- GMP Assessment
Determine which GMP pathway applies for the Australian market. TGA is a PIC/S founding member — its GMP standards are fully aligned with EU-GMP.
- Manufacturer location?
Where is the manufacturing site? TGA accepts its own certificates and those from MRA partner countries.
- Australian Manufacturer — TGA licensed site
Australian manufacturers are inspected by TGA and hold TGA manufacturing licences. These are the gold standard for Australian supply — no additional GMP steps needed.
- TGA manufacturing licence
- Annual TGA GMP compliance audit
- Cannabis-specific manufacturing scope required
- Overseas Manufacturer — MRA or TGA inspection
TGA accepts GMP certificates from EU (EMA/national authorities), Canada (Health Canada), UK (MHRA), Switzerland (Swissmedic), Japan (PMDA), NZ (Medsafe), and Israel (IMFA) under bilateral arrangements.
- Certificate must be current and cannabis-scoped
- EU-GMP Part I accepted for finished product
- EU-GMP Part II accepted for API supply
- MRA partner country?
Is the manufacturing country in a TGA mutual recognition or bilateral arrangement?
- Certificate Accepted — EU, UK, Canada, Israel, NZ, CH, JP
TGA accepts the foreign GMP certificate directly. No TGA inspection of the overseas site required before first import. TGA may conduct a risk-based inspection subsequently.
- Certificate must specifically cover cannabis scope
- EU-GMP Part I: accepted for finished product
- Israeli IMFA: accepted under bilateral arrangement
- TGA Overseas Inspection — Non-MRA countries
For manufacturers in non-MRA countries, TGA may require an overseas GMP inspection before granting import approval. This adds significant time and cost.
- TGA inspection fee applies
- Site must be inspection-ready per TGA standards
- Inspection scheduling may take 6–12 months
- TGA GMP Clearance Issued
TGA issues GMP clearance for the overseas site. This clearance is required on the TGA import permit application.
- GMP clearance valid typically 3 years
- Must be renewed before expiry for ongoing supply
- Scope must match product being imported
- GMP Pathway Cleared ✓
GMP requirements satisfied. Proceed to TGA import permit and ODC import license applications.