A consultation launched by the Medicines and Healthcare products Regulatory Agency on the impact of a no-deal Brexit closes on Thursday 1 November. It deals with how legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no implementation period.
The consultation covers no-deal proposals on medicines, clinical trials and medical devices.
The overall approach in no-deal is for the MHRA to be a stand-alone regulator, taking decisions and carrying out functions which are currently handled at EU-level. This would include decisions on Marketing Authorisation applications which are currently authorised through the Centralised Procedure, as well as pharmacovigilance responsibilities.
The MHRA adds that it firmly believes it is in the interests of both the EU and the UK to strike a deal but that it is the job of a responsible government to prepare for all scenarios, including the unlikely event that March 2019 is reached without agreeing a deal.