Centralised authorisation procedure
The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. As of 1 January 2021, EU pharmaceutical law as laid out in the ‘acquis communautaire’ applies to and in the UK in respect of Northern Ireland only under the terms of The Protocol on Ireland / Northern Ireland. The Protocol is subject to periodic consent of the Northern Ireland Legislative Assembly. Its initial period of application is four years from 1 January 2021.
For information on what applies to centrally authorised products, we refer to the guidelines of the EMA.