Veterinary Medicines Regulatory Newsletter, October 2021

22 October 2021

Edition VMT006

Directors update: Dr Glen Edmunds and Dr Donald Sibanda

Welcome to the October 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 timeshift applications and the annual return of actives, as well as an update on our Veterinary Labelling Code review. We are also pleased to welcome Dr Glen Edmunds, who has joined the Veterinary Medicines Team as a Director.

In the fourth quarter of the 2020–21 financial year, the Veterinary Medicines Team focused our activities on meeting the application processing 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 conducted from February to October. 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. Please reach out to the Veterinary Medicines Team if you require assistance for issues related to the registration of veterinary medicines.

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.

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Performance report

The Veterinary Medicines Team delivered another strong quarter of timeframe performance at the end of the June quarter 2021 and finished 2020–21 with a performance high.

In the June quarter 2021, we completed:

  • 100% of veterinary medicines product applications within timeframe, increasing from 99% in March quarter 2021
  • 100% of applications requiring major assessment for veterinary medicines within timeframe, ahead of the 95% recorded in March quarter 2021.

230 veterinary medicine product applications remained in progress at the end of June quarter 2021, up from 224 in March quarter 2021.

At the conclusion of the 2020–21 financial year, we had finalised 99% of applications within timeframe, increasing from 89% at the end of the 2019–20 reporting period.

The full performance report for the June quarter 2021 and 2020–21 performance overview is available on our website.

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Christmas and New Year shut-down dates

The APVMA will be closed for the Christmas and New Year period from 25 December 2021 to 3 January 2022. All applications due during this period and the first week of January will be finalised before 25 December 2021. Please contact your Case Manager if you have any questions about applications due during this period.

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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.

Application no. Product name Active constituent/s Applicant name Summary of use Date of registration Product registration no.

121236

Stelfonta

1 mg/mL tigilanol tiglate

Qbiotics Group Limited

For the treatment of non-metastatic (WHO staging) cutaneous mast cell tumours (located anywhere on the body, legs or head in dogs), and subcutaneous mast cell tumours located at or distal to the elbow or the hock in dogs

6 July 2021

88412

126983

Dectomax V Dual Combination Injection for Cattle

150 mg/mL levamisole hydrochloride equivalent to 127 mg/mL levamisole, 5 mg/mL doramectin

Zoetis Australia Pty Ltd

For the treatment and control of gastrointestinal worms, cattle tick and sucking lice in cattle

22 July 2021

90001

126327

DeLaval Prima

102.9 g/L glycerine, 5.1 g/L hydrogen peroxide

Delaval Pty Ltd

For use as an aid in reducing the spread of mastitis-causing organisms in dairy cattle

27 September 2021

89910

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Veterinary Labelling Code review

The Veterinary Medicines Team has reached a significant milestone in our review of the Veterinary Labelling Code (VLC), with the release of the revised VLC and accompanying guidance to industry for final consideration. We will commence a broader public consultation in November 2021.

Depending on the volume of comments received from the public consultation, we anticipate the revised VLC will be published to our website in March 2022.

In total, the Veterinary Medicines Team has reviewed 47 labelling requirements (18 specific) that were developed section by section. We have also developed 2 new specific labelling requirements and one new guidance webpage, and revised the presentation of the VLC on our website by integrating specific labelling requirements into the general label content section and using buttons and drop-down menus to improve readability and functionality.

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Useful information for industry

Information about tailored guidance pathways, related submissions and timeshift applications.

Tailored guidance pathways

The APVMA has developed tailored guidance pathways to provide applicants with the information they need to lodge the correct application, with the right data and appropriate supporting evidence to meet APVMA criteria, before entering our Online Services Portal. The tailored guidance pathways are provided in addition to the decision tree, which is still available on our Online Services Portal. Queries about our suite of tailored guidance pathways can be directed to enquiries@apvma.gov.au.  

Related submissions

We receive a number of applications to register or vary a suite of veterinary chemical products. Some applications are related – for example, product ranges for large, medium and small dogs.

