Veterinary Medicines Regulatory Newsletter, July 2026

1. Veterinary Medicines Team update

Welcome to the July 2026 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Veterinary Medicines Regulatory Newsletter. This edition includes information on the APVMA’s: 

• Veterinary Industry Day in August
• regulatory posture 
• release of Technical Reports
• permit requirements
• vaccine formulation information
• quarterly performance reporting
• Australia-NZ joint product registrations
• adverse experience reporting
• advice for managing manufacturer information on the product register. 

Stakeholders are welcome to get in touch using the contact options available below. Whether you have a general enquiry, require an update on your application or have feedback, there are several convenient ways to reach the APVMA, and we look forward to hearing from you.

If you are seeking an update on an application currently under assessment but not addressed under the scope of the stakeholder meeting, please contact your case manager.

If you require assistance regarding a future application, please submit an enquiry directed to the Veterinary Medicines Team. 

If you have suggestions or requests for content for upcoming editions of the APVMA’s Veterinary Medicines Regulatory Newsletter, please direct these to the APVMA’s Communications Team.

2. Veterinary Industry Day 18 August 2026

The APVMA is pleased to be hosting a Veterinary Industry Day (VID) on Tuesday 18 August 2026 in Sydney.

The VID will bring together stakeholders from the veterinary industry – primarily those working within regulatory affairs and/or closely with the APVMA – to interact with APVMA staff and learn about recent changes to our registration processes, as well as the information we require to streamline approvals.

We received a great amount of interest in the VID and have now closed our expression of interest (EOI) form. Stakeholders who submitted an EOI will soon be provided with more information on how to register to attend. If you missed out on the EOI, please contact Enquiries@apvma.gov.au and ask to be placed on the waitlist. 

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 December 2025 are listed in Table 1.

4. Useful information for industry

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

• The APVMA regulatory posture statement 2026–30
• Clarification on the release of Technical Reports
• Manufacturing details on the product register
• Chemistry and manufacture: active approvals
• Process guidance for permit applications for veterinary chemicals
• Updated approach to veterinary vaccine formulation recording
• Quarter 3 performance reporting (March 2026)
• The Trans‑Tasman pilot for joint product registrations
• Harmonised labels
• Periodic Summary Updates Reports (PSURs) for FY2025–26

4.1. APVMA regulatory posture statement 2026–30

In February 2026, the APVMA released its Regulatory Posture Statement 2026–30. This statement sets out how we will apply our statutory powers, deliver our regulatory functions, and engage with industry, government and the community to build trust and maintain confidence in Australia’s agricultural and veterinary (agvet) chemicals regulatory system.

The Statement clearly articulates the principles, behaviours and expectations underpinning the APVMA’s role as an independent regulator. It also reinforces our commitment to being trusted, transparent, fair and accountable. It aligns with the Australian Government’s Regulatory Policy, Practice and Performance Framework and the principles of best‑practice regulator performance and complements the APVMA’s Strategic Plan 2025–30 and Corporate Plan 2025–29.

A key focus of the Statement is the APVMA’s risk‑based and proportionate approach to regulation, prioritising resources toward the areas of greatest risk to human and animal health, the environment and Australia’s trade, while supporting agricultural productivity and innovation. The Statement also emphasises the importance of evidence‑based decision‑making, consistent and predictable outcomes, and clear agency – stakeholder communication.

The Regulatory Posture Statement responds to recommendations from the Australian Government’s review of the APVMA’s future governance arrangements and reflects our renewed focus on continuous improvement, transparency and stakeholder engagement to strengthen confidence in the agvet chemical regulatory system.

4.2. Clarification on release of Technical Reports

The APVMA engages internal and external experts across risk assessment disciplines, including Chemistry, Safety and Efficacy, Health, Environment, Residues and Trade, to prepare Technical Reports in support of application assessments. These reports provide detailed scientific and technical advice to inform regulatory decision making.

Technical Reports are prepared for internal use by APVMA risk managers and delegates. They form one component of the evidentiary base considered in reaching a decision, alongside the application, supporting data, and the relevant legislative criteria.

In many cases, past practice has involved providing these reports to applicants upon completion, prior to delegate consideration. This has contributed to process inefficiencies, as applicants have responded to preliminary scientific views before the delegate had formed a position. In some instances, this has resulted in unnecessary submission of additional information and extended assessment timeframes, particularly where the delegate did not intend to adopt the conclusions of the Technical Report. This approach has also blurred the distinction between scientific assessment and regulatory decision making.

