This document outlines good regulatory distribution practices for pharmaceutical products in Pakistan. It discusses the objectives to ensure all federal and provincial legal and regulatory compliances. The scope covers the issuance of pharmaceutical products to distributors across Pakistan. Responsibilities include distribution departments ensuring valid drug sale licenses before issuing orders. It provides definitions and discusses standard procedures such as verifying license validity. A table outlines the different license forms required for distributors and pharmacies in each Pakistani province.

1. GOOD REGULATORY DISTRIBUTION
PRACTICE IN PAKISTAN
Good Medicine Regulatory
Distribution Practices
1
GOOD MEDICINE REGULATORY
DISTRIBUTION PRACTICES IN PAKISTAN
BY:
RASHID MUREED
(LLB-PHARM-D & MBA)16-7-2016

2. Good Medicine Regulatory Distribution Practices in Pakistan 2
CONTENTS
1. Disclaimer
2. Objective
3. Scope
1. Legal References
2. Responsibility
3. Definitions
4. Standard Practices & Procedures
5. Important Note
6. License chart

3. Good Medicine Regulatory Distribution Practices in Pakistan 3
The information contained in this Presentation/procedure is a guidance document for
pharmaceutical industry, importer and distributors in Pakistan. This guidance provides
recommendation to pharmaceutical manufacturers, Importers distributors & retailers to
comply good distribution regulations. The information is not final verdict, and should not be
treated as such.
Without prejudice to the generality of the presentation, Rashid Mureed does not warrant that:
 The regulatory information in this presentation will be constantly available, or available at all or
 The legal information in this presentation is complete, true, accurate, up-to-date, or non-misleading.
If you have any specific question about any Regulatory/legal matter regarding distribution, you
should consult with your company consultant or you may email me at
rashidmureed@yahoo.com
Disclaimer

4. 1.Objective:
The purpose of this document is to ensure all federal and provincial
pharmaceutical legal & regulatory compliances
2. Scope:
This document is applicable for the issuances of pharmaceutical, imported,
contract manufacturing heath & OTC and Medical devices products to distributors across
the Pakistan.
3. Responsibility:
Distribution/Relevant departments are responsible to ensure the drug sale
Licenses (DSL) before issuing orders.
Good Medicine Regulatory Distribution Practices in Pakistan 4
Objectives, Scope & Responsibility

5. Drugs Act, 1976
Sindh Drug Rules, 1979
Sindh Drug Rules, 1979 Amendments, 2010
Punjab Drugs Rules, 2007
Northern Areas Drugs Rules, 1996
Medical Devices Rules, 2015
Alternative Medicines and Health Products (Enlistment) Rules, 2014
Good Medicine Regulatory Distribution Practices in Pakistan 5
Legal References

6. Company: Means pharmaceutical company, importer, Medical Devices and Health & OTC
product License Holder
DSL: Drug Sale License
Form-11: License to sell drugs as distributor in Punjab Region
Form-6: License to sell drugs by way of retail sale in Sindh Region
Form-7: License to sell drugs by way of wholesale in Sindh Region
 Form-10: License to sell drugs in “Medical Store” in Punjab Region
Form-9: License to sell drugs in a Pharmacy in Punjab region
Form-9: License to sell drugs Narcotics drugs in Sindh Region
Form-10: License to sell drugs as distributor in Baluchistan/KPK & in AJK Region
Form-11: License to sell drugs Narcotics drugs in Baluchistan/KPK & in AJK Region
Form-7A: Drug License by way of Wholesale as authorized agent of manufacturer/importer
or indenter in Sindh region
Good Medicine Regulatory Distribution Practices in Pakistan 6
Definitions

7. Good Medicine Regulatory Distribution Practices in Pakistan 7
Standard Procedure & Practices
1. In Sindh Province, Distribution department will ensure validity of Form-7A license
before issuance order/warranty to any distributor across the Sindh region
2. In Sindh Province, On Form 7-A license, Company name must be reflected,in
case name is not present then before issuing order, communicate to share
acknowledgment of intimation letter that distributor appointed by company
(additional list of companies)
3. Company should have Valid Drug license of all distributors, institutional distributor
and institutions (Govt. & Private), however there is no such clear requirement of
DSL for Govt. institutions other than Sindh region.
4. Warranties can pass through only two steps that is from manufacturer to its
authorized distributors and from authorized distributors to retailers

