixty (60) calendar days from the date the query
letter is received. The application will be rejected/closed if no response is received from the
applicant within the sixty (60) calendar days allotted. A new application will have to be
submitted if the applicant wishes to pursue the registration of the product.
4. Laboratory analysis of the samples will be performed against the pharmacopoeia
specifications using the analytical method provided by the applicant.
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2.5. Cost of Registration
The GDPA may charge appropriate non-refundable fees as specified in the related regulation, as
follows:
 Evaluation fee
 Laboratory testing fee
 Product license fee
 Renewal fee
 Variation fee
The fees should be paid during every step of the registration process; otherwise the application will
not be processed. Payment should be made through “Da Afghanistan Bank.”
3. MINISTRY OF PUBLIC HEALTH-GDPA DECISION

The final decision on the approval or rejection of an application will be made by the MoPH based on
the outcome of the evaluation of the submitted documentation and the recommendation of the
GDPA. The decision will be sent to the applicant by the GDPA.
3.1. Product Registration Number
1. A registration number will be given when a product application is found to have satisfied the
registration requirements for quality, safety, and efficacy and is granted registration approval
by the MoPH.
2. The registration number is specific to the product registered, with the name identity,
composition, characteristic, origin (manufacturer), as specified in the registration documents.
It should not be used for any other product.
3.2. Product Registration Certificate
1. A certificate of registration with the name, composition, characteristic, and name and address
of the manufacturer, as specified in the registration documents, will be issued to the
manufacturing company of FPP.
3.3. Rejection, Cancellation, and Suspension of an Application
1. The GDPA may reject, cancel, or suspend the application for the registration of any product
if there are deficiencies in safety, quality, or efficacy of the product or if it fails to comply
with the conditions of registration.
3.4. Appeal Against the MoPH– GDPA Decision
1. If a product has been rejected for registration by the MoPH-GDPA, the applicant may file a
written appeal with the National Medicines and Food Board (NMFB) by using the prescribed
form issued by the GDPA.
2. All appeals should be made within fifteen (15) calendar days of the date of receipt of the
GDPA notification by the applicant.
3. A period of sixty (60) calendar days from the date of the notice of appeal is given for
submission of any supporting data or documents. The appeal is considered closed if all the
required information is not submitted within the allotted time.
4. Any request for an extension of this period will not be entertained.
5. The decision of the NMFB concerning an appeal is final.
6. An electronic copy of the appeal form may be obtained from the GDPA website
(www.gdpa.gov.af). A sample copy of the Appeal Form is provided in Annex 5. A hard copy
of the completed Appeal Form should be submitted to the NMFB.
3.5. Reapplication for Rejected Products
1. Reapplication for products rejected for reasons of safety and efficacy will not be accepted
within two (2) years after the rejection. However, if the product is registered with the stringent
regulatory authority (SRA) countries, submission of an application may be made earlier.
2. If an application for the registration of a product is rejected by the GDPA for a second time
for any reason, the applicant is not allowed to submit an application for a third time.
10
However, if the product is registered with the SRA countries, submission of an application
may be made earlier.
4. MAINTENANCE OF REGISTRATION
4.1. General Registration Conditions
The general registration conditions for pharmaceutical products are as follows:
1. The Marketing Authorization Holder (manufacturer of the finished product) and Importer
will ensure that the product will be manufactured, imported, sold and supplied in accordance
with the approved application and in compliance with all registration conditions, applicable
legislation, and guidelines.
2. No changes will be made to any approved product without prior approval of the GDPA. Any
changes or variation to an approved product will be done in accordance with the “Variation
Guidelines”.
3. The Registration Number MUST be:
 Printed on the product label
 Labeled on the immediate container/packaging and immediate outer container/ packaging
 Printed in an indelible manner
 Printed—NOT handwritten
 Before being imported, sold, or supplied, “imported products” should be labeled by the
manufacturer
 Before distribution, sale, or supply, “locally manufactured products” should be labeled
by the manufacturer
4. Labeling: The labels for the registered product should comply with all of the labeling
requirements specified in these guidelines. (Refer to Section Two of the guidelines.)
5. Adverse Drug Reactions: The MAH and importer must inform the GDPA of any adverse
reactions arising from the use of the registered product immediately after he/she receives
notice of such adverse reactions.
6. Product Complaint: The MAH and importer should notify the GDPA of any product quality-
related problems (with registered products) of which the MAH and importer are aware.
7. Laboratory Testing: Samples of products registered with the GDPA may be taken and tested
for compliance with official pharmacopoeia standards.
8. Quality Defect: If a registered product sample fails to meet adequate specifications, the MAH
and importer will be issued a warning. If the failure is serious enough to justify a recall of the
product, the MAH has up to ninety (90) calendar days to identify the source/cause of the
quality defect and the actions to be taken to improve quality. Based on the source/cause of
the quality defect, the GDPA will make the appropriate decision in accordance with
Afghanistan laws and regulations, and in coordination with the MAH and importer.
9. Amendment of Patient Information Leaflet and Labels: All PILs and labels must be amended
to include any new adverse reaction, warning, precautions, etc. within the time frame given
by the GDPA.
10. Cancellation and Suspension of the Registration of a Product Registered with the GDPA:
A product registration may be cancelled or suspended for the following reasons:
a) If the product is removed from the Afghanistan Licensed Medicines List.
b) The information provided at the time of the submission of the application is later found to
be false or insufficient.
c) If it is substantiated that the product has serious side effects, and based on WHO or
national and international agency recommendations, use of the product is prohibited.
d) If it is found that the manufacturer is not in compliance with Good Manufacturing Practices
(GMP), or for any other reasons, that the manufacturer has repeated violations.
e) If the MAH and the importer fail to inform the GDPA of any serious adverse reactions of
the registered product upon receipt of such reports.
f) If two (2) years following the issue of the product registration license, the production and
importation of the product did not occur, the GDPA may cancel the registration of the
product.
11
g) If the composition, label, packaging, and any other specification of the product has been
changed without the approval of the GDPA.
h) Any of the general conditions of the registration have been contravened or changed.
i) Defaulting on the timely renewal of the product registration before the given time period.
j) For any other reasons, as specified by the GDPA at the time of cancellation.
The holder of the registration certificate shall immediately surrender the product registration
certificate upon cancellation or suspension of the registration of the product.
11. Withdrawal from Registration: The MAH must inform the GDPA in writing of any decision
to withdraw the registration of a product before the end of the validity of such registration,
stating the reasons for the decision. The MAH must surrender the product registration
certificate immediately to the GDPA.
12. Product Recalls: The MAH and importer are responsible for conducting recalls of defective
or unsafe products. It is also the MAH’s and importer responsibility to notify the GDPA of
any recall decision. No recall should take place without first consulting/informing the GDPA.
4.2. Validity Period of Product Registration
1. The registration of a product shall be valid for five (5) years, unless suspended or cancelled
by the GDPA or withdrawn earlier by the license holder.
2. When it suspends or cancels the registration, the GDPA will give the reasons in writing.
Likewise, the license holder will provide reasons in writing for terminating the registration of
a product.
3. Once terminated, the license of a registered product will not be re-registered. A new
application must be submitted.
4.3. Product Registration Renewals
1. Application for renewal of a product registration should be submitted to the GDPA not later
than six (6) months prior to the expiry of the validity period of the product registration.
2. Upon the expiry of the validity period of the product registration, the renewal of the product
registration will no longer be accessible; if the MAH has not submitted a renewal application,
an application for a new registration of the product will need to be submitted.
5. CHANGE IN PARTICULARS OF REGISTERED PRODUCTS

The MAH and importer must inform the GDPA of any changes to any aspect of the registered product,
i.e., any variation from what has been specified in the registration documents. All applications for
variation to a registered product must be made according to the “Variation Guidelines”.
6. CHANGE IN IMPORTER OF A REGISTERED PRODUCT

The importation license of a registered product may be transferred from the existing importer to
another importer. Applications for transferring to anther importer must be made according to the
“Variation Guideline.”
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SECTION TWO
ADMINISTRATIVE DATA AND PRODUCT INFORMATION
1. Cover Letter
1. The cover letter on the applicant company original letterhead submitted with the application
for registration.
2. The letter should be dated and signed by the responsible person in the applicant company,
which may be the president or deputy for the company or organization.
2. Completed and Signed Application Form

