ACVM Christmas cut-off and NZFS shutdown dates for 2024 

As we near the end of 2024, please be aware of the cut-off dates for applications submitted to the Agricultural Compounds and Veterinary Medicines (ACVM) teams. These dates (below) are also in the email signatures of the Operations Team and the automatic reply from the Approvals inbox.

New Zealand Food Safety (NZFS) will endeavour to process ACVM applications prior to Christmas. Applications must have been submitted by 12 noon, Monday 2 December 2024 to be considered for the last pre-screen of 2024.

For any applications submitted after this date, you may not be notified of the pre-screen outcome until after Thursday 16 January 2025. 

Should the need arise for us to request further information, your application is unlikely to be approved prior to Thursday 16 January 2025. For all other applications received after 12 noon Monday 2 December, these may not be processed until the new year.

NZFS sites will also be closed from 12 noon, Tuesday 24 December 2024 and will reopen on Friday 3 January 2025. Our emails will not be monitored over this period, and there will be minimal staff available from 23 December 2024 through to 6 January 2025. For urgent issues during this time, key staff contact details will be outlined on the applicable out-of-office messages of the various inboxes as necessary or please phone 0800 008 333.

Welcoming Ilze Baiza and Derek Hopkins to the Agricultural Chemicals Assessment team

The Ag-Chem & VTAs Assessments team are pleased to share that they have welcomed two new advisers into the team:

• Derek Hopkins started at the end of October; filling the fixed-term vacancy (maternity cover). Derek comes to ACVM with considerable industry experience as a formulation chemist for agricultural chemicals, most recently at Arxada.
• Ilze Baiza started mid-November as a permanent adviser. Ilze also comes to ACVM with extensive experience, including roles as Regulatory Manager (Arxada), Regulatory Manager/Residue Expert (Agchem Project Consulting Ltd, UK) and Senior Scientific Officer (State Plant Protection Service of Latvia, Europe).

Derek and Ilze are great additions to the team and given their experience have both hit the ground running. They are fully immersing themselves into the team and the work that we do.

Compliance update

There were 35 reports of potential or confirmed non-compliant ACVM products or activities received from mid-October to mid-November 2024:

Inhibitor update

On 27 November, ACVM held the 8^th Inhibitor Operational Forum meeting. The Forum meets three times a year and was established in August 2022 to bring manufacturers, researchers, producer sectors and other interested parties together to discuss regulatory matters on inhibitor products. The Ministry for Primary Industries (MPI) provided updates on the Ministry for Regulation’s review of the ACVM/HSNO (Hazardous Substances and New Organisms) regulatory systems and progress on the Regulatory Systems (Primary Industries) Amendment Bill were provided. The latter is of interest as it is amending the definition of an ‘agricultural compound’ under the ACVM Act 1997 to include inhibitors. The final report and recommendations from the Ministry for Regulation review are due early next year. The other item of interest was the work to further streamline efficacy requirements for inhibitors under the ACVM Act. Attendees appreciated the updates, and the forum continues to have good engagement with the membership now at around 35 members.

Our Senior Advisor Inhibitors Maggie Wuerz left to return home to Canada on 11 October 2024. We are close to appointing a new person in this role.

AMR team update

World Antimicrobial Resistance (AMR) Awareness Week (WAAW) took place from 18-24 November, with the theme ‘Educate, Advocate, Act Now’. MPI worked together with the New Zealand Veterinary Association (NZVA) and the Veterinary Council of New Zealand (VCNZ) to promote vaccination of animals to prevent infections and therefore reduce the need for antibiotics. A poster was developed and distributed to veterinarians.

To promote WAAW, we:

• contributed articles in the veterinary industry magazines, VetScript and Hoofprint, and the New Zealand Veterinary Nurse Association newsletter;
• published a media release on the MPI website;
• posted on the MPI social media platforms; and
• held a webinar for veterinary professionals in collaboration with the NZVA and VCNZ to share practical ways veterinary staff can help prevent AMR. If you missed the webinar, you could watch it here: Webinar link.

We are continuing our outreach programme and recently delivered a webinar on AMR to veterinary nurse and technician students at Otago Polytechnic. In early December, we will be presenting an AMR team update to the One Health Symposium and also talking to Massey University’s veterinary students.