8. Good Medicine Regulatory Distribution Practices in Pakistan 8
5. In Punjab Province, Distribution department will ensure validity of Form-11
license according to Punjab Notification, Feb-2014 before issuance of
order/warranty to any distributor across the Punjab region.
6. In Punjab region, distributors those still have valid or renewed distributor license
on Form-10 should not be accepted for issuance of future orders/Warranty
7. In Punjab Region, drugs that’s fall under “Schedule G” should not be sold/stored
by Medical store license holder (Form-10)
8. If provided DSL get expired, then distributor must submit receiving copy of
prescribed renewal application with bank Challan requisite fee copy. On the basis
of Challan Copy and evidence of renewal application, order can only be place
accordingly for all provinces.
Standard Procedure & Practices

9. Good Medicine Regulatory Distribution Practices in Pakistan 9
9. If distributor is unable to provide prescribed renewed DSL then Company should
not sale Pharmaceutical stock.
10.If any distributor shares only evidence of fresh license application letter with
Challan that submitted in regulatory authority, Company will not issue the
pharmaceutical stocks until they get approved license from respective authority.
11.Company may issue order/warranty directly distributors or retailers to those have
valid Pharmacy license on prescribed form except Sindh region.*
12.In Case of contract/toll manufacturing, either X company manufactured products
for Y company, or Y company manufactured the products for X, not required any
DSL in transferring the finished goods to their warehouses
Standard Procedure & Practices

10. Good Medicine Regulatory Distribution Practices in Pakistan 10
12. If company has only marketing rights as per agreement from any other
manufacturing company or vise versa, should not be need of DSL for transferring
of goods from one manufacturing unit to marketing company distributors.
13. Subsequent to point 11,if marketing company also import and market products in
Pakistan, then there must be have distribution license according to provincial
regulations & requirements
14. At present regarding health & OTC products and medical devices, Company can
issue warranty/orders as per requisite regulations without considering DSL,
however Company communicate distributors to share the DSL in case of Nutrition
products.
Standard Procedure & Practices

11. Good Medicine Regulatory Distribution Practices in Pakistan 11
Important Note
16. Company would only invoicing and issuing warranty from its registered office
(address that reflected on DSL)
17. If drugs are sold, stored, exhibited for sale or distributed or more than one place,
a separate license shall be required in respect of each such place and validity of
all types of sales licenses are two years across all provinces
18. There is no such provision and not allowed that more than one company which
have legal entities are sold, stored, exhibited for sale or distributed drugs from a
single place.
19. All invoices and bills of purchase of drugs shall be reserved for a period of at
least three years. All registers and records maintained under these rules shall be
preserved for a period of not less than five years from the date of last entry (both
sellers & manufacturers)

12. Good Medicine Regulatory Distribution Practices in Pakistan 12
20.In Northern areas, drugs specified in Schedule "B" and "D" and preparations
containing such drugs shall not be sold by retail sale, except on, and in
accordance, with the prescription of a registered medical practitioner with the
PMDC and shall only be sold those have pharmacy license (Form-12)
21. Regulatory Affairs with Liaison with QA department of each unit will audit the
distributor licenses once a year to verify the legal and regulatory compliances
according to said procedure and current regulations.
22. Company being manufacturer/importers, ensure only below table warranty
Forms before issuing order of any type of product.
Warranty Drugs/Medicine Medical Devices Health & OTC
Form Form-2A Form-5 Form-11
Important Note

13. Good Medicine Regulatory Distribution Practices in Pakistan 13
License Chart
Province Distributor Lic. Pharmacy Lic.
Medical Store
Lic. Narcotics Lic.
Punjab 11 9 10 N/A
Islamabad 11 9 10 N/A
KPK 10 12 9 11
Sindh 7(a) 8* 6 9
Baluchistan 10 9 9 11
AJK 10 9 9 11
Company being manufacturer, ensure only below table distributors and
Pharmacy column valid licenses in all provinces before issuing warranty of any
product.

14. THANKS
Appreciate Your Comments Please 
Good Medicine Regulatory Distribution Practices in Pakistan
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