Agricultural Compound and Veterinary Medicine (ACVM) registration process
How to apply to register an agricultural compound or veterinary medicine (ACVM) in New Zealand, and how MPI assesses your application.
Apply to register an ACVM
You can apply to register an ACVM trade name product (TNP), or to vary an existing registration.
Applications may be:
- single – for example, an application for a new TNP, or
- have multiple changes – for example, an application for change in shelf life, change to manufacturing process, and addition of a new active ingredient manufacturer.
The process to register an ACVM differs depending on your product type. Check these pages to find out about registering:
- agricultural chemicals – most products for plants
- veterinary medicines – most products for animals
- vertebrate toxic agents – most products that limit the viability of animals
How we process your ACVM registration application
MPI's process for assessing your application and registering an agricultural compound or veterinary medicine (ACVM) includes the following steps.
Your application has to be complete before MPI can start processing it.
We'll pre-screen your application to make sure it contains all the required information and that this information is appropriate for the application type.
There are 2 pre-screening stages. At either one, we may reject your application.
We'll let you know when we receive your application.
We'll check that your application includes all of the required supporting documents, create an electronic product file to hold the documents, and give your application a number.
If your application isn't complete, we'll contact you. If it is complete, your application progresses to the technical pre-screen.
Once your application is ready for technical pre-screen, you can't make any changes to it. For example, you can't add a change in shelf life (C3) variation to an application requesting a change of final product manufacturer (C2) variation. You will have to wait until the initial variation is processed.
Our technical appraisers will decide whether the data supplied with your application is adequate to support registration.
If we don't think it is, we'll contact you with a request to address any issues. Note, we'll charge an additional technical pre-screen fee if this is necessary.
If you provide adequate information, your application will be accepted into the system. This marks the start of the 40-working-day timeframe for completing registration, provided that the application does not require prior public notification.
The ACVM Act requires MPI to publish a notice in the NZ Gazette for registration (or variations to existing registrations). However, MPI can waive this notification if:
- there is a registered product with the same active ingredients and an equivalent formulation as your product
- the variation to an existing registration doesn't affect the evaluation of risks for that product.
Typically, MPI will publish a notice for:
- new product registrations with new risk profiles:
- new active ingredient (A1 application), or
- registered active ingredient with a new risk profile (A2 application)
- new use applications with a new risk profile.
We'll let you know if your application will be publicly notified.
The notification period is 30 working days to allow for submissions on the application. This is done before technical appraisal and risk assessment.
MPI will determine:
- whether your product meets the criteria for registration
- what conditions to place on registration to manage risks.
By law, the timeframe for this phase is 25 working days.
During this stage, we may contact you for extra information or clarification. If you can't provide the information within 5 working days, you should ask MPI for a waiver of time. This won't normally be more than 20 working days.
If we accept your request, we'll pause the 'clock' for appraisal of your application until we receive the extra information. If you don't ask for a waiver – or if you do and we don't accept it (we'll tell you why) – we'll complete the appraisal based on available information. In these cases, the appraiser is likely to recommend that your application is refused in step 4.
With certain applications, MPI may need more time to complete the technical appraisal and risk assessment. This could be due to staff resourcing, or because we need to:
- consult with experts for scientific and technical support
- get consent from Medsafe before products containing prescription medicines can be registered
- consult with another directorate within MPI or with other government agencies before we can make a decision
- get Environmental Protection Authority approval before MPI can approve registration
- draft new MPI policy, amend existing policy, or obtain in-house legal opinion.
We'll ask you for an extension if we need more time.
- If you accept, we'll pause the 'clock' for appraisal.
- If you can't agree on a reasonable extension with MPI, we'll process the application based on available information. In these cases, the appraiser is likely to recommend that your application is refused in step 4.
The appraiser will recommend that we either grant or refuse your application. They may make a split recommendation for applications with multiple changes.
A delegate from the Director-General of MPI then decides whether to grant or refuse your application. This decision must be made within 15 working days.
The appraiser may recommend granting the application along with changes to the original product data sheet (PDS) or label content. If this happens, we'll ask you to submit the revised PDS or label content. The delegate’s decision won't be made until all outstanding issues have been addressed.
You must not import, manufacture, or sell the product until you receive your approval documentation.
When we approve your application, we'll issue you the appropriate registration documentation. This includes:
- the certificate of registration, which contains a unique registration number, registration expiry date, and any conditions applied
- the approved PDS, which details all the relevant information about the product (such as its manufacturer, formulation, and use)
- the approved label content.
Registrations are always conditional. If you don't comply with the conditions, MPI may prohibit importation, manufacture, and sale of the product. It's important that you read the list of conditions on the certificate of registration. That way, you'll be fully aware of your legal obligations.
Registration is normally for 5 years, after this you'll need to renew.
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