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

In this month’s edition we will cover:
•    Upcoming ACVM events and meetings
•    Staff updates
•    VICH Guidelines update
•    Compliance update
•    Inhibitor update
•    Approvals Team Tips
•    ACVM applications approved in March 2025 
•    Agricultural chemicals application update
•    Veterinary medicines application update 
•    Veterinary medicines – multidose vials preservative release and expiry specifications reminder
•    Minor update to the veterinary medicines residues guidance
•    Subscribe to receive ACVM updates

 

Upcoming ACVM events and meetings

Workshop on minor uses of agricultural chemicals 
The Agricultural Compounds and Veterinary Medicines (ACVM) team is planning an in-person workshop on ‘minor uses of agricultural chemicals’ in Wellington on Monday 19 May. Many growers of minor crops do not have a large range of agricultural chemicals available for use on-label. This workshop is for all interested parties to come together to talk about the current situation for off-label use of agricultural chemicals in New Zealand and discuss ideas for possible improvements. 

The workshop is expected to cover the following topics:

  • residues and Maximum Residue Levels (MRLs) (New Zealand and Codex) – including the default MRL;
  • authorisation of label uses and obligations around off-label use; and
  • growing for domestic versus export markets.

A detailed agenda will be available soon.

Event Details:
Date: Monday 19 May 2025
Time: 1 - 4pm
Venue: Wellington (venue to be confirmed)
Charge: No cost
Register your attendance here: ACVM Minor Use Workshop registration

ACVM Annual Winter Workshop 
This year’s workshop will be held at Te Papa, Wellington, on Thursday 12 June, the day after the planned Animal Plant Health New Zealand (APHANZ) Annual Conference. We are currently planning this event and invite your suggestions for topics of interest to cover on the day. Please email these to karen.booth@mpi.govt.nz  

Presentations from previous events can be found here on our website.

A detailed agenda will be available soon.

Event Details:
Date: Thursday 12 June 2025
Time: 8:30am - 4pm
Venue: Te Papa, Wellington
Charge: $140 ex GST
Register your attendance here: ACVM Annual Workshop 2025 registration 

ACVM 101 Workshop 
ACVM will be offering an ACVM 101 Workshop on Friday 13 June, the day after the planned ACVM Annual Workshop. This event is targeted at regulatory affairs staff and other people that are new to the ACVM regulatory system. This will be an interactive day and as such, attendance is capped at 50. 

A detailed agenda will be available soon.

Event Details:
Date: Friday 13 June 2025
Time: 9am - 4pm
Venue: Wellington (venue to be confirmed)
Charge: $40 ex GST to cover catering (morning and afternoon tea, and lunch)
Register your attendance here: ACVM 101 Workshop 2025 registration

 

Staff updates

The Agricultural Chemicals & Vertebrate Toxic Agents Assessments (Ag-Chem & VTAs assessment) team welcomed back Monique Thomas from parental leave, who has returned as Adviser Ag-Chem and is working part-time (3 days per week).

The team has appointed Derek Hopkins into the full-time permanent role of Adviser Agricultural Compounds. Derek joined the ACVM team in October 2024 as an Adviser Ag-Chem, providing parental leave cover for Monique Thomas. Derek brings an extension knowledge in agricultural chemical manufacturing through his many years’ experience as a formulation scientist.

The recent recruitment round to fill an Adviser vacancy in the Veterinary Medicines team was unfortunately unsuccessful, and the team are managing increased workload resulting from this vacancy. Another recruitment round will be commenced later in the year.

 

VICH Guidelines update

VICH Guidance documents open for consultation

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

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
 

Compliance update

ACVM compliance received 35 reports of potential or confirmed non-compliant ACVM products and activities in March (as of 26 March 2025), and 81 reports have been received to date:

 

Inhibitor update

So far this year, 15 parties have met with ACVM, expressing interest in registering their products as environmental inhibitors across nitrogen and methane. Currently, five products are undergoing assessment in the registration process. 

The ninth Inhibitor Operational Forum (IOF) meeting was held on 2 April, with 42 people attending online and in-person. Forum members were updated on the progression of proposed changes to the current regulatory framework and discussed the update of the methane inhibitor efficacy guidelines to better accommodate the use of qualitative label claims. 

The revised guidance document for methane inhibitor efficacy has been circulated for targeted consultation with the IOF, and consultation will close on 9 May 2025.

