New Zealand
NZOceania
Regulatory Overview
New Zealand is regulated by the Medsafe (New Zealand Medicines and Medical Devices Safety Authority). The country has 1 documented regulatory pathway for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.
Regulatory Authority
Medsafe (New Zealand Medicines and Medical Devices Safety Authority)
Regulatory Pathways (1)
New Zealand Medsafe allows prescribers to obtain and use unapproved medicines for specific patients under Section 29 of the Medicines Act 1981 in special clinical circumstances.
Application Form: Medsafe S29 Notification
Legal Basis: Medicines Act 1981 Section 29
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: Medsafe Section 29 Guidance
Drugs Available (1)
| Drug | Access Route | Status | Lead Time |
|---|---|---|---|
| azathioprine | — | — | — |
New Zealand
| ISO Code | NZ |
| Region | Oceania |
| Regulatory Authority | Medsafe (New Zealand Medicines and Medical Devices Safety Authority) |
| Pathways | 1 documented |
| Drugs Available | 1 drug(s) |