Authorisation of veterinary medicines under special circumstances
Find out what information you need to give MPI if you want to get a veterinary medicine authorised in special circumstances.
Situations that are special circumstances
1. No suitable product in New Zealand
If there is no suitable authorised product in New Zealand, section 8C of the ACVM Act permits the Director-General of MPI to allow under "special circumstances" the import, manufacture, sale or use of unauthorised veterinary medicines without registration.
To get authorisation under such special circumstances, you must apply for approval:
- Application to import for special use [DOC, 493 KB]
- Special circumstances approval – ACVM information requirements [PDF, 297 KB]
2. Research on non-trade name products
You need approval in special circumstances to do research or testing on a veterinary medicine that is not a trade name product (TNP).
Find out more about TNPs:
For research approval, you need to fill out the application form (product data sheet) and send it to us with all the required information. The following documents help you through the process:
- Research approval in New Zealand [PDF, 91 KB]
- Product data sheet for research approval [DOC, 528 KB]
- Estimated fees for ACVM regulatory assessment of veterinary medicines [PDF, 229 KB]
3. Use under an approved operating plan
Some agricultural compounds can be authorised via approval in special circumstances if an operating plan has been approved (under section 28 of the Act). For example, this pathway may be used for a substance needed to manage an exotic organism that has arrived in New Zealand.
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