The United Kingdom will formally leave the European Union on 31 January 2020 and will become a third country to the EU. On 1 February 2020 a transition period will start which is due to end on 31 December 2020.
During the transition period, EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ will continue to be applicable to the UK, meaning that pharmaceutical companies can continue to carry out activities in the UK until the end of the year.
Companies have until 31 December 2020 to make the necessary changes to ensure that their authorised medicines comply with EU law and can remain on the EU market. Marketing authorisation holders / applicants can still be established in the UK and Qualified Persons for Pharmacovigilance (QPPVs) and pharmacovigilance system master files (PSMFs), as well as quality control testing sites, can still be based in the UK until the end of 2020.
Updated Brexit-related guidance for companies will be published shortly.
The withdrawal agreement foresees that following its departure from the EU on 31 January 2020, the UK will no longer participate in EU institutions and their decision-making. For EMA this means that as of 1 February 2020, no one who represents the UK, or is appointed or nominated by the UK can participate in meetings of EMA’s scientific committees, working parties or the Agency’s Management Board.
The Agency would like to thank all UK delegates and experts for their involvement in the scientific and regulatory activities of EMA since its establishment 25 years ago. Their professionalism and commitment have contributed greatly to the development and functioning of the strong and efficient system for medicines regulation that we have in the EU today.