Veterinary medicine registration under the ACVM Act 1997
Registering a veterinary medicine under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 means it can be imported, manufactured, sold, or used in New Zealand. Find out how to apply for veterinary medicine registration.
About veterinary medicine registration
Registration authorises your trade name product for import, manufacture, sale, and use in New Zealand. It is an approval to market your product.
All registered veterinary medicines have some conditions on their registration to manage risks – for example, that they must be manufactured according to specifications approved during registration.
Registered veterinary medicines are classified as unrestricted or restricted. Restrictions are conditions that limit a product's sale, purchase, or use.
- An unrestricted veterinary medicine is one that's been registered with no extra restrictions on its sale, purchase or use. For example, a flea treatment that anyone can purchase in a supermarket.
- A restricted veterinary medicine (RVM) is one that's been registered with extra restrictions. For example, an antibiotic that can't be purchased and used without a veterinary prescription.
Register a vet medicine
To register your veterinary medicine, you need to fill out the application form and send it to us, along with the required information outlined in the information requirements document and on the application form.
Information needed for vet medicine registration [PDF, 127 KB]
You'll need to provide a completed product data sheet. Follow our guideline for help completing it.
Product data sheet guideline - veterinary medicine [PDF, 457 KB]
Product data sheet - veterinary medicine - Form ACVM 1-2 [DOC, 323 KB]
New Zealand (MPI), Australian and Canadian regulators have collaborated to produce a guidance document for undertaking a joint review of registration applications. This can be used to bring innovative veterinary medicines to market here at the same time as in other countries while contributing to improved animal health and food safety.
Renew a veterinary medicine registration
Use the renewal of registration form if it's an application to renew registration of a product.
Supporting information for registration application
You may need a number of other documents and information specific to your application, relating to:
- data protection
- chemistry and manufacturing
- target animal safety
Find out what you need to provide:
If your product is for an animal that will be used for human food and it has an active ingredient that has not been assessed in New Zealand before, a maximum residue level (MRL) may need to be set. We'll do this as part of the registration application.
Consider using an ACVM consultant
If you are unsure how to register your product, consider hiring a consultant to help you. As the regulatory body, MPI cannot provide consultation services through the registration process. Listed consultants, are not MPI-endorsed. They nominate their own areas of expertise – check the key at the bottom of the consultants list.
Before an application can be put into the system, MPI or a third party must assess all required data. Data assessment is generally quicker if you use an independent assessor.
Data assessment reports must be made by an independent assessor. You can't use in-house assessors or assessors related to your company. Your registration consultant can't also be your data assessor.
It is your responsibility to ensure that the person doing the data assessment has appropriate qualifications. If a data assessor is not on our list below, you must include their CV with your application.
Templates for data assessment reports are available by searching for 'data assessment' in our list of veterinary medicine documents.
If you think you may not need to provide some of the required information, read:
Request a change to a veterinary medicine registration
To make a change to your product registration, you need 2 forms:
- Variation to registration of an ACVM product: Application form ACVM 1V [DOC, 481 KB]
- One of ACVM forms 6 to 14, depending on the type of change (check the list in section 6 of the variation form).
Download the relevant form from the MPI list of veterinary medicine documents.