Regulatory update #235

5 July 2016

Updated advice for industry—Federal Court decision involving reference products

The Federal Court decision on 10 June 2016 confirmed the importance of the APVMA’s obligations to appropriately protect confidential commercial information (CCI) about a reference product when assessing product registration applications.

The APVMA has updated its advice for industry on the processes for applications and will be holding discussions with industry during August 2016. See the full update here.

Efficacy contestability pilot

An efficacy contestability pilot will determine whether data assessment can be moved to the private sector and consider:

  • feasibility
  • efficiencies for APVMA and industry
  • quality decision-making for registration and variation applications.

Please contact the Efficacy Assessment Coordinator if you have questions or want to participate.

Report active constituent data

The APVMA has resumed collection of data for active constituents imported, manufactured and exported—commencing with the financial year 2015–16.

An online reporting system has been set up for industry to enter the details online.

Reporting for the 2015–16 year is required by the end of September 2016.

Legislative changes taking effect 1 July 2016

Two legislative changes to support variations to non-active constituents in registered chemical products come into effect on 1 July 2016.

Substitution of non-active constituents of registered chemical products as a prescribed variation can be made under Item 13A using online services—in limited circumstances.

There is now a manual process for Interchangeable constituent determination which allows for the interchange of non-active constituents in a chemical product or across a class of chemical products.

Help and assistance

Telephone: +61 2 6210 4701

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