UK – MHRA, EMA issue guidelines on eve of Brexit

On the eve of Brexit, the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released information for drugmakers and medical device companies regarding the transition period and future relationship between the EU and UK.

EMA informs companies that EU pharmaceutical law will continue to apply to the UK through the transition period that will run from 1 February 2020 to 31 December 2020, “meaning that pharmaceutical companies can continue to carry out activities until the end of the year.”

Through the transition period, marketing authorization holders and applicants may remain based in the UK, as can their qualified persons for pharmacovigilance (QPPVs), pharmacovigilance system master files (PSMFs) and quality control testing sites.

EMA reminds marketing authorization holders that they have until the end of the transition period to make any necessary changes to their authorized medicines to ensure they comply with EU law and says it will publish additional updated Brexit-related guidance shortly…