Ministry for Regulation’s agricultural products regulatory review

On 13 June, the Minister for Regulation announced a review of the regulatory approval pathways for new agricultural and horticultural products. Currently, new agricultural products (e.g. veterinary medicines, pesticides, herbicides, environmental inhibitors) require approval from the Environmental Protection Authority (responsible for the Hazardous Substances and New Organisms Act 1996) and New Zealand Food Safety (NZFS) at the Ministry for Primary Industries (responsible for the Agricultural Compounds and Veterinary Medicines Act 1997). The Ministry for Regulation will lead the review. MPI is engaging closely on this with the Ministry for Regulation alongside relevant government agencies.

ACVM annual workshop

Thank you to all who have already registered for our annual workshop, being held at Te Papa, Wellington, on Wednesday 31 July 2024.  You can register here: ACVM Annual Workshop 2024 Tickets, Wed, Jul 31, 2024 at 9:00 AM | Eventbrite

The workshop is scheduled to run from 9am to 4pm, with tea and coffee available from 8.30am. Please see the draft agenda below.

Information requirements to support efficacy of generic intramammary products used in cattle

Clinical endpoint studies are generally required to confirm the efficacy of generic intramammary products, given that their administration into, and local action in, the target site of action (for example the udder) precludes the use of blood level studies to support bioequivalence. However, where a product is ‘closely similar’ to the reference product, ACVM may waive the requirement to provide in vivo studies to support efficacy. The MPI Equivalence of Veterinary Medicine Trade Name Products guidance has been updated to reflect this.

MPI will reference information requirements found in the Annex of the EMA/CVMP/344 Guideline on the conduct of efficacy studies for intramammary products for use in cattle when assessing these applications.

Following the above equivalence guidance document: a ‘closely similar’ product contains:

the same Active Pharmaceutical Ingredients (APIs) at the same concentration, administered in the same dosage form using the same formulation type, at the same dose rate, to the same target animal, for the same clinical indications AND contains non-active ingredients that are the same or equivalent at the same or equivalent concentrations or, if non-active ingredients are not the same or equivalent, differences are minor and will not affect product quality or biological activity, and product specifications AND physico-chemical properties are the same or equivalent or, if different, will not adversely affect product quality or biological activity.

Compliance update

The number and status of incidents received in May 2024 (Total 39)

Inhibitor update

The next Inhibitor Operational Forum meeting is on 24 July 2024 in Wellington. This will be an avenue for regulators, researchers, consultants, and industry to meet to discuss regulatory requirements for inhibitor products. If you are interested in attending, please contact Warren Hughes at warren.hughes@mpi.govt.nz

ACVM continues to work through the processing of four urease inhibitor products for trade name registration. Additionally, ACVM has received and approved 43 research approval applications, which include trials on methane inhibitors and urease/nitrification inhibitors.

ACVM has not received any registration applications for methane inhibitor products.

New Zealand Food Safety annual package

New Zealand’s reputation for safe and suitable food has been built over generations and is backed by a robust and respected regulatory regime based on international best-practice science and risk assessment.

As a critical part of this system, NZFS provides a range of vital services to New Zealand food businesses to help manage risks to human and animal health.

As part of an annual cost recovery update to reflect changes in financial environment and requirements, the annual levy and fees in the ACVM regulatory system are increasing. Thank you to all those who submitted feedback on the Annual Review 2024.

Cost recovery plays an important role in funding these services and ensures that those who use government services for commercial or private benefit pay for those services. After considering all feedback, the Government decided to increase the Agricultural Compounds and Veterinary Medicines (ACVM) levy and fees.

A phased approach will be taken to increasing the annual levy and fees in the ACVM regulatory system to fully recover annual costs and accumulated deficits.

Both the levy and the fee will be phased in over several years to reduce the initial burden on industry. This is achieved by delaying the recovery of the deficit.

