Veterinary Medicines Regulatory Newsletter, October 2023

Edition VMT012

• Directors update: Dr Donald Sibanda and Dr Sam Beckett
• APVMA holiday closure
• New product registrations
• Useful information for industry
• Change to the APVMA Standard for Maximum Residue Limits
• New, suspended, or cancelled manufacturer licences
• Special interest topic: Varroa destructor (varroa mite)

Directors update: Dr Donald Sibanda and Dr Sam Beckett

Welcome to the October 2023 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Veterinary Medicines Regulatory Newsletter. This edition includes information on several regulatory topics, including preliminary assessments when there is Limits on Use of Information, manufacturing sites listed on applications, and temporary requirements for submitting Certificate of Export documents. This edition also includes changes to the APVMA Standard for Maximum Residue Limits (MRLs) and a special interest topic on Varroa destructor. As this is the final Veterinary Medicines Regulatory Newsletter for 2023, we’ve also included notice of the APVMA’s holiday closure.

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 Veterinary Medicines Team. Meetings can be used to discuss current and future applications, priorities, and to provide a forum to work through any concerns. Meetings can be organised through your case manager. 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.

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APVMA holiday closure

The APVMA will be closed for the holiday period from close of business Friday 22 December 2023 until Tuesday 2 January 2024. We will aim to finalise applications due during this period by end of day Friday 15 December 2023. Please contact your case manager if you have any questions about applications due during this period.

As this is the final Veterinary Medicines Regulatory Newsletter for 2023, the Veterinary Medicines Team would like to take this opportunity to wish all our stakeholders a safe and happy holiday period.

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New product registrations

The APVMA publishes a fortnightly Gazette that includes information about new product registrations and variations to current registered products, particulars, or conditions of registration.

One new veterinary product registration based on a new active constituent was published in the Gazette in the June to October 2023 quarter and is listed in Table 1.

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Useful information for industry

In this edition, we’ve included information for applicants on:

• manufacturers nominated or listed on applications
• preliminary assessments with Limits on Use of Information (‘Protected Data’)
• products listed for Item 13A applications
• temporary requirements for uploading Certificate of Export documents.

Manufacturers nominated or listed on applications

The APVMA publishes a list of licensed Australian manufacturers of veterinary chemical products. This list only includes the primary premises. When granted, a GMP licence may contain authorisation to perform steps of manufacturer at a secondary premises. As per Regulation 16 of the Agvet Code Regulations, the name of each manufacturer of the chemical product and the address of each site at which the chemical product is manufactured by the manufacturer are defined as particulars of registration and recorded in the Register.

The Agvet Code Application Requirements Instrument requires the following information:

• The street address of each site at which steps in the manufacturing process are undertaken by the manufacturer.
• The steps in the manufacturing process that take place at the site. 

When listing the manufacturers of a product in the application form you are required to identify the exact facility where manufacturing is taking place and the appropriate steps of manufacture – not just the primary facility on the licence.

Preliminary assessment where there is Limits on Use of Information (‘Protected Data’)

Applicants are reminded of the need to declare any data items that are subject to limits on use of information (commonly referred to as ‘protected data’) on reference product(s) when submitting applications. Data items that are subject to limits on use can be found on the APVMA’s Public Chemical Registration Information System Search (PubCRIS) database. PubCRIS generally lists each data item with the title, author, authorising party, and period of protection; however, specific data items may not appear for products registered as repacked products via an item 8 application.

Under subsections 9(1)(e) and 9(1)(f) of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 (Application Requirements Instrument), applicants are required to declare any relevant data items that are subject to limits on use of information in their application to register a chemical product.

Under subsections 2(1)(g) and 27(1)(h) of the Applications Requirements Instrument, applicants are required to declare any relevant data items that are subject to limits on use of information in their application to vary a currently registered chemical product.

‘Relevant’ data items are items that the APVMA would need to assess to decide on an incoming application – for example, product specifications for the reference product on an Item 7 application.