1. A completed, signed, and dated application form should be submitted for each finished
pharmaceutical product. A copy of the form may be obtained from the GDPA website
(www.gdpa.gov.af).
2. A competent qualified person shall complete all application forms. He/she shall ensure that
all information provided to the GDPA is true and correct to the best of his/her knowledge.
The applicant should be aware that if he/she makes any false statement, representation, or
declaration in connection with an application to the GDPA, he/she will have committed an
offence.
3. The submission should include hard and electronic copies in PDF format and in Microsoft
Word on DVDs/CDs.
3. Letter of Authorization
1. The applicant should provide a copy of the letter of authorization from the manufacturing
company for the application of the product registration (not applicable if the applicant is the
manufacturer).
2. The letter of authorization should be on the manufacturing company original letterhead and be
dated and signed by the president or deputy for the company or organization.
4. Certifications
The applicant should provide a copy of the following types of certifications for the registration
application for the product:
1. For Locally Manufactured Products:
a) A copy of the “Manufacturing License”
b) A copy of the “GMP Certificate” of the manufacturer
2. For Imported Products:
a) A copy of the “Manufacturing License*” of the manufacturing site (issued by the
competent authority in the country of origin).
b) A copy of the “Product Manufacturing License*” (issued by the competent authority in
the country of origin)
c) A copy of the “Certificate of Pharmaceutical Product*” (issued by the competent
authority in the country of origin according to the current WHO format).
d) A copy of the “Site Master File” (SMA) of the manufacturing sit
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e) A copy of the “GMP Certificate*” of the manufacturing sit
f)A copy of the “Certificate of Analysis” (CoA)
g) A copy of the “Registration Certificate*” for the product from one other country
________________________________________________________________________________
_
*Copies of the documents must be duly endorsed by three agencies (Ministry of Health, Ministry of Commerce, and Ministry of
Foreign Affairs) in the country of origin and the Afghanistan Embassy; in the absence of the Afghanistan Embassy in that country, the
non-resident embassy may endorse the documents.
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5. Product Labeling Requirement
1. The applicant should provide samples or proposed drafts of product labeling for the
registration application for the product.
2. The language used for labeling should be English or Dari/Pashto.
3. Samples or proposed drafts of the product labeling are for the unit carton, inner label, and
blister/strips, as follows:
S/No Parameters Unit Inner Blister/
Carton Label Strips
1 Product Name (generic name should be greater than the brand name) √ √ √
2 Dosage Form √ √* √
3 Name of Active Ingredient(s) √ √ **√
4 Strength of Active Ingredient(s) √ √ **√
5 Batch Number √ √ √
6 Manufacturing Date √ √ √
7 Expiration Date √ √ √
8 Route of Administration √ √ √
9 Storage Conditions √ √* NA
10 Country’s Registration Number √ √ √
11 Name and Address of Importer √ √ √
12 Name and Address of Manufacturer √ √ √
13 Special Labeling (if applicable), e.g., Sterile, External Use, √ √ NA
Cytotoxic, Alcohol content
14 Warning (if applicable) √ √ NA
15 Pack sizes (Unit/Volume) √ √ NA
16 The words “Keep Out of Reach of Children” √ NA √
*Exempted for small labels, such as those used for ampoules and vials.
**Exempted for multi-ingredient products with more than three ingredients. For example, for multivitamins
and multi minerals, it is suggested to label them as multivitamins and multi minerals.
NA (Not Applicable)
6. Product Information
1. The applicant should provide samples or proposed drafts of the PIL for the registration
application for the product.
2. The language used for product information should be English or Dari/Pashto.
3. Samples or proposed drafts of the product information for the PIL, as follows:
Patient Information
S/No Parameters Leaflet
1 Product Name (generic name must be greater than brand name) √
2 Dosage Form and Packaging Available √
3 Name of Active Ingredient(s) √
4 Strength of Active Ingredient(s) √
5 Product Description √
6 Pharmacodynamics/Pharmacokinetics √
7 Indication √
8 Recommended Dose √
9 Route of Administration √
10 Contraindications √
11 Warnings and Precautions (if applicable) √
12 Interactions with Other Drugs √
13 Pregnancy and Lactation √
14 Undesirable Effects or Adverse Effects √
15 Overdose and Treatment √
16 Storage Conditions √
17 Name and Address of the Importer √
18 Name and Address of the Manufacturer √
19 Date of publication of the Patient Information Leaflet √
15
SECTION THREE
ACTIVE PHARMACEUTICAL INGREDIENT(S)
The information on the active pharmaceutical ingredient(s) (API) should be submitted according to
the following order of preference. Provide at least the following information for each active
pharmaceutical ingredient:
1. Nomenclature
 International Nonproprietary Name (INN)
 Compendial Name, if relevant
 Chemical Name(s)
 Company or laboratory code, if applicable
 Other nonproprietary name(s) (e.g., National Name, United States Adopted Name, British
Approved Name, Japanese Accepted Name)
 Chemical Abstracts Service (CAS) registry number
2. Properties of Active Pharmaceutical Ingredient(s)
2.1. API Described in a Recognized Pharmacopeia (BP, USP, EP, IP)
 APIs are described in a recognized pharmacopoeia. Proof of structure may be demonstrated
by comparison of spectral data (in particular, infrared overlay and/or nuclear magnetic
resonance [NMR] spectra), with an official reference standard.
2.2. API NOT Described in a Recognized Pharmacopeia (BP, USP, EP, IP)
Provide the following information:
 Chemical structure, including relative and absolute stereochemistry, (e.g., racemate, pure (S)
- isomer, 50/50 mixture of (Z)- and (E)- isomers), the molecular formula, and the relative
molecular mass).
 Isomeric nature, including stereochemical configuration.
 Provide documented evidence of the correctness of the structure and stereochemistry, such as
infrared, NMR, ultraviolet, mass and X-ray spectra, together with the interpretation of the
relevant parts of the spectra. Correlation of the spectral data with data from peer-reviewed
literature may also be used for confirmation.
 Physicochemical and other relevant properties of the API, such as solubility in water;
solubility in other solvents, such as ether, ethanol, acetone; solubility in buffers of different
pH, including pH 1.2, acetate buffer at pH 4.5, and phosphate buffer at pH 6.8; partition
coefficient; existence/absence of polymorphic forms and water/solvent crystallization; results
of hygroscopicity testing; and particle size.
3. Site(s) of Manufacture–Active Pharmaceutical Ingredient(s)
Provide the name, street address (including the block or unit number), telephone, fax, email, and
responsibility of each manufacturer, including contractors, and information on each proposed
production site or facility involved in manufacturing and testing. Include any alternative
manufacturers.
The facilities involved in the fabrication, packaging, labeling, testing, and storage of the API should
be listed. It should be clearly indicated if certain companies are responsible only for specific steps
(e.g., milling of the API).
A valid manufacturing authorization (license) should be provided for the production of the API.
A certificate of GMP compliance in the format of a WHO-type GMP certificate from the competent
authority of the country of manufacture should be provided.
For domestic sites, attach a copy of the current site license issued by the MoPH.
4. Route(s) of Synthesis of Active Pharmaceutical Ingredient(s)
If the API is the subject of a monograph in a recognized pharmacopoeia, provide an outline of the
route of synthesis (a flow chart and a qualitative description of the manufacturing method, including
the names of solvents, reagents, and catalysts). However, note that pharmacopoeia monographs are
16
designed to control impurities from those routes of synthesis that were considered during monograph
development, and impurities from other routes of synthesis may not be controlled. In the case of the
European pharmacopeia, provide a European certificate of suitability together with a report. When
certificates of suitability are not available, and in the case of other pharmacopoeias, provide evidence
that the monograph is able to control the impurities that actually occur following this route of
synthesis. Normally, the evidence will comprise the results of chromatographic tests (using at least
two chromatographic systems) on several batches. In addition, specifications may be requested by
evaluators for starting materials, solvents, reagents, and intermediates whose purity is critical to the
impurity profile of the final API.
If the API is not the subject of a monograph in a recognized pharmacopoeia, submit a sequential
procedural narrative of the manufacturing process, supplemented by a flow chart reflecting the
structures of the starting materials, intermediates, reagents, catalysts, and solvents used in the
process. The narrative should include, for example: quantities of raw materials, solvents, catalysts,
and reagents reflecting the representative batch scale for commercial manufacture; identification of
critical steps, process controls, equipment and operating conditions; comment on known and likely
synthesis impurities (inorganic, organic, and residual solvents) and degradation products (related
substances), including methods for detection and controlling of same.
Note: If an API is obtained from more than one manufacturer, the methods of synthesis (including
the purification step) may not be identical. Submissions are then required for the material obtained
from each of the different sources, and comparative data should be submitted demonstrating
differences and similarities. It should be ensured that the impurities (especially organic and volatile
impurities) are adequately controlled and that the physical properties (such as particle size and
crystal form, when there are polymorphs) are similar to ensure similar pharmaceutical product
characteristics of the finished products.
5. Specification for the Active Pharmaceutical Ingredient(s)
A copy of the API specifications, dated and signed by authorized personnel (e.g., the person in
charge of quality control or the quality assurance department) should be provided in the dossier,
including specifications from each API manufacturer. The specification reference number and
version (e.g., revision number and/or date) should be provided for version control purposes.
Provide a copy of the monograph together with any test methods referenced in the monograph. Note that
the current monograph should always control the quality of the API.
Any additional tests, with limits, not appearing in the monograph should be described in sufficient
detail to be replicated by another laboratory. Additional tests may include, for example, synthesis-
(process-) specific impurities not covered by the monograph, and requirements that are important for
the pharmaceutical product (for instance, particle size and crystal form when there are polymorphs).
Provide a list of tests and limits for results of the API. Include test methods in sufficient detail for
them to be replicated by another laboratory. Provide the results of the validation of the methods for
the assay of the API and of impurities. If the ingredient is tested on the basis of a monograph in a
pharmacopoeia, it is sufficient to provide a copy of the monograph together with any test methods
referenced but not duplicated in the monograph. Provide details of any specifications additional to
those in the pharmacopoeia.
6. Batch Analysis
Provide certificates of analysis for at least two batches produced at each manufacturing site by each
synthetic method, including results for impurities. The information provided on batch analysis
should include the batch number, batch size, and date and production site of relevant API batches
used in comparative bioavailability studies, preclinical and clinical data (if relevant), stability, pilot,
scale up and production scale batches, if available. These data are used to establish the specifications
and evaluate consistency in API quality.
17
7. Container Closure System
Provide a description of the container closure system(s), including the identity of construction
materials for each primary packaging component and their specifications. The specifications should
include the description and specific test for identification (and critical dimensions with drawings,
where appropriate).
Provide only a brief description for non-functional secondary packaging components (e.g., those that
do not provide additional protection). Provide additional information on functional secondary
packaging components.
The suitability should be discussed with respect to, for example, choice of materials, protection from
moisture and light, compatibility of the construction materials with the API, including sorption to
container and leaching, if applicable, and/or the safety of construction materials.
Copies of the labels applied on the secondary packaging of the API should be provided and should
include the storage conditions. In addition, the name and address of the manufacturer of the API
should be stated on the container.
8. Stability Testing of the Active Pharmaceutical Ingredient(s)

Provide the results of stability testing of the API. If the API is well established, information on its
stability may be provided in the form of papers from the scientific literature.
Results should be included for physical as well as chemical tests, e.g., particle size and polymorphic
form, where relevant. The study should be designed to show whether trends occur over time.
Provide specifications for the primary packaging materials used in stability testing and those
proposed for routine storage and transport of the API, including the nature of each material.
Data from stability testing of not less than three primary batches of the API should be provided. The
batches should be manufactured by the same synthesis route as production batches, and using a
method of manufacture and procedure that simulates the final process to be used for production
batches. The information on stability studies should include details, such as storage conditions, batch
number, batch size, container closure system, and proposed test intervals.
Describe the methodology used during stability studies; if this is identical to the methodology
described elsewhere in the dataset, a cross-reference will suffice. If a different methodology was
used, provide validation of tests for impurities and assay, and for other tests, as necessary (e.g.,
particle size testing).
The minimum data that are required at the time the dossier is submitted (in the general case):
Storage Condition Relative Humidity Minimum Time Period
Study (ºC) (%) (months)
Accelerated 40 ± 2 75 ± 5 6
Long-term 30 ± 2 65 ± 5 or 75 ± 5 12
Provide the post-approval stability protocol and stability-testing commitment, when applicable.
A storage statement should be proposed for the labeling (if applicable), which should be based on
the stability evaluation of the API.
The shelf life should be derived from the stability information, and the approved shelf life should be
displayed on the container label and CoA.
The WHO guidelines, Stability Testing of Active Pharmaceutical Ingredients and Finished
Pharmaceutical Products, WHO Technical Report Series, No. 953, 2009 – Annex 2, should be
consulted for further guidance on stability studies.
18
SECTION FOUR
FINISHED PHARMACEUTICAL PRODUCTS
The information on FPPs should be submitted according to the following order of preference:
1. Description of the Finished Pharmaceutical Product

