- GMP Assessment
Netherlands requires EU-GMP Part I for all finished medicinal cannabis imports. As an EU member state, Dutch rules are aligned with EU-GMP — no additional Dutch-specific GMP requirements exist beyond the EU baseline.
- Finished product or API?
Finished product requires EU-GMP Part I. API/bulk supply to a Dutch finisher requires EU-GMP Part II.
- EU-GMP Part I Required — All finished imports
Mandatory for all finished medicinal cannabis imported and distributed directly to Dutch pharmacies. Certificate must be issued by an EEA competent authority or PIC/S-recognised body.
- EEA authority or PIC/S recognised certificate
- Cannabis scope explicitly stated
- QP at Dutch importer certifies each batch
- EU-GMP Part II Accepted — API/bulk supply
For supply of bulk cannabis API to a Dutch Medicines Act §18 licensed manufacturer who completes finishing under Part I.
- Part II for active substance manufacturing
- Dutch finisher takes Part I responsibility
- Dutch QP releases finished batch
- Manufacturer in EEA?
EEA-based manufacturers are directly certified by their national authority. Non-EEA manufacturers need a recognised certificate.
- EEA Authority Certificate — Direct acceptance
Certificate from any EEA competent authority (ANSM, IMB, BfArM, AGES, etc.) accepted directly by IGJ and CCBM. Gold standard for Dutch market entry.
- Any EEA national authority certificate
- Scope must cover cannabis manufacturing
- Directly valid — no additional IGJ step
- PIC/S / Bilateral Certificate — MHRA, TGA, IMFA, Health Canada
PIC/S mutual recognition — MHRA (UK), TGA (Australia), Health Canada, and IMFA (Israel) certificates accepted under EU bilateral arrangements.
- PIC/S or MRA certificate
- IMFA certificates accepted under EU-Israel MRA
- Cannabis scope required on certificate
- Dutch QP Batch Release
All batches released to the Dutch market must be certified by an EU Qualified Person named on the Dutch importer's WDA.
- QP named on Dutch WDA
- QP reviews full batch record and COA
- QP signature on batch certificate required
- Legally liable for each released batch
- Released for Dutch Supply ✓
QP-certified batch available for distribution to pharmacies via licensed Dutch wholesaler.