The Medicines and Healthcare Products Regulatory Agency (MHRA) has opened a consultation on how legislative and regulatory processes would have to be modified in the event of a ‘no deal’ when the United Kingdom (UK) leaves the European Union (EU) in March 2019, with no implementation period. The consultation closes at 11:45pm on 1st November and covers no-deal proposals on clinical trials, medicines and medical devices.
The MHRA believes that it is in the interest of both the EU and the UK to strike a deal, however it is necessary to prepare for all scenarios which includes the unlikely event that no deal is agreed when the UK leaves the EU in March 2019.
In case of a no-deal, the approach is for the MHRA to become a stand-alone medicines and medical devices regulator, taking any decisions and completing functions which are currently taken or carried out at EU-level. This would include decisions on Marketing Authorisation (MA) applications which are currently authorised through the Centralised Procedure, paediatric investigation plans and orphan status, as well as pharmacovigilance responsibilities.
To view the MHRA consultation on EU exit no-deal legislative proposals, please click here.