Veterinary Medicines Regulatory Newsletter, October 2022

Edition VMT009

• Directors update: Dr Donald Sibanda and Dr Valerie Villiere
• Performance report
• New product registrations
• Welcome to Dr Valerie Villiere, Director, Veterinary Medicines
• Important notice – changes to overseas GMP compliance assessment fee process
• Useful information for industry
• Q&A
• Interagency networking through Memoranda of Understanding
• APVMA news at a glance

Directors update: Dr Donald Sibanda and Dr Valerie Villiere

Welcome to the October 2022 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) quarterly Veterinary Medicines Regulatory Newsletter. In this edition, we have included information on a range of regulatory topics, including preliminary assessments, current manufacturing licences, interagency networking through Memoranda of Understanding (MoUs) and overseas Good Manufacturing Practice (GMP) compliance assessment fee process changes.

The Veterinary Medicines Team has continued to focus their efforts on ensuring Australians are provided with timely access to safe and effective products that support improved animal health, completing 99.5% of veterinary medicines product applications within timeframe in 2021–22. More information is available in the ‘Performance report’ section of this newsletter. 

Since our last newsletter, we have also welcomed Dr Valerie Villiere as a Director in the Veterinary Medicines Team. Our welcome to Dr Villiere is included in this edition.

We continue to encourage applicants to participate in APVMA stakeholder meetings, which are conducted from February to October. These meetings are a valuable forum for applicants, industry, and the APVMA Veterinary Medicines Team to discuss current and future applications and priorities and to work through any concerns. These meetings can be organised through your Case Manager by emailing casemanagement@apvma.gov.au.

Please reach out to the Veterinary Medicines Team if you require assistance with issues related to the registration of veterinary medicines.

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 them through to communications@apvma.gov.au.

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Performance report

The APVMA finished 2021–22 with continued high performance, finalising 97.0% of product, active, and permit applications within timeframe. At the end of the financial year, the Veterinary Medicines Team completed 99.5% of veterinary medicines product applications on time, up from 99% in 2020–21.

You can read the full 2021–22 performance overview and June quarter 2022 performance report on our website.

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New product registrations

The APVMA publishes a fortnightly Gazette that includes information about new product registrations and variations to currently registered particulars or conditions for registration.

The following table lists the new registrations of veterinary products based on new combinations of active constituents, new formulations, and new active constituents published in the Gazette during the last quarter.

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Welcome to Dr Valerie Villiere, Director, Veterinary Medicines

The APVMA warmly welcomes Dr Valerie Villiere to the Veterinary Medicines Team as Director, Veterinary Medicines.

Dr Villiere graduated as a Veterinarian in Lyon, France. She has a Master of Science and a PhD in Pharmacology (Cardiovascular and Pain Physiology), completed respectively at the University of Montreal (Canada) and University of NSW (Australia).

Dr Villiere has held various roles in Australia, including with Avcare (now CropLife and Animal Medicines Australia); WorkSafe Australia, where she was the Director of Registration for Agricultural and Veterinary Medicines; and more recently the Department of Health, where she was involved with influenza and COVID-19 vaccines.

As Director, Veterinary Medicines, Dr Villiere will be responsible for technical applications, including those related to immunobiological products, and is very much looking forward to working with applicants, registrants and stakeholders.

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Important notice – changes to overseas GMP compliance assessment fee process

The APVMA has extended the implementation of the proposed changes for the overseas GMP compliance assessment fee to the commencement of financial year 2024–25, following feedback received from registration holders and through public consultation.

The proposed changes have been paused to allow the APVMA time to develop the capability needed to provide holders with greater transparency over the manufacturing site details that are held in our Register in a timely and efficient manner.

Once this capability has been developed, all overseas manufacturing sites that remain on the product Register will be assessed for the Overseas GMP compliance assessment fee under Regulation 71A(2).

If a site of manufacture is no longer in use, registration holders may lodge a variation application to remove the site from their registration.

A notification letter informing holders of these plans has been sent to each registered holder with an overseas manufacturing site on the APVMA Register as at 1 July 2022.

Contact information

• Any questions regarding fees should be sent to the Manufacturing Quality and Licensing Team at mls@apvma.gov.au or +61 2 6770 2301.
• Application queries should be directed to Registration Management at enquiries@apvma.gov.au or +61 2 6770 2300.

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Useful information for industry

In this edition, we’ve included useful information about issues that may cause delays at preliminary assessment and current manufacturing licences.

Issues that may cause delays at preliminary assessment

Following our update in the March 2022 Veterinary Medicines Regulatory Newsletter, the Veterinary Medicines Team is still identifying issues at preliminary assessment stages that are delaying the progress of applications.

We’ve identified and provided guidance for these issues below.

