Keeping ACVM users, importers, and manufacturers up to date ✉️👍

No images? Click here

Welcome to our July 2025 edition of the ACVM News & Views newsletter.

In this month’s edition we cover:

  • Staff updates
  • Successful ACVM industry stakeholder workshops
  • AMR team update
  • Inhibitor update
  • Compliance and regulatory programmes update 
  • Agricultural chemicals application update
  • Veterinary medicines application update
  • ACVM applications approved in June 2025
  • VICH guidance update
  • Trial approval submission timeline reminder
  • Infection prevention and control policy
 

Above: Robert Yu, Adviser Inhibitors

Staff updates

The Agricultural Compounds and Veterinary Medicines (ACVM) team farewelled Richard McKinley on Friday, 27 June. Richard provided significant contributions to the ACVM team over his many years of service. His expert support and input, particularly in the ACVM Veterinary Medicines team, will be dearly missed and we thank him for all his efforts and wish him well for the future.

The ACVM team welcomed Robert Yu as the new Adviser Inhibitors. Robert has just completed a postgraduate certificate in Environmental Management with a strong emphasis on climate policy and ecological data analysis. He has worked in both human health and the dairy industry in analytical chemistry and test method development. Robert also holds a Postgraduate Certificate in Science (data science) and a PhD in biochemistry. His undergraduate degree was in science, covering a range of areas, including chemistry, biochemistry, animal physiology, molecular biology/genetics, soil, and environmental science.

 

Successful ACVM industry stakeholder workshops

The ACVM team held two successful workshops for industry stakeholders, following the Animal and Plant Health New Zealand (APHANZ) annual meeting on Wednesday, 11 June.

The ACVM Annual Winter Workshop, held on 12 June, spoke about the recent Ministry for Regulation (MfR) recommendations following their review of agricultural compound regulation, and the proposed actions. The workshop included a session discussing how industry would envisage prioritising applications (recommendation 9 on ”strategic pathways” in the MfR review report), as well as break-out sessions discussing issues relating to agricultural chemicals and veterinary medicines.

The interactive ACVM 101 workshop took place on 13 June and included taking new applicants through the process for registering or varying an agricultural compound. An introduction to the legislative framework set the scene for the day and was followed by sessions on:

  • the data or information that should be included in a data package;
  • tips for completing application forms and which documents are required;
  • a description of conditions used to manage risks; and
  • what to do if something goes wrong for a registered product.

Links to the presentations for both workshops, as well as the Minor Use Workshop held in May, are available on our ACVM resources webpage.

If you attended the workshops and did not receive the feedback survey, please complete the short survey here: Take the survey

Left: ACVM Manager Karen Booth leads an interactive session at the 12 June ACVM Annual Winter Workshop.

Above: Awilda Baoumgren explains the ACVM 101 agenda.

 

AMR team update

Low levels of resistant bacteria seen in sheep survey

The Antimicrobial Resistance (AMR) team has published the results of a one-off AMR survey in bacteria isolated from lamb carcasses. The AMR team contracted the Institute of Environmental Science and Research (ESR) to conduct a small survey of lamb carcasses from five processors over a period of four months in 2024. This survey followed the methodology of the larger AMR surveys conducted on other slaughtered animals (pigs, poultry, bobby calves) in the AMR surveillance programme.

In the annual Antibiotic Agricultural Compound Sales Analysis, sheep are reported to use low levels of antibiotics so it was expected there would be low levels of resistance in bacteria isolated from them at slaughter. This survey aimed to establish whether the perceived low risk of AMR from sheep is well-founded and determine if sheep should be included in the long-term, slaughtered animal AMR surveillance programme. The survey results showed there is a very low prevalence of AMR in bacteria isolated from lamb carcasses, and thus a low risk of transmission of AMR from this food animal.

No Campylobacter spp. or Salmonella spp. were isolated. Of the Escherichia coli isolated, all were susceptible to the antibiotics in the panel used. The proportion of resistant enterococci from lamb carcasses was generally equal to or lower than proportions of resistant enterococci from poultry, pigs, very young calves and dairy cattle in the 2018-2022 AMR survey conducted by ESR.

The full report is available on the AMR webpage under the AMR Surveillance and Monitoring heading.

 

Inhibitor update

Two additional urease inhibitors N-Protect and Flexi-N were registered on Wednesday, 25 June 2025. These products from Ravensdown Ltd, along with previously confirmed Ballance Agrinutrient’s SustaiN brings the total of environmental inhibitors authorised under the ACVM Act to three. An additional five trade name inhibitor products have been publicly notified and are being assessed.

The ACVM team has met with 19 organisations so far this year to discuss what is required to be registered. 

Consultation and refinement for efficacy requirements to support qualitative claims has continued and the ACVM team is intending to publish an updated guidance document in August.

The Ministry for Primary Industries (MPI) is currently consulting on proposed amendments covering changes to ACVM regulations, including aspects applicable to inhibitors, amending existing exemption categories, and proposed new exemption categories. Consultation will close on Sunday, 3 August 2025 and can be found on the MPI website. We encourage all interested parties to review this and submit their views on the proposed amendments.

