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United Kingdom's withdrawal from the European Union


As announced previously, Marketing Authorisation Holders (MAH), that still have relevant entities located in the UK, are again reminded to make the necessary changes until 31 December 2020 to ensure that their authorised medicines comply with EU law and can remain on the EU market after the transition period. In case e.g. the MAH, QPPV, batch release sites, batch control sites, etc. are not located in the Union (EEA) or Northern Ireland after 31 December 2020, the marketing authorisation is not in line with the Acquis Communautaire and Member States may not allow the product to remain on the market. The Ireland/Northern Ireland protocol will apply from 1 January 2021.