Brexit – Implications for Therapeutic Goods in Australia
Brexit ‘no deal’
Regarding medical devices, if there is a ‘no deal’ Brexit, the TGA will continue accepting conformity assessment documents issued by UK notified bodies for existing products while these remain current for the purposes of UK market authorisation. This will apply to both existing Australian Register of Therapeutic Goods (ARTG) entries and applications for new inclusions of medical devices in ARTG.
For medicines, in the event of a Brexit ‘no deal’, there will be no impact on the supply of medicines to Australia from the UK. Under the UK-Australia MRA on Conformity Assessment, existing arrangements will continue whereby, the TGA will accept batch certification on MHRA Certificates for supply of medicines from the UK to the Australian Market.
Brexit ‘deal’ or exit extension
For medical devices, under the proposed Brexit ‘deal’, UK notified bodies would continue to be recognised for a transition period through to 31 December 2020, so there will be no immediate impact on manufacturers certified by these notified bodies.
For medicines, under the proposed Brexit ‘deal’, there will be no immediate impact on the supply of medicines to Australia from the UK. The existing arrangements will continue under the UK-Australia MRA as under the EU-Australia MRA. Similarly, if the timeframe for the exit of the UK from the EU is extended, current arrangements will continue, under the EU-Australia MRA, until an exit occurs.
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