Veterinary Medicines Regulatory Newsletter, August 2025

1. Veterinary Medicines Directors’ update: Dr Mariette van den Berg and Dr Donald Sibanda

Welcome to the August 2025 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Veterinary Medicines Regulatory Newsletter. This edition includes information on changes to application requirements, process enhancement initiatives, and other regulatory updates.

We encourage applicants and holders to participate in our 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. RSVP for Animal Health Industry Meeting – August 26

The APVMA is pleased to announce its support for the upcoming Animal Health Industry Meeting hosted by the Veterinary Manufacturers and Distributors Association (VMDA) and Animal Medicines Australia (AMA). 

A highlight of the event will be a dedicated update from our Chief Executive Officer, Scott Hansen, who will speak directly to attendees about the APVMA’s current priorities, and future direction.

The APVMA will also contribute to a range of agenda including:

• GMP Code Review
• Manufacturing licences, audits, and audit duration
• EMA proposal to amend veterinary medicine requirements and EU approval of Australian products
• Active constituent approvals
• Regulatory timeframe performance
• Veterinary medicine compounding
• Manufacturing licences
• Online sales of unregistered or illegally imported products

This is a valuable opportunity for industry professionals to engage directly with APVMA experts, ask questions, and strengthen their understanding of regulatory processes in a dynamic and supportive setting.

Date: 26 August 2025
Location: Rydges Parramatta Hotel, James Ruse Drive, Rosehill
Cost: $60 per attendee
RSVP: vmda@vmda.com.au before 15 August to secure your tickets

3. 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 new active constituents that have been published in the Gazette since March 2025 are listed in Table 1.

4. Useful information for industry

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

• Newly appointed Director of Veterinary Medicines
• Swissmedic and the APVMA agree on closer cooperation in the regulation of veterinary medicines
• Update on Item 6 and 7 application requirements
• Immunobiological product data guidelines
• TGA ingredient name changes
• Updated minor use guidelines
• Process enhancement initiative
• Updated APVMA labels
• Ministerial Expectations and Directives
• Veterinary Medicines Working Group
• APVMA seeking external scientific reviewers

4.1. Dr Mariette van den Berg: Newly appointed Director for Veterinary Medicines

We are delighted to announce that Dr Mariette van den Berg has been permanently appointed to the position of Director of Veterinary Medicines and will be leading the Immunobiologicals product stream.

Dr van den Berg commenced her Bioveterinary science career at Wageningen University and Research (WUR) in the Netherlands, where she held positions in the research and development and manufacture of foot-and-mouth disease (FMD), Blue Tongue Virus (BTV), and Tuberculosis vaccines for the Dutch government at ID- Lelystad. She also worked for the exotic animal diseases diagnostics unit during those years.

In 2009, Dr van den Berg moved to Australia to pursue her passion in equine nutrition, specialising in gut microbiome and oro-sensory and post-ingestive feedback mechanisms. With over 15 years’ experience in consulting and tertiary education she held various research and academic roles at the Massey University (NZ) and University of New England (AUS). In 2017, Mariette joined the regulator based in Armidale NSW with an interest in veterinary Immunobiologicals and Nutritionals.

Dr van den Berg is looking forward to continuing her work with stakeholders and supporting the Veterinary Medicines Team.

4.2. Swissmedic and the APVMA agree on closer cooperation in the regulation of veterinary medicines

The APVMA and Swissmedic have signed a Memorandum of Understanding (MoU) that will facilitate collaboration in the regulation of veterinary medicinal products.

The MoU aims to promote an understanding of each other's regulatory circumstances, requirements and processes for veterinary medicinal products, and to facilitate the sharing of information and documents. This will promote collaboration between the 2 authorities both on bilateral initiatives and as part of multilateral bodies such as the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In particular, this MoU will help to increase exchanges in policies, practices, standards, pre-market assessment, post-market surveillance, pharmacovigilance, scientific advice market compliance, regulation of manufacturers and requirements for the regulation of veterinary medicinal products and undertake collaborative activities.

More information regarding this update can be found on apvma.gov.au.

4.3. Update on Application Requirements for ‘closely similar’ Item 6 and 7 Applications

On 11 June 2025, the APVMA provided an update on Item 6 and 7 Applications and their use of reference products. This update took effect immediately and applied to Item 6 and 7 applications already with the APVMA as well as those submitted in the future. Please note that while this update is specific to Item 6 and 7 applications, the APVMA is reviewing its position regarding the use of reference products more generally. As such, more updates should be anticipated.

More information regarding this update can be found on apvma.gov.au. Applicants are encouraged to contact the APVMA if they have any further questions regarding submissions of item 6 or 7 applications.

4.4. Immunobiological product data guidelines

In 2023, revisions to the APVMA Guideline for the registration of new veterinary vaccines were initiated to update our guidance to ensure that it remains fit-for-purpose in a modern regulatory environment.

The updates to the immunobiologicals guideline aims to outline the minimum data requirements and structure of the dossier for the registration of veterinary vaccines, immunosera or colostrum products with the APVMA. It also provides guidance for manufacturers seeking to vary the relevant particulars or conditions of a registered product.

Between 2023 and 2025, the Veterinary Medicines Team consulted with industry on the proposed revisions through the Immunobiological Working Group (VIWG). The Draft Guideline on Data Requirements for Veterinary Immunobiological Products was completed early 2025 and went out for public consultation on 11 March 2025. The public consultation closed on 8 April 2025 and a total of 4 relevant submissions have been received from veterinarians, consultants, registrants/manufacturers and/or industry groups.

The next steps are for the Veterinary Medicines Team to review the comments and work towards a final version for the Guideline on Data Requirements for Veterinary Immunobiological Products. The expected timeframe would be between August and September 2025.