 

Approvals Team Tips

Class Determination Master List

Class Determination (CD) applicants who require a master list of their exempt products will be charged at a rate of $262.20 per hour. Please provide a letter request for this in your CD applications or send an email to approvals@mpi.govt.nz.

 

ACVM applications approved in March 2025

 

Agricultural chemicals application update

As of 27 March, there were:

  • 30 applications in the queue
  • 64 applications in appraisal

In the queue, there are:

  • 15 new product applications (12 A-Type and 3 B-Type)
  • 11 new use or use change applications
  • 3 deviation application
  • 1 data assessment
  • There were no chemistry and manufacturing variation applications in the queue.

Half (15 of the 30; 50%) of the applications in the queue are for new products (12 A-type, 3 B-type). An additional 11 applications (37%) in the queue are new use/use change applications (C4-C8). These applications (87%) are more technical and can be complex to assess. The Ag-Chem and VTAs assessment team are working on options to progress the assessment of applications in the queue, particularly the new product applications.

Six of the new product applications in the queue are also waiting for Environment Protection Authority (EPA) approval.

 

Veterinary medicine application update

As of 27 March, there were:

  • 50 applications in the queue
  • 123 applications in appraisal
  • 3 applications with the Animal Imports team for biosecurity approval

In the queue, there are:

  • 14 new product applications (8 A-Type and 6 B-Type)
  • 5 new use or use change applications
  • 30 chemistry and manufacturing variations
  • 1 deviation application

The majority of applications in the queue are chemistry and manufacturing applications, making up 60% of the total queue. The oldest application in the queue was due to complete Technical Appraisal in December 2024, showing that queue time period is compact.

Across March, the Veterinary Medicines team received a higher number of applications compared to previous months, with 42 applications received. The team’s continued focus on processing applications has meant that the increase in incoming application numbers has not resulted in a significant increase in the queue numbers.

 

Veterinary Medicines – multidose vials preservative release and expiry specifications reminder

The current requirement for multidose sterile vials is that preservative efficacy testing (PET) will be performed to confirm that either:

  • inherent characteristics of the formulation mean it can withstand microbial contamination; or
  • where an antimicrobial preservative is added, PET identifies the minimum level of preservative necessary to ensure sterility will be retained during the approved in-use period. 

Where inclusion of a preservative is required, analytical testing confirming the expected quantity is included in every batch is now identified as a critical risk management quality control process. In consequence, historically approved multidose sterile products that currently do not stipulate a release specification for an antimicrobial preservative in the documentation on file with the Ministry for Primary Industries (MPI) will need to be updated when the next variation application is made.

A specification for preservative content at expiry, based on PET is also required. A copy of the fully validated method will also be required, in addition to a certificate of analysis with the preservative result. If an unrelated variation is submitted in the short-term, MPI will consider time extensions to enable the required work to be completed on a case-by-case basis.

 

Minor update to the veterinary medicines residues guidance

The Veterinary Medicines team has completed a minor update to the previously titled ‘ACVM Registration Standard and Guideline for Determination of a Residue Withholding Period for Veterinary Medicines’.

The update included:

  • a new document title, ‘Guidance Document: Determination of a Residue Withholding Period for Veterinary Medicines’; 
  • transfer of existing content into a new template;
  • replacing certain outdated terms e.g. ‘ACVM Group’ with ‘ACVM team’ and ‘waiver’ with ‘deviation’;
  • replacing outdated legislative references e.g. the New Zealand Mandatory Food Standard Table of MRLs with reference to the Food Notice: Maximum Residue Levels for Agricultural Compounds;
  • an update to the ‘Laboratory Data Handling and Statistical Analysis’ subsection for milk (previously section 8.3, now section 11.3), to include the criteria for considering dilution effects when setting milk withholding periods that was previously listed on the veterinary medicines withholding periods web page; and the
  • removal of Annexes 1 (template for other data elements summary) and 2 (data assessment report for WHP recommendation) in favour of links to the separate data assessment documents on the website.

The new document will available soon and will replace the New Zealand Food Safety Authority 2003 edition: ACVM-GUIDELINE-FOR-DETERMINATION-OF-A-RESIDUE-WITHHOLDING-PERIOD-FOR-VETERINARY-MEDICINES

We are also undertaking a complete review of all content in the veterinary medicines residues guidance, and stakeholder consultation will be conducted once the review is complete. 

 

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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