The tenth inhibitor operational forum (IOF) will be held on Wednesday, 30 July, in Wellington, and members should have received a calendar invite already. The agenda is being finalised and members will receive this the week prior. If you are a member and have not responded to the calendar invite, noting attendance in person or on-line, please make sure to accept or decline, for catering purposes.

 

Compliance and regulatory programmes update 

Summary of regulatory programmes activities (2024/2025 FY):

  • 27 Good Manufacturing Practice (GMP) audits conducted 
  • 59 GMP site audit days completed
  • 1833 Adverse Event Reports (AER) received 
  • 20 Restricted Veterinary Medicine (RVM) operating plans approved

Upcoming GMP audit programme (2025/2026 FY):

  • 25 GMP audits required 
  • 75 GMP site audit days required

Summary of compliance activities (2025 YTD):

 

Agricultural chemicals application update

As of the end of June, there were:

  • 37 applications in the queue
  • 61 applications in appraisal.

In the queue, there are:

  • 20 new product applications (13 A-Type and 7 B-Type)
  • 11 new-use or use-change applications
  • 5 deviation application
  • 1 data assessment.

There are no chemistry and manufacturing variation applications in the queue.

 

Veterinary medicine application update

As of the end of June, there were:

  • 30 applications in the queue
  • 126 applications in appraisal (this includes 40 C10 re-assessment applications)
  • 4 applications were referred to Biosecurity New Zealand for biosecurity approval.

In the queue, there are:

  • 18 new product applications (10 A-Type and 8 B-Type)
  • 6 new-use or use-change applications
  • 4 chemistry and manufacturing variation applications
  • 1 deviation application
  • 1 operating-plan application.
 

ACVM applications approved in June 2025

 

VICH guidance update

The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) has adopted nine guidance documents that come into effect October 2025:

  • VICH GL7 Efficacy of anthelmintics: general requirements
  • VICH GL12 Efficacy of anthelmintics: specific recommendations for bovines
  • VICH GL13 Efficacy of anthelmintics: specific recommendations for ovines
  • VICH GL14 Efficacy of anthelmintics: specific recommendations for caprines
  • VICH GL15 Efficacy of anthelmintics: specific recommendations for equines
  • VICH GL16 Efficacy of anthelmintics: specific recommendations for porcines
  • VICH GL19 Efficacy of anthelmintics: specific recommendations for canines
  • VICH GL20 Efficacy of anthelmintics: specific recommendations for felines
  • VICH GL21 Efficacy of anthelmintics: specific recommendations for chickens

The following guidance document was released at Step 4 for public consultation until 31 May 2025:

  • Draft VICH GL 8(R) – (Stability Premixes) – Stability testing for Medicated Premixes

When published, you will be able to view the comments received during public consultation here: Activities | vichsec.

 

Trial approval submission timeline reminder

The ACVM team continues to receive a high volume of trial approval applications for both provisional registration and research approvals. While provisional registrations have a regulated approval timeframe of 40 working days, there is no similar regulatory timeline for research approvals. Nonetheless, to ensure timely approval before trial commencement, applications should be submitted at least 40 working days in advance. This timeline accommodates additional assessments often required under the Animal Products and Biosecurity Acts and helps the ACVM team manage the applications amid a heavy workload and various high priority workstreams.

In both cases, the ACVM team will typically aim to provide a decision and any applicable documentation within 25 working days from the date of receipt, provided all relevant information has been submitted and there are no delays related to associated approvals. 

 

Infection prevention and control policy

New Zealand Food Safety has published an overarching national policy on infection prevention and control (IPC) on the AMR page of the MPI website under the AMR Policies and Guidelines heading. This document was developed in response to Activity 1, Objective 3 of the New Zealand Animal and Plant Sectors’ AMR Implementation Plan, setting expectations for animal health and horticultural industries to develop best practice IPC guidelines.

IPC is the term commonly used in human hospitals and health care settings as a specific discipline to reduce transmission of pathogens. IPC is being considered in a wider context for this policy, to cover all aspects of infection prevention and control in the animal and plant sectors.

The policy does not set specific sector guidance; rather it provides overarching guidelines on what should be included when sectors produce prevention and control management guidelines specific to their stakeholders. Implementing these measures also reduces transmission of infectious agents between animals, humans, plants, and the environment.

Tackling AMR requires a whole-system approach to preventing infection in humans, animals, and horticultural crops. Reducing the burden of infection improves human, animal, and plant health, resulting in less use of antimicrobials, and so lowering the risk of antimicrobial resistance developing and reducing the spread of resistance.

 

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)

Subscribe to ‘Agricultural Compounds and Veterinary Medicines’ and ‘ACVM recalls’ on the Ministry for Primary Industries website to receive email updates on matters relating to ACVM.

 
 
  Share 
  Tweet 
  Share 
  Forward 

New Zealand Food Safety
Telephone 0800 00 83 33

If you do not wish to receive future issues of this newsletter please unsubscribe

Preferences  |  Unsubscribe