Advice is available to assist applicants with the submission of primary and secondary applications. Other variation applications might be relevant between products that do not contain the same active and as such may not fall under primary and secondary applications. Applicants are encouraged to advise the APVMA of related submissions within the ‘executive summary’ field of each application form.

For products containing the same active constituent, applicants are also advised to use the ‘related submissions before the APVMA’ field on each application form to identify related submissions.

Timeshift applications

Timeshift applications provide for the staged submission of supporting data packages that allow for the commencement of longer assessments (such as toxicology and environment) while other supporting data packages (such as efficacy and target animal safety) are being completed.

Timeshift applications can be used for applications involving multiple assessment modules, including:

  • approval of a new active constituent
  • registration of a product that contains a new active constituent
  • registration of a product that contains an approved active constituent or variation of a registered product where 2 or more technical assessment modules (modules 2 to 10 of the module types) apply
  • global joint reviews
  • to facilitate the use of overseas assessments.

The application is assessed according to a project plan that is developed and agreed between the applicant and the APVMA as part of pre-application assistance (PAA) tier 2 or tier 3. A timeshift application cannot be submitted without an agreed project plan.

It is important to note that the agreed project plan sets out the sequence for the submission of each data package (chemistry and manufacture, toxicology, WHS, residues, environment, efficacy, target animal safety, trade – including non-food and any special data required) and the timeframe for conducting the necessary modular assessments. More information about timeshift applications is available our website.

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Q&A – Annual return of actives and Item 25/PAA

Our ‘Question and Answers’ (Q&A) section in this edition covers the annual return of actives, which was open until 1 October 2021, and Item 25/PAA.

Under section 69E of the Agricultural and Veterinary Chemicals (Administration) Act 1992, a person who imports into, manufactures in, or exports from Australia must provide the APVMA with the quantities of those active constituents imported, manufactured or exported during the previous financial year (a return).

Those who hold an approval for an active constituent, or the registration of a chemical product have an obligation to provide the APVMA with a return if import, manufacture, or export the active constituent or chemical product occurred within the reporting period.

A person must provide the APVMA with a return if between 1 July and 30 June they have imported into, manufactured in, or exported from Australia:

  • active constituents; and/or
  • chemical products.

More information about the annual return of actives, as well as answers to common questions received by the APVMA, is available on our website.

Item 25

An Item 25 application is a request for the APVMA to provide a technical assessment under Regulation 8AS of the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Regulations). These applications are for assessments of data to be considered as part of a proposed application to register a chemical product. The assessment would normally determine if a data package is sufficient for the completion of an assessment module.

Once an Item 25 application is received, the APVMA will determine which assessment modules are comparable and the timeframe for the assessment. Technical assessments are a service provided by the APVMA and as such they attract GST under the GST Act 1999. Visit our website for more information.

PAA

A PAA application is a request for the APVMA to provide advice to a potential applicant before that applicant submits an application to register a chemical product. There are 3 levels of assistance, with general examples for their use below:

  1. Tier 1: can be used to answer questions like “Does my product need registration?” or “What is the most appropriate application type?” and to provide a formal assessment of excluded nutritional or digestive (END) products (if sufficient information is provided).
  2. Tier 2: can be used to provide general advice on what type(s) of data might be required for a registration application and to obtain the required project plans for timeshift (Item 27) applications.
  3. Tier 3: this is a more detailed assessment for applications such as the appraisals of trial protocols, new methodologies and project plans for global joint reviews.

Like an Item 25, PAA is a service provided by the APVMA; however, unlike an Item 25 PAA fees are prescribed in the Agricultural and Veterinary Chemicals Code (Pre‑application Assistance Fee) Instrument 2015. As a result, no GST is paid for PAA applications.

More information about PAAs can be found on our website.

Item 25 and PAA comparison

Required application element

Item 25

PAA

Fees

Modular assessment fee calculated as per Schedule 6 of the Regulations.

Prescribed in the Agricultural and Veterinary Chemicals Code (Pre‑application Assistance Fee) Instrument 2015.

GST applied

Yes

No

Datalist required

Yes

No

Option to meet with APVMA officers

No

Yes

Timeframes

Outlined in table 2.1 of Schedule 6 of the Regulations.

