Regulatory update #232

20 May 2016

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

Telephone: +61 2 6210 4701

Reminder—open for public consultation

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