- GMP Assessment
Colombia's BPM (Buenas Prácticas de Manufactura) is the national GMP standard. For EU, UK, and Australian export, EU-GMP or equivalent is required. No Colombia-EU GMP MRA currently exists.
- Target export market?
EU markets require EU-GMP Part I. UK, Australia, and some others may accept bilateral arrangements or INVIMA BPM with additional inspection.
- EU-GMP Part I Needed — For EU market export
Colombian manufacturers must obtain EU-GMP Part I from an EEA competent authority for EU export. INVIMA BPM is not directly accepted by EEA. EEA authority inspection in Colombia required.
- EEA authority inspection of Colombian site (ANSM, IMB, etc.)
- Full EU-GMP implementation at site
- EU QP required for EU batch release
- Significant investment — few Colombian sites hold this
- INVIMA BPM + Bilateral — LATAM and some markets
INVIMA BPM certification for Colombian domestic use and LATAM export. Some markets accept with additional documentation.
- INVIMA manufacturing license and BPM inspection
- BPM certificate issued by INVIMA
- Accepted in LATAM markets
- Evaluate destination market requirements individually
- Strategic Note
Most Colombian export to EU currently as raw botanical material (bulk flower or extract) to EU-licensed finishers who hold Part I. Full EU-GMP Part I in Colombia is rare but growing.
- Supplying EU-licensed Part I finisher is common pathway
- EU finisher takes GMP Part I responsibility
- Colombian site holds GACP + BPM
- GMP Pathway Defined ✓
GMP pathway identified for target market. Proceed with export authorization.