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

Welcome to the December 2025 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Veterinary Medicines Regulatory Newsletter. This edition includes information on the APVMA’s new science leadership, application guidance, strategic planning and other regulatory 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 Veterinary Medicines Team via enquiries@apvma.gov.au.

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

Table 1: New registrations of a veterinary product with a new active constituent or a new formulation type of an existing active constituent.
Application no.Product nameActive constituent/sApplicant nameDescription of the application and its purposeDate of registrationProduct registration no.
141506Zenrelia 15 mg Tablets for DogsEach tablet contains 15 mg ilunocitinibElanco Australasia Pty LtdRegistration of a 15 mg ilunocitinib oral tablet product for the reduction of pruritus associated with allergic dermatitis and reduction of clinical signs of atopic dermatitis in dogs, in conjunction with the approval of a new active ilunocitinib.13 October 202594087
141510Zenrelia 8.5 mg Tablets for DogsEach tablet contains 8.5 mg ilunocitinibElanco Australasia Pty LtdRegistration of a 8.5 mg ilunocitinib oral tablet product for the reduction of pruritus associated with allergic dermatitis and reduction of clinical signs of atopic dermatitis in dogs, in conjunction with the approval of a new active ilunocitinib.13 October 202594088
141511Zenrelia 6.4 mg Tablets for DogsEach tablet contains 6.4 mg ilunocitinibElanco Australasia Pty LtdRegistration of a 6.4 mg ilunocitinib oral tablet product for the reduction of pruritus associated with allergic dermatitis and reduction of clinical signs of atopic dermatitis in dogs, in conjunction with the approval of a new active ilunocitinib.13 October 202594089

141512

 

Zenrelia 4.8 mg Tablets for DogsEach tablet contains 4.8 mg ilunocitinibElanco Australasia Pty LtdRegistration of a 4.8 mg ilunocitinib oral tablet product for the reduction of pruritus associated with allergic dermatitis and reduction of clinical signs of atopic dermatitis in dogs, in conjunction with the approval of a new active ilunocitinib.13 October 202594090

3. Useful information for industry

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

3.1. New science leaders for the APVMA

The APVMA has recently welcomed 3 outstanding executives to lead its new science branches:

  • Lee Metcalf, Executive Director of Veterinary Medicine
    • The Veterinary Medicine branch is responsible for pre-market regulation of veterinary chemical products. It is divided into Registration and Permits, Chemistry and Manufacture, Efficacy and Safety and Health, Residues and Trade.
  • Dr Maria Trainer, Executive Director of Science and Assurance
    • Dr Maria Trainer has served in an executive role at the APVMA for more than 7 years. She now oversees Chemical Review, Manufacturing Quality and Licensing (MQL) and Assurance, Science Policy and Capability. She also leads international engagement efforts, shapes operational policy, and develops guidance to support regulatory clarity and scientific integrity.
  • Dr Ed Cram, Executive Director of Agricultural Chemicals
    • The Agricultural Chemicals branch is responsible for premarket regulation of agricultural products.

Additional information regarding our new science leadership can be found on our website. 

In November the Veterinary Medicines Branch also welcomed Dr Helen Hughes as a Director, she is responsible for veterinary medicines registration, case management, and administrative sections. She joined the APVMA from the Therapeutic Goods Administration (TGA), where she held several senior regulatory roles.

3.2. Guidance on using reference products

The APVMA has published new guidance on how to use reference products to satisfy the statutory criteria. This clarifies how applicants can nominate reference products as part of an application, and how the APVMA considers reference products and other information against our statutory criteria. We are updating our web pages that set out requirements for applications relying on reference products. The new guidance sets out the requirements in one place while this update is underway.

The APVMA is contacting applicants with applications that were in progress on 11 June 2025 that relied on reference products to discuss next steps. Applicants can withdraw their application and request a refund of the original application fee and are encouraged to submit a new application in line with the updated guidance.

If you believe you have an application that is affected and you have not heard from us, please contact casemanagement@apvma.gov.au.

More information is available on our website.

3.3. FAQs – updates to manufacturing sites

Q: There is a change to the manufacturing site details for my veterinary chemical product or approved active. Do I need to lodge an application for this change?

A: Yes.  Under Regulation 17C of the Agvet Code, it’s a condition of approval or registration that the active record and product registers must contain information about current and approved manufacturing sites.

For information on options to update the registers, please see: Product Guidance and Active Guidance on www.apvma.gov.au.