To improve consistency and efficiency, the APVMA will no longer routinely provide Technical Reports to applicants prior to the delegate’s decision. Reports may instead be provided with a notice of proposed decision or the final decision notice, as appropriate.

Each application is assessed on its own merits against the legislative criteria in force at the time of decision. Previous assessment reports are not determinative for subsequent applications. An earlier assessment that appeared supportive does not establish an ongoing position and cannot be relied upon as the sole basis for a future application, nor should applicants assume that previous technical conclusions will be maintained. Each new application is assessed on its merits.

Applicants remain responsible for ensuring that applications are complete, accurate and supported by sufficient data at the time of submission.

4.3. Manufacturing details on the product register

Registrants can submit an Agvet Code request to ask for a record of the manufacturers listed for their product. Currently, the APVMA may not be able to release information for repacked products where the manufacturer details are Confidential Commercial Information (CCI). In these situations, the registrant may wish to consult with the holder of the original reference product and/or discuss options with the APVMA prior to lodging an Item 13A application. The APVMA has also initiated the inclusion of all the relevant particulars (includes manufacturers) in section 8F notices related to new registrations or variations involving changes to manufacturers. 

4.3.1. Where can I find the licence details for Australian-based manufacturers?

Australian-based manufacturers will have a printed copy of their licence in their possession. In addition, we publish a list of all licences held by Australian-based manufacturers on our website. This alphabetical list includes details about the approved site, licence number, licence category, and steps of manufacture.

Applicants are asked to check this list or confirm with the manufacturer before proposing the addition of an Australian-based manufacturer to a veterinary chemical product.

For Australian manufacturers:

• Confirm all Australian sites are current and correctly recorded on your registration.
• Check licence details using the APVMA list of licensed manufacturers.
• Ensure steps of manufacture match the information in your supporting documentation.
• Submit a variation to remove any Australian site no longer in use.

For overseas manufacturers:

• Review all o/node/12326verseas sites listed on your registration and confirm they remain in use. 
• Remove unused overseas sites via a variation application.
• Ensure GMP evidence is current and that listed manufacturing steps match your supporting documentation.

4.4. Chemistry and manufacture: active approvals

Section 7 of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 requires that an application for an active constituent or product include, or be accompanied by, safety criteria information. 

For active constituents, the delegate must have regard to the matters listed in section 5A(2) of the Agvet Code Act. Therefore, in order for the APVMA to assess an active constituent, the application for a new active or variation must be accompanied by safety criteria information which includes, but is not limited to, the: 

• method of manufacture
• extent and nature of the impurities
• toxicity of the constituent and its impurities
• metabolites and degradation products 
• analytical methods and results

For active constituents that claim to meet a pharmacopoeial standard, applicants may be asked to provide data to support the safety of the active constituent when the APVMA cannot be satisfied of the safety criteria from the Certificates of Analysis alone. The safety criteria can often be addressed by providing information such as data prepared in accordance with the APVMA Chemistry Data guidelines or a Drug Master File (DMF), including both the Applicant’s Part (AP) and Restricted Part (RP). 

In some circumstances, a Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) may be adequate to address the safety criteria. However, the APVMA  may request additional information about the manufacture and quality control of the drug substance, additional information about how the impurity limits specified in the CEP have been justified by the manufacturer and assessed by the European Directorate for the Quality of Medicines and Healthcare (EDQM), copies of the EDQM evaluation report and any related correspondence between the manufacturer and the EDQM.

Applicants are also reminded that the following guidelines are applicable to veterinary chemicals:

• VICH guideline GL18: impurities: residual solvents in new veterinary medicinal products, active substances and excipients
• ICH Q3D: Guideline for elemental impurities

Further guidance on the chemistry and manufacture of veterinary active constituents is available on our website.

4.5. Process guidance for permit applications for veterinary chemicals

From 1 September 2025, the Veterinary Medicines Team assumed responsibility for the processing and assessment of Item 19, 20, 21, 22 and 23 permit applications relating to veterinary chemicals.

