12/04/2022 (Agence Europe) – On Tuesday 12 April, the Council of the EU endorsed a directive and a regulation ensuring the continuity of supply of medicines to Northern Ireland, Cyprus, Ireland and Malta, following the green light given by the European Parliament (see EUROPE 12928/16). These texts will enter into force after their publication in the Official Journal of the EU in the coming days, and will apply retroactively from 1 January 2022. The purpose of the Directive is to safeguard the uninterrupted supply of medicines for human use in Northern Ireland under the Ireland/Northern Ireland Protocol. It provides for a transitional period of 3 years for the marketing in Ireland, Malta and Cyprus of medicines originating in the UK, but of which the authorisation holders are not established in the EU. The derogation is permanent for Northern Ireland. The Regulation deals with investigational medicines. (SP)