The description of the FPP should include the physical description, available strengths, release
mechanism (e.g., immediate, modified [delayed or extended]), as well as any other distinguishable
characteristics, e.g., “The proposed XYZ 50mg tablets are available as white, oval, film-coated
tablets, de-bossed with ‘50’ on one side and a break-line on the other side.”
2. Formulation
Provide the composition, i.e., list of all components of the dosage form in a table format, as shown
below:
 List all components of the dosage form, and their amount on a per unit basis (including
overages, if any), the function of the components, and a reference to their quality standards
(e.g., compendial monographs or manufacturer’s specifications). If an excipient performs
multiple functions, the predominant function should be indicated. Use the table format below
to present the information on the composition of the FPP.
Strength (label claim)
Component and quality Function Quality standards
standard (and grade, if Quantity per (e.g., USP, BP, EP, IP,
applicable) unit or per mL % in-house)
<Complete with appropriate title, e.g., core tablet, contents of capsule, powder for injection>
Subtotal 1
<Complete with appropriate title, e.g., film-coating>
Subtotal 2
Total
 The formulation for a typical batch (biobatch, commercial/production batch, stability or

validation batch) and for an administration unit, e.g., one tablet, 5ml of oral solution, or the
contents of an ampoule or bag of large volume parenteral solution. Use the format provided
in the table below to present the information on the batch formula.
19
Summary of formulation and discussion of any differences:
Relevant Batches
Comparative
Component and bioavailability or Stability Process validation Commercial
quality standard biowaiver
(e.g., USP, BP, EP, <Batch # and sizes> <Batch # and sizes> <Batch # and sizes> <Batch # and sizes>
IP, in-house) Theoretical % Theoretical % Theoretical % Theoretical %
quantity per quantity per quantity per quantity per
batch batch batch batch
<Complete with appropriate title, e.g., core tablet, contents of capsule, powder for injection>
Subtotal 1
<Complete with appropriate title, e.g., film-coating>
Subtotal 2
Total
 Excipients that may be removed during processing (e.g., solvents), those that may not be
added to every batch (e.g., acid and alkali for pH adjustment), and the qualitative and
quantitative composition of any tablet coating, capsule shell, and inked imprint on the dosage
form. State and justify any overages. State the function(s) of each excipient (e.g., antioxidant,
lubricant, and binder).
 Indicate any substances whose content may be varied (e.g., inked imprint, tablet coating).
 The components should be declared by their proper or common names, quality standards
(e.g., USP, BP, IP, EP, and in-house) and, if applicable, their grades (e.g., “microcrystalline
cellulose USP [PH 102]”) and special technical characteristics (e.g., lyophilized, micronized,
solubilized, or emulsified).
State how the content is decided for each batch (e.g., “The active therapeutic ingredient is adjusted
for water content to a constant dry weight content; the content of maize starch may be varied by up
to +25% depending on manufacturing conditions”).
Provide either validation data or a rationale to justify ranges in the content of excipients. Ranges
should not be excessive nor should they be automatic (e.g., “All excipients may be varied by ± 10 %”).
3. Pharmaceutics Development
Provide either the results of development pharmaceutics or a review of literature information on the
same topic, including, for example:
 The definition of the quality target product profile 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 of the FPP so as to adequately control
the product characteristics that could have an impact on quality.
 Studies of the chemical and physicochemical compatibility of the API with potential
excipients, and with other APIs, if present.
 Dissolution rate of pilot formulations, and the selection and justification of the dissolution
method and limit for the final product. Provide dissolution profiles for at least three
consecutive batches manufactured according to the final formulation and manufacturing
procedure.
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 Comparative dissolution of the batch used in pharmacokinetic or bioequivalence studies,
compared with an acceptable reference product or innovator product, should be submitted.
Recommendations for conducting and assessing comparative dissolution profiles may be
found in Annex VI.
 Stability of pilot formulations under accelerated conditions and under the maximum
recommended conditions for storage.
 Rationale for the selection of excipients and the function of each in the formulation.
For well-established products, a product quality review may be provided in lieu of the development
pharmaceutics. For this purpose, a well-established product is one that has been marketed by the
applicant or manufacturer associated with the dossier for at least five (5) years and for which at least
ten (10) production batches were produced in the previous year, or, if less than ten (10) batches were
produced in the previous year, not less than twenty-five (25) batches were produced in the previous
three years.
4. In Vitro Dissolution or Drug Release
The results of studies justifying the choice of in vitro dissolution or drug release conditions (e.g.,
apparatus, rotation speed, medium) should be provided. Data should also be submitted to
demonstrate whether the method is sensitive to changes in manufacturing processes and/or changes
in grades and/or amounts of critical excipients and particle size, where relevant. The dissolution
method should be sensitive to any changes in the product that would result in a change in one or
more of the pharmacokinetic parameters. Use of a single point test or a dissolution range should be
justified based on the solubility and/or biopharmaceutical classification of the API.
For slower dissolving immediate-release products (e.g., Q = 80% in 90 minutes), a second point in
time may be warranted (e.g., Q = 60% in 45 minutes).
Modified-release FPPs should have a meaningful in vitro release rate (dissolution) test that is used
for routine quality control. This test should preferably possess in vitro-in vivo correlation. Results
demonstrating the effect of pH on the dissolution profile should be submitted, if appropriate, for the
type of dosage form.
For extended-release FPPs, the testing conditions should be set to cover the entire time period of the
expected release (e.g., at least three test intervals chosen for a 12-hour release and additional test
intervals for a longer duration of release). One of the test points should be at the early stage of drug
release (e.g., within the first hour) to demonstrate the absence of dose dumping. For each test period,
upper and lower limits should be set for individual units. Generally, the acceptance range at each
intermediate test point should not exceed 25% or ±12.5% of the targeted value. Dissolution results
should be submitted for several lots, including those lots used for pharmacokinetic and
bioavailability or biowaiver studies.
5. Sites of Manufacture - Finished Product
Provide the name, street address, and responsibility of each manufacturer; each proposed production
site or facility involved in manufacturing and testing should also be provided.
The facilities involved in the fabrication, sterilization, packaging, labeling, and testing should be
listed. It should be clearly indicated if certain companies are responsible only for specific steps (e.g.,
manufacturing of an intermediate).
(The WHO Good Distribution Practices for Pharmaceutical Products, WHO Technical Report
Series, No. 957, 2010, Annex 5, should be consulted for further guidance.)
The list of manufacturers/companies should specify the actual locations of production or
manufacturing site(s) involved, including block(s) and unit(s), rather than the administrative offices.
For a mixture of an API with an excipient, the blending of the API with the excipient is considered
to be the first step in the manufacture of the final product, and therefore, the mixture does not fall
under the definition of an API. The only exceptions are in cases where the API cannot exist similarly
on its own. For a mixture of APIs, the blending of the APIs is considered to be the first step in the
manufacture of the final product. Sites for such manufacturing steps should be included in this
section.
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5.1. Imported Products
A valid manufacturing authorization for pharmaceutical production, as well as a marketing
authorization (registration), should be submitted to demonstrate that the product is registered or
licensed in accordance with national requirements in the country of origin or country of
manufacture.
For each site where the major production step(s) is/are carried out, when applicable, submit a valid
GMP certificate and attach an original certificate of a pharmaceutical product (CoPP) issued by the
competent authority in terms of the guidelines on the implementation of the WHO certification
scheme on the quality of pharmaceutical products moving in international commerce.
5.2. Domestically Manufactured Products
For all domestic manufacturing sites, provide a copy of a GMP certificate that contains all of the
information in the WHO model GMP certificate.
6. Detailed Description and Validation of the Manufacturing Procedure for the Finished
Product
Provide a detailed description of the manufacturing procedure for each strength and formulation of
the finished product, including packaging. Provide a flow diagram showing where materials enter
the process.
Identify any critical steps and points at which in-process controls apply. Provide a copy of the master
formula and a copy of a manufacturing record for a real batch (this should be the biobatch, i.e., the
batch used for the bioequivalence or comparative dissolution studies, if applicable).
A narrative description of the manufacturing process, including packaging, which represents the
sequence of steps undertaken and the scale of production, should also be provided. Equipment
should, at least, be identified by type (e.g., tumble blender, in-line homogenizer) and their working
capacity, where relevant.
Provide process validation data (manufacturing process, validation protocol, and manufacturing
process validation report) for critical manufacturing steps as described in WHO’s Supplementary
Guidelines on Good Manufacturing Practices: Validation, WHO Technical Report Series, No. 937,
2006. At a minimum, identify the parameters that must be controlled during the critical
manufacturing steps. Define optimum numerical values for each identified parameter.
7. Specifications for Excipients

Provide a list of tests and limits for results for each excipient, including solvents, liquids to adjust
pH, coatings, capsule shell, and inked imprint (on the dosage form). Include test methods in
sufficient detail for them to be replicated by another laboratory. If the ingredient is tested on the
basis of a monograph in a pharmacopoeia, it is sufficient to provide a copy of the monograph
together with any test methods referenced but not duplicated in the monograph. Include
microbiological limits for materials of natural origin. Only colors and other excipients permitted by
national regulation may be used.* For excipients of human or animal origin, provide information on
the control of adventitious agents, such as transmissible spongiform encephalopathies. For oils of
plant origin (e.g., soy bean or peanut oil), provide information on the control of aflatoxins and other
possible contaminants, such as pesticides.
7.1. Excipients Described in a Recognized Pharmacopeia (BP, USP, EP, IP)
Provide a copy of the monograph together with any test methods referenced in the monograph but
not duplicated in the monograph. Note that the current monograph should always control the quality
of the excipient. Provide details of any specifications additional to those in the pharmacopoeia. A
CoA for one batch of each excipient should be provided.
7.2. Excipients NOT Described in a Recognized Pharmacopeia (BP, USP, EP, IP)
For non-compendial excipients and those used for the first time in a FPP or by a new route of
administration, provide full details of manufacture, characterization, and controls, with cross
22
references to supporting safety data (non-clinical and/or clinical). A CoA for one batch of each
excipient should be provided.
* Colors permitted in the European Union may be found in the European Commission’s list of permitted food
colors. Colors permitted by the US Food and Drug Administration (FDA) are listed in the on-line database,
Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices.
8. Control of the Finished Pharmaceutical Products

8.1. Specifications for the Finished Pharmaceutical Product
A copy of the FPP specification(s) dated and signed by authorized personnel (i.e., the person in
charge of quality control or the quality assurance department) should be provided.
A list of tests and limits for results of the FPP must be provided, including sufficient detail of test
methods for them to be replicated by another laboratory.
Two separate sets of specifications may be set out: after packaging of the FPP (release) and at the end of shelf
life. In such cases, both release and end of shelf life specifications should be provided. Any differences
between release and shelf life tests and acceptance criteria should be clearly indicated and justified. Note that
such differences for parameters, such as dissolution, are normally not accepted.
Unless there is appropriate justification, the acceptable limit for the API content of the FPP in the
release specifications is (± 5%) of the label claim (i.e., 95-105%).
8.2. Analytical Procedures
All analytical test procedures, including biological and microbiological methods, where relevant,
must be described in sufficient detail to enable the procedures to be repeated, if necessary.
If the product is tested on the basis of a monograph in a pharmacopoeia, it is sufficient to provide a
copy of the monograph together with any test methods referenced in the monograph but not
duplicated in the monograph. Provide details of any specifications and test methods additional to
those in the pharmacopoeia.
8.3. Validation of Analytical Procedures
All non-compendial tests procedures need to be validated. Results of the validation studies,
comments on the choice of routine tests, and standards must be provided. For pharmacopoeia
methods, provide data to demonstrate that the method is applicable to this formulation.
The WHO guidelines, Validation of Analytical Procedures Used in the Examination of
Pharmaceutical Materials, and Guidelines for Registration of Fixed-dose Combination Medicinal
Products (WHO Technical Report Series, No. 929, 2005) should be taken into account.
8.4. Batch Analysis
Results of not less than three batch analyses (including the date of manufacture, place of
manufacture, batch size, and use of batch tested) must be presented. The batch analysis must include
the results obtained for all specifications at release. Copies of the CoAs for these batches should be
provided, and the company responsible for generating the test results should be identified.
9. Container Closure System(s) and Other Packaging

