European Medicines Agency (EMA) and EU GMP compliance pathways for Pakistani exporters.
Marketing Authorisation Application via centralised or national procedure
Annex 1–20 of EU GMP guideline compliance required
A QP in the EU must certify each batch before market release
Good Distribution Practice certification for EU supply chain
Accessing the European pharmaceutical market requires compliance with the EU GMP framework, governed by Directive 2003/94/EC and EudraLex Vol. 4. Pakistani facilities must undergo inspection by competent authorities of EU member states — typically the national medicine agency of the importing country. An EU-based Qualified Person (QP) must certify every batch released on the EU market.
There are four primary routes to marketing authorisation in the EU: Centralised Procedure (EMA, for innovative drugs), Decentralised Procedure (simultaneous submission across multiple member states), Mutual Recognition Procedure (based on an existing national approval), and National Procedure (single member state). For generic manufacturers in Pakistan, the Decentralised or National Procedure is most appropriate.
EU GMP inspections of third-country (non-EU) facilities are conducted upon application for marketing authorisation or upon request. Pakistan's DRAP has a Memorandum of Understanding (MoU) with the EMA to facilitate regulatory cooperation. Companies already holding WHO GMP or PIC/S certification have a stronger baseline for EU GMP compliance but still require a separate EU inspection.