Tier 1: one month

Tier 2: 2 months

Tier 3: 3 months

Outcome

If the technical assessment outcome is positive and the same data is provided for a subsequent registration application, the APVMA may waive the fees required for that assessment module.

Written advice from APVMA to address questions outlined in PAA request. Applicants may take notes during meetings, which the AVMA may endorse.

Rebate on fees for future application

No

Yes, as per subregulations 70(3), 70(4) and 70(4A) of the Regulations.

How do I apply?

Our decision tree allows applicants to obtain decisions numbers for their respective Item 25 or PAA application.

Tier

Decision tree options

1

  • General guidance on the types of regulatory assessments likely to be needed in a particular application as it relates to the item, module levels, timeframes and fees for an assessment
  • Advice on the relevance of the efficacy criteria to a proposed product/permit
  • Technical clarification of guidance documents on our website

2

  • Types of supporting information and data that may be appropriate in a particular application
  • Assistance in determining the types of trials that may be undertaken, including specific guidelines that could be considered in generating data
  • Assistance determining whether overseas data and/or assessment reports can be considered relevant or suitable
  • Advice on a scientific matter or specific aspect of the conduct and design of a study or trial
  • Assistance on how to develop an agreed project plan for a timeshift application (including global joint review applications)

3

  • Appraisal of a trial protocol before commencement of studies
  • Assistance with a proposed new methodology or variations to an existing guideline in generating data to support an application
  • Finalisation of a project plan for a Global Joint Review

The expected outcome is a DC25-XXXXXXXX or DCPAA[T]-XXXXXXXX decision number where T is the PAA Tier level (1,2 or 3) and X is a system generated random digit. The decision number can then be used by applicants in their Online Services Portal account to start an application.

Applicants can contact the APVMA via +61 2 6770 2300 or enquiries@apvma.gov.au should you have any questions about the application process.

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Recalls

Section 161 of the Agvet Code requires that holders of approvals, registrations and permits must notify of any relevant information they become aware of regarding an active ingredient or chemical product as soon as they become aware of it.

Where the notification is of information regarding issues with active or chemical product quality or compliance, the APVMA may require the recall of that active or product. When the recall notification is received, the APVMA will assess the risk and provide prompt advice about the holder’s responsibilities. Where both parties agree the process to conduct and monitor the recall, we will publish the recall on our website and work with the holder to ensure the actions are completed.

In some instances where there is a need for an immediate response, the APVMA may initiate and regulate the recall, in particular where:

  • a product is unregistered or the registration is being re-considered
  • the formulation does meet the safety, trade or efficacy criteria
  • the concentration, composition or purity differs more than the prescribed extent
  • the label differs from the approved label, (including being unapproved);or
  • there is an absence of responsible product stewardship.

The APVMA has published 11 recalls to date in 2021. More information about recalls and how to notify the APVMA is available on our website.

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MQL – Overseas GMP compliance assessment fee

Regulation 71A(2) requires that the holder of the registration of a veterinary chemical product fully or partially manufactured overseas must pay an annual overseas Good Manufacturing Practice (GMP) compliance assessment fee for each site outside Australia. The APVMA recently reviewed the way the overseas GMP compliance assessment fee was collected and determined that as the fee is an additional product registration fee, it should be charged in the same manner as the product registration fee, i.e. that it should be charged in advance not in arrears. This year the APVMA moved to billing in advance with the fees collected this July/August for the 2021–22 financial year.

To finalise the transition to advanced billing, the APVMA is informing holders of registrations where part or all of the manufacturing of a product is performed overseas to update the information held by the APVMA to ensure only those relevant manufacturing sites are held in the register. The APVMA will calculate the overseas GMP compliance assessment fee from the data held in the register from the 2022–23 financial year.

The APVMA will send a reminder email to holders in March 2022 about ensuring the accuracy of the register, noting that it is an obligation under section 161 for holders to maintain an accurate record and correct errors in the register as they become aware of them, including the sites of manufacture of products.

Please do not hesitate to contact the team at mls@apvma.gov.au if you have any questions about the overseas GMP compliance assessment fee.

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Your feedback will be submitted to the APVMA anonymously. If you require a response, please contact us.