GMP Pathway

Workflow steps

1. GMP Assessment
   Uruguay does not have an EU-GMP Mutual Recognition Agreement. Domestic production operates under MSP GMP (Buenas Prácticas). For imported products, EU-GMP or FDA GMP are accepted.
2. Domestic or import?
   Uruguayan GMP pathway depends on whether the product is manufactured domestically or imported. No EU-GMP MRA exists for domestic manufacturers.
3. MSP GMP Standard (Buenas Prácticas) — Domestic production
   Domestic cannabis production under MSP GMP standard (Buenas Prácticas de Manufactura). MSP conducts GMP inspections for Uruguayan manufacturing facilities. This standard applies to all domestic cannabis product manufacturing.
   • MSP GMP inspection of facility
   • Buenas Prácticas de Manufactura compliance
   • MSP manufacturing license
   • Annual MSP inspection cycle
4. EU-GMP or FDA Accepted — Imported products
   For imported cannabis products, Uruguay accepts EU-GMP or FDA GMP certification from the country of origin. No bilateral MRA — acceptance is by MSP policy rather than formal treaty.
   • EU-GMP certificate from EEA authority
   • OR FDA GMP certificate
   • MSP import authorization required separately
   • COA and product specifications
5. GMP Pathway Defined ✓
   GMP pathway identified. Domestic production follows MSP Buenas Prácticas; imports require EU-GMP or FDA GMP certification.