Updated guidance has been issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019 with no withdrawal arrangements in place, referred to as a “no deal” scenario.
The guidance updates the MHRA’s technical notice published in August 2018 and takes into account the responses to the public consultation in October 2018 on the changes that would be necessary to current UK legislation in the event of a no deal Brexit. The MHRA proposals are still subject to parliamentary approval of the relevant statutory instruments that are required to bring these proposals into law.
The guidance confirms that in the event of “no deal”, the UK would no longer participate in the EU regulatory networks for medicines or medical devices and the functions currently carried out at EU level for such products on the UK market would be transferred to the MHRA.
The updated guidance is generally consistent with the previous position but provides additional details and confirmation on matters such as the process and timing of marketing authorisation assessments, to help companies prepare for a possible “no deal”. Generally industry has welcomed this further guidance with the BIA indicating that it has addressed some of the concerns it had. For example the MHRA reconsidered the proposal to introduce a requirement for the sponsor to have a UK chief investigator as contact point for the licensing authority. However there is still further work to be done and industry is still raising concerns with some of the proposals such as the need for an additional oversight system to verify QP certification of IMPs imported from EU/EEA countries. The ABHI indicates that whilst the guidance provides information for those manufacturers wishing to place product on the UK market post-Brexit, further discussions are required to address how this is reciprocated at a pan-European level.
The full guidance can be accessed here.