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Veterinary Medicines Regulatory Newsletter, December 2020

Edition VMT003

Directors update: Dr Martin Ilott and Dr Donald Sibanda

Welcome to the third 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 APVMA-New Zealand harmonised labels, immunobiological assessment templates and submission of European Union (EU) dossiers. We have also provided details and key dates for the upcoming holiday period.

The Veterinary Medicines Team is focusing its activities on meeting the application target for the 2020–21 financial year set at 90%. Halfway through the year we are pleased to report the Veterinary Medicines Team continues to deliver high performance by meeting and exceeding the target.

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 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, access and use of veterinary medicines.

We extend seasonal greetings to all our stakeholders and wish you a peaceful and relaxing holiday period with friends and family.

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Performance report

The Veterinary Medicines Team delivered another strong quarter of timeframe performance at the end of the September quarter 2020.

We completed:

  • 98% of veterinary medicines product applications within timeframe, up from 95% in June quarter 2020
  • 90% of applications requiring major assessment for veterinary medicines within timeframe, increasing from 89% in June quarter 2020.

244 veterinary medicine product applications remained in progress at the end of September quarter 2020, down from 268 in June quarter 2020.

The full performance report for the September quarter 2020 is available on our website.

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Christmas and New Year holiday shut-down dates

The APVMA will be closed for the Christmas and New Year break from 25 December 2020 until 3 January 2021. All applications which are due during this period and the first week of January will be finalised before 25 December 2020. Please contact your Case Manager if you have any questions about applications due during this period.

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APVMA Stakeholder Engagement Framework

We have published our Stakeholder Engagement Framework, which sets out the APVMA’s strategic approach to stakeholder consultation and collaboration for the 2020–23 period.

Further information about the Framework, as well as some of the activities we intend to undertake during the 2020–21 financial year, 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 or new active constituents published in the Gazette during the last quarter.

Application number

Product name

Active constituent/s

Applicant name

Summary of use

Date of registration

Product registration number

117504

Nobivac Canine Oral Bb Live Vaccine

Live attenuated Bordetella bronchiseptica, strain B-C2 (≥1 × 10^9 CFU per dose)

Intervet Australia Pty Ltd

For the active immunisation of healthy dogs and puppies from 7 weeks of age to reduce coughing and shedding caused by Bordetella bronchiseptica infection

24 August 2020

87083

120388

Calpro Intra-Ruminal Calcium Bolus For Cattle

114.3 g calcium chloride, 45.7 g calcium sulphate, equivalent to 43 g calcium per 203 g bolus

 Elanco (Bayer Australia Ltd)

For prevention of subclinical hypocalcaemia and as an aid in the prevention of clinical hypocalcaemia (milk fever) in cows

2 October 2020

88138

107550

Vanguard Intranasal Resp 3 Live Vaccine For Dogs

Each dose contains live attenuated: Canine Adenovirus Type 2 (≥10^3.1 TCID50), Canine Parainfluenza Virus (≥10^5.0 TCID50), Bordetella bronchiseptica (≥1.3 x 10^6 CFU)

Zoetis Australia Pty Ltd

For the active immunisation of healthy dogs and puppies from 8 weeks of age to reduce clinical signs associated with respiratory tract disease and shedding induced by Bordetella bronchiseptica, Canine Parainfluenza Virus (CPI) and Canine Adenovirus Type 2 (CAV-2)

13 November 2020

83109

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Tailored guidance pathways complete

In October 2020 we published our final tailored guidance pathway, to assist with applications to vary the dose, frequency or route of administration for a veterinary medicine product.

Designed to provide industry with current and clear guidance for the most common application types, the release of the final pathway marks the end of our ‘Top 20’ project to develop and improve guidance material for stakeholders. The full list of tailored guidance pathways is available on our website.

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Veterinary Labelling Code update

Following our previous Veterinary Labelling Code (VLC) update, the first 4 batches of VLC sections have now been circulated to industry bodies and we are currently reviewing the feedback received. There is only one more batch to be reviewed internally before all VLC guidance notes have been through an initial review.

The Veterinary Medicines Team continues to meet with Animal Medicines Australia (AMA) and the Veterinary Manufacturers and Distributors Association (VMDA) to discuss specific label sections that may require further industry discussion.

We intend to complete the review in early 2021, before the revised VLC guidance notes are collated on our website for final review. We anticipate publishing the final updated Veterinary Labelling Code by the end of the financial year.

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Veterinary immunobiologicals

Autogenous vaccine guideline update

Autogenous vaccines are a useful addition to registered vaccines in animal disease control and maintaining animal health and welfare. The use of veterinary vaccines, including inactivated autogenous vaccines, can also be an additional prophylactic tool to avoid occurrence of diseases, which require antibiotic treatment.

The growing interest in the use of autogenous vaccines led to a joint APVMA-industry review of the current guidance for autogenous vaccines (also referred to as custom vaccines) for granting permit applications.

Following the APVMA’s public consultation that closed on 4 June 2020, the updated guidance was discussed by the Veterinary Immunobiological Working Group (VIWG) at its 2 September 2020 meeting. A post-meeting consultation with VIWG members ended 7 December 2020. 

