The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. A transition period began on 1 February 2020, during which EU pharmaceutical law remains applicable to the UK. The European Medicines Agency (EMA) has made preparations to ensure it continues to deliver on its mission to protect public and animal health throughout the Brexit process. However, the transition period after Brexit comes to an end on 31 December 2020. For this reason, the UK Government is realising new guidelines to steer citizens and professionals among the new rules from January 2021. In the field of paediatric clinical studies conduction, three new guidelines were released and are available on UK Government official website:
- The Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs) from 1 January 2021
- The procedure for applicants applying for a Paediatric Investigation Plan (PIP) from January 2021. The guidance also covers information for applicants or companies with an agreed EU-PIP opinion conferred prior to 1 January 2021.
Guidance on format and content of applications for agreement or modification of a PIP. The guide provides information also on requests for waivers or deferrals and concerning the operation of the compliance check from 1 January 2021.