Situations that are "special circumstances"
Most products are authorised through either:
- registration under the Agricultural Compound and Veterinary Medicines (ACVM) Act 1997, or
- exemption from registration under the ACVM Act.
In some cases, however, a product can be authorised to be imported, manufactured, sold, or used in "special circumstances". These are:
- A veterinarian needs to treat a specific case and there is no suitable authorised product available in New Zealand.
- To treat an animal or a plant in post-entry quarantine, or as an export requirement before leaving New Zealand, with an unauthorised product.
- Other situations where use of an unauthorised product is needed. For example:
- managing a biosecurity outbreak or for research
- teaching
- testing on a veterinary medicine that is not a trade name product (TNP).
How to get authorisation
Information about each of these situations is provided below. Detailed information on getting authorisation under "special circumstances" is available in our guidance document.
Guidance document: Special circumstances approval [PDF, 297 KB]
Approval for use of an unauthorised veterinary medicine by a veterinarian
If there's no suitable authorised product in New Zealand, a veterinarian can request approval under "special circumstances". The Director-General of MPI may allow the veterinarian to import, sell, or use an unauthorised veterinary medicine without registration.
To apply for this type of approval, the veterinarian must:
- fill out the ACVM 3 application form
- send it to us along with any other required information.
ACVM 3: Special circumstances import approval request [DOC, 770 KB]
Other information you need to provide is in section 4 of the Guidance document: Special circumstances approval [PDF, 297 KB]
Approval for use of an unauthorised veterinary medicine in quarantine or to meet an export requirement
There may be situations where an animal needs to be treated with an unauthorised product:
- after arriving in New Zealand before being released from quarantine, or
- before leaving New Zealand.
In these cases, the owner should contact MPI for approval to get and use these products.
Approval to do research on non-trade name products
You may want to use unauthorised non-trade name products as part of your work if you're:
- a researcher
- part of an organisation that does research, teaching, or testing.
To get and use those products, you'll need "special circumstances" approval. To get approval to work with one unauthorised product:
- fill out the application form ACVM 5
- send it to us with all the required information.
ACVM 5: Research approval product data sheet [DOC, 495 KB]
Help with the process and information you need to provide is in Research approval in New Zealand [PDF, 91 KB]
The minimum requirements for designing, conducting, monitoring, and reporting of laboratory, field and clinical studies are in the ACVM research standard [PDF, 36 KB]
If you are looking to conduct research using unauthorised trade name products, you will need a provisional registration instead of a research approval.
Find out more about provisional registration of a veterinary medicine
Approval to use unauthorised products under an operating plan
You may require an operating plan if:
- your organisation need to work with more than one unauthorised product, or
- your work is part of a larger project using several unauthorised products.
Operating plans are required when there is a need for a risk management plan around the use of the products. For example:
- an unauthorised product being used to manage an exotic disease or organism
- where multiple products are being used in research.
More information about this type of approval is in section 3.4 of the Guidance document: Special circumstances approval [PDF, 297 KB]
What we charge
This document has an estimate of the costs for approval under "special circumstances":
Estimated fees for ACVM regulatory assessment of veterinary medicines [DOCX, 82 KB]
Who to contact
If you have questions about veterinary medicines, email info@mpi.govt.nz