4.5.1. Application requirements for permit applications

Full details of the application requirements for permit applications can be found in sections 36 to 55 of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014. Some, but not all, of the requirements include:

• The application (form) must clearly specify each of the active constituent(s) or chemical product(s) for which a permit is being sought. 
• The application form is limited to only the display of one formulation for an unregistered product. Formulation information for multiple formulations much be provided as attachment(s) and must meet section 4.
• The application form must be complete, with all fields populated with appropriate and specific responses. The use of “As per PER XXX” is not acceptable, as it does not meet the information requirements of the Instrument.
• For Item 21 and 22 applications, section 46 of the Instrument requires that a statement of reasons be provided that clearly justifies the need for a minor or emergency use permit and explains why no registered chemical product is suitable or effective.
• For Item 19, 21, 22 and 23 (research/ miscellaneous) permit applications covering products, applicants must identify the manufacturers and provide all relevant steps of manufacture for the product. This is not required for miscellaneous permit, specifically supply of batch or oversticker for label. 
• Item 21, 22 and 23 applications must include the relevant safety criteria information listed in section 5 of the Instrument, as well as information on product efficacy. Where data are not available, applicants may provide a justification for consideration by the APVMA delegate.
• For Item 21, 22 and 23 (miscellaneous) applications covering products, applicants must provide appropriate evidence or justification of Good Manufacturing Practice (GMP) as part of the safety information submitted with the application.

4.5.2. Pathways for permit extensions

The APVMA provides several pathways for extending permits, and applicants must choose the appropriate route based on their circumstances.

Item 20 – Extensions based on existing assessments

Where an applicant considers that their application is fully supported by a previous assessment and no new technical data are required, an extension may be sought under an Item 20. However, applicants should note that applications to extend the duration of a permit made under section 115(3) of the Agvet Code is not subject to a preliminary assessment and cannot be altered. After the application is lodged, we will determine it under this section of the Agvet Code. 

An Item 20 may also be used for new permit applications where reliance on a previous valid assessment is justified; applicants should clearly identify this at the time of submission. These applications are assessed under section 112 of the Agvet Code.

The applicant should consider if their previous assessment remains contemporary and that the requirements of section 115(3A) or section 112 of the Agvet Code are fully met. The APVMA must refuse applications that do not meet the legislative criteria. 

When an item 20 is not appropriate

An item 20 is not appropriate in situations in which one or more of the following scenarios apply:

• There are administrative or technical changes to the permit.
•  Applicants are required to report against existing permit conditions.
• The previous assessment is not contemporary and/or has missing information to satisfy the statutory criteria.

In these circumstances, applications must be submitted under the relevant Item 19, 21 or 23 pathways.

Other Relevant Pathways

• Item 19, 21 or 23: Used for new permits or extensions involving changes or additional information.
• Item 22: Required for extensions of existing emergency permits.

Timing and compliance expectations

Applicants are responsible for lodging extension applications with sufficient time to allow for APVMA assessment. Applications submitted late may not be assessed before the expiry of the existing permit.

Applicants seeking to extend a permit must demonstrate that all conditions of supply under the current permit have been met. Where conditions have not been met, applicants must provide a clear justification for APVMA consideration on a case-by-case basis. The APVMA delegate may refuse an application if not satisfied that the applicant can comply with permit conditions.

Should you have any questions in relation to these arrangements please contact enquiries@apvma.gov.au.

4.6. Updated approach to veterinary vaccine formulation recording

The current approach to recording veterinary vaccine formulation information has resulted in inconsistencies, due to the use of dual formats that split information between final product bulk formulation and the administered dose formulation. These inconsistencies vary across presentations (e.g. ready-to-use, frozen, lyophilised) and administration methods (e.g. eye drops, coarse spray).

For regulatory alignment and consistency, the APVMA will align vaccine formulation recording with the standard approach used for pharmaceutical and agricultural chemical products. Going forward, the Register will reflect the manufacturing final product bulk formulation i.e. the composition used to fill the final container for each net content presentation. Where this differs from the labelled or administered dose formulation, this will be documented separately.

Applicants will be required to provide final product bulk formulation details in the application form, with administered-dose formulation information included in the Part 2 (Chemistry & Manufacture) dossier or as an attachment. Historical APVMA records will not be comprehensively updated; instead, changes will be made progressively through variation applications or voluntary updates. Further guidance will be provided via the Veterinary Industry Working Group and future newsletters.

Vaccines with materially different antigen inputs or potency at the final product bulk formulation level are considered new product formulations and requires separate registration. If your products or applications in progress are affected, please contact the APVMA.

4.7. Quarter 3 performance report 2025–26

The APVMA has released its quarter 3 (Q3) performance report for the 2025–26 financial year. The report demonstrates continued delivery of science-based regulatory outcomes that protect human health, animal welfare and the environment.