Should subsections 9(1)(e), 9(1)(f), 27(1)(g) or 27(1)(h) apply, the APVMA will require written consent from the authorising party to rely on those data items during assessment. This is specified under subsection 9(2) for registration applications, or subsection 27(2) for variation applications, of the Application Requirements Instrument.

The written consent should be included as a data item for the incoming application. Alternatively, applicants should indicate if they do not intend to provide consent and explain why any data items that are subject to limits on use are not relevant to their application. Applicants can do this in the Executive Summary of the application form.

Please note that written consent is not required when the applicant is the owner or authorising party of the protected information. Consent is implied in these situations.

Incoming applications will not pass preliminary assessment (sections 11 and 28 of the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code Act)) if consent is not provided. In these situations, we will issue a defect notice and provide applicants with one month to rectify the situation. Alternatively, if the situation cannot be rectified, applications may be refused under section 14(2) of the Agvet Code Act at preliminary assessment.

Listing details for all approved manufacturers on variation applications

Applicants submitting an Item 12 or Item 14 application to vary a manufacturing site (add, remove, or substitute) for a registered chemical product are reminded to include the details for all approved manufacturers in their applications. This information is required under subsection 27(1)(i) of the Application Requirements Instrument.

Required details for all approved manufacturers include:

• The name of the manufacturer.
• The ACN or overseas equivalent.
• The street address for the manufacturing site.
• The steps of manufacturer performed at that site for the product.

If applicants do not know or have these details available, they may consider the following options:

• Check the license details for Australian-based manufacturers of veterinary chemicals on the APVMA website.
• Submit an Agvet Code Request to the APVMA to confirm their manufacturing details before lodging the Item 12 or Item 14 application.
• Ask the manufacturing sites to provide their details directly to the APVMA for the Item 12 or Item 14 application. Manufacturers may email vetadmin@apvma.gov.au in these situations and quote the application ID Number (DCXX-XXXXXXXX).

Incoming applications will not pass preliminary assessment (sections 11 and 28 of the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code Act)) if the manufacturer details are not provided for all approved sites. In these situations, the APVMA will issue a defect notice and provide applicants with one month to provide the information and update their application form.

The APVMA will contact applicants by email if the manufacturer details are provided but are incorrect. In such situations, applicants will be given the option to correct the details at preliminary assessment.

Alternatively, the application may pass into the evaluation stage where the applicant may be issued with a notice under either section 159 (Request for Further Information) or Regulation 8AHAA (Clarification of Information).

Item 13A applications – request for limited products per application

Applicants can submit one Item 13A (prescribed variation) application to request the same variation for a number of products. However, the APVMA has received several applications where the request is not for the ‘same variation’. For example, an application to add a manufacturer to 25 products where the manufacturer is already approved for 5 of the products.

Identifying the required changes and assessing each product application can be a time-consuming exercise for APVMA staff.

While it is open to the APVMA to consider the refusal of applications where the manufacturer details have not been listed accurately on the application form, we would prefer to work with applicants to clarify and correct their records. In these situations, applicants are asked to either:

• consider submitting an Agvet Code Request to the APVMA to confirm manufacturing details with approved steps of manufacture before lodging the Item 13A application
• ensure the same requested change(s) apply to every product included in the application and submit separate application(s) where the change(s) is/are different
• limit the number of products included in an Item 13A application to under 15 products, to assist APVMA staff in the assessment of the applications.

Known system issue – attachments to Certificate of Export applications

Applicants can submit an application for an APVMA Certificate of Export through our Online Services Portal.

As part of the application process, applicants are asked to upload letters of support from manufacturers when the applicant is not the manufacturer, and the manufacturer details are to be listed on the certificate. This is because the manufacturer details are not publicly available.

