Veterinary Medicines Regulatory Newsletter, July 2021

Edition VMT005

• Directors update: Dr Martin Ilott and Dr Donald Sibanda
• Performance report
• New product registrations
• Veterinary Labelling Code Review
• Useful information for industry
• Compliance

Directors update: Dr Martin Ilott and Dr Donald Sibanda

Welcome to the July 2021 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 prescribed variations and section 8F notices, as well as an update on the Veterinary Labelling Code review.

In the third quarter of the 2020–21 financial year, the Veterinary Medicines Team focused its activities on meeting the application target set at 90%, which we are pleased to report was exceeded. More information is available in the ‘Performance report’ section of this Newsletter.

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

If you have any suggestions or requests for future editions of the APVMA’s Veterinary Medicines Regulatory Newsletter, please send them through to communications@apvma.gov.au.

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

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Performance report

The Veterinary Medicines Team delivered another strong quarter of timeframe performance at the end of the March quarter 2021.

We completed:

• 99% of veterinary medicines product applications within timeframe, holding steady from December quarter 2020.
• 95% of applications requiring major assessment for veterinary medicines within timeframe, increasing from 93% in December quarter 2020.

224 veterinary medicine product applications remained in progress at the end of March quarter 2021, up from 221 in December quarter 2020.

The full performance report for the March quarter 2021 is available on our website.

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New product registrations

The APVMA publishes a fortnightly Gazette, which 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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Veterinary Labelling Code Review

Following our previous Veterinary Labelling Code (VLC) update, all VLC sections have completed internal APVMA review and been sent to Animal Medicines Australia (AMA) and the Veterinary Manufacturers and Distributors Association (VMDA) for feedback. While we review the feedback received from these industry bodies, the Veterinary Medicines Team continues to meet with industry to discuss specific label sections that may require further discussion.

The VLC project is progressing well with nearly all guidance documents updated and reviewed by the APVMA and AMA. We expect to have the revised version of the VLC published on our website for full public consultation in November 2021 and, depending on the volume of comments received from the consultation, for the APVMA to have formally adopted the revised VLC in February 2022.

In May 2021 we hosted an APVMA-industry workshop to:

• better understand issues facing industry and identify possible solutions through the VLC
• build a shared awareness and understanding of labelling issues and difficulties
• promote flexibility in the VLC to accommodate the diversity of veterinary labelling formats
• discuss pathways to manage labels where it is impossible to be compliant with VLC requirements (e.g. very small packs).

The workshop highlighted some of the difficulties companies encounter when transferring the approved relevant particulars and conditions to the marketed label. As the APVMA no longer reviews or approves marketed labels, the outcome from the workshop is to improve the current VLC requirements for label presentation and layout to bridge the gap between approved and marketed labels.

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Useful information for industry

Updates to module descriptors

The APVMA has updated the following module descriptors to clarify the circumstances when particular modules should be applied during the application process.

The changes relate to:

• removing reference to a residues module from the pathway ‘Apply for approval of an active constituent only’, as this module is relevant for product registration but not active constituent approval
• clarifying the use of the finalisation modules when an application requires consideration of a number of modular assessment reports prepared as part of a previous application (either an Item 25 application or a previously refused or withdrawn application).

The module descriptors were designed to inform the APVMA and applicants on which modules should apply for different types of applications. Assessment fees and assessment periods are based on the modules and module levels recommended by the guideline. 

Any questions on the use of this guideline should be directed to enquiries@apvma.gov.au.  

Variation notices

The Veterinary Medicines Team has been asked if the section 8F ‘variation’ notices, issued by the APVMA when an application or variation is finalised, could be more ‘descriptive’ so it is clear what details have been approved (for example, if an application is to add a manufacturer, then could the details of that manufacturer be listed in the section 8F notice).

The details the APVMA must provide in a notice are outlined in section 8F of the Agricultural and Veterinary Chemicals Code Act 1994, but there is a caveat that notes the APVMA should not disclose confidential commercial information (CCI). Details of a manufacturer or manufacturing site address would normally be considered CCI and not be included in a notice.

If a company would like specific details included in a section 8F notice, they can provide the APVMA with approval to include these details. Companies should consider their target audience before making such a request, as the APVMA will typically only issue one section 8F notice for the respective delegated decision. If amended notices were later required, issuance would be at the discretion of the delegate on a case-by-case basis.

Approval to include specific details in a notice can be provided in the ‘Executive Summary’ text on the application form, and the APVMA will endeavour to comply with any requests received.

13A applications

A variation of one or more constituents of a chemical product

Registrants can change excipients in their chemical formulations under an Item 13A but only in limited situations. These are outlined in sub-Item 4 of the Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019 (the Instrument).

The proposed change must satisfy all 14 requirements listed in sub-Item 4 of the Instrument, including the following:

• The original and replacement excipients must have the same purpose.
• The original and replacement excipients can only differ in solvates or hydrates.
• The original and replacement excipients must have the same pH, dissolution profile, hydrophilic or hydrophobic behaviour and hygroscopic behaviour.

There are also requirements for the type of material and the number of excipients that can be changed in a formulation.

Before lodging an Item 13A application to change a chemical excipient, applicants should consider the APVMA’s guidance material and sub-Item 4 of the Instrument. Sufficient supporting information should be provided with the application to address all assessment requirements.

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. The proposed site must have appropriate GMP certification.

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 a registrant is not sure if the steps of manufacture are comparable, it is advisable to submit an Item 12 application.

More information is available on our website.

Tailored guidance for applicants

Applicants are encouraged to make use of the tailored guidance pathways published on the APVMA website. The pathways are designed to provide applicants with the information you need to lodge the right application, with the right data and supporting evidence to meet APVMA criteria.

If in doubt, please contact our Enquiries Team. For technical assistance, applicants are encouraged to make use of pre-application assistance for technical advice, and technical assessments (Item 25) for technical assessments.

Application summaries Q&A

This quarter, we feature a ‘Question and Answers’ (Q&A) section for application summaries.

For many applications, the APVMA is required to publish a summary of the application once the applicant has been notified it has been accepted for assessment. The summary will be removed once the application is finalised.

The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.

The summaries include details of the applications as specified in Divisions 2.1 and 2.2 of the regulations.

Please remember to follow the guidance for preparing information lists when preparing your application to avoid sensitive information being published.

Visit our website for more information.

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Compliance

The APVMA has published a new Infringement Notice Guideline made under section 6A of the Agvet Code.

The guideline provides information about the performance of APVMA functions and exercise of powers in respect of infringement notices and is intended to provide a synopsis of the legislative provisions relevant to infringement notices.

More information about infringement notices, including penalty amounts, is available on our website.

Questions about the new Infringement Notice Guideline may be directed to compliance@apvma.gov.au.

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