Regulatory update #219

Pre-application assistance: new arrangements and fee structure from 5 November 2015

Following extensive consultation with industry and stakeholders, new arrangements for pre-application assistance come into effect from 5 November 2015.

Learn more about pre-application assistance

Access to chemicals—crop groupings project

As part of the Australian Government’s initiatives to improve access to safe and effective agricultural and veterinary chemicals the APVMA will establish an official list of Australian crop groups. Consultation is now underway with industry and community and submissions are invited until the end of January 2016.

More information on this and other initiatives

Seeking input on the contestability of the efficacy assessment

The APVMA proposes to trial a process to see if it is possible to move the function of conducting or commissioning data assessments from the APVMA to the private sector while retaining quality decisions for registration and variation applications.

We are currently seeking submissions on a proposal for the pilot, and consultation is open until close of business on 1 February 2016. More information

Data guidelines

Amended data guidelines

The following data guidelines have been reviewed by the APVMA and changes made:

• Chemistry and manufacture of product (Part 2)
  Minor change to include reference and links to the European Medicines Agency guidance note on in-use stability
  (EMEA/CVMP/424/01)
• Additional data guidelines for chemistry and manufacture (Part 2)
  Minor change to include reference and links to the European Medicines Agency guidance note on in-use stability
  (EMEA/CVMP/424/01).

Fenthion—cease use now!

Products containing fenthion may not be used after October 2015. This marks the end of a 12–month phase out period that commenced following the finalisation of the review into fenthion and subsequent cancellation of the active constituent. Any product that remains unused should be disposed of responsibly.

Detailed information is available on our website.

Help and assistance

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

Reminder—open for public consultation

• Proposed approval of the new active constituent clitoria ternatea extract  – until 17 November 2015
• Proposed approval of the new active constituent, 4-aminopropiophenone and registration of Foxecute Fox Bait and PAPP Wild Dog Bait – until 1 December 2015
• Establishing an Australian crop grouping list – until 31 January 2016
• Seeking input on the contestability of the efficacy assessment – until 1 February 2016