ACVM Approvals Online Project update

The ACVM Approvals Online Project (the Project) aims to replace a number of existing aging, 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

Phase 1 of the Project lays the building blocks of the overall solution and delivers the digitisation of several simple application processes, including the ‘Class Determination’ process. This has now been integrated into the MPI self-service platform ‘MyMPI portal’, and user testing is underway. The new ACVM Class Determination online system is scheduled to launch in early 2025.

External Reference Group (ERG)

We are grateful for the representatives from industry who joined the ERG to guide and assist the Project, and recently undertook user testing. 

The ERG will be among the first non-MPI users of ACVM Class Determination in soft launch which will deliver all the functionality a user needs to submit an application for class determination. Soft launch is expected to commence late January and will ensure the system is ready before it is released to all class determination users.

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

ACVM applications approved in November 2024

Agricultural chemicals application update

As of 29 November, there were:

• 37 applications in the queue
• 74 applications in appraisal

In the queue, there are:

• 24 new product applications (13 A-Type & 10 B-Type)
• 9 use-change applications
• 3 deviation applications
• 1 data assessment application
• 1 data assessment and deviation combined application.

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

Veterinary medicine application update

As of 29 November, there were:

• 51 applications in the queue
• 103 applications in appraisal
• 3 applications sitting with the Animal Imports Team for biosecurity approval.

In the queue, there are:

• 15 new product applications (10 A-Type & 5 B-Type)
• 5 use-change applications
• 29 chemistry and manufacturing applications
• 1 deviation application

International update

Codex Committee for the Residues of Veterinary Drugs in Food (CCRVDF)

The 27^th Session of the Committee on Residues of Veterinary Drugs in Foods was held from 21-25 October in the Unites States. The New Zealand delegation, led by Bill Jolly and included Warren Hughes, Karen Booth, Raj and Rachelle Linwood (from AgriZero), were successful in getting the Codex Committee on Residues of Veterinary Drugs in Food to agree to prioritise its first assessment of a methane inhibitor, bromoform, for a potential food safety and trade facilitating Maximum Residue Limit. The data package to support the application must be ready and assessed via ACVM by July 2025, so that bromoform can be considered by the Codex’s Joint FAO/WHO expert group (JECFA) in 2026. The data pack will be due to the Codex by the end of 2025.

At the same Codex Committee, New Zealand held our second side-event on Environmental Inhibitors (EIs). This event was well attended by Codex member countries. Raising awareness on EIs during this session at the beginning of the week helped to the build the support we needed to have bromoform agreed as a priority for a Codex risk assessment.

VICH 43^rd Steering Committee meeting (International Cooperation on Harmonisation of Technical Requirements of Veterinary Medicinal Products)

Karen Booth, Manager ACVM Programmes & Appraisals, attended the VICH Steering Committee and 7^th VICH Public Conference in Amsterdam in early November. VICH is an international body that works to harmonise technical requirements for the approval of veterinary medicinal products.

Karen provided an update on New Zealand’s activities in Codex on Environmental Inhibitors to Steering Committee regulators. Steering Committee members include founding members (European Union, Japan, and the United States) and standing members (Australia, New Zealand, Canada, and the United Kingdom). MPI, representing New Zealand, asked the group to consider opportunities that VICH provides for the regulation of EIs when used in the veterinary context. There was in-principal support from regulators for VICH to play a role here.

VICH Guidance documents update

The following nine guidance documents were adopted at Step 6, and 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 is released at Step 4 for public consultation until 31 May 2025:

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

Updated Ag-Chem application forms and templates came into effect from 11 November 2024

On 11 November, the following updated templates and forms were made available for use, which aligned with the new Chemistry & Manufacturing Guidance for Agricultural Chemicals:

• Agricultural Chemical Product Data Sheet (PDS) template;
• PDS guidance;
• Chemistry and Manufacturing data assessment report template; and
• Chemistry and Manufacturing variation application forms.

We understand that some applications will have already been in the process of being prepared prior to the new forms being made available, therefore we will accept applications on the old forms and templates until the end of 2024.

From 3 January 2025, any applications submitted will need to use the new versions available on the website: Agricultural chemicals documents, including agricultural chemical registration | NZ Government.

ACVM News & Views end-of-year survey

As we near the end of 2024, we’ve included a short survey asking about your experience with receiving ACVM News & Views. We would love to hear your thoughts so we can ensure we are sending you the content you want to see.

Please complete the short survey here. The survey will close on Monday 8 January 2025.

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)