Updated advice for industry following Federal Court decision regarding applications 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 decision requires the APVMA to manage each application involving reference product CCI on a case by case basis.

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.

Source: APVMA