The suitability of the container closure system used for the storage, transportation (shipping), and
use of the FPP should be discussed. This discussion should consider, for example: the choice of
materials; protection from moisture and light; compatibility of the construction materials with the
dosage form (including sorption to container and leaching); safety of the construction materials; and
performance (such as reproducibility of the dose delivery from the device when presented as part of
the FPP).
Give a detailed description of the container closure system(s), including any liner or wadding, and
provide details of the composition of each component. Provide the specifications for any part of the
container closure system(s) that comes into contact with the product or is protective. For important
products, such as parenteral and ophthalmic products, components that will at any stage come into
contact with any part of the product must comply with requirements specified by the BP, USP, EP,
and IP.
23
The specifications for the primary packaging components should include a description and
identification (and critical dimensions, with drawings, where appropriate). Non-compendial methods
with validation should be included, where appropriate. Primary packaging components are those that
are in direct contact with the API or FPP.
Describe other (e.g., outer) packaging and the materials they are made from.
10. Stability Testing of the Finished Product

The design of the formal stability studies for the finished product should be based on knowledge of
the behavior and properties of the API and the dosage form.
Provide the results of stability testing of the formulation in each of the proposed marketing packs.
Results of testing-related formulations and/or the same formulation in other packaging may be
provided as supporting information. Describe the methodology used during stability studies; if this is
identical to the methodology described elsewhere in the dataset, a cross-reference will suffice. If a
different methodology was used, the test procedures applied (for impurities and assay, and for other
tests, as necessary, e.g., particle size testing) to the stability tests on the finished product should be
validated or verified, and the accuracy as well as the precision (standard deviations) should be
recorded.
10.1. Stability-Indicating Quality Parameters
Stability studies should include testing of those attributes of the FPP that are susceptible to change
during storage and are likely to influence quality, safety, and/or efficacy.
Characteristics studied should be those in the finished product specification that are likely to be
affected by storage and/or not monitored routinely at the time of manufacture, but which may be
indicative of the stability/instability of the particular dosage form. These include:
 Physical characteristics (such as organoleptic properties, physical properties characteristic of
the dosage form, important quality parameters, e.g., in vitro dissolution, moisture content,
and change of polymorphs, if relevant). As regards tablets and capsules packed with semi-
permeable blister films, loss or uptake of water must be tested during stability studies.
 Efficacy of additives, such as antimicrobial agents, to determine whether such additives
remain effective and within the accepted validated range throughout the projected shelf life.
 Chemical characteristics (assay of the API, content of degradation products, content of other
ingredients, such as preservatives, antioxidants).
 Study of the container and closure interaction with the contents, when applicable.
 Where the product is to be diluted or reconstituted before being administered to the patient
(e.g., a powder for injection or a concentrate for oral suspension). “In use” stability data must
be submitted to support the recommended in-use storage time and conditions for those
storage forms.
Shelf life acceptance criteria should be derived from consideration of all available stability
information. It may be appropriate to have justifiable differences between the shelf life and release
acceptance criteria based on the stability evaluation and the changes observed on storage. Any
differences between the release and shelf life acceptance criteria for antimicrobial preservative
content should be supported by a validated correlation of chemical content and preservative
effectiveness demonstrated during development of the pharmaceutical product with the product in its
final formulation (except for preservative concentration) intended for marketing. A single primary
stability batch of the FPP should be tested for effectiveness of the antimicrobial preservative at the
proposed shelf life for verification purposes, regardless of whether there is a difference between the
release and shelf life acceptance criteria for preservative content.
10.2. Selection of Batches
At the time of submission, data from stability studies should be provided on at least three primary
batches of the FPP. The primary batches should be the same formulation and packaged in the same
container closure system as that proposed for marketing. The manufacturing process used for
primary batches should simulate that to be applied to production batches and should provide a
product of the same quality and meeting the same specification as that intended for marketing.
24
One of the three batches should be of production scale and the remaining two batches should be at
least a pilot scale batch. The composition, batch size, batch number, and manufacturing date of each
of the stability batches should be documented and the CoA at batch release should be attached.
10.3. Container Closure System
Stability testing should be conducted on the dosage form packaged in the container closure system
proposed for marketing. Any available studies carried out on the FPP outside its immediate container
or in other packaging materials can be considered as supporting information, if applicable.
10.4. Testing Frequency
The frequency of testing of the long-term storage condition should normally be every three (3)
months over the first year, every six (6) months over the second year, and annually thereafter
throughout the proposed shelf life, to establish the stability characteristics of the FPP.
At the accelerated storage condition, a minimum of three time points, including the initial and final
times (e.g., 0, 3, and 6 months), from a six-month study are recommended.
10.5. Storage Conditions
In general, a FPP should be evaluated under storage conditions with appropriate tolerances, its
sensitivity to moisture, or potential for solvent loss. The storage conditions and the lengths of studies
chosen should be sufficient to cover storage, shipment, and subsequent use with due regard to the
climatic conditions for Climatic Zone IV.
Stability testing of the finished product after constitution or dilution, if applicable, should be
conducted to provide information for the labeling on the preparation, storage conditions, and in-use
period of the constituted or diluted product. This testing should be performed on the constituted or
diluted product through the proposed in-use period on primary batches as part of the formal stability
studies at initial and final points in time.
The long-term testing should cover a minimum of six (6) or twelve (12) months duration at the time
of submission and should be continued for a period of time sufficient to cover the proposed shelf
life.
Data from the accelerated storage conditions may be used to evaluate the effect of short-term
excursions outside the label storage conditions (such as might occur during shipping).
The minimum data required at the time the dossier is submitted (in the general case):
Storage Condition Relative Humidity Minimum time period
Study (ºC) (RH) (%) (months)
Accelerated 40 ± 2 75 ± 5 6
Long-term 30 ± 2 65 ± 5* 12
*Stability studies conducted at 75% relative humidity are also acceptable
Other storage conditions are outlined in the WHO stability guidelines for FPPs packaged in
impermeable and semi-permeable containers and those intended for storage in a refrigerator and in a
freezer. FPPs intended for storage below -20°C should be treated on a case-by-case basis.
10.6. Stability Result
Provide the summary of accelerated and long-term testing parameters (studies conducted) using the
format provided in the table below:
Storage Conditions Strength and Batch Size Container Completed (and
(°C, % RH) Batch Number Closure proposed) Test
System Intervals
Provide the summary of the accelerated and long-term stability results using the format in the table
below:
25
Test Results
Description
Moisture
Impurities
Assay
Etc.
For most types of products, results should be included for physical as well as chemical tests, e.g.,
(where relevant) the presence of particles in a solution and the dissolution rate of solid oral dosage
forms.
If the product contains an antimicrobial preservative, then preservative efficacy should be
demonstrated at batch release and at the end of the shelf life.
For sterile products, sterility should be reported at the beginning and end of shelf life. For parenteral
products, sub visible particulate matter should be reported frequently, but not necessarily at every
test interval. Weight loss from plastic containers should be reported over the shelf life. In-use
periods for parenteral and ophthalmic products should be justified with experimental data.
The information on the stability studies should include details, such as storage conditions, strength,
batch number, including the API batch number(s) and manufacturer(s), batch size, container closure
system and orientation (e.g. erect, inverted, on-side), where applicable, and completed (and
proposed) test intervals.
The discussion of results should focus on observations noted for the various tests, rather than
reporting comments, such as “all tests meet specifications.” This should include ranges of analytical
results and any trends that were observed. For quantitative tests (e.g., individual and total degradation
product tests and assay tests), actual numerical results should be provided rather than vague statements,
such as “within limits” or “conforms.”
Applicants should consult ICH’s Evaluation for Stability Data Q1E guidelines
(http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1E/Step4/
Q1E_Guideline.pdf) for details on the evaluation and extrapolation of results from stability testing.
Proposed storage statement and shelf life
The proposed storage statement and shelf life (and in-use storage conditions and in-use period, if
applicable) for the FPP should be provided. This should be justified in terms of the results of the
stability testing, the difference between release and expiry specifications, and the labeled storage
conditions. In interpreting the results of stability studies, the proposed storage conditions should be
realistic and achievable in the Afghanistan context.
Provide the proposed shelf life and storage conditions using the format in the table below:
Container Closure System Storage Statement Shelf Life
The recommended labeling statements for use, based on the stability studies, are provided in the
WHO stability guidelines.
10.7. Stability Commitment
Primary Stability Study Commitment
When the available long-term stability data on primary batches do not cover the proposed re-test
period (shelf life) granted at the time of approval, a written commitment should be made to continue
the stability studies post-approval in order to firmly establish the re-test period (shelf life).
The stability protocol used for studies on commitment batches should be the same as that for the
primary batches, unless otherwise scientifically justified.
26
Commitment Stability Studies
The long-term stability studies for the commitment batches should be conducted through the
proposed shelf life on at least three production batches for each strength and in each container
closure system. Where stability data was not provided for three production batches for each strength,
a written commitment (signed and dated) should be included in the dossier.
Ongoing Stability Studies
After a marketing authorization has been granted, the stability of the FPP should be monitored
according to a continuous appropriate program that will permit the detection of any stability issue
(e.g., changes in levels of impurities or dissolution profile) associated with the formulation in the
container closure system in which the FPP is marketed. The purpose of the ongoing stability
program is to monitor the product over its shelf life and to determine that the product remains, and
can be expected to remain, within specifications under the storage conditions on the label.
Unless otherwise justified, at least one batch per year of product manufactured for each strength and
every container closure system, if relevant, should be included in the stability program (unless none
is produced during that year), and a written commitment (signed and dated) to this effect should be
included in the dossier.
Any differences in the stability protocols used for the primary batches and those proposed for the
commitment batches or ongoing batches should be scientifically justified.
27
SECTION FIVE
SUMMARY OF PHARMACOLOGY, TOXICOLOGY AND EFFICACY
For each of the following types of applications, provide complete information on safety and efficacy,
as defined in guidelines of the European Union, the US FDA, the Japanese Ministry of Health and
Welfare, or the ICH:
1. New active ingredients
2. New indications
3. New routes of administration
4. New dosage forms
5. All modified-release dosage forms
6. New combinations of active ingredients
References:
http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
http://www.ich.org/products/guidelines/safety/article/safety-guidelines.html
28
Annexes
Annex I: Application Form for the Registration of a Product
General Directorate of Pharmaceutical Affair
Application for Registration of a Product
1. Application Number (for GDPA use only):
Instruction:
1. Applicants are advised to refer to the “GDPA Medicines Registration Guideline”

and the “GDPA Guide on How to Complete the Application Form for Registration of a
Product" (Annex 2) for guidance before completing this application form.
2. The application submission should include duplicate hard copies and electronic copies
in PDF format and Microsoft Word on DVD/CDs for each product. The form MUST be
typed.
3. The completed, signed, and dated application form should be submitted to the
Registration and License Issuing Department of the General Directorate of Pharmaceutical
Affairs.
2. Applicant Company Particulars
2.1. Name of Company (in block

letters)
2.2. Business Registration Number
2.3. Company Address and Contact Information
2.3.1.
2.3.6. Fax Number
Country
2.3.2.
2.3.7. Official E-Mail Address
Province
2.3.3.
2.3.8. Telephone Number
City
2.3.4.
2.3.9. Company Website
Mailing
29
Address
2.3.5. Postal
Code
Note:
a. Please enclose a copy of the Letter of Authorization from the Manufacturer (attach this letter
as attachment A)
b. Please attach a copy of the Business registration certificate of the applicant company
(attach the registration certificate as attachment B)
3. Applicant Particulars (Person authorized to submit and handle application on behalf of the company)
3.1. First Name
3.2. Family Name
3.3. Designation
3.4. ID Card or Passport