Q: My product is a repack and I don’t know the original manufacturer details. What should I do?

A: Under Regulation 17C, it’s a condition of registration that the manufacturing site details on the product register are up to date. The APVMA will also require the details for the sites you wish to remove from the register(s).

If you do not know the original manufacturing sites, you have the following options:

  • Request the relevant information from the registrant of the repacked product and provide it to the APVMA with your application.
  • Apply for the update and have the other party provide the details direct to the APVMA for the application.
  • Obtain written consent from the other party for the APVMA to access the information from the register for the purposes of the variation application.

Applicants can submit an Agvet Code Request to obtain the information from the APVMA, but the APVMA cannot disclose the manufacturers’ details if they are identified as Confidential Commercial Information unless consent is obtained.

Q: The manufacturer has already updated their license details with the APVMA. Do I still need to lodge an application to update this change of manufacturer’s information on my product?

A: Yes. Only the registrants of registered products, their nominated agents or the authorised agents for either party can apply to update a product register.

If the company is a registrant and/or a manufacturer, they will need to update both their manufacturing license and their product register.

Q: If a manufacturer changes its license, how will I know?

A: The APVMA publishes details of current manufacturing sites and licenses on our website, and publishes new or changes licenses in the APVMA Gazette. Stakeholders can also subscribe to receive email notifications.

3.4. Process guidance for permit applications for veterinary chemicals

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

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 should be complete with all fields entered with appropriate responses. The use of “As per PER XXX” is not acceptable as it does not provide the required information under the above Instrument.
  • Applicants are required to provide steps of manufacture and appropriate evidence or justification of Good Manufacturing Practise (GMP) with their application (s.37(2) of the Instrument).
  • A statement must be provided with the application justifying the need for the permit (s.37(2)). For item 21 or item 22 applications this should include reasons why the permit is minor or emergency use and why no registered chemical product is suitable or effective (s.46).
  • Item 21, 22 and 23 applications must contain the relevant safety criteria information listed in section 5 of the Instrument, and information relevant to the efficacy of the product. If data is not available, applicants can choose to provide a justification for the APVMA delegate.

Applicants wishing to extend an existing permit must demonstrate that they have met all conditions of supply on the current permit(s) before a new permit approval will be considered.  Alternatively, an applicant must provide a justification for the reasons why these conditions have not been met for the APVMA delegate to consider on a case-by-case basis. The delegate may refuse an application if they are not satisfied the applicant is able to comply with permit conditions.

Please note that for an extension of an existing permit, where no technical assessment is required, an item 20 application can be lodged. Otherwise, a new permit application under the relevant item number is to be submitted. An extension of an existing emergency permit should be lodged as an item 22. It is the applicant’s responsibility to ensure they lodge their extension application with sufficient time for the APVMA to assess it.

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

3.5. APVMA Annual Report 2024–25

The APVMA Annual Report for FY2024–25 provides a comprehensive overview of the agency’s operations, achievements and challenges during the last financial year.

The report offers an overview of the APVMA’s performance against strategic goals and regulatory responsibilities, reflecting our commitment to accountability by providing transparency to Parliament and the Australian public.

Key highlights include:

The full Annual Report for FY2024–25 is available on apvma.gov.au.

3.6. APVMA releases its Strategic Plan 2025–30

The APVMA has released its Strategic Plan for 2025–30. This plan outlines a clear purpose to protect the health and safety of people, animals and the environment, and to support primary industries, biosecurity and international trade for all Australians. The plan sets out 5 strategic objectives that will shape the agency’s priorities over the next 5 years. Its release coincides with the release of the APVMA Corporate Plan 2025-29.

The 5 strategic objectives featured in the plan are:

  1. Being a trusted, transparent and fair regulator
  2. Supporting a contemporary regulatory system
  3. Building regulatory foresight capability
  4. Striving for operational excellence
  5. Attracting, developing and retaining talented people

Each objective is supported by targeted activities and performance measures. These include improving the timeliness and quality of decisions, enhancing communication with stakeholders, and investing in digital infrastructure and workforce capability.

3.7. New APVMA Chemical Products Standards

The Agricultural and Veterinary Chemical Code (Chemical Products) Standard 2025 (the Products Standard) is a legislative instrument made on 6 August 2025 under section 6E of the Agricultural and Veterinary Chemicals Code (the Agvet Code), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.

