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Brexit – What’s the impact on medicines and medical devices supplied in Australia?

Brexit

 

The long-awaited Brexit is underway with the UK exiting the EU on 31 January 2020

A transition period is now in effect until the end of 2020 with the possibility for extension. Its status quo for Australia during the transition period, with the current regulations for therapeutic goods continuing to apply.

The TGA have recently published guidance for sponsors and the main impact on the supply of medical devices and medicines in Australia will occur after the end of the transition period.

 

Medical devices

The TGA will continue accepting conformity assessment documents issued by UK notified bodies (under MHRA oversight) for medical devices currently on the ARTG, meaning products may continue to be imported and/or supplied in Australia.

The TGA are currently amending legislative instruments to allow new applications for ARTG inclusion to proceed with conformity assessment documents issued by UK notified bodies.

It should be noted that some UK-based device manufacturers are transferring EU certificates from UK notified bodies to EU notified bodies. In this situation sponsors will need to submit variations to update the manufacturers evidence or in some cases submit a device change request if the ARTG entry is impacted.

 

GMP clearances

Sponsors are strongly encouraged to submit extension applications prior to expiry of current GMP clearances for UK manufacturing sites that are supported by MHRA desk-top assessments.

 

Medicines

There is minimal impact to medicines, as Australia and the UK have signed a Mutual Recognition Agreement (MRA) guaranteeing continuity of the existing mutual recognition arrangements when the transition period ends.

Sponsors will need to consider the impact of changes to the supply chain if manufacturing steps such as ‘release for supply’ to the Australian Market are transferred from a UK-based site to EU-based manufacturing sites, to ensure replacement sites are GMP cleared and registered on the ARTG. In this situation, forward planning will be imperative to minimising the impact on medicine supply and avoiding medicine shortages.

 

If you need assistance with assessing the impact of Brexit or navigating your regulatory strategy, please contact our Regulatory Service team at [email protected].

 

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