Number
3.5. Official E-mail

Address
3.6. Telephone Number
3.7. Fax number
3.8. Applicant Address
3.8.1. Co 3.8.4. Address

untry Line – 1
3.8.2. Pr 3.8.5. Address

ovince Line – 2
3.8.3. Cit 3.8.6. Address

y Line - 3
4. Product Details
4.1. Generic Name
4.2. Proprietary/Brand Name
30
4.3.
Chose an Item
Dosage Form
4.4. Physical Description of the

Product
4.5. Product Formula (if space is not sufficient please use a separate piece of A4 paper):
4.5.1. 4.5.3. Strength

4.5.4. Quality standards
Component (e.g. USP, BP, JP,
and quality 4.5.2. F Quant. per %
EP ,IP , in-house)
standard (and unction unit or per mL
grade, if
applicable)
<complete with appropriate title e.g. Core tablet, Contents of capsule, Powder for injection>
Subtotal 1
<complete with appropriate title e.g. Film-coating >
Subtotal 2
Total
Note: Please describe the roles of excipients in the respective column indicated as follows:
F – Flavoring, C – Colorant, P – Preservatives, S – Stabilizers
4.6. Therapeutic Classification (WHO ATC Code for the

proposed indication(s))
4.7. Chose and Item

Rout of Administration
4.8. Indication (attach information on the indication(s) as an attachment C)
4.9. Recommended Dosage (attach information on the recommended dosage as attachment

D)
4.10. Proposed Shelf Life

4.10.1. Packing, shelf life and storage condition
4.10.1.1. Container 4.10.1.2. Quantity per 4.10.1.3. Shelf 4.10.1.4. Storage 4.10.1.5. Pack
Closure System Container life Conditions size
31
4.10.2.Other shelf life information:
4.10.2.1. Proposed shelf life after first opening (hours/day/month) (hours/day/month)
4.10.2.2. Proposed shelf life after reconstitution (hours/day/month) (hours/day/month)
4.11. Forensic Classification in Afghanistan

☐
4.11.1.Prescription Only (PO)
☐
4.11.2.Over the Counter (OTC)
4.12. Regulatory Situation in the Country of Origin and in Other Countries (provide
information, as appropriate) List all countries where the product is:
4.12.1. Country 4.12.2.Approved Forensic 4.12.3.Registration Status 4.12.4.Date
Classification of the (Day/Month/Year)
Product
Prescription Only ☐ Authorized ☐ Rejected ☐ Day/Month/Year
Over the Counter ☐ Pending ☐ Withdrawn ☐
Note: Please enclose one certified copy of the Product License issued by the relevant authority. (Attach
the certificate as attachment E )
4.13. Proposed Price of the Product

4.13.1.Wholesale Price )USD ( ) USD Dollar
Dollar(
4.13.2.Retail Price )USD Dollar( ( ) USD Dollar
5. Manufacturer’s Particulars
5.1. Active Substance Manufacturer
S/No 5.1.1. Name of Active 5.1.2. Name of Country
Substance Manufacturer
5.1.3. Site Address 5.1.4. Office
Address
1
2
3
32
5.2. Excipient Manufacturer
5.2.1. 5.2.2.
S/No Country
Name Name
of Excipient of
Manufacturer
5.2.3. Site 5.2.4. Offic
Address e Address
1
2
3
5.3. Finished Pharmaceutical Product Manufacturer

S/No 5.3.1. Name of Country
Manufacturer
5.3.2. Site Address 5.3.3. Office Address
1
6. Certification by a Responsible Person in the Applicant Company
On behalf of [insert the name of the company], I hereby declare that:
6.1. All of the information in this application is true.

6.2. Information in all of the annexes attached to this application is true and complete. All
available data, reports, and information relevant to the benefit/risk assessment of the product
have been provided.
6.3. [Insert the name of the company] agrees to abide by the Afghanistan Medicines Law and
Manufacturing and Importing Medicine and Medical Appliances Regulation.
6.4. [Insert the name of the company] agrees to notify the General Directorate of
Pharmaceutical Affairs, Ministry of Public Heath, of any change in the information
submitted in this application and of any new safety information during the course of the
evaluation of this application and as long as the product remains on the market.
6.5. [Insert the name of the company] confirms that it has a standard operating procedure for
handling adverse reaction reports for its products.
6.6. [Insert the name of the company] confirms that it has a standard operating procedure for
handling batch recalls of its products.
I understand that any false statement is an offence under the laws of Afghanistan and that all
documents submitted for evaluation will not be returned.
Submitted by:
Name: (in block letters)
Position in the Applicant Company: (in block letters)
Date:
Signature: Company Stamp
Received by: (GDPA)

33
Position: (in block letters)
Date:
Signature:
Note: all pages of the application form must be signed and stamped.
Annex II. Guide on How to Complete the Application Form for the Registration of a Product
Notes:
1. All sections of the application form MUST be completed. Please indicate N.A. (Not
Applicable) in those areas that are not relevant to the application.
2. All information and documents must be prepared in English or Dari/Pashto.
3. If additional sheets are required, use A4-size paper, cross-reference the relevant section of
the application, and attach the page(s) immediately behind the application form.
4. If more than one application is submitted, common information or documents should not be
cross-referenced, i.e., any common information or documents supplied in one application
should be repeated in the next application.
5. A separate application is required for each FPP, i.e., products containing the same
ingredient(s) but made with different dosage forms (in terms of strength/content of
ingredient[s], dosage form, description) or by a different manufacturer, requires separate
applications for product registration.
1. Application Number
This section will be completed by the GDPA. Do not fill in this part.
2. Applicant Company Particulars
2.1. Name of Company:
The company named in this section should be based and registered in Afghanistan. The
company making an application is called the applicant company. For every successful
application for the registration of a product, a Product Registration Certificate will be issued
in the name of the manufacturing company of the finished pharmaceutical product. Only the
applicant company can import the registered products to Afghanistan. (Attach the letter of
authorization.)
2.2. Business Registration Number:
34
Type the business registration number of the applicant company that is issued by the Ministry
of Commerce and Industries (MoCI) and registered in the MoPH - GDPA. (Attach the
business registration certificate.)
2.3. Company Address and Contact Information:
Provide the following information:
2.3.1. Country: Put “Afghanistan”; see section 2.1 above.
2.3.2. Province: Provide the applicant company’s state in Afghanistan.
2.3.3. City: Provide the applicant company’s city in Afghanistan.
2.3.4. Mailing Address: Type the detailed mailing address of the applicant company in
Afghanistan.
2.3.5. Postal Code: Provide the postal code of the applicant company in Afghanistan.
2.3.6. Fax Number: Type the fax number of the applicant company in Afghanistan (if
applicable).
2.3.7. Official E-Mail Address: Provide the official e-mail address of the applicant company in
Afghanistan. An official e-mail address is the one that is officially assigned by the company
and that is used for official communications. It is NOT a personal e-mail address.
2.3.8. Telephone Number: Type the telephone number of the applicant company in
Afghanistan that has been assigned for official communications.
2.3.9. Company Website: Provide the website address of the applicant company (if
applicable.)
3. Applicant Particulars
Provide information on the person who is authorized to submit the application and manage it
on behalf of the company. The person named in this section should be available to be
contacted at all times. During the initial evaluation process and after a product is registered in
Afghanistan, the GDPA will liaise only with this person. It should be noted that the applicant
bears full responsibility for ensuring that all available and relevant information is submitted
to support the application.
3.1. First Name:
Provide the first name of the applicant (as it appears on his/her ID card or passport)
3.2. Family Name:
Type the family name of the applicant (as it appears on his/her ID card or passport)
3.3. Designation:
Provide the designation of the applicant in the applicant company.
3.4. ID Card or Passport Number:
Provide the Tazkira number or passport number of the applicant.
3.5. Official E-mail Address:
Type the official e-mail address of the applicant. The official e-mail address is the one
officially assigned by the company, which is used for official communications. It is NOT a
personal e-mail address.
3.6. Telephone Number:
Provide the telephone number of the applicant in Afghanistan, which is assigned for official
communications.
3.7. Fax Number:
Provide the fax number of the applicant (if applicable).
3.8. Applicant’s Address:
3.8.1. Country: Put “Afghanistan”; see section 2.1 above.
3.8.2. Province: Type the applicant’s province in Afghanistan.
3.8.3. City: Provide the applicant’s city in Afghanistan.
3.8.4. Address: Provide the applicant’s mailing address in Afghanistan.
4. Product Details
4.1. Generic Name:
This is the name that will be shown on the product labeling (must be greater than the brand
name), i.e., the inner label, outer carton, and patient information leaflet.
35
4.2. Proprietary/Brand Name:
This is the name that will be shown on the product labeling, i.e., the inner label, outer carton,
and patient information leaflet.
The applicant should ensure that the name does not:
Suggest greater safety or efficacy than what is supported by clinical data.
Imply superiority over another similar product on the market in Afghanistan.
4.3. Dosage Form:
The applicant should clearly indicate the pharmaceutical dosage form of the product, e.g.,
tablet, capsule, injection (select from the dropdown list).
4.4. Physical Description of the Product:
The applicant should note the visual and physical characteristics of the product, including its
shape, size, superficial markings, color, odor, taste, type of tablet coating, type of capsule,
etc., and as applicable.
4.5. Product Formula:
The product formula should provide the composition of all active substances and excipients
that appear in the final dosage form. The name(s) of the active substance(s) should be given
first, followed by the names of the excipients. Any alcohol or gelatin component must be
included and described in the formulation, if available. International units of measure should
be used wherever appropriate. The role of each excipient should be indicated, i.e., ‘C’ for
colorant, ‘F’ for flavoring, ‘P’ for preservative, ‘S’ for stabilizer.
4.5.1. Component and quality standard (and grade, if applicable): Describe each component
of the product. See the example in the table below.
4.5.2. Function: Describe the function of each component. See the example in the table
below.
4.5.3. Strength: Note the strength of the product. See the example in the table below.
4.5.4. Quality standards (e.g., USP, BP, EP, IP, and in-house) : Note the quality standard of
the product. See the example in the table below.
4.5.1. Component and 4.5.3. Strength (180mg) 4.5.4. Quality
quality standard (and 4.5.2. standards (e.g., BP,
Function Quantity per USP, EP, IP, in-
grade, if applicable) %
unit or per mL house)
Core tablet
Fexofenadine Active 180.00 43.69 BP/EP
hydrochloride substance
Microcristalline Diluent 200.00 48.54 USP-BP
Cellulose
Croscarmellose sodium Disintegrant 25.00 6.07 USP-BP
Colloidal anhydrous Glidant 2.00 0.49 USP-BP
silica
Magnesium stearate Lubricant 5.00 1.21 BP/EP
Subtotal 1 412.00 100.00
Film-coating
Opadry pink Coating 12.00 -- IH
material
Hypromellose Film forming 3.30 -- BP/ EP
agent
Macrogols Plasticizer 1.50 -- BP/ EP
Colloidal anhydrous Viscosity 1.20 -- BP/ EP
silica enhancer/
antiadherent
Purified water Solvent q.s -- BP/ EP
Subtotal 2 18.00
Total 430.00
36
4.6. Therapeutic Classification:
The applicant should indicate the WHO Anatomical Therapeutic Chemical (ATC) code for
each distinct therapeutic indication proposed for the product. The applicant may refer to the
WHO Collaborating Centre for Drug Statistics Methodology (www.whocc.no) for more
information.
4.7. Route of Administration:
The applicant should note all routes of administration proposed for the product (select from
the dropdown list).
4.8. Indication(s):
The applicant should describe the proposed clinical use(s) of the product; indicating clearly
whether curative, palliative, etc. (Attach the information on indication[s] as attachment C.)
Notes:
 Indications should be specific; phrases such as “associated conditions” or “allied
diseases” would not normally be considered appropriate.
 Indications other than those specified and accepted at the time of registration should not
be included in any product literature, patient information leaflet, labels, etc., without
prior permission from the GDPA.
4.9. Recommended Dosage:
The applicant should indicate the proposed dose (normal dose, dose range), and dosage
schedule (frequency, duration) appropriate for each therapeutic indication for the product.
The dosage for adults, and where appropriate, for children, should be given. Dosage
adjustments for special conditions, e.g., renal, hepatic, cardiac, nutritional insufficiencies,
where relevant, should be noted. (Attach the recommended dosage information as attachment D.)
Notes:
 Where appropriate, diluents and instructions for dilution, reconstitution, and use or
administration of the product should be clearly described.
 A distinction should be made between therapeutic and prophylactic doses and between
dosages for different clinical uses, where applicable.
4.10. Proposed Shelf Life:
4.10.1. Packing, shelf life, and storage conditions:
Using the template below, the applicant should provide the following information:
4.10.1.1.All the different container closure systems for the product.
4.10.1.2.The quantity of the product per container.
4.10.1.3.The shelf life of the product for each container closure system.
4.10.1.4.The recommended storage conditions of the product.
4.10.1.5.Information on the commercial pack sizes should also be provided.
4.10.1.1. Container 4.10.1.2. Quantity 4.10.1.3. Shelf 4.10.1.4. Storage 4.10.1.5.
Closure System per Container Life Conditions Pack Size
4.10.2. Other shelf life information:

