Veterinary Medicines Regulatory Newsletter, May 2024

1. Directors update: Dr Donald Sibanda and Dr Taseer Bashir

Welcome to the May 2024 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Veterinary Medicines Regulatory Newsletter. This edition includes information on several regulatory topics, including new product registrations, efficacy and safety, licensing, permits, and chemical review.

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.

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 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 a new active constituent which have been published in the Gazette since October 2023 are listed in Table 1.

3. Simultaneous AU–UK veterinary medicine approvals protocol finalised

In case you missed it, potential registrants of veterinary medicines can now have their products reviewed by the Australian and United Kingdom regulators at the same time, to facilitate speedier registration in both countries.

In January 2024, we published the United Kingdom–Australia Regulatory Cooperation: Guidance on Veterinary Medicines Simultaneous Reviews, which was developed by the APVMA and United Kingdom Veterinary Medicines Directorate. The guidance will serve as the foundation for simultaneous reviews of veterinary medicines submissions by the 2 agencies. If you have any questions about the guidance, please contact the APVMA’s International Coordinator.

4. Useful information for industry

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

• Using an Item 24V: Removing a manufacturing site from an active constituent record
• Preliminary assessment: 3-month data-list trial commenced 2 April 2024
• Efficacy and safety dossiers: Using published scientific literature effectively
• Annual licencing fees
• Identifying existing manufacturers of a current product

4.1. ‘Item 24V’ used to remove manufacturing sites from (MS and pharmacopoeia) active constituent records

An Item 24 application is a modular application that can be used to approve a new source of pharmacopoeia active and to vary the relevant particulars for an approved active constituent in the APVMA’s Record. In our application portal, this application will be designated as an ‘Item 24V’.

Applicants can use an Item 24V application to remove a manufacturing site from either a pharmacopoeia or non-pharmacopoeia approved active constituent on the APVMA Record.

To apply for an Item 24v:

• there must be at least one approved manufacturing site on the active record
• the remaining manufacturing site(s) on the record must cover all manufacturing steps
• the remaining site(s) must still comply with their relevant approval conditions.

If these requirements are met, applicants can choose an Item 24 application from the decision tree and note in the Executive Summary that the application is to vary the details on the active constituent record to remove a site of manufacture. No assessment modules are required, meaning only Module 1.0 ($902) and Module 11.3 finalisation ($1,730) would apply.

Please see our website for guidance on active constituents and application options, or contact enquiries@apvma.gov.au should you have any questions.

4.2. Draft data-lists at preliminary assessment – 3-month trial commenced 2 April 2024

In accordance with the Agricultural and Veterinary Chemicals Code Act 1994, applicants must provide a short description of each item of information that is included in, or accompanies, an application – that is, a data-list.  The APVMA system assigns each data item a unique number when an application is processed; however, under current arrangements, applicants may not receive a copy of their data-list until an application is finalised.

In recent stakeholder meetings, companies have commented that it may be useful to have a copy of their data-list at an earlier stage in the application process.

For 3 months (from 2 April to 2 July 2024), the Veterinary Medicines Administration Team will provide applicants with a copy of their submitted data-list when the application passes preliminary assessment. The goal of the trial is to identify whether having a copy of the data-list:

•  allows applicants to check the details and identify any Confidential Commercial Information (CCI), or errors, they can resolve with their Risk Manager during the assessment of the application
• facilitates shared communication about the data between the applicant and assessors during the assessment of the application
• allows applicants to quote data items for any related or subsequent applications where they are using the same data.

During this 3-month period, applicants can provide feedback to the Veterinary Medicines Administration Team about this data-list process. The success of the trial will be determined based on the feedback received.

4.3. Using published scientific literature effectively in efficacy and safety dossiers

Registrants often use published literature to support various aspects of veterinary product registration and variation applications. This includes during the initial stages of drug development, dosage characterisation, design of the target animal safety evaluation, prediction of potential adverse effects, and evidence of effectiveness. We acknowledge the value of using published scientific literature in supporting product registrations and variations as it may reduce the number of animals needed for studies to support registration. Scientific literature may also be used to respond to specific regulatory questions, identify data gaps, and inform protocol design.

To assist the APVMA with expediting our reviews and assessments, we’ve provided the following tips and reminders on how to use published literature in dossiers effectively.

4.3.1. Tips for using published literature in dossiers effectively

• Do not submit references that are irrelevant to an evaluation. Supporting literature should be meaningful with respect to the proposed formulation, use pattern, Australian conditions, and industry practices.
• Do not submit abstracts. Only full versions of referenced literature are acceptable.
• Do not submit multiple references which constitute the same evidence.
• Scientific literature that supports a general understanding of the proposed product or active constituent, or information referencing other risk assessments (such as off-target effects), do not belong in the efficacy and safety dossier. Instead, this information should be categorised under general information.
• Literature submissions must include all relevant findings on a particular aspect of a proposed product’s claims of efficacy or target safety. This is regardless of whether the literature supports your claims or not. ‘Cherry-picking’ studies for submission will not facilitate the weight of evidence approach to assessment taken by the APVMA.
• Dossiers that contain excessive and unnecessary material for review may result in delays in assessment, particularly if the purpose of each paper is not clear.
• The published literature provided should also be accompanied by a summary table, as explained in the efficacy and target animal safety guidance.

