Veterinary Medicines Regulatory Newsletter, March 2025

1. Veterinary Medicines Directors’ update: Dr Donald Sibanda and Dr Dharma Purushothaman

Welcome to the March 2025 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Veterinary Medicines Regulatory Newsletter. This edition includes information on public consultations, strategic planning, manufacturing practices, changes to procedures, an update on guidelines, and general industry updates.

We continue to encourage applicants and holders to participate in the APVMA’s stakeholder meetings, which are conducted from February to October. These meetings are valuable for applicants, industry, and the APVMA. Meetings can be used to discuss current and future applications, priorities, and to provide a forum to work through any concerns. Please contact your case manager if you would like to organise a meeting. If at any time, you require assistance with matters related to the registration and variation of veterinary medicines, please reach out to the Enquiries Team.

If you have any suggestions or requests for content to be included in future editions of the APVMA’s Veterinary Medicines Regulatory Newsletter, please send these to the APVMA Communications Team.

2. New product registrations

The APVMA publishes a fortnightly Gazette, which includes information about new product registrations and variations to current registered products, particulars, or conditions of registration.

New veterinary product registrations based on existing active constituents that have been published in the Gazette since October 2024 are listed in Table 1.

3. Useful information for industry

In this edition, we have included information for industry on:

• stakeholder consultation on the APVMA draft Strategic Plan 2025–30
• requests for feedback on our draft Guideline on Data Requirements for Veterinary Immunobiological Products
• update to APVMA-Approved Labels logo
• updates to Good Manufacturing Practice (GMP) Audit Procedure
• the removal of 532 unregistered products from online stores
• Objective Connect: an alternative to Sigbox data transfer
• the new 6A guideline on remittance of certain application fees under the Agvet Code
• cost recovery performance reporting for the 2023–24 fiscal year
• the neomycin chemical review.

3.1. Have your say on the APVMA draft Strategic Plan 2025–30

The APVMA has opened consultation on the draft Strategic Plan 2025–30, outlining the organisation’s priorities and performance measures for the next 5 years. Stakeholders are encouraged to review the plan and provide feedback on its 5 strategic pillars and the proposed performance measures that will track progress.

Public consultation on the draft Strategic Plan 2025–30 is open until Wednesday 30 April 2025.

3.2. Submit your feedback on proposed updates to our Draft Guideline on Data Requirements for Veterinary Immunobiological Products

The APVMA is seeking feedback on proposed updates to our draft Guideline on Data Requirements for Veterinary Immunobiological Products (previously known as Guidelines for Registration and Data for New Veterinary Immunobiological Products).

The purpose of these updates is to outline the minimum data requirements and structure of the dossier for registering a veterinary vaccine, immunoserum, or colostrum product with the APVMA. It also provides guidance for manufacturers seeking to vary the particulars of a registered product.

Public consultation is open until Tuesday 8 April 2025.

3.3. Update to APVMA-Approved Labels logo

From 25 March 2025, the logo displayed on PubCRIS by the Australian Pesticides and Veterinary Medicines Authority (APVMA) on approved agricultural and veterinary chemical product label will change. Find out what is changing.

3.4. APVMA has updated Good Manufacturing Practice (GMP) Audit Procedure

In Australia, manufacturers of veterinary chemical products must be appropriately licensed by the APVMA, unless specifically exempt. As part of the
licence application approval or variation process, if an audit is required, the manufacturer must engage an APVMA–authorised GMP auditor to inspect the premises, equipment, processes, and facilities proposed to be used for the manufacture of a veterinary chemical product. The APVMA requires licence holders to arrange periodic re-audits to maintain a licence and confirm ongoing compliance. The GMP Audit Procedure document provides detailed instructions on how routine (full or partial) GMP audits of premises are to be planned, conducted and reported to the APVMA. The GMP Audit Procedure is also used when overseas manufacturing sites are audited for GMP by the APVMA.

The APVMA has recently updated the GMP Audit Procedure to enhance efficiency, transparency and compliance with audit best practice. This revision introduces a risk-based approach, streamlining audits while maintaining quality assurance standards. These updates reinforce APVMA’s commitment to excellence in veterinary chemical product manufacturing, promoting regulatory integrity, and industry collaboration. Please reach out to the Manufacturing Quality and Licensing (MQL) Team if you have any questions regarding the updated GMP Audit Procedure.

