LONDON (Reuters) – Britain’s medication regulator stated on Tuesday it could work to minimise disruption brought on by the nation leaving the European Union because it tried to allay a few of the worst fears of pharmaceutical firms.
The extremely regulated medication trade is worried about Brexit fallout because the European Medicines Agency (EMA) relocates from London to Amsterdam, creating uncertainty about drug approvals after 2019.
The Medicines and Healthcare merchandise Regulatory Agency (MHRA) stated in an replace on its web site that it hoped to have a seamless relationship with the EMA after Brexit, but when this didn’t occur it could be “pragmatic” in setting UK drug guidelines.
“There would be no sudden changes to the UK regulatory framework … we would give adequate notice and ensure that companies had sufficient time to implement any changed requirements,” it stated.
The company additionally famous that London and Brussels agreed final month that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling”.
The Association of the British Pharmaceutical Industry stated it welcomed the MHRA’s pragmatism however warned that planning for a situation the place Britain had a separate regulatory system required additional element, highlighting the necessity for a sensible Brexit implementation interval.
Pharmaceutical firms are used to decade-long product growth cycles. Maintaining well timed approvals for brand spanking new medication is essential each for getting new medicines to sufferers and making certain monetary returns.
Reporting by Ben Hirschler; Editing by Raissa Kasolowsky and Alexander Smith