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

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

In this month’s edition we cover:

  • Staff updates
  • AMR team update
  • Inhibitor update
  • Compliance update 
  • Agricultural chemicals application update
  • Veterinary medicines application update
  • ACVM applications approved in August 2025
  • International update - VICH
 

Above: Alison Weaver, Team Manager Assessments - Veterinary Medicines

Staff updates

We are pleased to introduce the new Team Manager Assessments - Veterinary Medicines, Alison Weaver.

Alison brings more than two decades of scientific, regulatory, and leadership experience across human and animal health, molecular diagnostics, and biotechnology to her new role as Team Manager Assessments - Veterinary Medicines at MPI.

Her career began in veterinary and agricultural science at Wallaceville Research Centre, working on fertility in sheep and Johne’s disease in cattle, before progressing into molecular genetics, microbiology, and applied diagnostics in human health. She has since held senior scientific and management positions in New Zealand and internationally, including at Novartis Pharma AG in Switzerland, Merus N.V. in the Netherlands, and within Contract Research organisations in the UK.

Early on in her career, she was the recipient of the Queen Elizabeth II technicians study award while at the University of Surrey in the UK. This led to her exposure to the development of antibody technologies for use in diagnostics, both human and animal, which at that time was a fast-emerging area. This fuelled her interest in immunotherapeutics, leading to her completing a Ph.D. in Molecular Immunology, also at Surrey University.

She has managed complex, multi‑country research programmes from early‑stage laboratory development through to regulatory submission and product approval, often in collaboration with large pharmaceutical partners. Her expertise spans stakeholder engagement, contract negotiation, regulatory compliance, and the coordination of multidisciplinary teams — skills that will be central to guiding the Veterinary Medicines team’s work.

More recently, Alison was an Alliance Manager for the Dutch biotech, Merus N.V. where she built and managed strategic partnerships. She also functioned as the bridge between internal teams and external partners and ensured both were aligned on objectives, timelines, and deliverables.

When she returned to New Zealand a year ago, Alison worked as a Molecular Technical Specialist at Ngaio Diagnostics, where she supported molecular biology products New Zealand wide and built strong relationships with scientists in universities, research institutes, and biotech companies.

With her blend of technical depth, regulatory insight, and proven leadership in both human and animal health contexts, Alison is well‑placed to lead the team in delivering robust, science‑based assessments that support the safe and effective use of veterinary medicines in New Zealand.

She looks forward to meeting both internal and external stakeholders of the Agricultural Compounds and Veterinary Medicines (ACVM) team.

Veterinary Medicine team vacancies
The Veterinary Medicines Team (Vet Meds) has recruitment underway to fill three vacancies in the team - for two permanent Advisers and one fixed-term Adviser for maternity cover. While this recruitment is underway, the Vet Meds team is operating at significantly reduced capacity.

 

Inhibitor update

The ACVM team is currently consulting on a new draft of the Guidance Document: Efficacy of Methane Inhibitor Products. The revised document has updated guidance on supporting qualitative label claims, providing more flexibility for registrants to obtain a market entry claim while managing the risks to animal welfare, food safety, and trade. Registration with a qualitative claim will enable registrants to enter the market and develop the additional data needed to demonstrate inhibitor efficacy at the scale required for carbon market and national Green House Gas Inventory inclusion.

Support meetings - we are here to help
While we are still waiting on the ACVM legislation to be amended to include inhibitors, we are mindful that the application process can be quite a challenging exercise for companies new to this requirement and can take longer than first thought. The anticipated amendment to the legislation will mean companies with products making inhibitor claims will have 12 months to obtain ACVM registration. Inhibitor products that require ACM registration, but remain unregistered after that period, will need to be withdrawn from the market until successfully registered under the ACVM Act.

For this reason, we are keen to engage with anyone who is contemplating ACVM registration for an environmental inhibitor product so we can support the development of their applications as soon as they are able. In the first instance, email Senior Adviser - Inhibitors Mark Aspin: Mark.Aspin@mpi.govt.nz. Mark can then advise on the process required and arrange, if needed, for additional technical input to answer any specific questions.

 

Compliance update 

ACVM compliance received 25 reports of potential or confirmed non-compliant ACVM products and activities in August, and 254 reports have been received to date:

 

Agricultural chemicals application update

As of the end of August, there were: 

  • 35 applications in the queue 
  • 62 applications in appraisal

In the queue, there are: 

  • 19 new product applications (14 A-Type and 5 B-Type) 
  • 11 new-use or use-change applications 
  • 4 deviation applications
  • 1 data assessment 

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

The uptake of new applications from the Ag-Chem queue has slowed, as Advisers are currently focused on a proportionally higher number of complex applications — such as those for new products, new uses, or changes to existing uses. These types of applications require more time to assess, which has reduced the capacity for picking up additional new applications from the queue. Meanwhile, new applications continue to be submitted steadily each week. To maintain efficiency, many chemistry and manufacturing variation applications are being appraised directly following the technical pre-screen (where accepted), with the screening Adviser completing the appraisal.

Veterinary medicine application update

As of the end of August, there were: 

  • 48 applications in the queue 
  • 103 applications in appraisal (36 of these are C10-Reassessment applications)

In the queue, there are: 

  • 18 new product applications (10 A-Type and 8 B-Type) 
  • 9 new-use or use-change applications 
  • 16 chemistry & manufacturing change applications
  • 3 deviation application 
  • 2 operating plans 

The Vet Meds team has been operating at about half capacity over the past eight weeks due mainly to open vacancies. This has directly impacted the team’s ability to complete assessments and take on new applications from the queue. At the same time, there has been a noticeable spike in new application submissions over the past month. The majority of these have been chemistry and manufacturing variation applications, which are automatically accepted into the Vet Meds queue. As a result, the overall number of applications in the queue has increased compared to the previous month.

ACVM applications approved in August 2025

 

International update - VICH

VICH is a trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration.  The Draft VICH GL 62 – (Biologicals) – TAS Evaluation for VMAP: Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products has been signed off at Step 3 of the VICH process by the VICH Steering Committee. It is now released at Step 4 for a 6-month public consultation period until 15 February 2026. The draft can be found on the VICH website here.

The following revised VICH Safety Guidelines have been signed off by the Steering Committee and formally sent to the VICH regions for implementation:

  • Draft VICH GL 22(R) – (Safety) – Reproduction: Studies to evaluate the safety of residues of veterinary drug in human food: reproduction studies
  • Draft VICH GL 23(R2) – (Safety) – Genotoxicity: Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing

These revised Guidelines are released for implementation at step 7 in the VICH regions by August 2026 and will be made available on the VICH public website.

 

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.

 
 
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New Zealand Food Safety
Telephone 0800 00 83 33

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