Registering a veterinary medicine

Find out what information you need to give MPI if you want to register a veterinary medicine or change an existing registration.


Defining registration

Registration means obtaining authorisation under section 21 of the ACVM Act for importing, manufacturing, selling, or using an ACVM trade name product in New Zealand. It is an approval to market your product.

To manage risks, all registered veterinary medicines have conditions placed on their registration. A registered veterinary medicine without extra restrictions is called 'unrestricted'. A veterinary medicine registered with extra restrictions on its sale, purchase, and use is called a 'restricted veterinary medicine' (RVM).

Find out more about the registration process, including timeframes:

How to register your product

To 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. Read the information requirements document first.

Guidelines, application form, and product data sheet: 

Look at the compliance documents for veterinary medicines to find information requirements on these topics: chemistry and manufacturing, target animal safety, residues, efficacy, therapeutic equivalence, and labelling. 

Another useful labelling guide has been produced by Agcarm:

If your product has an active ingredient that has not been assessed in New Zealand before, a maximum residue level (MRL) may need to be set. For more information, go to:

Consultants

If you are unsure of how to 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 the following list.

Data assessment

All required data must be assessed by MPI or by a third party before an application can be put into the system. Data assessment is generally quicker if you engage an independent consultant. 

You may choose to do your own data assessment, but reports must be made by an independent assessor. In-house assessors or assessors related to your company in some way are not acceptable, owing to conflict of interest issues. Your registration consultant cannot 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 already known to us, you must include their CV along with your application. 

Templates for data assessment reports can be found here:

If you think some of the required information may not be necessary in your case, read:

Making changes

To make a change to your product registration, you need two forms: (1) the Variation to Registration of an ACVM Product (ACVM 1V) application form and (2) the relevant form for the type of change you wish to make (ACVM 6 – 14, as specified in section 3 of the Variation form).

When we receive your variation application, we will determine whether the change requested is minor or major. A change is considered minor if the information can be summarised in the application and if it requires minimal supporting data.

  • Minor changes require limited regulatory appraisal, so are quicker to process.
  • Major changes require more assessment and may require additional information.

We will inform you by email as to whether your application falls into the minor or major category.

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