- Ministry of Health — Ministerul Sănătății
Sets national medical cannabis policy. Oversees ANMDM and the implementation of Legea 339/2005 on cannabis-based medicines. Approves national formulary entries.
- National cannabis policy framework
- Oversight of ANMDM
- Patient access policy and specialist approval
- ANMDM — Agenția Națională a Medicamentului și a Dispozitivelor Medicale
National Agency for Medicines and Medical Devices. Primary regulatory authority for cannabis-based medicines. Issues import authorizations, manufacturing licenses, and product approvals.
- Import authorization per shipment
- Manufacturing and wholesale distribution licenses
- GMP inspections (EEA-aligned)
- Product marketing authorization
- Hospital Pharmacies — Spital farmacie
Medical cannabis in Romania is dispensed only through hospital pharmacies — not community pharmacies. This is a significant access restriction unique to Romania.
- Hospital pharmacy license
- Controlled substance storage requirements
- Dispensing only against specialist prescription
- Specialist Physicians — Neurology / Oncology / Pain
Only specialist physicians (neurologists, oncologists, pain specialists) may prescribe cannabis-based medicines. General practitioners cannot prescribe. Named-patient requirement applies.
- Specialist physician credential required
- Named-patient prescription
- Hospital-based practice setting
- Patients — Named-patient basis
Patients receive cannabis-based medicines on a named-patient basis, prescribed by a specialist physician and dispensed through hospital pharmacies. Strict named-patient protocol — no general access pathway.