Remember:

• Vast quantities of submitted literature will not necessarily support a positive assessment outcome.
• The APVMA considers the quality, relevance, source integrity, and currency of the literature to be of paramount importance to the related assessment.

4.4. Annual fee for licence to manufacture

Manufacturers of veterinary chemical products in Australia must be appropriately licensed by the APVMA. This applies to anyone in Australia involved in any step of manufacture of a veterinary chemical product, unless specifically exempt.

The holders of a licence must pay an annual licence fee, for each financial year in which the licence is valid. If the licence is active on 1 July of a financial year, then the fee is payable for that financial year. Fees per licence category can be found in the timeframe and fees section on our website.

If the holder wishes to suspend or cancel their licence, they should notify the APVMA no later than 30 June. For further information on suspension or cancellation please visit the APVMA website.  Suspensions and cancellations of licences are published in the Gazette.

4.5. Assessment fees for overseas GMP compliance

For the registration of a veterinary chemical product, an annual fee is payable by a holder, for each site outside Australia at which either:

• their product is manufactured
• a step in the manufacture of the product occurs.

If the holder wishes to remove the overseas sites of manufacture of veterinary chemical product(s) from the Register, they should apply to the APVMA to vary the sites of manufacture. Removing manufacturing sites from a veterinary chemical product fall under a Prescribed Variation (Item 13A), an Item 12, or an Item 14 application. If a holder removes a manufacturing site, the product still needs to meet the safety and efficacy requirements in the Agvet Code. Applicants may wish to provide details in the application form about which remaining sites will perform which steps to facilitate the assessment. If the holder wishes to remove the overseas sites from the Register, they should submit the application to the APVMA as soon as possible, to ensure timely processing of the application for the 2024–25 financial year.

Information on lodging a variation application is available via our guidance for applicants.

4.6. Identifying the current manufacturers of your product

To request a record of the manufacturers listed for a product, including the steps of manufacture performed by each manufacturer, registrants can submit an Agvet Code request.  It is important to note that manufacturer details are considered Confidential Commercial Information so the APVMA may not be able to release information to the holder in all cases. In these situations, the registrant may wish to consult with the relevant authorising party (for example, the holder of the original reference product) prior to lodging Item 12, 13A, or 14 applications.

5. Emergency permit renewal process

To assist applicants with timely emergency permit processing, the APVMA would like to clarify changes to the emergency permits application process.

The renewal of a previously issued emergency permit (either current or expired) is no longer accepted under an Item 20 application. As a result, applicants will be asked to consider withdrawing any Item 20 application lodged for the extension of an emergency use permit. Instead, an Item 21 with minor use justification or an Item 22 with emergency use justification will be required. The parameters for these items are outlined below.

5.1. Item 21 (minor use permit)

An Item 21 is appropriate when a use pattern previously allowed by an emergency permit now meets the minor use criteria. An Item 21 application for a new minor use permit may be submitted if the holder wishes to apply for a continuation of the use pattern for a longer period of time.

5.2. Item 22 (emergency use permit)

For the extension of an emergency permit, a new Item 22 application is required in place of an Item 20 renewal application. Any such application will require renewed justification for the continuation of the emergency status for evaluation by the APVMA.

5.3. Re-categorising an Item 22 to an Item 21

An Item 22 application submitted for a situation that is determined to no longer be an emergency, but which may be considered minor use, may be re-categorised to an Item 21 application. If an application is re-categorised from an Item 22 to an Item 21, the related fees and modular timeframes of an Item 21 will apply, and additional information may be sought to support the assessment.

Please visit our website for details on the differences between emergency and minor use permits, plus more information about what determines the classification of emergency uses or research purposes.

6. Regulatory decision-making and public consultation

The APVMA continues to progress the reconsiderations subject to the Ministerial Direction on Chemical Reviews given by the Minister for Agriculture, Fisheries and Forestry, Senator the Hon Murray Watt in July 2023.

The chemical review section on our website details how legislative, administrative, and scientific elements all play an essential role in the APVMA’s final regulatory decision to support the ongoing registration of an agvet chemical product.  Reconsiderations rely on contemporary assessments of the available information to determine whether products and active constituents continue to meet the statutory criteria of safety, efficacy, and trade.

On 12 December 2023 we published the proposed regulatory decision (PRD) for the reconsideration of chlorpyrifos. Public consultation on the PRD closed on 11 March 2024, and the APVMA is now considering the submissions received.

On 27 February 2024 we published the PRD for reconsideration of neomycin, which is currently open for consultation until 26 May 2024.

The PRD for the reconsideration of diazinon was published on 12 March 2024 and is open for public consultation until 11 June 2024.

A summary of work plans for the reconsiderations listed in the Ministerial Direction, including current forecast dates for PRDs, public consultations and final regulatory decisions, is available on our website.

7. New, suspended, or cancelled manufacturer licences

The APVMA’s Manufacturing Quality and Licensing (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 September 2023.

Tables 3 and 4 list the suspended (since December 2023) and cancelled (since September 2023) licences, respectively.

You can view the complete list of current licenced Australian manufacturers on our website.

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