- GMP Assessment
Determine which GMP pathway applies to your cannabis-based medicine for the Romanian market. Romania is an EEA member — EU-GMP is the national standard.
- EU-GMP Part I Required — Finished product
All finished cannabis-based medicines imported into Romania must be manufactured under EU-GMP Part I. As an EEA member, Romania directly applies EU pharmaceutical legislation.
- EU-GMP Part I certificate (current, cannabis scope)
- Certificate issued by any EEA competent authority
- GACP certificate for cultivation site
- QP at importing entity for batch release
- Manufacturer location?
Where is the manufacturing site? This determines whether ANMDM accepts the GMP certificate directly or requires additional steps.
- EEA Authority Certificate — Directly accepted
EEA competent authority issues EU-GMP Part I directly. Fully accepted by ANMDM with no additional steps. Romania recognizes all EEA-issued GMP certificates.
- Any EEA authority (ANSM, IMB, PEI, AGES, etc.)
- Certificate directly valid for Romanian import
- QP batch release at importing entity
- PIC/S Member Certificate — ANMDM accepts EEA + PIC/S
ANMDM accepts GMP certificates from PIC/S members as equivalent. This includes TGA (Australia), Health Canada, MHRA (UK), and other PIC/S authorities.
- TGA (Australia) — accepted
- Health Canada — accepted
- MHRA UK — accepted under MRA
- Certificate must cover cannabis manufacturing scope
- QP Release in Romania
Regardless of origin, all batches must be QP-certified by a Qualified Person named on a Romanian or EEA manufacturing authorization before distribution to hospital pharmacies.
- QP named on EEA manufacturing authorization
- QP certifies compliance batch-by-batch
- QP batch certificate required for hospital pharmacy supply
- GMP Pathway Defined ✓
EU-GMP Part I standard met. Product eligible for ANMDM import authorization and hospital pharmacy distribution in Romania.