Updated advice for industry following Federal Court decision regarding applications involving reference products

5 July 2016

NOTICE: This document is no longer current and has been retained for historical purposes only

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 decision requires the APVMA to manage each application involving reference product CCI on a case by case basis.

There are a range of applications that nominate a reference product. The APVMA is considering how to best manage these applications in a way which protects the interests of all parties and provides assurance that reference product CCI is not disclosed.

The Federal Court decision also outlined that the APVMA should provide applicants with an opportunity to comment on any proposed re-categorisation for assessment of their applications. The APVMA will commence this process now.

More information about the Federal Court decision on 10 June 2016 is available here.

Certainty for industry

During July 2016 the APVMA will continue to develop options to appropriately manage reference product CCI and revise the process for re-categorisation of applications where this is required to enable assessment by the APVMA.

During August 2016 discussions will be held with industry on the options and any revised systems and processes that may be required, including consideration of previously refused applications.

In the interim, for applications already submitted, or about to be submitted to the APVMA, the following approach will apply:

  • Where an application relies on a reference product to establish safety and efficacy the APVMA will look at the reference product to determine if there is a potential risk for disclosure of confidential commercial information (CCI)
  • Every affected application will be evaluated individually
  • People who have already received a notice should respond to those notices in the stated timeframe to enable the application to progress
  • Where the APVMA is considering re-categorising an application, applicants will be contacted prior to any decision being made and provided with an opportunity to comment.

For more information please contact your case manager on +61 2 6210 4701.

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