Regulatory update #224

12 February 2016

Industry Information and Education Sessions: Melbourne 2016 session—save the date!

We are holding a series of Industry Information and Education Sessions across 2015 and 2016.

The first session this year will be held in Melbourne on 9 May 2016. Please save the date if you are interested in attending.

The session will cover key areas of the APVMA’s work, as well as provide an opportunity to discuss the APVMA’s direction and priorities.

Registrations and details of the program will be available in early March 2016.

Please visit our Events page for further information and keep an eye on the Regulatory Update for the latest announcements.

Changes to the scheduling and management of APVMA GMP audits

The public consultation on proposed changes to APVMA audit scheduling and closure processes has been completed. We thank all respondents for their feedback.

The finalised policy has now been published with the changes to come into effect from 1 March 2016. Revised audit documentation and forms containing further guidance will be published on that date.

If you have any questions on these changes please email the Manufacturing Quality and Licensing Section of the APVMA.

Managing release for supply of contract manufactured veterinary medicines

The public consultation on proposed guidance for release for supply of contract manufactured veterinary medicines has been completed. We thank all respondents for their feedback.

The finalised guidance has now been published, with effect from 1 March 2016.

If you have any questions please email the Manufacturing Quality and Licensing Section of the APVMA.

Waiver period extended for current 161 notifications and veterinary active constituents

We have extended the period to waive or refund fees associated with Item 18 applications for veterinary active constituents until the end of April 2016.

This transition measure means, for all the existing section 161 notifications already received by the APVMA, applicants will not be charged for variations where the APVMA redirects the 161 notification to an application item.

The refund for any new 161 notifications for variations will be considered on a case-by-case basis.

More information about making changes to veterinary products and applications is available on our website.

Last chance: website and online services review


We are undertaking a major review of our website and online application services and we need volunteers from a range of business profiles for one-on-one discussions. Please email us to register your interest in being a participant. Numbers are limited, so please register now if you would like to participate.

Thank you to those who have already volunteered their time. You will be contacted shortly, with more information.

Help and assistance

Visit: www.apvma.gov.au
Telephone: +61 2 6210 4701
Email: enquiries@apvma.gov.au

Reminder—open for public consultation

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