Regulatory update #214

Annual return of actives

On behalf of the Department of Agriculture, the APVMA will recommence collecting data from industry on actives imported, manufactured and exported for the 2015 16 year.

Reports will be due by the end of September 2016, with an online system developed to assist holders in reporting the data.

We will write directly to everyone affected by this requirement and a test version of the reporting system will be made available for comment and feedback.

View more information on annual return of actives.

Fenthion use to cease in October 2015

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. Existing stocks can be used until current permits and conditions expire in October 2015. Any product that remains unused should be disposed of responsibly.

Detailed information is available on our website.

Relevant label particulars

At the time a product is registered the APVMA is required to publish the approved label on the APVMA website—this is a text document which includes all the relevant label particulars which have been approved by the APVMA for that product.

View more information on label approvals.

Transitional arrangements for applications received before 1 July 2014

Applications received before 1 July 2014 were subject to transitional arrangements for a period of one year.

From 1 July 2015, any unfinalised applications are considered under the provisions of the current agvet legislation. The APVMA has written to people with affected applications to advise recalculated timeframes.

View more information on transitional arrangements.

Data guidelines

Amended data guidelines

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

• Guidelines for efficacy evaluation of herbicides: weeds in Australian forests 
  This is a minor update of the 2009 version of the same guideline to bring it into line with the post-July 2014 format for data guidelines. No substantial changes have been made to the content of the document.

Draft data guideline: Guidelines for efficacy evaluation of on-farm dairy cleansers and sanitisers

The APVMA in conjunction with Dairy Australia have developed draft data requirements for what information should be provided with an application to satisfy the efficacy criteria for dairy cleansers and sanitisers for use on-farm.

We invite comment on the technical aspects of the proposed data guideline up until 7 September 2015.

Help and assistance

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

Reminder—open for public consultation

• Seeking stakeholder input into guidance on managing release for supply of contract manufactured veterinary medicines – until 21 August 2015
• Draft data guideline ‘Guidelines for Efficacy Evaluation of On-farm Dairy Cleansers and Sanitisers’ – until 7 September 2015
• Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code –until 8 September 2015
• Proposed approval of a new active Buprenorphine and registration of the product Bupredyne Injection containing Buprenorphine – until 8 September 2015
• Proposed approval of a new active Telmisartan and registration of the product Semintra 4 mg/ml oral solution for cats containing telmisartan– until 8 September 2015
• Refinement of aquatic exposure estimates in environmental run-off assessments for pesticides: dryland cropping regions – until 21 September 2015