Unfortunately, we are currently experiencing a system issue after applicants upload these letters of support. Although applicants can still upload the letters of support, they will not transfer across with the application. This issue is being investigated and we apologise for any inconvenience caused.

In the meantime, rather than uploading the letters of support, applicants are asked to please email these to the APVMA at certificatesofexport@apvma.gov.au. Please quote the certificate number in your email (COE-XXXXXXXXX).

Other important APVMA updates

• Our cannabis in veterinary chemical products information page was published in August 2023 and provides up-to-date advice on the registration and approval of veterinary products containing cannabis.
• We released the APVMA Strategy 2030, which provides the themes and strategic outcomes that will drive our decision making and priorities into the future.
• The APVMA’s Annual Report 2022–23 and Corporate Plan 2023–24 are now available on our website.
• We’ve released the results of our 2023 Stakeholder Survey and our compliance statistics for FY2022–23.

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Change to the APVMA Standard for Maximum Residue Limits

A Maximum Residue Limit (MRL) is the maximum concentration of a residue resulting from the registered use of an agricultural or veterinary chemical that is legally permitted or recognised as acceptable to be present in or on a food, agricultural commodity, or animal feed.

The APVMA MRL Standard is referenced by various state laws. MRLs become standards that are used in determining whether approved directions for use of agricultural and veterinary chemicals have been followed. MRLs are established in Legislative Instruments, and a new Instrument has recently been established and is now in force.

The Agricultural and Veterinary Chemicals (MRL Standard for Residues of Chemical Products) Instrument 2023 is now in force and supersedes the Agricultural and Veterinary Chemicals Code (MRL Standard) Instrument 2019, which has been repealed.

Recent amendments made to section 7A of the Agricultural and Veterinary Chemicals (Administration) Act 1992 allow for the APVMA to approve standards for residues of chemical products as often as we find necessary. The 2023 Instrument has been established so that this new mechanism for establishing MRLs by legislative instrument can be utilised.

The standards approved for residues of chemical products under the 2023 Instrument are identical to those previously provided for by the 2019 Instrument. This means that while the mechanism for establishing MRLs has changed, the existing MRLs have not.

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New, suspended, or cancelled manufacturer licences

The APVMA’s Manufacturing Quality and Licensing (MQL) Team records 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) of the Agvet Code in the Gazette.

Tables 2 and 3 list the new licences and licences cancelled since 29 June 2023.

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

 No licences were suspended by the APVMA under subsection 127(1) of the Agvet Code during this period.

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

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Special interest topic: Varroa destructor (varroa mite)

Varroa destructor (varroa mite) is a parasitic mite of European honeybees (Apis mellifera), that feeds on adult bees and the developing young (pupae). Until 22 June 2022, Australia was free of varroa mite. It was first detected at the Port of Newcastle in NSW. Since then, extensive efforts have been aimed at eradicating varroa mite in Australia; however, recent developments have shifted the focus from eradication to the management of the mite. 

Over recent months, the spread of varroa mite has increased in the state of NSW with further detections in the greater Newcastle area, Hunter Valley, Central Coast, Mid North Coast, Tamworth, Cuttabri and Riverina areas. Varroa mite is now an emerging threat to the Australian bee industry and those industries that rely on honeybees for pollination. Of further concern is varroa mites’ ability to act as an effective virus vector allowing the transfer of viruses such as the Deformed Wing Virus (DWV) between individual bees.

The National Varroa Mite Emergency Response, which initially aimed to eradicate varroa mite, is now focused on the management of the mite in Australia. The APVMA has been following these developments closely to provide support with the eradication and management phases.

Emergency permits and veterinary chemical products have been approved and registered by the APVMA to support Australian beekeepers in the control of varroa mite. Users must adhere to the approved product label or permit instructions due to the potential risks of chemical resistance and chemical residue in honey and wax.

Information about products and permits approved by the APVMA can be found on our PubCRIS and permits databases.

If you have any questions about managing varroa mite, please contact your state or territory regulator.

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