Provisional registration of a veterinary medicine
Find out what information you need to give us if you want to provisionally register a veterinary medicine.
Defining provisional registration
Provisional registration means getting authorisation under section 27 of the ACVM Act so you can do trial work with a trade name product. This may be for the following purposes:
- to obtain more information on that product (for example, about its efficacy, safety, or residue levels) and determine whether it should be registered in New Zealand, or
- to perform general research on the product or trials required for registration of the product in another country.
These products may be used only for the purposes specified in the provisional registration. You're not allowed to market them.
Products that can be provisionally registered
Provisional registration can be issued only for trade name products (TNPs). The characteristics of a TNP are that
- it is in the formulation (or not materially different from the formulation) that will be specified in an application to register.
- it is intended to be marketed under a specified trade name.
- it is packaged or has (or will have) packaging specifications for marketing in New Zealand.
To do trial work on an agricultural compound that is not a TNP, you will need approval in special circumstances rather than provisional registration.
When provisional registration is needed
Provisional registration is necessary for trial work on agricultural compounds that
- are not registered or
- are registered for a different purpose or use, and off-label use of the product is prohibited by its conditions of registration.
How to provisionally register your product
To provisionally register your veterinary medicine, you need to fill out the application form (product data sheet) and send it to us along with all the required information. The following documents help you through the process.
- Provisional registration in New Zealand [PDF, 91 KB]
- Product data sheet for provisional registration [DOC, 536 KB]
- Estimated fees for ACVM regulatory assessment of veterinary medicines [PDF, 229 KB]
If you are unsure of how to provisionally register your product, you should hire a consultant to help you. As the regulatory body, MPI cannot provide consultation through the registration process.
Listed consultants, who are not MPI-endorsed at this stage, nominate their own areas of expertise. Refer to the key at the bottom of this list:
Has this been useful? Give us your feedback