GMP Pathway

Workflow steps

1. GMP Assessment
   Thai FDA GMP is PIC/S-aligned (ASEAN GMP basis). Thai FDA certificates are increasingly recognized internationally, but EU-GMP Part I certification is still preferred for EU export.
2. Target market?
   Destination market determines GMP certification needed. EU markets require EU-GMP Part I. Non-EU markets may accept Thai FDA GMP.
3. Thai FDA GMP — ASEAN / domestic markets
   Thai FDA GMP inspection and certification. Accepted within ASEAN and some non-EU markets.
   • Thai FDA GMP inspection
   • ASEAN GMP standards
   • Cannabis-specific scope required
4. EU-GMP Part I — EU market export
   For EU market export, Thai manufacturers need EU-GMP Part I from an EEA authority. No ASEAN-EU GMP MRA currently exists — EEA authority must inspect.
   • EEA authority inspection (ANSM, IMB etc.)
   • Cannabis manufacturing scope
   • EU QP required for EU market batch release
5. GMP Pathway Cleared ✓
   GMP certification obtained for target market. Proceed to export license application.