TGA moves to ease fears over a ‘no deal’ Brexit

The increasing likelihood of the UK leaving the European Union with no deal in place has led to uncertainty over UK-certified imported products that would no longer be covered by regulators the Therapeutic Goods Administration (TGA) considers to have comparable standards.
 
Under a ‘no deal’ Brexit, certification from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) would no longer be automatically accepted by the EU’s network of notified bodies.
 
The possibility of such an outcome has led to fears more than 13,000 Australian Register of Therapeutic Goods (ARTG) entries reliant on CE certificates issued by British Notified Bodies could have been affected.
 
However, a TGA spokesperson told newsGP the regulator would implement ‘transitional arrangements’ to ensure minimal interruption in the supply of medical devices to Australia.
 
‘In the event of a “no deal” exit of the UK from the European Union, 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,’ the spokesperson said.
 
‘This will apply to both existing Australian Register of Therapeutic Goods entries and applications for new inclusions of medical devices in ARTG.’
 
According to the TGA website, such a move would require amendments to the Therapeutics Goods Act 1989 to include recognition of notified bodies granted ongoing legal status by the MHRA, but these changes would not have to go through Australia’s Parliament.
 
The TGA also clarified that a Mutual Recognition Agreement signed by the UK and Australia in January ensures the TGA will accept batch certification on MHRA Certificates for the supply of medicines from the UK.
 
Should the proposed Brexit deal proceed, UK-notified bodies will continue to be recognised for a transition period through to 31 December 2020. During this time, sponsors would be able to provide these certificates as conformity assessment documents for their medical devices in Australia.

Brexit imported medicines medical devices Therapeutic Goods Administration