Insife

It’s becoming clear that the United Kingdom leaving the EU on the 29 th March without a deal is a very real possibility. The UK Government’s position remains unchanged in that a deal with the European Union remains its top priority. However, the clock is ticking, and the government has stated that as a responsible legislator it must make plans for every eventuality and this includes no deal. The MHRA, as a government body, is therefore making preparation that, in the event of no deal, regulatory submissions (including pharmacovigilance) and notifications can continue to be made to the UK authority. The monitoring of the safety of medicines on the market is currently coordinated at EU level. However, if there is no deal then the MHRA will have primary responsibility for the conduct and oversight of all pharmacovigilance activities in relation to UK Marketing Authorization, certificates of registrations and traditional registrations. Sharing of common systems, formal exchange and