Regulatory update #239

26 September 2016

Annual return of actives 2015–16 update

Reporting of the annual return of actives is due to conclude at the end of September 2016. We will continue to accept annual returns until 21 October 2016.

If you have not done so already, you can submit your report online now.

Log in to online services, registrations and permits and the annual return of actives tab will be on the left hand side. Click ‘commence reporting’ to begin report.

See frequently asked questions for more information about who can report from your business.

If you have any enquiries, please email the Chemical Review team.

Review of GMP approach

We are currently reviewing our approach to the quality assurance of veterinary chemical products manufactured in Australia for domestic use or export, as well as products manufactured overseas and imported for use in Australia.

The review—distributed to manufacturers and registrants—aims to assess options to effectively deliver on the legislative framework for Good Manufacturing Practice (GMP) under the Agvet Code.

For further information, please email the Manufacturing Quality and Licensing team.

Proposal to use New Zealand registration for Australian companion animal veterinary chemicals

A discussion paper on a proposal to use the New Zealand (NZ) registration of companion animal veterinary chemicals in Australia is now available for public consultation.

The paper explores how we can refer to assessments and registration decisions made in NZ for the registration of veterinary chemicals for non-food producing animals in Australia.

Industry can contribute their feedback on this proposal until 4 November 2016. 

Canberra industry information session—register now

Registrations are open for the Canberra industry information and education session on 8–9 November 2016.

Day one of the program will focus on regulatory science and innovation in the global context and day two will be an update on important registration-related topics. The full program will be available in late September.

For more information and to register please see our events page.

Efficacy contestability pilot—reminder

The APVMA is running a pilot to determine the feasibility of moving the function of conducting or commissioning a data assessment from the APVMA to the private sector.

The pilot aims to identify and rectify any potential issues and demonstrate whether the proposed process can increase the efficiency of application processing. If you are interested in participating in the pilot, please contact the Efficacy Assessment Coordinator.

TGA consultation on Poisons Standard—including pentobarbitone

The Therapeutic Good Administration (TGA) has opened a consultation process on proposed amendments to the Poisons Standard.

Pentobarbital (pentobarbitone) is being considered for up-scheduling. The proposed changes would mean that when packed and labelled for injection it would change from Schedule 4 (prescription medicines only or prescription animal remedy) to Schedule 8 (controlled drug—like morphine).

If you would like to contribute to the consultation it will be open from 22 September 2016 to 20 October 2016.

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.