Compliance update

The number and classification of incidents received in February 2024 (Total 18):

Inhibitor update

ACVM has accepted two urease inhibitor applications for appraisal.  Both products have undergone public notification and are being appraised by the ACVM team. Both are agricultural chemicals that prevent the release of ammonia into the atmosphere. Ammonia is a precursor to the greenhouse gas nitrous oxide.

ACVM has yet to receive any methane inhibitor applications, which would classify as veterinary medicines.

ACVM continues to meet with prospective applicants to discuss regulatory requirements. Given that the technologies behind inhibitors are diverse, there is a wide range of stakeholders with whom to engage.

The three-yearly inhibitor operational forum took place on 27 March 2024. This ACVM-run forum included representatives from the Ministry for Primary Industries’ Policy and Greenhouse Gas Inventory teams, and from the Environmental Protection Authority, to inform on inhibitor matters under the Hazardous Substances and Novel Organisms Act 1996. Members from industry, academia and consulting are all represented at this forum. It is a place for members to discuss regulatory requirements for their developing inhibitor products. Should you wish to attend the next meeting scheduled for July 2024, please contact approvals@mpi.govt.nz 

Application processing times 

ACVM Applications approved in February 2024:

Veterinary Medicines Queue update

The Veterinary Medicines team has seen an uptick in the number of applications submitted through the month of March, which has resulted in an increase in the queue numbers. The oldest application in the queue for completing technical appraisal (day 25 of the 40 working day timeframe) was due on 31 January 2024. This shows that the team has worked through the peak of applications that were due to complete technical appraisal between September 2023 and November 2023, and the tail of the queue is significantly shorter.

The queue still remains largely chemistry and manufacturing (C1-C3) changes, with these applications making up about 85% of the total queue. This is similar for the number of applications that are referred back to the applicant with a Request For Information (RFI), where 75% of these are chemistry and manufacturing changes.

The trial to reduce the queue and increase efficiency - where C1, C2 & C3 applications were automatically accepted into the queue without pre-screen - has proven successful. This has now moved from a trial to standard procedure. The trial has had positive impacts across the board. The impact of this process change has on the number of applications that are on time waiver is yet to be fully seen. This emphasises the importance of ensuring all of the correct data, documents and justification are submitted with your application. 

New Agricultural Chemicals Requirement and Guidance

Public consultation closed on 8 December 2023 for two agricultural chemical documents:

• Registration Information Requirements for Agricultural Chemicals
•  Agricultural Chemical Registration Guidance Document

Thank you to those who provided feedback. We have responded to your emails individually. These documents are now replacing the previous ‘ACVM Registration Information Requirements for Agricultural Chemicals in New Zealand’, dated April 2011.

Veterinary Medicine BCS Class II Active Ingredient Particle Size Reminder

The following was communicated in the April 2021 edition of ACVM News and Views:

It is now well understood that for veterinary medicines active ingredients like benzimidazoles that have low aqueous solubility and high permeability (Biopharmaceuticals Classification System Class 2 substances) will exhibit particle size dependent dissolution. It is also recognised that absorption, and hence efficacy of poorly soluble actives after administration, is limited by dissolution.

To ensure the bioavailability and efficacy profiles of suspensions containing such substances are not compromised by the presence of large particles, ACVM expects that particle size distribution specifications will be included as part of the active ingredient and/or formulated product release specifications. Registrants, please review the suitability of existing active ingredient and formulated product specifications for veterinary medicines that contain BCS Class 2 active ingredients and, where necessary, take the appropriate steps to establish particle size distribution specifications.

Submit variation applications as soon as specifications have been established and no later than 5 years. If specifications have been historically established for the active ingredients, please confirm what they are when you submit your next variation application.

The ACVM team would like to remind registrants with products containing these actives, to review and ensure that there are particle size distribution specifications for the actives. If not, submit a variation application as soon as specifications have been established before March 2026.

Charging for ACVM public notification/gazettal

Following a review, we have looked at our on-charging process for ACVM public notification or gazettal. We have had a longstanding nominal charge of $160 plus a half hour admin charge. To reflect actual cost from the Gazettal office, we will now on-charge any fees charged for public notification in addition to New Zealand Food Safety’s hourly rate, based on cost versus time it takes to process the notification.

These costs took effect from 1 April 2024. For information on the New Zealand Gazette’s fees and charges please refer to the Fee’s page on New Zealand Gazette website.

ACVM AOL 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 investment in the ACVM Approvals Online (AOL) solution and proceeding with 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 in iterative releases, over the next 12 to 18 months. The project team is working on the first of those releases, which includes the “Class Determination” process, the development is well underway and is expected to be completed by July 2024.

The project’s cost recovery model and the impact from Phase 1 on the ACVM levies and fees were assessed and are part of the current Cost Recovery Annual Package review process.

External Reference Group (ERG)

The external reference group (ERG) has been established with representatives from the industry to disseminate project information to their industry bodies and represent their industry’s views. The ERG will also guide/help the project in performing user testing and change-management activities. The last ERG meeting was held in February 2024. The next meeting is expected to be in April 2024

Contact Us

ACVM Team, Assurance, New Zealand Food Safety / Haumaru 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)