- INFARMED — Autoridade Nacional do Medicamento e Produtos de Saúde
Primary regulator. Issues cultivation, manufacturing, import, and export licenses. Issues EU-GMP Part I certificates — Portugal is an EEA authority. Oversees pharmaceutical-grade cannabis access under Law 33/2018.
- Cultivation/manufacturing/import/export licenses
- EU-GMP Part I certification and inspections
- Pharmacovigilance
- Narcotic import/export licensing
- Ministry of Health — Ministério da Saúde
Sets national cannabis access policy. Oversees INFARMED. Law 33/2018 legalized medical cannabis in Portugal.
- National medicinal cannabis policy
- Oversight of INFARMED
- EU treaty obligations
- Licensed Producers — Tilray Portugal, Aurora Portugal, others
Major export sector. Portugal is a MAJOR EXPORTER of medicinal cannabis — large EU-GMP certified cultivation and processing sector. Climate advantage: outdoor cultivation, lowest production costs in EU. Exports to EU, UK, Germany, Australia, Canada, Israel.
- INFARMED cultivation/manufacturing license
- EU-GMP Part I certification
- GACP certification for cultivation
- Export authorization per shipment
- Pharmacies / Hospitals — Dispensing via SSN
Dispensing against physician prescription. SSN (Serviço Nacional de Saúde) coverage limited but growing. Domestically registered products dispensed at pharmacies and hospital pharmacies.
- Portuguese pharmacy license
- Physician prescription required
- Narcotic dispensing register
- Patients — End recipients
Receive medicinal cannabis via prescription at pharmacies and hospitals. SSN coverage limited but expanding.