The draft Products Standard was published for consultation (as required under regulation 8AF(1) of the Agricultural and Veterinary Chemicals Code Regulations (the Regulations) on the APVMA Website and in the APVMA Gazette, on 10 June 2025. Consultation closed on 8 July 2025, and no comments were received in response to the consultation.

This instrument has been made to set standards for agricultural and veterinary chemical products containing malathion as the active constituent. In undertaking its recent reconsideration of malathion, the APVMA identified a risk to users from toxic impurities formed during manufacture and storage of products containing malathion. To treat this risk, the APVMA imposed several new controls on products containing malathion, including making a standard to limit impurities in products containing malathion as an active constituent.

Further information on the APVMA’s Final Regulatory Decision on malathion can be found in the APVMA Special Gazette, 2 May 2024. The Products Standard will help ensure that continued use of products containing malathion are safe for people, plants, animals and the environment by setting limits for toxic impurities.

It is envisaged that the Products Standard will be amended from time to time as required, for example if a need is identified in a future reconsideration of another active constituent for a standard to ensure that continued use of that active is safe for people, plants, animals and the environment.

For further information please contact:  Director of Chemistry and Manufacture via enquiries@apvma.gov.au.

3.8. Non-steroidal anti-inflammatory drugs efficacy evaluation guidance

The APVMA has published a guideline for the evaluation of efficacy of non-steroidal anti-inflammatory drugs (NSAIDs).

This guideline has been developed to specify recommendations for the design, conduct, and evaluation of clinical studies for NSAIDs to be provided in support of an application to register a new NSAID, or to vary the indications of an already registered NSAID. It provides recommendations on how to appropriately demonstrate clinical efficacy through clinical trials where the selection of control and efficacy endpoints is regarded as a key issue for obtaining conclusive information. The guideline also includes safety aspects when studies are undertaken to assess efficacy.

We consulted on the draft guidance document, a total of 3 submissions were received from industry groups, and the feedback was considered in the development of the final guideline.

3.9. Beransa canine injections – updated labels

The APVMA has updated the labels for Beransa Solution for Injection for Dogs (also known as ‘Librela’ overseas).

This update includes rare, and very rare side effects identified through adverse experience reporting.

Beransa is a monoclonal antibody drug used for the alleviation of pain associated with osteoarthritis in dogs. The APVMA registered Beransa in September 2022. This product is available by veterinarian prescription only, and veterinarians are best placed to assess the individual needs of each dog, balancing potential risks and benefits of the product.

The APVMA follows international best practice for the categorisation of side effects based on how likely they are to occur.

The APVMA rigorously assessed available evidence during the initial registration process and is satisfied that the product meets the safety, efficacy, trade, and labelling criteria, when used as directed.

Additional information is found on our website.

The APVMA encourages anyone who believes they have experienced problems with an agvet chemical product to submit a report to the Adverse Experience Reporting Program (AERP) via the online reporting form.

3.10. Immunobiological product data guidelines update

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 Veterinary Medicines Team have reviewed the comments and completed a final version for the Guideline on Data Requirements for Veterinary Immunobiological Products. This was presented at the Veterinary Immunobiologicals Working Group (VIWG) meeting on 27 November 2025. We hope that we will publish the guideline in first quarter of 2026.

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.

3.11. VICH Guideline for consultation

VICH GL62 Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products was released for a 6 months consultation in August 2025. The use of this VICH guideline (GL) is recommended for the Target Animal Safety evaluation of a veterinary monoclonal antibody product (VMAP), a class of biological therapeutic products which contain a monoclonal antibody (mAb) or a mAb fragment.

The consultation is open until 15 February 2026. If you have any comments, please submit them to VICH.

3.12. APVMA holiday closure

The APVMA will be closed for operations from close of business Wednesday 24 December 2024 and re-open Friday 2 January 2026. The APVMA Enquiries line will be closed from 12 pm AEDT Wednesday 24 December 2025 and reopen at 9:30 am AEDT Friday 2 January 2026.

As this is the final Veterinary Medicines Regulatory Newsletter for 2025, the Veterinary Medicines Branch would like to take this opportunity to wish all our stakeholders a safe and happy holiday period.

4. Chemical Review

4.1. Final regulatory decisions for neomycin reconsideration

The APVMA has published its final regulatory decisions for the reconsideration of neomycin.

