ACVM registration process: step by step
MPI’s process for registering an agricultural compound or veterinary medicine includes the following steps.
- Administrative pre-screen
- Technical pre-screen
- Public notification
- Technical appraisal and risk assessment
- Waiver of time
- Extension of time
- Post decision
Making sure your application is complete
If you're applying to register an ACVM trade name product (TNP), your application has to be complete before MPI can start processing it. Criteria that your application must meet are specified in our pre-screening processes.
Pre-screening ensures that your application contains all the required information. It also ensures that this information is appropriate for the application type. This is a two-step process. At either step, we may reject a deficient application.
We'll let you know when we receive your application, which will be processed by the operations team of MPI Approvals. We'll check that your application includes all of the required supporting documents. Whether your application is complete or not, we'll assign it a number, create a product file to hold the documents, and enter the relevant information into an internal database.
If your application is not complete, the Adviser-Operations (AO) will contact you. If it is complete, your application progresses to the next step, the technical pre-screen. AOs normally have a set of pre-assigned clients with whom they communicate regularly.
At this pre-screen stage, Technical Appraisers (TAs) decide whether the data supplied with your application will be sufficient to support registration. If they think the information is inadequate, your application won't be accepted for technical appraisal and risk assessment. The TA will then return your application to the relevant AO, along with a note identifying the deficiencies. The AO then contacts you with a request to address the deficiencies. (Note: Along with the standard pre-screen fee, we charge an additional technical pre-screen fee if this step is necessary.)
If you provide adequate information, your application will be accepted into the system. This marks the start of the 40-working-day regulatory timeframe for completing the registration, provided that the application does not require prior public notification (see below).
The application is allocated to a TA for the next step of the registration process: technical appraisal and risk assessment. (Unlike the AOs, TAs do not have pre-assigned clients.) The TA advises the relevant AO of the application’s technical pre-screen acceptance, and the AO in turn communicates this to you.
Section 14 of the ACVM Act requires all those applying for registration (or variations to existing registrations) to publish a notice in the NZ Gazette. However, section 15 of the Act grants MPI the ability to waive this notification if:
- there is a registered TNP with the same active ingredients and an equivalent formulation as the TNP being submitted for registration, and
- the variation to an existing registration does not affect the evaluation of risks relevant to the TNP.
Typically, you need to publish a notice when you're making an application for a new active ingredient (A1) or for a registered active ingredient with a new risk profile (A2).
The decision on whether or not to waive the requirement for public notification is made at the technical pre-screen stage. We'll inform you if the requirement is not waived. The notification period is 30 working days. This precedes the technical appraisal and risk assessment stage of the application.
TAs carry out the technical appraisal and risk assessment of the applications. They determine whether or not the product meets the criteria for registration as well as what conditions should be placed on the registration to manage any risks that have been identified. This phase can take 25 working days.
The TAs' recommendations on applications are made within the context of existing policies. The setting of these policies is separate from the registration process.
During the technical appraisal and risk assessment stage, the TA or the AO may contact you for additional information or clarification. If you can't provide the information within 5 working days, you should ask MPI for a Waiver of Time (WOT). WOTs do not normally exceed 20 working days.
If we accept your WOT request, we'll pause the regulatory clock for the appraisal of your application until we receive the additional information. If you don't make a WOT request – or if you make one, but we don't accept it for reasons we will communicate to you – the TA will complete the appraisal based on the available information. In such cases, the TA is likely to recommend that your application be declined.
With certain applications, MPI may need more time than specified in the regulatory framework to complete the technical appraisal and risk assessment part of the registration process. In addition to staff resourcing issues, the reasons for this could relate to one or more of the following:
- When processing registrations, TAs may need to consult with MPI experts or external experts for scientific and technical support. Obtaining expert opinion takes time.
- TNPs that contain prescription medicines as defined under the Medicines Act require consent from Medsafe before they can be registered under the ACVM Act. The time period for obtaining such consent is outside the control of MPI. Likewise, we may have to consult with another directorate within MPI or with other governmental agencies before we can make a decision on registration. Such consultations add time to the appraisal of a registration application.
- Some registration applications may require us to draft new MPI policy, amend existing policy, or obtain in-house legal opinion.
After the technical appraisal and risk assessment, the TA makes a recommendation either to approve or decline the application to register the product. A split recommendation may also occur. A delegate from the Director-General of MPI then decides whether the application should be approved or declined. As required by the ACVM Act, the decision must be made within 15 working days.
The TA may recommend an approval while also advising changes to the original product data sheet (PDS) or label content. In such cases, the AO will ask you to submit an amended PDS or label content. The delegate’s decision won't be made until all outstanding issues have been addressed. (This means you're not yet allowed to import, manufacture, or sell the product.)
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 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 normally issued for three years. After this period, they must be renewed.