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/20226
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Regulatory update #232
Proposal to add new notifiable variations
The APVMA is proposing to add five new notifiable variation items to remove the need for full applications for simple changes to product registrations and active approvals. The draft legislative instrument detailing the proposed new notifiable variations is now available for public comment.
Consultation closes on 29 June 2016.
Update to Hendra virus vaccine information
The APVMA has now approved a variation application to extend the duration of immunity to 12 months. The data provided with the variation application demonstrated that horses vaccinated with the product developed immunity for up to 12 months.
Melbourne Industry Information Session—thank you
Thank you to everyone who attended the Melbourne Industry Information and Education Session on 9 May 2016.
Over 130 industry representatives attended to hear and discuss updates on the APVMA’s priorities, the application and registration process, lower regulatory approaches, regulatory science, compliance, MQL and our online systems and services.
Audio recording of the presentations will be available in the coming weeks for those who were unable to make it.
The next industry session will be held in Canberra during September/October this year and will be a two-day event with a special science feature day. The final dates will be available in the coming weeks through the Regulatory Update newsletter and our events page.
Help and assistance
Reminder—open for public consultation
- Proposal to amend Schedule 20 of the revised Australia New Zealand Food Standards Code – until 31 May 2016
- Seeking stakeholder input on two user guides for the use of international data, assessments, standards and decisions – until 3 June 2016
- Proposed approval of spironolactone and registration of Prilactone 80 mg tablets for dogs, Prilactone 10 mg tablets for dogs and Prilactone 40 mg tablets for dogs – until 14 June 2016
- Seeking comment on five new notifiable variation items – until 29 June 2016
- Omethoate proposed regulatory decisions report – until 4 August 2016