This content is current only at the time of printing. This document was printed on 13 December 2019. A current copy is located at https://apvma.gov.au/node/19831
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Regulatory update #224
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
Reminder—open for public consultation
- Request for comments and suggestions—efficacy criteria – until 12 February 2016
- Proposed registration of the product Bollgard III – until 16 February 2016
- APVMA Regulatory Science Strategy – until 17 February 2016
- Proposed approval of decoquinate and the registration of Deccox – until 24 February 2016
- Proposal to amend Schedule 20 of the revised Australia New Zealand Food Standards Code – until 8 March 2016
- Propiconazole in the product Chairman Fungicide – until 11 March 2016