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.

Links

Brexit: the United Kingdom's withdrawal from the European Union

Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community withdrawal agreement

Questions and answers to Stakeholders on the implementation of the Protocol on Ireland/Northern Ireland

Notices to stakeholders - Withdrawal of the United Kingdom from the EU