COVID-19: advice for veterinary medicine manufacturers and holders

Date of current advice: 7 August 2020

Date range for affected audits: 1 April 2020 through 31 March 2021

1. Background

Following the World Health Organization’s 11 March 2020 declaration of the novel coronavirus (COVID-19) pandemic, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is providing support to holders and manufacturers of veterinary medicines.

The COVID-19 pandemic has resulted in travel restrictions and guidelines for social distancing that have affected the ability to perform Good Manufacturing Practice (GMP) inspections in Australia and overseas.

The APVMA has developed the following guidance to allow veterinary manufacturers audited by the APVMA to demonstrate compliance with GMP while social distancing measures and travel restrictions are in place. This advice was first published on 1 April 2020, and has been updated in August 2020.

This guidance applies during the time that physical audits cannot be carried out due to COVID-19. Further extensions may be made if the relevant restrictions are still in place.

Due to the evolving nature of the pandemic, this advice may change. Where necessary, this may involve extension to relevant timeframes in locations where COVID-19 remains a relevant consideration.

2. Overseas manufacturers

All overseas manufacturers with an audit scheduled before 31 March 2021 (whether this was the original or the extended date) will receive an automatic six-month extension to their current GMP compliance letter expiry date.

There are no changes to the terms of recognition of evidence of overseas GMP compliance.

3. Domestic manufacturers

For domestic manufacturers with an audit due date before 31 March 2021 (whether this was the original or the extended date) the following advice applies.

3.1. Automatic extension—the majority of manufacturers

Domestic manufacturers with two or less major non-conformances will receive an automatic six-month extension to their audit due date.

For example, if an audit was due by 1 November 2020, it would now be due by 1 May 2021.

These extensions will be automatically granted without the need to apply for them. Further extensions may be made if the relevant restrictions are still in place.

3.2. Interim report—medium- and high-risk manufacturers

Domestic manufacturers with three or more major non-conformances identified in their last routine audit will be asked to provide the completed, signed COVID-19 Corrective Action Progress Review Form to the MQL Team.

These manufacturers will be required to provide details of the actions they have implemented to address the non-conformances identified in their previous GMP audit, as well as any other information relevant to their GMP operations. Unless otherwise advised by the APVMA, the evidence specified will be required 14 days before their audit due date or by 30 December 2020, whichever comes first.

Pending consideration of the material submitted, manufacturers with this risk rating will be eligible for up to a six-month extension to their audit date if the APVMA is satisfied that non-conformances have been, or are being, effectively addressed. Further extensions may be made, if the relevant restrictions are still in place.

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