EU-GMP Part I

Good Manufacturing Practice requirements for finished medicinal cannabis products.

EU-GMP Part I is the manufacturing standard for finished medicinal products — and the gate most cannabis products must pass to reach EU pharmacies. Any finished product (dried flower, extract, oil) dispensed in markets like Germany must be manufactured at a site holding a valid EU-GMP certificate issued by an EEA competent authority or a recognized PIC/S member authority such as the TGA, Health Canada, or the MHRA.

Every batch released to the market must be certified by an EU Qualified Person (QP). For non-EU manufacturers this usually means partnering with an EU-based importer whose QP performs batch certification. Certificates from PIC/S members are broadly accepted; US-origin product requires a separate EU batch-certification step because the FDA does not issue EU-GMP certificates.

Key considerations

• Part I applies to finished products destined for patients — flower, extracts, oils
• Manufacturing sites are certified by EEA authorities or recognized PIC/S members
• QP batch release is mandatory before any product reaches a pharmacy
• PIC/S certificates (TGA, Health Canada, MHRA) are accepted; FDA certificates are not
• National regulators can inspect foreign manufacturing sites, increasingly remote-first