In light of the Mutual Recognition Agreement between the UK and Australia, agreed in early 2019, the Australian Therapeutic Goods Administration (TGA) has released guidance concerning Brexit-related contingency plans.
These plans confirm that, in the event of a no-deal Brexit, the TGA will continue to accept conformity assessments from UK-based Notified Bodies relating to currently-listed or new applications to the Australian Register of Therapeutic Goods (ARTG). In addition, devices listed on the ARTG with current CE Mark certifications may still be marketed in Australia.
In the event that a deal is reached or that an extension is agreed, current ARTG listing arrangements will remain in place until the UK leaves the EU, which would likely be after 31st December 2020.
These plans aim to prevent or minimise market and supply disruptions, and have received a favourable analysis from consultants at Emergo by UL:
‘TGA preparations should result in minimal short-term impact, if any, on manufacturers marketing their devices in Australia.’
For further information, please see the full press release from the ARTG here.