Neomycin was nominated for reconsideration due to concerns that its use in various forms could exceed the Australian MRLs and considered the risks posed by residues in food, risk to trade and animal safety.

The reconsideration related to the use of oral, intramammary and injectable preparations of neomycin, in accordance with the registered use pattern.

The final decisions varied and then affirmed all 7 chemical product registrations and associated label approvals within scope of the reconsideration.

The APVMA varied the conditions of registration to require that holders of neomycin products undertake additional trials within 2 years of the decision, to fully determine the level of residues remaining after treatment with neomycin.

This will allow calculation of permanent Maximum Residue Limits (MRLs) and withholding periods (the minimum time that must elapse between administration of neomycin to an animal and their processing for food).

The current temporary MRLs will remain in place until this additional data has been evaluated.

There is no concern related to food safety in taking this approach.

Minor changes have also been made to the instructions for use to improve worker health and safety and that of treated animals.

A summary of the underlying risk assessments and the product-specific assessment outcomes, including consideration of the submissions received during the 3-month public consultation period that ended on 26 May 2024, has been published in the Neomycin Final Review Technical Report.

The APVMA Gazette No 19, Tuesday 16 September 2025 includes more information about the decision.

5. 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 11 February 2025.

Table 3 lists licences cancelled since 10 June 2025.

Table 4 lists suspended licences since 29 July 2025.

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

Table 2: New licences issued by the APVMA under subsection 123(1) of the Agvet Code
Company nameLicence numberCompany ACNAddressProduct typesSteps of manufactureDate issued
The Pharmaceutical Plant Company Pty Ltd2286154 371 678

3 Sigma Drive

Croydon South VIC 3136

Category 2: Liquids (Oral and Topical), and Creams / Lotions 

Category 4: Supplements (liquid)

Quality Assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, secondary packaging, relabelling, microbiological reduction treatment (filtration), analysis and testing (physical and chemical), storage and release for supply.11 February 2025
Tismor Health & Wellness Pty Limited2209136 806 936

19A Garema Circuit

Kingsgrove NSW 2208

Category 2: Tablets, creams/lotions, ointments, pastes, powders, liquids, suspensions and gels

Category 4: Premixes and Supplements-powders

Quality assurance (QA) of raw materials, formulation including blending, dry milling, wet milling, granulation, filling, packaging, labelling, strip, blister or sachet packaging, tableting, tablet coating, analysis and testing (physical and chemical) storage and release for supply.6 May 2025
Angron Pty Ltd6256169 815 383

Unit 6
10 Brumby Street

Seven Hills NSW 2147

Category 6: All non-sterile dosage formsSecondary labelling, secondary packaging, relabelling, storage and release for supply.20 May 2025
Vetlab Sterile Pty Ltd1112616 832 010

41 Harris St

North St Marys NSW 2760

Category 1: Sterile productsQuality assurance (QA) of raw materials, formulation including blending, filling, aseptic filling, sterilisation (heat, and filtration), microbiological reduction treatment (heat and filtration), packaging, labelling, analysis and testing (physical), storage, and release for supply.21 May 2025
Symbio Laboratories Pty Ltd6210079 645 015

2 Sirius Road, 

Lane Cove West NSW 2066

Category 6: All dosage formsAnalysis and testing (physical, chemical and microbiological).2 June 2025
Diversey Australia Pty Limited2287080 527 117

1612-1624 Centre Road 

Springvale VIC 3171

Category 2: Liquids - topicalQuality assurance (QA) of raw materials, formulation including blending, filling, packaging, secondary packaging, labelling, secondary labelling, analysis and testing (physical, chemical, and microbiological), storage, and release for supply.12 June 2025
DHL Supply Chain (Australia) Pty Limited6239071 798 617

1 Botero Place 

Truganina VIC 3029

Category 6: All dosage formsStorage.23 June 2025
MNAQ (Australia) Pty Ltd6259004 319 171

3 Lennon Street

West Melbourne VIC 3003

Category 6: Non-sterile dosage formsAnalysis and testing (microbiological).26 June 2025
MNAQ (Australia) Pty Ltd6197004 319 171

52-58 Mark Street

North Melbourne VIC 3051

Category 6: All dosage formsAnalysis and testing (chemical and physical).26 June 2025
SW Translink Packaging Pty Ltd6261611 928 486

100 Momentum Way

Ravenhall VIC 3023

Category 6: All non-sterile dosage forms, unless otherwise specifiedPackaging, labelling, repackaging, relabelling, sachet packaging, storage and release for supply.7 July 2025
Pack and Fill Australia Pty Ltd6262685 439 954