ACVM applications approved in May 2024

Agricultural chemicals application update

As of 21 June, there were:

• 30 applications in the queue
• 121 applications in appraisal
• 0 applications sitting with the Plant Imports Team for biosecurity approval

In the queue there are:

• 19 new product applications
• 9 use-change applications
• 1 data assessment
• 1 deviation application

Brodifacoum review

Work continues to review, summarise and respond to all of the submissions from the public consultation which closed on 26 January 2024 on the proposed changes to the regulatory controls covering the manufacture, sale, storage and use of brodifacoum. Once finalised, this document will be shared with all submitters at the end of July 2024.

There has been a delay in the publishing of a dedicated web page to share all the relevant information and ongoing updates in relation to this area of work. We now expect to share the link to this in the August edition of ACVM News and Views.

ACVM and APVMA joint position statement on harmonised labels

In June, the ACVM and APVMA published a joint position statement on harmonised veterinary medicine labelling. This can be found on the ACVM website in the alerts and notifications section.

Obtaining Animal Products Act approval for past veterinary medicine trials

The new veterinary medicine trial approval process is now up and running. This allows for simultaneous approvals under the ACVM, Animal Products and Biosecurity Acts to be granted at the same time. Because the previous process required Animal Products Act (APA) approvals to be sought separately, we have noted that there are some registrants and researchers now looking to get their APA approvals in place after their trials have finished, and are unsure of how to proceed.

Trials approved without assigned withholding periods and with animals excluded from the food chain. Trials are approved without withholding periods and food chain approval when an applicant declares trial animals will be excluded from the food chain or when there is insufficient information available to set a withholding period. To get APA food chain approval granted in these cases, registrants and researchers will need to apply to both vary the ACVM controls and get APA approval. They can do this by submitting a completed Veterinary Medicine Trial Approval Data Sheet (ACVM 81), proposing the withholding period(s) requested and providing the data and information to justify the proposal. The new trial animal controls, including APA food chain eligibility, will then be assessed as a variation to the original approval, even if the trial has already been completed.

Trials approved with assigned withholding periods under the previous process, where APA approval has not yet been sought. If a trial approval has been granted with withholding periods in place, the ACVM assessment has concluded that the trial animals can be eligible for the food chain and the ACVM controls do not need to be reconsidered. To get APA food chain approval granted for these trials, applicants can either:

a) Complete and submit an Veterinary Medicine Trial Approval Data Sheet (ACVM 81)with Parts A-F and Appendix 1 completed, or;

b) Resubmit the provisional registration or research approval Product Data Sheet approved when the ACVM trial approval was granted and a completed Appendix 1 from ACVM 81.

Please note the information in Parts A-F of ACVM 81 (or the old Product Data Sheet) is used to inform the APA assessment and controls, so the submission of a completed Appendix 1 alone will not be accepted.

If you have any questions regarding a specific ACVM or APA trial approval, please contact us.

ACVM approvals online IT system project update

The project objective is to replace a number of existing ageing, disparate systems that support the current ACVM process with a new solution that:

•  is online, supports self-service, and improves overall business process efficiency and transparency to make it easier for the ACVM customers to work with MPI;
• provides MPI with data insights to facilitate continuous business process improvements.

Project status

In December 2022, MPI formally approved the investment in the ACVM Approvals Online (AOL) solution and to the build of Phase 1. Phase 1 aims to lay the reusable building blocks of the solution and deliver the digitisation of several simple application processes.  The development of ACVM AOL Phase 1 - which includes the “Class Determination” process - is expected to be complete by 31 July 2024. Once completed, the solution will be merged with the MPI self-service initiative.

The project’s cost recovery model and the impact on the ACVM levies and fees were finalised and became effective from 1 July 2024

External reference group

The external reference group (ERG) has been established with representatives from industry to disseminate project information to their industry bodies and represent their industry’s views. ERG will also guide/assist the project in performing user testing and change management activities.

The last ERG meeting was held in May 2024. The next meeting date will be communicated in July 2024.

For any queries or additional information, please contact us at approvals@mpi.govt.nz

Contact Us

ACVM Team, Assurance, New Zealand Food Safety / Haumaru Kai Aotearoa

Pastoral House, 25 The Terrace

PO Box 2526

Wellington 6140

New Zealand

Email approvals@mpi.govt.nz  

Website Agricultural compounds and veterinary medicines (ACVM) | Agriculture | NZ Government (mpi.govt.nz)