Deal or no-deal


TGA says it is prepared for any shortages resulting from a no-deal Brexit

The Therapeutic Goods Administration (TGA) says it will implement “transitional arrangements to provide for minimal interruption in the supply of medical devices in Australia” in the event of a ‘no deal’ exit of the United Kingdom (UK) from the European Union (EU).

In newly-issued advice to health practitioners and consumers, the TGA says it is accounting for “the various scenarios” that may result from Brexit. 

The UK and EU recently agreed to a Brexit extension, through to 31 January 2020. The UK may leave with ‘no deal’ if the withdrawal agreement (‘deal’) is not approved by 31 January 2020, or at the end of a transition period.

In the event of a Brexit ‘no deal’, there will be no impact on the supply of medicines to Australia from the UK, the TGA says.

“Under the UK-Australia MRA on Conformity Assessment, existing arrangements will continue, with the TGA accepting batch certification on MHRA Certificates for supply of medicines from the UK to the Australian Market”.

Under the proposed Brexit ‘deal’, there will also 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, the agency says.

“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”.

In the event of a ‘no deal’ exit, the TGA will implement transitional arrangements to provide for minimal interruption in the supply of medical devices from the UK.

The TGA says it 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.

 

 

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