Unit 3, 30 Heathcote Road

Moorebank NSW 2170

Category 6: All dosage formsFilling, packaging, labelling and storage.10 July 2025
Agricure Pty Ltd2285676 259 573

19 Gantry Place,

Braemar NSW 2575

Category 2: Creams / Lotions, ointments, pastes, powders, sprays, liquids and pellets

Category 4: Premixes and supplements

Quality assurance (QA) of raw materials, formulation including blending, dry milling, wet milling, granulation, pelleting, filling, packaging, labelling, analysis and testing (physical and chemical), storage and release for supply.16 July 2025
PAH Australia Pty Ltd6260643 835 698

20 Buontempo Road

Carrum Downs VIC 3201

Category 6 (Single-step manufacture) – All dosage formsLabelling, release for supply, storage.3 August 2025
Sydney Scientific Laboratories Pty Ltd6253169 611 456

71 Milperra Road

Revesby NSW 2212

Category 6 (Single-step manufacture) – All dosage formsQuality Assurance (QA) of raw materials, Analysis and testing (physical, chemical, endotoxin testing, antibiotic assay, microbiological, sterility testing).7 August 2025
Nature’s Care Manufacture Pty Limited2288059 975 834

5 Minna Close

Belrose NSW 2085

Category 2: Capsules, creams / lotions, gel, liquids, powders, tablets, and suspensions.

Category 4: Supplements

Quality assurance (QA) of raw materials, formulation including blending, dry milling, wet milling, granulation, capsule filling from bulk, tableting, tablet coating, filling, packaging, labelling, secondary packaging, secondary labelling, repackaging, relabelling, strip, blister or sachet packaging, analysis and testing (physical, chemical, and microbiological), storage, and release for supply.8 September 2025
Viking Blues Pty Ltd6255656 947 296

Unit 2
4 Endeavour Rd

Caringbah NSW  2229

Category 6: All dosage formsAnalysis and testing (Chemical, Physical), storage.8 September 2025
Ausvetlab Pty Ltd1063001 611 516

105 Norman Jones Lane 

Alstonville NSW 2477

Category 1: Immunobiologicals (tick antiserum and snake antivenoms)Quality assurance (QA) of raw materials, serum collection, management and immunisation of donor animals, formulation including blending, aseptic filling, sterilisation (heat and filtration), microbiological reduction treatment (heat, filtration and chemical), packaging and labelling, analysis and testing (physical, immunological, and other pharmacological test), storage, and release for supply.11 September 2025
Probiotec Multipack Pty Ltd6263100 109 019

14 Dingu Place

Kemps Creek NSW 2178

Category 6: Non-sterile dosage formsPackaging, blister packaging, labelling, secondary packaging, secondary labelling, repackaging, relabelling, storage, and release for supply.17 September 2025
Table 3: Licences cancelled by the APVMA under subsection 127(1) of the Agvet Code
Company nameLicence numberCompany ACNAddressDate cancelled
Chemcert Limited6244072 731 894Room 104
Building 485 Biyal Place
Charles Sturt University
Wagga Wagga NSW 2678
10 June 2025
Australian Rickettsial Reference Laboratory Foundation Limited1121103 665 621CSIRO Australian Centre for Disease Preparedness
5 Portarlington Road
Geelong VIC 3219
11 June 2025
Rural Chemical Industries (Aust) Pty Ltd6203003 842 402Unit 4
26 Kent Road
Mascot NSW 2020
24 June 2025
Nutrien Ag Solutions Limited6235008 743 217Level 5, Building A
26 Talavera Road
Macquarie Park NSW 2113
15 July 2025
Diversey Australia Pty Limited2276080 527 1171-7 Bell Grove
Braeside VIC 3195
29 July 2025
Hall Family Group Pty Ltd6198166 410 671Unit 3, 30 Heathcote Road
Moorebank NSW 2170
29 July 2025
Catalent Australia Pty Ltd2271007 219 990217 – 221 Governor Road 
Braeside VIC 3195
15 August 2025
Table 4: Licences suspended by the APVMA under subsection 127(1) of the Agvet Code
Company nameLicence numberCompany ACNAddressPeriod of suspension
Redox Limited6182000 762 3457-11 Burr Court
Laverton North VIC 3026
29 July 2025

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

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