Publications

This is the draft for 3rd Edition of the Post-registration variation guidleines. This document is intended to provide information for submission of post registration variation application by the registrations / marketing authorization holders of drug products and includes categories of variations and the required documentation & procedures for submission of an application for a particular variation. Keeping in view of the decisions of the Registration Board, the following changes have been incorporated in this edition:

1. Changes in Labelling & Prescribing Information and/or SmPC
2. Standardization of formulation in accordance with the innovator’s product/ approvals of reference regulatory authorities/ pharmacopeias.
3. Change in packaging design/color scheme of packaging material
4. Grant of additional pack size for locally manufactured products (non-essential      drugs) (except injectables and ophthalmic preparations)
5. Change in registration Status from finished import to bulk labelled primary pack import local secondary packing. 
6. Change in registration status from finished import to ready-to-fill bulk/ bulk concentrate import local processing.

Call for Stakeholder Input

DRAP invites healthcare professionals, pharmaceutical manufacturers, researchers, policymakers, and the public to review the draft guideline and provide constructive feedback. Your expertise will ensure the framework is robust, transparent, and aligned with international best practices.

Submit Feedback: Email comments to sanakanwal2010∂gmail.com by 26th March, 2026.

Deadline for Feedback: 26th March, 2026

The Drug Regulatory Authority of Pakistan has revised and updated the requirements for Establishment of pharmaceutical unit and also developed new guidance annexure VI (A) for requirements for grant of Drug manufacturing license by way of Basic and semi basic manufacturing for Blood and plasma Establishments in line with DRAP Act 2012, Drug Act 1976 and rules framed there under.
These requirements serve a reference document for the applicants intended to apply for grant of Drug Manufacturing Licenses for Blood/Plasma Establishments by way of basic/semi-basic manufacturing. The requirements aim to facilitate harmonization with international regulatory requirements, enabling Pakistani plasma establishments to meet the stringent standards required by international fractionators and foreign regulatory authorities.
These requirements are applicable to a broad range of entities and activities within the plasma supply chain. All Plasma Establishments that hold Drug Manufacturing Licenses and engage in the collection, testing, processing, storage, or distribution of plasma intended for fractionation must comply with these requirements. This also includes blood establishments that collect whole blood from which plasma is recovered, and plasma warehouses and distribution facilities that handle plasma after collection.
Accordingly, the 3rd version of guidance document titled “ESTABLISHMENT OF PHARMACEUTICAL UNIT AND POST LICENSE CHANGES “along with newly drafted Annexure VI ( A) REQUIREMENTS FOR GRANT OF DRUG MANUFACTURING LICENSE BY THE WAY OF BASIC & SEMI-BASIC MANUFACTURING FOR BLOOD/ PLASMA ESTABLISHMENTs are uploaded on the official website of DRAP on the 29th of December , 2025 to seek comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on submitting comments, visit the DRAP website or click here. Comments and suggestions can be forwarded via email to akbar.ali∂dra.pk and drapakbar∂gmail.com or can be posted at the mailing address, Director, Division of Drug Licensing , Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.