Discrepancies with product manufacturing site information

• Applicants should ensure the manufacturers’ details listed on the application form match the same details contained in supporting evidence, including Certificates of Analysis and Good Manufacturing Practice Certificates.
• The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 requires that applicants for veterinary products list all the proposed steps of manufacture that each manufacturer will conduct. Instead of listing all steps, some applicants are incorrectly selecting the option ‘all steps’ in the application form. Applicants are reminded they must list each step rather than selecting this option.
• Applications cannot pass preliminary assessment if the licence for the Australian site of manufacture is not current, or the approved steps of manufacture for the nominated site are not included under the nominated licence. Applicants are reminded to check our list of licensed Australian manufacturers of veterinary chemical products and confirm with the manufacturer any amendments to the license that may not yet appear in the list or APVMA Gazette.

Variation to an overseas site of manufacture for veterinary products

The addition of an overseas site of primary steps of manufacture will usually be processed as a non-technical application (Item 12). The proposed new site must hold acceptable evidence of overseas Good Manufacturing Practice (GMP) compliance and this will be assessed as part of an Item 12 application.

In limited circumstances, the addition of an overseas site of primary steps of manufacture can be made as a prescribed variation (Item 13A). A prescribed variation can be submitted when the proposed site of manufacture is already recorded as a site of manufacture for another veterinary product with the same holder. Registrants are reminded to include information of another registered veterinary product in your application and confirm the primary steps of manufacture are the same. Each step in the manufacture of the veterinary product at the new site of manufacture must conform to a standard that the APVMA has determined is comparable to the manufacturing principles and Australian GMP Code. If you’re unsure whether the steps of manufacture are comparable, it is advisable to submit an Item 12 application.

More information about varying overseas sites of manufacture is available on our website.

List of new, suspended or cancelled manufacturer licences

The APVMA’s Manufacturing Quality and Licensing Team gazettes a list of licences for new manufacturers issued under subsection 123(1) of the Agvet Code and licences suspended or cancelled under subsection 127(1) the Agvet Code.

The following tables list the new licences and licences suspended or cancelled since 26 May 2022.

You can view the complete list of currently licensed Australian manufacturers on our website.

Any questions can be directed to the Manufacturing Quality and Licencing Team.

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Q&A

Our ‘Question and Answers’ (Q&A) section in this edition covers the APVMA’s Assessment, Investigations and Monitoring Team.

What is the Assessment, Investigations and Monitoring Team?

The Assessment, Investigations and Monitoring (AIM) Team is responsible for compliance with agvet legislation within the schemes administered by the APVMA. The AIM Team consists of 2 units – the Regulatory Intelligence Unit (RIU) and the Investigation and Monitoring Unit (IMU).

What are the AIM Team’s responsibilities?

The AIM Team undertakes compliance and enforcement activities to ensure agricultural and veterinary chemical products available for use in Australia comply with the legislation. The AIM Team’s compliance responsibilities include unregistered and registered products, as well as those that are listed, exempt or reserved. The AIM Team also undertakes monitoring activities that can include remotely assessing and visiting holders, manufacturers, wholesalers and retailers of agvet chemicals. Monitoring compliance helps us identify emerging issues so corrective actions can be undertaken promptly, which helps protect the health and safety of people, animals and the environment – as well as Australia’s trade interests.

Information about how we monitor compliance, including our compliance plan and how you can report suspected non-compliance, is available on our website.

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Interagency networking through Memoranda of Understanding

To facilitate cooperation and the exchange of information, the APVMA has established Memoranda of Understanding (MOU’s) with other Australian and international government regulators in the veterinary and agricultural chemical sectors and broader chemical regulation scheme. Collaboration with other regulators is a key principle of regulator best practice. Strengthening and formalising relationships with government partners promotes information and intelligence sharing delivering outcomes within the Regulator Performance Guide. In turn, this enables the APVMA to regulate the agricultural and veterinary scheme more effectively and efficiently whilst avoiding unnecessary impost on regulated entities.

The APVMA has finalised 18 MOUs with a range of other regulatory bodies including the Department of Health, the Greyhound Welfare & Integrity Commission (NSW), and the Office of Chemical Safety – Australian Industrial Chemicals Introduction Scheme, which is responsible for the national regulation of industrial chemicals. This MoU was important to establish as many active constituents overlap between the agvet and industrial chemical schemes. The agreement builds upon the long-standing relationship between both agencies.

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APVMA news at a glance

• On 4 October, the APVMA published a notice of reconsideration to expand the scope of the review of fipronil. The APVMA is seeking public comment on the matters being considered in the expanded scope, with submissions closing 18 January 2023.
• The APVMA’s public consultation on our draft Cost Recovery Implementation Statement (CRIS) closed on 8 September 2022. The draft CRIS outlined the fees and levies for recovering costs associated with the APVMA’s regulatory activities.
• On 1 July 2022 we published our Corporate Plan 2022–23, which outlines are strategic objectives and performance measures for the period 2022–23 to 2025–26.

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