Compliance update

The initial classification of incidents received in January 2024 (Total 13):

Inhibitor update

ACVM has formally received and accepted its first two inhibitor products for assessment for trade name registration. Both products are urease inhibitors, with proposed label claims of reducing ammonia emissions when applied alongside urea fertilizers. Both have been publicly notified in the New Zealand Gazette.

ACVM continues to communicate with prospective applicants on the requirements for registration.

In February 2024, the Senior Advisor Inhibitors presented on regulation of inhibitor products at the Farmed Landscape Research Conference. These avenues of communication add to the understanding for companies looking to register inhibitor products with ACVM in the future.

Application forms updated

There are now two new veterinary medicine application forms available on  MPI’s  Veterinary Medicine Documents webpage for variation applications:

• a veterinary-medicine-specific 1V form (1V-VM), and
• one consolidated veterinary medicine chemistry and manufacturing variation form (ACVM 79).

The new veterinary medicine 1V-VM  now includes post-approval assessment and vet medicine reclassification application options in section 7, more guidance on the documentation to be provided to support each application, a new section to identify when a product has outstanding conditional data requirements, and a revised biosecurity section. 

The new consolidated veterinary medicine chemistry and manufacturing form ACVM 79 simplifies the process of applying for these kinds of changes by combining expectations set out in ACVM 6 (C1 changes), ACVM 7, 8, and 9 (C2 changes), and ACVM 10 and 11 (C3 changes). The new form also ties directly to the Chemistry and Manufacture of Veterinary Medicines (Chemical) guidance document, facilitating a clearer approach to both applying for and assessing veterinary medicine chemistry and manufacturing applications.

The existing 1V and ACVM 6-11 forms have been amended to remove veterinary medicine content and refocus those forms on agricultural chemical and VTA applications. The 1V has also been amended to update the biosecurity section, as per the 1V-VM, to clarify expectations in that space, but otherwise remains unchanged with respect to agricultural chemical and VTA applications. These updated versions are also available on the Agricultural chemicals documents, including agricultural chemical registration MPI webpage.

The ACVM 12 (C4/C5 applications), ACVM 13 (C6/C7 applications), and ACVM 14 (C8 applications) remain unchanged.

Veterinary medicine registrants are encouraged to start using the new 1V-VM and ACVM 79 application forms for veterinary medicine applications, although the previous forms will continue to be accepted until 30 April 2024. From that point, veterinary medicine applications will not be accepted for assessment without the 1V-VM (all veterinary medicine variations) and ACVM 79 (veterinary medicine chemistry and manufacturing variations) forms being provided.

Application processing times 

Key points for January 2024:

Work on assessments for agricultural chemicals (Ag-Chem) and vertebrate toxic agents (VTAs) was balanced with the post consultation work for the updated Information Requirements and Guidance documents as well as the updated Chemistry and Manufacturing Guidance document.

Applications Approved in January 2024:

Veterinary Medicines Queue update

The Veterinary Medicine Queue continues to trend downwards, with the queue sitting at 70 applications as of Friday 16 February. The earliest due applications are now due in December 2023, so the queue is currently only 2 months behind. The table below shows snapshots of the queue just after the start of the pre-screen trial, the end of 2023, and the most recent snapshot.

The pre-screen trial has proven to be beneficial to the team, in allowing additional time to work on applications. In the past few weeks, the team has been picking up more applications from the queue that have not been pre-screened. While some of these have needed to go back to applicants with requests for more information, a number of these have been able to progress straight to Delegate Decision, indicating a complete and high-quality application.

Education and Resources section of AMR webpage updated 

New resources available on antimicrobial resistance (AMR) and methicillin-resistant Staphylococcus aureus (MRSA) on MPI website.

The AMR team has collaborated with industry to develop resources for veterinarians about antimicrobial resistance and methicillin-resistant Staphylococcus aureus (MRSA) in dairy cattle.

In New Zealand, MRSA is an increasing cause of serious infections in humans. Veterinarians have recently diagnosed MRSA in dairy cattle on a few farms. Genetic analysis suggests humans may have been the initial source of infection. A diagnosis of MRSA should be based on tests carried out by a laboratory with validated methodology to confirm MRSA.

The resources include advice on:

• managing cattle diagnosed with MRSA;
• steps to prevent introduction of MRSA to the farm;
• reducing transmission within the herd;
• reducing risk to people working with dairy cattle;
• use of milk and meat from MRSA infected cattle; and.
• sale of MRSA infected cattle.

Veterinarians can use the farmer fact sheet on the MPI website to help explain MRSA to their clients.

The veterinarians fact sheet provides a more detailed review of MRSA in dairy cattle.

In addition, there is general information on antimicrobial resistance (for any veterinarians who would like a refresher on AMR, including resistance mechanisms and definitions, such as multi-drug resistance).

See MPI’s AMR webpage under “AMR education and resources” to find out more about antimicrobial resistance.

If you would like more information about MRSA or AMR, or you have a case study of MRSA that you would like to share, contact the AMR team at amrteam@mpi.govt.nz.

Minor update to the Guidance Document: Chemistry and Manufacturing of Veterinary Medicines (Chemical)

Registrants may have noted that the Chemistry and Manufacture of Veterinary Medicines (Chemical) guidance document is now dated 13 February 2024 due to a recent minor update to its content. The only change was an update to and reformatting of the recognised regulatory authorities table in Appendix 5: Acceptable Evidence of GMP Compliance for Formulated Product Manufacturers. All other content in the document remains unchanged.

A review of this guidance document will start soon to ensure all chemistry and manufacturing data expectations are clear and complete. Consultation will be undertaken with veterinary medicine registrants once a revised draft is completed.

Revised Veterinary Medicine Trial Approval Guidance and data sheet nearly completed

Our revision of the veterinary medicine trial approval process is nearly complete. This work, which aims to consolidate the ACVM and Animal Products Act approval processes to streamline and expedite trial approvals, will result in a new Veterinary Medicine Trial Approval Guidance document and one new veterinary medicine data sheet for both provisional registration (section 27 of the ACVM Act) and research approval (section 8C) trial approvals. The new guidance and form will also incorporate information to facilitate both Biosecurity Act and Animal Products Act approvals, meaning that applicants will be able to submit one application for all three approvals at the same time.

The guidance and form are currently being finalised and are expected to be available on the MPI website for veterinary medicine use in early March. The existing provisional registration and research approval guidance documents and data sheets will also be revised to refocus their use for agricultural chemical and VTA applications only. They will be available on the MPI website at the same time.

Reminder: Electronic submission file names and collating of documents

ACVM is continuing to receive files submitted for applications without sufficient identification in the file name, for example no ACVM number, PDS and/or labels without dates.  Please familiarise yourself with the guidance for electronic submission of applications. Please pay particular attention to structuring the submission, using the file naming convention, and ensuring all files are fully indexed and searchable. This will expedite the screening and review process, and result in reduced assessment time and associated fees. If you submit large files that are not clearly indexed and are unable to be searched, you may be asked to resubmit these in a more appropriate format.

ACVM is also receiving variation applications with many single or couple of page electronic files (>20).  For larger variations, with many single-page supporting documents, for example CofA, packaging specifications, it is expected that these are collated into one electronic file. Larger files should be indexed with summary/discussion, and supporting evidence attached. Even combining three CofA with an appropriate file name ‘Axxxxx Ivermectin Batch analysis (YY manufacturer) – 3 batches’, rather than submitting three individual files makes a difference. 

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)