Following the review of final guideline, the Veterinary Medicines Team is intending to commence the revisions to the APVMA Guideline for variations to registered veterinary vaccines.

4.5. TGA ingredient name changes

In recent years, the TGA has been amending ingredient names and these are now being updated in the Poisons Standard (the Standard for the Uniform Scheduling of Medicines and Poisons, or SUSMP). While there had been a discretionary period in which dual naming was permitted, affected medicines released for supply, with some minor exceptions, are now required to reflect the new names. Additional information regarding this change can be found at Updating medicine ingredient names - the overview | Therapeutic Goods Administration (TGA).

The APVMA is working to align the naming of agvet chemicals with the Poisons Standard. Under the Veterinary Labelling Code, the name for a scheduled constituent must be the name specified in the current Poisons Standard. Applicants and holders are encouraged to check and adopt the new ingredient naming requirements for new product registrations and active approvals, where applicable. Applying these changes to existing product registrations, by updating relevant particulars of the label and registration at the next or future variation application is also advised. For existing active approvals, there is no requirement for amendments to naming under a variation application, but holders can contact the APVMA at their discretion should they wish to have the new ingredient name.

Please contact us through enquiries@apvma.gov.au if you have any further questions.

4.6. Updated minor use guidelines published

The APVMA has published updated guidelines for determining minor use.

The new guidelines came into effect on 5 August 2025. Prior to this, the APVMA contacted permit holders directly via email to manage the transition to the new guidance.

Implementation of the new guidelines will be accompanied by a 12 month phase-in period, as outlined in the transition map.

A detailed response addressing the consultation feedback has now been published on our website.

Enquiries about the new guidelines should be sent to enquiries@apvma.gov.au.

4.7. Process Enhancement Initiative – have your say!

To help shape the future of the APVMA and drive operational efficiency, the APVMA is undertaking a Process Enhancement Initiative.

We want to ensure that our processes are regularly updated and remain accessible for regulated entities. We are committed to remaining efficient, effective and accountable by keeping up to date with advancements in processes and technology.

Since the release of the Australian Government’s detailed response to the Rapid Evaluation, we have taken significant steps in the implementation of efficiencies, including the identification and review of current processes. We are also currently seeking constructive feedback from stakeholders on how our processes can continue to be further improved, while continuing to meet statutory criteria.

4.8. Update to APVMA approved labels

In line with Section 8 of the Agricultural and Veterinary Chemicals Code Regulations 1995, labels displayed on PubCRIS for approved veterinary products will now display the official APVMA logo. This logo change came into effect as of 25 March 2025.

4.9. Ministerial Expectations and Directives

Ministerial Statements of Expectations (MSoEs) are issued to regulators by the minister responsible for that portfolio. MSoEs offer clarity on government policies and objectives which are relevant to the regulators. After receipt of an MSoE, a regulator is required to respond with a ‘Statement of Intent’ which outlines how the regulator will deliver on ministerial expectations. 

The APVMA is considered an entity performing a regulatory function as part of the Department of Agriculture, Fisheries and Forestry portfolio. As such, the APVMA responds to a Ministerial Statement of Expectations issued by a responsible Minister with a Regulator Statement of Intent which outlines how the agency will deliver on Government expectations.

4.10. Veterinary Medicines Working Group

The Veterinary Medicines Working Group members have been appointed. The working group facilitates engagement between the APVMA and registrants, permit holders, industry representatives, and other regulated entities to discuss fees and levies, application processes, regulatory requirements, and operational matters related to the regulation of veterinary medicines.

Current members and information on the terms of reference and meeting summaries are found on apvma.gov.au.

4.11. APVMA seeking external scientific reviewers

The APVMA is seeking to expand its pool of External Scientific Reviewers (ESRs) to support the scientific assessment of agricultural and veterinary (agvet) chemical products.

We invite expressions of interest from professionals with expertise in environmental toxicology, human health toxicology and efficacy and target animal safety.

If you are interested in joining the pool of ESRs, more information is available on apvma.gov.au.

5. Temporary Extension of MQL Audit Review Timeframes

The Manufacturing Quality and Licensing (MQL) Team will continue the temporary extension to the timeframe for completing audit reviews.

This adjustment will continue for the financial year 1 July 2025 to 30 June 2026, during which the APVMA will target completing 90% of audits within 4 months of receiving the information.

The continued extension will allow the MQL team to focus on key areas including the review the new Good Manufacturing Practice (GMP) Audit procedure and Australian Code of Good Manufacturing Practice for Veterinary Chemical Products, work instructions, additional process enhancement activities and APVMA structural changes. This will provide opportunity to improve our services into the future.

The MQL Team understands that some audits may need to be prioritised. Any priority requests should be directed to the Assistant Director in MQL for consideration where capacity allows.

The APVMA expects return to the completion target of 90% of audits within 3 months from 1 July 2026.

6. Chemical Review

6.1. Forecast chemical review timeframes extended

The APVMA has revised the expected publication dates for some proposed regulatory decisions.

The APVMA is committed to undertaking rigorous evidence-based reviews and must consider all relevant information. Consequently, the timeframes for these reviews have been extended to appropriately consider information that has been provided or identified.

6.1.1. Fipronil

The expected publication of the proposed decisions on fipronil veterinary chemical products has been delayed until March 2026.

6.1.2. Neonicotinoids

Proposed decisions on the individual chemistries within the neonicotinoid review (acetamiprid, clothianidin, dinotefuran, imidacloprid, thiacloprid and thiamethoxam) will be published separately commencing in late 2025.

7. 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 13 February 2025.

Table 3 lists licences cancelled since 21 February 2025.

Table 4 lists suspended licences since 7 March 2025.

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

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