The applicant should provide the following information, where appropriate:
4.10.2.1.Information on shelf life after first opening, e.g., for eye drops.
4.10.2.2.Information on shelf life after reconstitution, e.g., for lyophilized powder for
reconstitution. The information should be supported by stability test data.
4.11. Forensic Classification in Afghanistan:
The applicant should indicate the proposed forensic classification of the product in
Afghanistan. The forensic classifications are:
4.11.1. Prescription only (PO) (Check if appropriate)
4.11.2. Over-the-counter (OTC) (Check if appropriate)
4.12. Regulatory Situation in the Country of Origin and in Other Countries:
Provide the information on the registration status of the product in the country of origin and
in other countries.
37
4.12.1. Country: Provide the name of the country.
4.12.2. Approved Forensic Classification of the Product: Check the appropriate box.
4.12.3. Registration Status: Check the appropriate box for the status of the product’s
registration (Authorized, Pending, Rejected, and/or Withdrawn).
4.12.4. Date: For each registration status (Authorized, Pending, Rejected, and/or
Withdrawn), provide the date (use the Gregorian calendar).
Please enclose one certified copy of the Product License issued by the relevant
authority. (Attach the certificate[s] as attachment E.)
4.13. Proposed Price of the Product:
The applicant should indicate the proposed price of the product:
4.13.1. Wholesale Price: The applicant should indicate the proposed wholesale price of the
product in US Dollars.
4.13.2. Retail Price: The applicant should indicate the proposed retail price of the product in
US Dollars.
5. Manufacturer’s Particulars
5.1. Active Substance Manufacturer:
Using the template provided, the applicant should provide the following information:
5.1.1. Name(s) of the active substance(s).
5.1.2. Name(s) of the manufacturer(s) of the active substance(s).
5.1.3. Manufacturing site address(s) of the active substance(s).
5.1.4. Manufacturing office address(s) of the active substance(s).
5.2. Excipient Manufacturer:
5.2.1. Name(s) of the excipient(s).
5.2.2. Name(s) of manufacturer(s) of the excipient(s).
5.2.3. Manufacturing site address(s) of the excipient(s).
5.2.4. Manufacturing office address(s) of the excipient(s).
5.3. Finished Pharmaceutical Product Manufacturer:
Provide information on the finished pharmaceutical product manufacturing company. The
manufacturer is responsible for all aspects of the product, including quality and compliance
with the conditions of marketing authorization.
5.3.1. Name of the manufacturing company of the finished pharmaceutical product.
5.3.2. Manufacturing site address(s) of the finished pharmaceutical product.
5.3.3. Manufacturing office address(s) of the finished pharmaceutical product.
6. Certification by the Responsible Person in the Applicant Company
The application form for registration of a product MUST be duly completed and signed.
Submitted by:
Name: Type the name of the person who is authorized to submit and manage the application on
behalf of the company.
Position in the applicant company: Provide the title of the position of the person in the applicant
company.
Date: Note the date that the company’s authorized person is submitting the application to the
GDPA.
Signature: Signature of the president or deputy of the applicant company.
Company Stamp: Place the applicant company’s stamp in the space provided.
This section will be completed by the responsible person in the GDPA; the applicant should not fill
in this section.
Received by:
38
Name: Name of the authorized person in the GDPA who has received the application.
Position: Title of the position of the person who has received the application in the GDPA.
Date: Date that the GDPA’s authorized person has received the application.
Signature: Signature of the GDPA’s authorized person has received the application
Note: All pages of the application form must be signed and stamped.
Annex III. Checklist for Submission of Documents for the Registration of a Product
Administrative Data and Product Information
Application Number:
Product Name (Generic and Proprietary Name):
Strength and Dosage Form:
Manufacturer:
Manufacturing Country:
Applicant Name:
Date:
Applicant GDPA GDPA

S/No Documents Required
(√) (√) Remarks
1 Cover Letter
 Cover letter is available
2 Application Form
 A Completed and Signed Application Form
(Hard & Electronic Copies on CD/DVD )is
available
3 Business Registration Certificate
 Business Registration Certificate is available.
4 Letter of Authorization
 Letter of Authorization from the Manufacturing
Company is available
Note: (Not applicable if the applicant is the
manufacturer)
39
Applicant GDPA GDPA
(√) (√) Remarks
5 Certifications
1. For Locally Manufactured Products
a. Copy of “Manufacturing License” is
available.
b. Copy of “GMP Certificate" of the
manufacturer is available
2. For Imported Products
a. Copy of “Manufacturing License” of the
manufacturing site (issued by the
competent authority in the country of
origin) is available
Note: (Copies of the documents must be duly
endorsed by the authorized agencies in the country
of origin and the Afghanistan Embassy; in the
absence of the Afghanistan Embassy in that
country, the non-resident embassy may endorse the
license.)
b. Copy of “Product Manufacturing License”
(issued by the competent authority in the
country of origin) is available.
Note: (Copies of the documents must be duly
license.)
c. Copy of “Certificate of Pharmaceutical
Product” (issued by the competent authority
in the country of origin according to the
current WHO format) is available
Note: (Copies of the CoPP must be duly endorsed
by the authorized agencies in the country of origin
and the Afghanistan Embassy; in the absence of the
Afghanistan Embassy in that country, the non-
resident embassy may endorse the certificate.)
d. Copy of “Site Master File" of the
manufacturer is available
e. Copy of “GMP Certificate" of the
manufacturing site is available
Note: (Copies of the certificate must be duly
certificate.)
f. Copy of “Certificate of Analysis” is
available
g. Copy of “Registration Certificate of the
Product in One Other Country” is available
Note: (Copies of the certificate must be duly endorsed
by the authorized agencies in the country of origin and
the Afghanistan Embassy; in the absence of the
40
Applicant GDPA GDPA
(√) (√) Remarks
Afghanistan Embassy in that country, the non-resident
embassy may endorse the certificate.)
6 Product Labeling
 Copy of the proposed “Unit Carton Label” is
available
 Copy of the proposed “Inner Label” is available
 Copy of the proposed “Blister/Strips Label” is
available
7 Product Information
 Copy of the proposed “Patient Information
Leaflet” is available
8 Other data if any
Submitted by:
Date:
Received by: (GDPA)
Date:
Signature:
Note: all pages of the checklist must be signed and stamped.
41
Checklist for Submission of Documents for the Registration of a Product
Active Pharmaceutical Ingredient(s)
Application Number:
Manufacturer:
Applicant Name:
Date:
S/No Documents Required Applicant GDPA GDPA

(√) (√) Remarks
1 Nomenclature
 International Nonproprietary Name
 Compendial Name, if relevant
 Chemical Name(s)
 Company or laboratory code, if applicable
 Other nonproprietary name(s)
 Chemical Abstracts Service registry number
2 Properties of the APIs
 Properties of the APIs
3 Site(s) of Manufacture
 Name, address, phone number, email
 Responsibility of each manufacturer and
proposed production site
 List of facilities involved in:
- Fabrication
- Packaging and labeling
- Testing
- Storage of the APIs
4 Route (s) of Synthesis of the API(s)
 Outline of the route of synthesis
 Flowchart of the structures of the starting
materials, intermediates, reagents, catalysts, and
solvents used in the process
 Sequential procedure of the manufacturing
process
5 Specification of the API(s)
 Copy of the API specification dated and signed
by the authorized person
 Copy of the monograph with test methods
 List of tests and limits for results of the API
 Results of validation of the methods for assay of
the API and impurities
6 Batch Analysis
 Certificate of Analysis for at least two batches of
products at each site, by each synthetic method
7 Container Closure System
 Description of the container closure system
 Specifications of the packaging materials
 Copies of secondary packaging labels
42
S/No Documents Required Applicant GDPA GDPA
(√) (√) Remarks
8 Stability Testing of the API(s)
 Results of stability testing of the API
 Stability testing data for not less than three primary
batches
 Methodology of the stability studies
9 Other data, if any
Submitted by:
Date:
Received by: (GDPA)

Date:
Signature:
43
Checklist for Submission of Documents for the Registration of a Product
Finished Pharmaceutical Products
Application Number:
Manufacturer:
Applicant Name:
Date:
S/ Documents Required Applicant GDPA GDPA

