Registering a veterinary medicine
Registration is an approval to import, manufacture, sell, and use a veterinary medicine in New Zealand.
Conditions of registration
All veterinary medicines are registered with conditions to manage risks. Conditions include:
- controls requiring manufacture according to specifications approved during registration
- other controls on sale, use, and reporting back to The Ministry for Primary Industries (MPI).
Classifications of 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 or pet store.
- A restricted veterinary medicine (RVM) is one that has been registered with a restriction that it can only be purchased and used when authorised, or prescribed, by a veterinarian. RVMs must only be used as the veterinarian has prescribed.
Consider using a consultant
If you're not sure how to register your product, consider hiring an ACVM consultant to help you. As the regulatory body, MPI can't provide consultation services during the registration process.
Registering a veterinary medicine
To register a veterinary medicine, you need to complete and send us the following forms:
ACVM 1: Registration of an ACVM trade name product [DOC, 480 KB]
ACVM 1-2: Veterinary medicine product data sheet [DOC, 351 KB]
This guideline will help you to fill out the product data sheet (ACVM 1-2):
Veterinary medicine product data sheet guideline [PDF, 457 KB]
There are also 4 other approaches to registering.
Supporting information required
Your application to register a veterinary medicine must be supported by data and information relating to:
- chemistry and manufacturing
- target animal safety
- residues, when used on a food-producing animal.
All applications also need a product datasheet. This must contain:
- all the details of your product and its manufacture and packaging
- a draft product label.
Some applications will also need data and information to outline the risks and risk management for other areas. For example:
- biosecurity for products with ingredients of plant or animal origin
- antimicrobial resistance for products containing antibiotics.
The ACVM information requirements document tells you what to include with your application form:
If you think you may not need to provide some of the required information, read this document:
Data assessment report
Before we can accept your registration application into our system, we need an assessment report of your data. This report is done by an independent data assessor. The report confirms that all the data and information submitted with the application meets the requirements and expectations for ACVM assessment. You cannot use:
- in-house assessors
- assessors related to your company
- your registration consultant.
We keep a list of MPI-approved data assessors:
Note: It's your responsibility to ensure that the person doing the assessment has appropriate qualifications. If the data assessor you use isn't on our list, you must include their CV with your application.
Data assessment report templates
Templates for data assessment reports are available from this page:
The following applications are eligible for data protection:
- all applications to register new products
- some applications to change existing registrations.
This document has information on what data protection is and how it's applied.
Application form for data protection
Submit the ACVM 1DP form when you submit your application that is eligible for data protection.
There are 4 other approaches:
- joint reviews
- harmonised labels
- registration by reference to an APVMA registration.
This is when a company proves that their product is equivalent to a product that's already registered in New Zealand. They can submit data and information to do this. For more information, use this guidance document:
New Zealand and the following overseas jurisdictions have put in place guidance documents to allow joint reviews for the registration of a veterinary medicine product:
- New Zealand, Australia, and Canada
- New Zealand and United Kingdom
A company can request a joint review. This will:
- trigger applications in New Zealand and the overseas jurisdictions at the same time
- allow them to launch the product in multiple countries at the same time.
The guidance documents have more information.
This is when a product is registered in both Australia and New Zealand, with one label that's approved for marketing in both countries.
ACVM Requirement: Labelling veterinary medicines [PDF, 217 KB]
Registration by reference to an APVMA registration
This is where registration in New Zealand is supported by the assessment done by the APVMA (the Australian version of ACVM). This is done instead of doing a separate data assessment report.
Renew a veterinary medicine registration
Veterinary medicine registrations are approved for periods of up to 5 years.
If you need to renew a product's registration as a veterinary medicine, use the renewal of registration form.
Registration renewals can only be done where there is no change to any other product or registration details.
If there are any changes to the product or registration, an application to change the veterinary medicine registration must be submitted, rather than a registration renewal application. In those cases, the registration period will be renewed with the change approval.
Request a change to a veterinary medicine registration
If you want to make a change to a product's registration, you will need to complete 2 forms:
- ACVM 1V: Variation to registration of an ACVM trade name product [DOC, 490 KB]
- One of ACVM forms 6 to 14 – depending on the type of change (see the list in section 6 of the ACVM 1V form).
ACVM forms 6 to 14 can be found on this page:
What we charge
This document provides you with an estimate of the costs for registration, including renewals, provisional registrations, and research approvals:
Who to contact
If you have questions about veterinary medicines, email firstname.lastname@example.org