The new technical guidance, which is expected to be adopted and published by the APVMA in early 2021, will facilitate the application and approval process and reduce regulatory burden to ensure autogenous vaccine permits for products of appropriate quality and safety are granted in a timely manner.

New ESR technical report template and guidance for immunobiologicals

The APVMA has developed a new technical report template and associated guidance material for immunobiologicals. The report template is to be used by External Scientific Reviewers (ESRs) to assess new veterinary immunobiologicals applications for both the registration and variation of registered products.

Access to the immunobiological technical report template and associated guidance material can be located on the APVMA website:

The technical report template and guidance for ESRs has been developed to encourage high quality and consistent regulatory reports for immunobiologicals. The APVMA intends to seek feedback from ESRs during the initial testing phase with the aim of updating the template and guidance material in 2021. Additional comments from industry or other stakeholders are welcome and can be emailed to Dr Martin Ilott at Martin.Ilott@apvma.gov.au.

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Submission of EU dossier – including data list requirements

We have seen an increased number of applications submitting EU dossiers, especially in cases where there has been a parallel APVMA/EU submission. Please note there is no requirement to submit the EU dossier for applications that will be submitted using the APVMA data format. The EU dossier links currently do not work when the data is transferred to the APVMA system.

For international assessments, EU dossiers are acceptable as long as they are submitted in an electronic format that is searchable, and ideally, editable. The assessment must contain a full reference list of all the studies cited in the report. The full reference list must align with the data/information list that is submitted with the application. The Agvet Code requires a specific level of detail for each piece of data including the title of the information, the name of the author and study dates for each data item. A data item listed as ‘EU Dossier’ on an information list does not satisfy the Agvet legislative requirements.

Please contact your Case Manager if you experience issues uploading large amounts of data with any application. They will advise alternative submission methods which may include:

  • Email – the APVMA email system is secure and can be used for files up to 10MB.
  • USB – submission of a USB is a suitable alternative for ‘EU Dossiers’ or large amounts of data.
    • USBs can be posted to the APVMA via GPO Box 3262, Sydney NSW 2001, or
    • Couriered to the APVMA Veterinary Administration Team at 102 Taylor Street, Armidale NSW 2350.
    • Please contact the APVMA via +61 2 6770 2300 if you experience issues with this method of submission.

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Prioritisation of applications

The Veterinary Medicines Team understands applicants and registrants may need to request prioritisation of applications. These requests will be evaluated on a case-by-case basis considering overall workloads for the team and legislated timeframes. It is advisable to request prioritisation prior to or early in the assessment period. The team will endeavour to assist particularly when the request is based on animal health, animal welfare or public health reasons.

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Product and label variations that do not require APVMA notification

The APVMA has provided advice to product holders on the types of product or label updates that can be made by a product holder without requiring APVMA application or notification. Further information is available on our website.

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Changes to how public consultation submissions are published

The APVMA has updated the process for handling submissions received in response to formal public consultations conducted under the Agricultural and Veterinary Chemicals Code Act 1994.

For public consultations starting on or after 2 September 2020, submissions will be published on our website unless:

  • the author requests the submission (or part(s) of it) remain confidential, or
  • we determine it would be unreasonable to publish the submission.

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New Zealand label harmonisation

The harmonisation of labels between New Zealand and Australia is acceptable if the New Zealand-specific information does not contradict the APVMA approved label. The following New Zealand-specific information must be included in a ‘New Zealand box’ that is prominently identified by words such as ‘New Zealand Information’:

  • ACVM registration statement
  • ACVM classification of the product (restricted or unrestricted)
  • Contact details of New Zealand-based registrant and/or agent

Further information about New Zealand harmonised requirements is available from the New Zealand Ministry for Primary Industries.

The APVMA may consider requests to add specific label statements which are required by the New Zealand regulator on APVMA approved labels. The approval of these requests will be based on internal risk assessments. Common requests we receive from applicants and registrants include:

  • additional safety information required by New Zealand
  • withholding periods for horses
  • specific wording of claim statements.

Please contact your Case Manager or the APVMA Enquiries Team if you have a specific request for harmonised labels. Alternatively, a pre-application assistance (PAA) application may be submitted.

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MQL news

The Manufacturing Quality and Licensing (MQL) Team has conducted 2 workshops with auditors and industry, to identify the impacts and potential mitigations of impacts caused by the SARS Coronavirus 2 pandemic on the successful audit of Good Manufacturing Practice (GMP) in Australian veterinary chemical manufacturing sites. Work continues on a strategy to ensure routine auditing can occur from March 2021, including the use of risk based semi-remote, remote and face to face auditing.

The APVMA report on a summary of outcomes of stakeholder engagement as part of the Good Manufacturing Practice Code Review was published on our website on 30 September 2020.

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Staff news

  • Dr Rachel Chay has been appointed as APVMA Executive Director, Registration Management.
  • Dr Donald Sibanda continues to act as a Director for the Veterinary Medicines Team.
  • Dr Martin Ilott has been appointed to the panel of experts for the British Pharmacopeia Commission for Veterinary Immunological Products (VIP), for a 2-year term ending 31 December 2022.

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URL

http://apvma.gov.au/node/77296
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