3.5. APVMA removes 532 unregistered products from online stores in 6 months

The APVMA continues to take action to protect the Australian community, most recently by removing 532 unregistered agricultural and veterinary (agvet) chemical products from online stores in the 6-month period from July to December 2024. 

The sale of unregistered products creates a serious risk to human health, animal welfare, or environmental safety, and this is reflected in the penalties associated with this unlawful activity. 

The law allows courts to impose penalties of up to $391,250 for advertising an unregistered product for sale, and up to $2.3 million for the supply or sale of an unregistered product.

To find out more information relating to this matter, please see the APVMA’s published media release.

3.6. Objective Connect: an alternative to Sigbox data transfer

The Veterinary Medicines Team is moving away from the Sigbox system for the receipt and transfer of data over the coming months. We are implementing an alternative system, Objective Connect, which is a faster, more user friendly, and more secure method for data transfer.

You can email the Veterinary Medicines Team to request the use of the Objective Connect service and provide the email address(es) for one or 2 people to use that workspace. The APVMA will open a ‘collaborative workspace’ where participant(s) can upload or download data files, folders or zipped folders.

Zipped folders are recommended for international dossiers and other situations where the folder structure is important and must be retained throughout the transfer.

You will initially receive an invitation to access the workspace and will need to follow the instructions to register an account with Objective Connect. After that you can sign into your account to access any open workspaces. Multiple folders can be open at the same time for applications in progress or pending submissions to the APVMA.

3.7. New 6A guideline on remittance of certain application fees under the Agvet Code

Section 6A of the Agvet Code provides that the APVMA may make written guidelines for performing our functions and exercising our powers under the Agvet Code. The APVMA has made a new 6A guideline on remitting certain application fees under the Agvet Code. Section 6A guidelines are intended to assist our staff in making decisions in a consistent and transparent way. While these are not guidelines for applicants, they may find them useful for understanding our decision-making processes. APVMA decision makers must now have regard to this new 6A guideline whenever deciding to remit application fees associated with application types described within this guideline.

A section 6A guideline is not the law and decision makers may depart from this guideline when appropriate to do so.

If you have any questions or comments on the section 6A guideline for remittance of certain application fees under the Agvet Code, please contact the Enquiries Team.

3.8. Cost recovery performance report: 2023–24 financial year

The APVMA published its cost recovery performance report for the 2023–24 financial year last year. The report details the financial outcomes of cost recovery activities for the 2023–24 financial year and has been prepared in accordance with the requirements of the Australian Government Cost Recovery Policy.

Please contact the APVMA’s Cost Recovery Team if you have any questions about the report.

3.9. Regulatory decision-making and reporting on adverse events

3.9.1. Neomycin chemical review

The APVMA is currently considering the submissions received in response to the neomycin public consultation prior to making a final regulatory decision.

Publication of the final regulatory decision is expected in the week commencing 19 May 2025.

For updates on this review process, please see the listing of neomycin status updates.

3.9.2. Adverse Experience Reporting Program

The APVMA operates an Adverse Experience Reporting Program (AERP) which is a post-registration program that assesses reports of adverse experiences associated with the use of a registered chemical product (or those on permit). Reports of adverse experiences are closely monitored by the APVMA.

It is important to record, assess, and classify adverse experiences to detect uncommon events not evident during the initial registration process of a product.

Problems reported with chemical products may result in further regulatory action in accordance with the legislation, for instance, through compliance action or chemical review. If the issue reported is related to control of use, or is otherwise outside the jurisdiction of the APVMA, the information may be referred to the appropriate authority.

Find out more about how to assess and report an adverse experience.

4. New, suspended, or cancelled manufacturer licences

The APVMA’s MQL Team record a list of licences for new manufacturers issued under subsection 123(1) of the Agvet Code and suspended or cancelled licences under subsection 127(1) of the Agvet Code. These records are then published in the Gazette.

Table 2 lists new licences issued since 1 October 2024.

Table 3 lists licences cancelled since 1 October 2024.

You can also view the complete list of current licenced Australian manufacturers.

Any questions about these licenses can be directed to the MQL Team.