No (√) (√) Remarks
1 Description of the Finished Pharmaceutical Product
 Physical characteristic of the product
2 Formulation
 Complete formula of the product in a table
3 Pharmaceutical Development
 Information on development studies for the
product
 Literature information for the product
4 In-Vitro Dissolution or Drug Release
 In-vitro dissolution study results
5 Sites of Manufacture-Finished Product
 Manufacturer name, address, and responsibility
6 Detailed Description and Validation of the Manufacturing Procedure for the Finished
Product
 Detailed description of the manufacturing
procedure
 Controls of critical steps
 Description of the manufacturing process
 Process validation data (manufacturing process,
validation protocol, and manufacturing process
validation report)
7 Specification for Excipients
 List of tests and limits for results of excipients
 Test methods
8 Control of the Finished Pharmaceutical Products
1. Specifications for the Finished Pharmaceutical Product:
 Copy of the FPP specification
 List of tests and limits for results of the FPP
2. Analytical Procedures:
 Analytical test procedure and methods
3. Validation of Analytical Procedures
 Required for non-compendial method
4. Batch Analysis
 Results of the analysis of three batches
 Copies of the certificates of analysis for these
batches
9 Container Closure System(s) and Other Packaging
 Description of the suitability of the container
closure system
 Description of the container closure system
44
S/ Documents Required Applicant GDPA GDPA
No (√) (√) Remarks
 Primary packaging components specifications
and test methods
10 Stability Testing of the Finished Product
 Stability studies report
 Methodology for stability studies
 A tabulated summary of stability results should be
provided
11 Other data, if any
Submitted by:
Date:
Received by: (GDPA)

Date:
Signature:
45
Application form obtained from
GDPA website
Annex IV: Flowchart for the Application
Procedure for the Registration of a Product
Application form complete

according to guideline
Appointment made with GDPA for

submission of application
Stage 1 Application form with relevant

documents submitted to GDPA
Doc. screened by Incomplete

GDPA for Applicant informed that application is
completeness incomplete & returned
according to checklist
Complete
Submitted Doc. Incomplete Applicant informed to Application rejected if no

Checked for additional
information & submit additional response received from applicants
supporting Doc supporting documents after 60 calendar days
Stage 2
Complete
Receipt of applications Additional supporting documents
acknowledged by GDPA submitted by applicant
Required Documents
submitted
Evaluation by GDPA/ Clarification/further Query letter

Stage 3 committee documents required issued
Rejected
Committee Applicant
Stage 4 meeting informed
Approved
Applicant informed for payment

of Product License Fee
If a product is rejected for registration,
Stage 5 applicant may make a written appeal
within fifteen (15) calendar days from
Issuance of Product License the notification date.
Certificate by GDPA
46
Annex V: Appeal Form
Appeal for Registration of Rejected Product
Date: dd/mm/yy
To: National Medicines and Food Board, Ministry of Public Health
From: (Name of Company Appealing)
Particulars of Appealer: (name of the
person who is fully authorized to submit
Designation Address Phone Number
and process the appeal on behalf of the
company)
I wish to appeal for registration of the below Medicine in Afghanistan.
Details of the Rejected Product

Application Number:
Date of Rejection:
Generic Name of Product:
Proprietary Name of Product:
Dosage Form:
Active Ingredient (s):
Proposed Indication(s):
Proposed Dosage Regimen(s):
Countries where the product is registered with
the above indication(s) and dosage regimen(s):
Countries where the product has been
rejected/withdrawn with the above indication(s)
and dosage regimen(s):
Reasons for Appeal:
Documents Submitted to Support the Appeal:
Note:
Only appeals accompanied by relevant new information or supporting documents NOT previously
submitted will be considered. The appeal must be submitted within fifteen (15) calendar days from
date of rejection; otherwise a new application is required to be submitted according to the
“Medicines Registration Guideline”.
Name and Address of the Company:

