What is provisional registration?
Provisional registration means authorisation to do trial work in New Zealand with a product that fits the definition of a trade name product.
This may be to:
- get more information on the product (for example, about its efficacy, safety, or residue levels) and determine whether it should be registered in New Zealand, or
- perform general research or trials required for registration of the product in another country.
You can only use these products for the purposes in the provisional registration. You're not allowed to advertise or sell them.
When is it required?
Provisional registration is necessary for trial work on agricultural compounds that:
- aren't currently registered in New Zealand, or
- are registered for a different purpose or use, and off-label use is prohibited under the conditions of registration.
Provisional registration must be approved before trial work begins.
Products that can be provisionally registered
You can only get provisional registration for products that meet the definition of a trade name product (TNP).
A TNP is a product that:
- has or intended to have a TNP which it will be marketed under
- has the same formulation that will be used in a future application to register it
- is packaged or will have packaging specifications for marketing it in New Zealand.
If you're planning to do trial work with an agricultural compound that is not a TNP, you'll need either:
- a research approval, or
- operating plan under "special circumstances".
Find out more about authorisation of veterinary medicines under special circumstances
How to apply for provisional registration
To apply for provisional registration of your veterinary medicine:
- fill out the application form ACVM 21
- send it to us along with all the required information.
Contact details are on the form:
ACVM 21: Provisional registration product data sheet [DOC, 492 KB]
Help for this process and what information you need to provide is in the guidance document Provisional registration in New Zealand [PDF, 91 KB]
Get help from a consultant
If you're not sure how to provisionally register your product for trial work, consider hiring an ACVM consultant to help you. As the regulatory body, the Ministry for Primary Industries (MPI) can't provide consultation services during the registration process.
Consultants for risk management programmes, food control plans, food labels, and ACVM registration
What we charge
This document has an estimate of the costs for provisional registration:
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