GMP Part II

API (Active Pharmaceutical Ingredient) manufacturing standards by jurisdiction.

EU-GMP Part II covers Active Pharmaceutical Ingredients — and it is the standard pathway for bulk cannabis entering the EU supply chain. Bulk cannabis API (flower or extract destined for further manufacture) may be supplied under Part II to a licensed EU manufacturer, who then performs the finishing operations under Part I before the product reaches pharmacies.

This split is the primary route for Israeli, Canadian, and Colombian suppliers into markets like Germany: bulk ships under Part II, an EU manufacturer with the appropriate authorization finishes and releases under Part I with QP certification. Choosing between a Part I and Part II supply model determines which partners you need, which regulator inspects you, and how the chain of custody must be documented.

Key considerations

• Part II is the bulk/API standard — it does not cover finished, patient-ready product
• Bulk supply pairs with an EU Part I finisher who performs QP release
• Primary pathway for Israeli, Canadian, and Colombian suppliers into the EU
• Chain of custody must link the GACP cultivation site to the GMP certificates
• Inspection scope and documentation differ from Part I finished-product audits