Contact Number:
Signature and Stamp of the Company:
47
Annex VI. Recommendations for Conducting and Assessing Comparative Dissolution Profiles
The dissolution measurements of the two FPPs (e.g., test and reference [comparator], or two
different strengths) should be made under the same test conditions. A minimum of three points in
time (zero excluded) should be included, the points in time for both the reference (comparator) and
test product being the same. The sampling intervals should be short for a scientifically sound
comparison of the profiles (e.g., 5, 10, 15, 20, 30, 45 [60, 90, 120] minutes). Inclusion of the 15-
minute timeframe in the schedule is of strategic importance for profile similarity determinations
(very rapidly dissolving scenario). For extended-release FPPs, the timeframe should be set to cover
the entire time period of the expected release, e.g., 1, 2, 3, 5 and 8 hours for a 12-hour release, and
additional test intervals for a longer duration of release.
Studies should be performed in at least three (3) media covering the physiological range, including
pH 1.2 hydrochloric acid, pH 4.5 buffers, and pH 6.8 buffers. Compendia buffers are recommended.
The GDPA recognizes the International Pharmacopeia, British Pharmacopeia, United States
Pharmacopeia, and the European Pharmacopeia. Water may be considered as an additional medium,
especially when the API is unstable in the buffered media to the extent that the data are unusable.
If both the test and reference (comparator) products show more than 85% dissolution in 15 minutes,
the profiles are considered similar (no calculations are required). Otherwise:
Similarity of the resulting comparative dissolution profiles should be calculated using the following
equation that defines a similarity factor (f2):
 Where Rt and Tt are the mean percent API dissolved in the reference (comparator) and test
product, respectively, at each point in time. An f2 value between 50 and 100 suggests the two
dissolution profiles are similar.
 A maximum of one point in time should be considered after 85% dissolution of the reference
(comparator) product has been reached. In the case where 85% dissolution cannot be reached
due to poor solubility of the API, the dissolution should be conducted until an asymptote
(plateau) has been reached.
 At least 12 units should be used for each profile determination. Mean dissolution values may
be used to estimate the similarity factor, f2. To use mean data, the percentage coefficient of
variation at the first point in time should not be more than 20%, and at other points in time
should not be more than 10%.
 When delayed-release products (e.g., enteric coated) are being compared, the recommended
conditions are acid medium (pH 1.2) for 2 hours and buffer pH 6.8 medium.
 When comparing extended-release beaded capsules, where different strengths have been
achieved solely by means of adjusting the number of beads containing the API, one condition
(normally the release condition) will suffice.
 Surfactants should be avoided in comparative dissolution testing. A statement that the API is
not soluble in any of the media is not sufficient, and profiles in the absence of surfactants
should be provided. The rationale for the choice and concentration of surfactant should be
provided. The concentration of the surfactant should be such that the discriminatory power of
the test will not be compromised.
48
GLOSSARY
Accelerated testing
Studies designed to increase the rate of chemical degradation and physical change of an API or FPP
by using exaggerated storage conditions as part of the stability testing program. The data thus
obtained, in addition to data derived from long-term stability studies, may be used to assess long-
term chemical effects under non-accelerated conditions and to evaluate the impact of short-term
excursions outside the label storage conditions, as might occur during shipping. The results of
accelerated testing studies are not always predictive of physical changes.
Accelerated stability studies
Studies designed to simulate the rate of chemical and/or physical degradation of an active ingredient
or dosage form or product, under exaggerated storage conditions. The purpose is to determine the
kinetic parameters, if possible, and/or predict a tentative shelf life.
Active pharmaceutical ingredient
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage
form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form.
Adverse medicines reaction (adverse drug reaction)
A response to a pharmaceutical product that is harmful and unintended and that occurs at doses
normally used or tested in humans for prophylaxis, diagnosis, or treatment of disease, or for the
modification of physiological function.
Applicant
The person or company that submits an application for the registration of a product, or for making an
update or amendment to a registered product, the applicant must be physically located in Afghanistan.
Authorized person
The authorized person is an appointed person with the qualifications, knowledge, and sufficient
experience in the area of the application.
Batch
A defined quantity of raw material, packaging material, or finished pharmaceutical product
processed in a single process or series of processes so that it is expected to be homogeneous. It may
sometimes be necessary to divide a batch into a number of sub-batches, which are later brought
together to form a final homogeneous batch. In the case of terminal sterilization, the batch size is
determined by the capacity of the autoclave. In continuous manufacture, the batch must correspond
to a defined fraction of the production, characterized by its intended homogeneity. The batch size
may be defined either as a fixed quantity or as the amount produced in a fixed time interval.
Bioavailability
The extent to which, following administration of a medicine to human subjects or animals, the active
component reaches the supposed site of action or the system in sufficient amounts to exert an effect.
Bioequivalence
Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their
bioavailability (rate and extent of availability) after administration in the same molar dose are similar
to such a degree that their effects may be expected to be essentially the same.
Certificate of analysis
An authoritative document showing the results of analysis of a particular product batch
Composition
Composition in relation to a medicinal product means the ingredients of which it consists, and the
proportions, degree of strength, quality, and purity of those ingredients.
Commitment batches
Production batches of an API or FPP for which the stability studies are initiated or completed post-
approval through a commitment made in a regulatory application.
49
Container closure system
The sum of packaging components that together contain and protect the dosage form, this includes
primary packaging components and secondary packaging components, if the latter are intended to
provide additional protection to the FPP. A packaging system is equivalent to a container closure
system.
Dosage form
The form of the FPP, e.g., tablet, capsule, elixir, or suppository
Dossiers
Set of documents or data to support the product application/registration.
Drug
Any substance or pharmaceutical product for human or veterinary use that is intended to modify or
explore physiological systems or pathological states for the benefit of the recipient
Excipient
A substance or compound, other than the API and packaging materials, that is intended or designated
to be used in the manufacture of a FPP. It also means any component of a finished dosage form that
has no therapeutic value.
Expiry date
The date given on the individual container (usually on the label) of a product up to and including the
date at which the API and FPP are expected to remain within specifications, if stored correctly. It is
established for each batch by adding the shelf life to the date of manufacture.
Finished pharmaceutical product
A product that has undergone all stages of production, including packaging in its final container and
labeling, an FPP may contain one or more APIs.
Formulation
The composition of a dosage form, including the characteristics of its raw materials and the
operations required to process it.
Generic name
A unique name identifying a particular pharmaceutical substance Generic names are officially
assigned by international medicines nomenclature commissions, and nowadays mostly conform to
those assigned by the WHO program on the selection of INNs.
Good manufacturing practices
Good and standard practices for activities related to manufacturing a medicine. They are part of a
pharmaceutical quality assurance system that ensures that products are consistently manufactured,
produced, and controlled to the quality standards appropriate to their intended use and as required by
the marketing authorization.
Impermeable containers
Containers that provide a permanent barrier to the passage of gases or solvents, e.g., sealed
aluminum tubes for semisolids, sealed glass ampoules for solutions, and aluminum blisters for solid
dosage forms.
Importer
A person to whom an import license has been issued under Regulation on Manufacturing and
Importing Medicine and Medical Appliances issue number 916 dated 24 February, 2007
In use
See utilization period.
International nonproprietary name
The shortened scientific name (also known as the generic name) of a pharmaceutical substance
assigned by the WHO program on the selection of INNs, the INN is recognized worldwide.
50
Label
A printed text attached to or comprising part of a medicine container or package, specifying the
name, dosage form, composition, batch number, manufacturing date, and expiry date of the contents
as well as the name and address of the manufacturing company and/or importer of the product, the
product license holder, the permitted retail price, and other relevant information (e.g., recommended
storage conditions).
Licensed medicines list
All medicines that are approved for use in Afghanistan at different levels of the health system
License
See marketing authorization.
Long-term stability studies
Experiments on the physical, chemical, biological, biopharmaceutical, and microbiological
characteristics of an API or FPP, during and beyond the expected shelf life and storage periods of
samples under the storage conditions expected in the intended market. The results are used to
establish the re-test period or the shelf life, to confirm the projected re-test period or shelf life, and to
recommend storage conditions.
Marketing authorization
An official document issued by the competent medicines regulatory authority for the purpose of
marketing or free distribution of a product after evaluation for safety, efficacy, and quality. It must
set out, inter alia, the name of the product, the pharmaceutical dosage form, the quantitative formula
(including excipients) per unit dose (using INNs or national generic names, where they exist), the
shelf life and storage conditions, and the packaging characteristics. It specifies the information on
which authorization is based (e.g., “The product(s) must conform to all the details provided in your
application and as modified in subsequent correspondence”). It also contains the product information
approved for health professionals and the public, the sales category, the name and address of the
holder of the authorization, and the period of validity of the authorization. Once a product has been
given marketing authorization, it is included on a list of authorized products (the register), and is
often said to be “registered” or to “have registration.” Market authorization may occasionally also be
referred to as a license or product license.
Marketing authorization holder
The company or drug store in whose name the marketing authorization (registration) has been
granted. This party is responsible for all aspects of the product, including its quality and compliance
with the conditions of the marketing authorization.
Manufacturing process validation
The documented evidence that the procedure or process operated within established parameters, and
can perform effectively and reproducibility, based on the approved process method and product
specification.
Manufacturing process protocol
Document that explains, in a stepwise manner, how to implement a given manufacturing process
Ongoing stability study
The study carried out by the manufacturer on production batches according to a predetermined
schedule in order to monitor, confirm, and extend the projected re-test period (or shelf life) of the
API, or confirm or extend the shelf life of the FPP.
Over-the-counter medicines
Medicines that are generally regarded as safe for the consumer to use by following the required label
directions and warnings, and which may be purchased without a prescription
Patient information leaflet
A leaflet containing information for the patient
51
Periodic review
The regular process, usually occurring every five years, by which the validity of a marketing
authorization is renewed and information on a product is reviewed (validated), consolidated, and
sometimes expanded.
Pharmaceutical development
All stages and processes in the discovery, evaluation, and formulation of a new pharmaceutical
product, until it reaches the market.
Pharmaceutical product
Any preparation for human or veterinary use that is intended to modify or explore physiological
systems or pathological states for the benefit of the recipient
Product information
A document defining information that may be supplied with or about a pharmaceutical product by or
on behalf of the marketing authorization holder; the minimum information in the product information
should be defined by the drug regulatory authority. The content of the product information is agreed
upon between the marketing authorization holder and the DRA at the time the market authorization is
issued.
Pharmacopoeia
A publication issued by an authorized national or international commission that specifies quality
standards and other properties of pharmaceutical substances and dosage forms.
Pilot-scale batch
A batch of an API or FPP manufactured by a procedure fully representative of and simulating that to
be applied to a full production-scale batch, for example, for solid oral dosage forms, a pilot scale is
generally, at a minimum, one-tenth that of a full production scale for 100,000 tablets or capsules,
whichever is larger, unless otherwise adequately justified.
Prescription only medicines
Medicines that may only be made available to the consumer through a written order signed by a duly
qualified and registered medical prescriber and dispensed by a registered pharmacist.
Primary batch
A batch of an API or FPP used in a stability study, from which stability data are submitted in a
registration application for the purpose of establishing a re-test period or shelf life, as the case may
be. A primary batch of an API should be at least a pilot-scale batch. For an FPP, two of the three
batches should be at least pilot-scale batches, and the third batch may be smaller if it is
representative of the critical manufacturing steps. However, a primary batch may be a production
batch.
Product recall
A process for withdrawing or removing a pharmaceutical product from the pharmaceutical
distribution chain because of defects in the product or complaints of serious adverse reactions to the
product
Production batch
A batch of an API or FPP manufactured at production scale by using production equipment in a
production facility as specified in the application.
Registration
See marketing authorization.
Registered drug products
Pharmaceutical products that have a marketing authorization
Registration number
A number assigned to a medicinal product after being given marketing authorization.
52
Registration status
Means either “registered,” “pending,” “rejected,” “withdrawn,” “suspended,” or “revoked.”
Release specification
The combination of physical, chemical, biological, and microbiological tests and acceptance criteria that
determine the suitability of an API or FPP at the time of its release
Re-test date
The date after which an active API should be re-examined to ensure that the material is still in
compliance with the specification, and therefore, is still suitable for use in the manufacture of an
FPP.
Re-test period
The period of time during which the API is expected to remain within its specification, and
therefore, may be used in the manufacture of a given FPP, provided that the API has been stored
under the defined conditions. After this period, a batch of API destined for use in the manufacture of
an FPP should be re-tested for compliance with the specification and then used immediately. A batch
of API may be re-tested multiple times and a different portion of the batch used after each re-test, as
long as it continues to comply with the specification. For most substances known to be labile, it is
more appropriate to establish a shelf life than a re-test period. The same may be true for certain
antibiotics.
Semi-permeable containers
Containers that allow the passage of solvent, usually water, while preventing solute loss. Examples
of semi-permeable containers include plastic bags and semi-rigid, low-density polyethylene (LDPE)
pouches for large volume parenteral, and LDPE ampoules, bottles, and vials.
Shelf life (after first opening of the container)
The time interval that a product is expected to remain within the approved shelf life specifications,
provided that it is stored under the conditions defined on the label and in the proposed container and
closure system after the first opening of the container.
Shelf life (after reconstitution)
provided that it is stored under the conditions defined on the label and in the proposed container and
closure system after reconstitution.
Shelf life (expiry dating period)
provided that it is stored under the conditions defined on the label, and in the proposed container and
closure system. Or, the period of time during which an API or FPP, if stored correctly, is expected to
comply with the specification as determined by stability studies on a number of batches of the API
or FPP. The shelf life is used to establish the expiry date of each batch.
Storage condition
The storage condition that guarantees the maintenance of the quality of the product in relation to its
safety, efficacy, and acceptability throughout the shelf life, as may be predicted from the stability
studies. The described conditions should indicate the temperature or temperature range in degree
Celsius, as well as humidity, light, and other relevant conditions.
Strength
Strength of the medicinal product means the content of the active ingredient expressed quantitatively
per dosage unit, per unit of volume or mass or weight, according to the dosage form.
Shelf life specification
The combination of physical, chemical, biological, and microbiological tests and acceptance criteria
that an FPP should meet throughout its shelf life, in certain exceptional cases, an unstable API might
have a shelf life specification.
53
Specification
A list of tests, references to analytical procedures, and appropriate acceptance criteria, which are
numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to
which an API or FPP should conform to be considered acceptable for its intended use.
Stability tests (protocol)
A series of tests designed to obtain information on the stability of a pharmaceutical product in order
to define its shelf life and utilization period under specified packaging and storage conditions.
Stability
The capacity of an active ingredient or medicine or dosage form to remain within specifications
established to maintain its identity, purity, strength, and other critical physico-chemical,
microbiological, and organoleptic properties during its shelf life.
Stability studies (stability testing)
Long-term and accelerated (and intermediate) studies undertaken on primary and/or commitment
batches according to a prescribed stability protocol to establish or confirm the re-test period (or shelf
life) of an API or the shelf life of an FPP
Variation
A change to any aspect of a pharmaceutical product, including but not limited to a change of
formulation, method, site of manufacture, specifications for the finished product and ingredients,
container and container labeling, and product information.
Utilization period
A period of time during which a reconstituted preparation of the finished dosage form in an
unopened multi-dose container may be used
54
This publication is made possible by the generous support of the American people through the US
Agency for International Development (USAID), under the terms of cooperative agreement number
GHN-A-00-07-00002-00. The contents are the responsibility of General Directorate of Pharmaceutical
Affairs (GDPA)-Ministry of Public Health (MoPH) of the Islamic Republic of Afghanistan with the
technical support of Management Sciences for Health and do not necessarily reflect the views of
USAID or the United States Government.
About SPS
The Strengthening Pharmaceutical Systems (SPS) Program strives to build capacity within developing
countries to effectively manage all aspects of pharmaceutical systems and services. SPS focuses on
improving governance in the pharmaceutical sector, strengthening pharmaceutical management systems
and financing mechanisms, containing antimicrobial resistance, and enhancing access to the most
efficacious, safe and cost-effective medicines and appropriate use of medicines.

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Islamic Republic of Afghanistan

Ministry of Public Health

Medicines Registration Guideline

3. Provide guidance on technical and other general data requirements.

1. GENERAL REGISTRATION PROVISIONS

2. APPLICATION PROCEDURE FOR PRODUCT REGISTRATION

4. A flowchart on the application procedure for the registration of a product is provided

3. MINISTRY OF PUBLIC HEALTH-GDPA DECISION

5. CHANGE IN PARTICULARS OF REGISTERED PRODUCTS

6. CHANGE IN IMPORTER OF A REGISTERED PRODUCT

2. Completed and Signed Application Form

8. Stability Testing of the Active Pharmaceutical Ingredient(s)

1. Description of the Finished Pharmaceutical Product

 The formulation for a typical batch (biobatch, commercial/production batch, stability or

7. Specifications for Excipients

8. Control of the Finished Pharmaceutical Products

9. Container Closure System(s) and Other Packaging

10. Stability Testing of the Finished Product

1. New active ingredients

3. New routes of administration

4. New dosage forms

5. All modified-release dosage forms

6. New combinations of active ingredients

1. Application Number (for GDPA use only):

1. Applicants are advised to refer to the “GDPA Medicines Registration Guideline”

2. Applicant Company Particulars

2.1. Name of Company (in block

2.2. Business Registration Number

2.3. Company Address and Contact Information

3.1. First Name

3.2. Family Name

3.4. ID Card or Passport

3.5. Official E-mail

3.6. Telephone Number

3.7. Fax number

3.8. Applicant Address

3.8.1. Co 3.8.4. Address

3.8.2. Pr 3.8.5. Address

3.8.3. Cit 3.8.6. Address

4.1. Generic Name

4.2. Proprietary/Brand Name

4.4. Physical Description of the

4.5.1. 4.5.3. Strength

4.6. Therapeutic Classification (WHO ATC Code for the

4.7. Chose and Item

4.8. Indication (attach information on the indication(s) as an attachment C)

4.9. Recommended Dosage (attach information on the recommended dosage as attachment

4.10. Proposed Shelf Life

4.11. Forensic Classification in Afghanistan

4.13. Proposed Price of the Product

4.13.2.Retail Price )USD Dollar( ( ) USD Dollar

5.3. Finished Pharmaceutical Product Manufacturer

6.1. All of the information in this application is true.

Received by: (GDPA)

4.10.2. Other shelf life information:

Applicant GDPA GDPA

Note: all pages of the checklist must be signed and stamped.

S/No Documents Required Applicant GDPA GDPA

Received by: (GDPA)

Note: all pages of the checklist must be signed and stamped.

S/ Documents Required Applicant GDPA GDPA

Received by: (GDPA)

Note: all pages of the checklist must be signed and stamped.