- HPRA — Health Products Regulatory Authority
Primary regulator for all medicines including cannabis. Issues import authorizations and EU-GMP certificates. Ireland is EEA — HPRA is a major EU-GMP issuing authority (world's largest pharma manufacturing hub).
- Per-shipment import authorizations
- EU-GMP certification (EEA authority)
- Wholesale dealer authorizations
- Pharmacovigilance
- Ministry of Health — Policy oversight
Sets national medicinal cannabis policy. Established MCAP (Medical Cannabis Access Programme) in 2019 via Misuse of Drugs (Amendment) Act. Oversees HPRA.
- National cannabis access policy
- Oversight of HPRA and MCAP
- Misuse of Drugs legislation
- MCAP — Medical Cannabis Access Programme
Named-patient access programme for specific conditions only: MS spasticity, intractable nausea (chemo-resistant), and severe treatment-resistant epilepsy. Products supplied via MCAP are imported under HPRA authorization.
- Eligibility: MS spasticity, intractable nausea, severe treatment-resistant epilepsy
- Consultant specialist referral required
- MCAP authorization for named patient
- Products from MCAP-approved suppliers only
- Hospital / Community Pharmacies — Dispensing
Cannabis medicines dispensed against specialist prescription. Hospital pharmacies are primary dispensers for MCAP products. Community pharmacies may dispense with appropriate controlled drug license.
- Pharmacy license from PSI (Pharmaceutical Society of Ireland)
- Specialist prescription required
- Controlled drug register maintained
- Patients — End recipients
Access primarily through MCAP for the three specified conditions. Section 14 license also available outside MCAP for individual patient authorization. Out-of-pocket cost is primary barrier — MCAP is improving access but reimbursement remains limited.