APVMA COVID-19 update—industry advice

24 April 2020

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) has implemented business continuity arrangements to ensure we can continue to deliver efficient, effective, timely, and science-based agvet chemical regulation.

Maintaining agency operations and continuing to serve the Australian community and our stakeholders is our core focus during this period.

We understand that many of you are facing unprecedented circumstances and we are encouraging you to reach out to us to discuss your needs during this period.

In line with Australian Government advice, we have introduced a social distancing policy, which incorporates staff working from home wherever possible.

APVMA staff are well placed to work from home—our IT systems allow for it and our staff have significant experience working remotely, and seamlessly.

All APVMA staff are still contactable via their email and office phone numbers, and services will continue as usual during our standard operating hours from 9 am to 5 pm AEST, Monday to Friday.

General enquiries should continue to be directed to the APVMA Enquiries Team via email or telephone, +61 2 6770 2300.

COVID-19 processes for seeking changes to existing products and actives

Due to COVID-19, the APVMA understands there are changes registrants may need to make to existing products and actives which may require regulatory approval.

These could include changes to manufacturing sites, product formulations, new sources of active constituent, and product labelling and packaging.

The APVMA has various pathways to progress changes including approvals and variations for products and actives and the issuance of permits.

To minimise any disruption to the current supply of existing registered products during this period, the APVMA may be able to provide expedited assessment for changes to registered products and approved actives in some circumstances.

Applicants seeking to make changes should approach the change in the usual manner with relevant supporting data where required.

Applicants are encouraged to first contact the APVMA to discuss the change. Depending on the circumstance, the APVMA will provide guidance including the most appropriate pathway for the lodgement of applications (ie registration variation, permits or notifiable variations).

COVID-19 processes for seeking extensions to notices

We understand that because of COVID-19, some applicants may need to seek an extension of time to respond to notices. This includes but is not limited to s159 (requirements), s8S (proposal to refuse) and 70B (re-categorisations) notices.

Applicants seeking an extension should put their request in writing with their proposed timeframe for responding to the notice. All requests should include the application number and be sent to casemanagement@apvma.gov.au.

The APVMA has modified its notices to reflect these changes.

Veterinary product site licencing and audits

Advice for veterinary medicine manufacturers and holders in relation to manufacturing quality and licencing, including audits is available on our website.

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.