The European Parliament adopted under urgency procedure, on Thursday 7 April, measures to continue the supply of medicines from Great Britain to Northern Ireland, Cyprus, Ireland and Malta, as proposed by the Commission in December (see EUROPE 12856/1).
The Council of the EU adopted its mandate on 9 March (see EUROPE 12907/20). These are a directive and a regulation on medicines and investigational medicinal products, adopted by 547 votes to 0 with 4 abstentions and 555 votes to 0 with 3 abstentions respectively.
The provisions adopted amend EU legislation to provide medicines authorised in the UK to Northern Ireland via a temporary authorisation valid for a maximum of 6 months or until the European Medicines Agency grants or refuses a marketing authorisation in the EU.
This allows marketing authorisation holders to be based in Great Britain and batch testing to be carried out in parts of the UK other than Northern Ireland.
Investigational medicinal products manufactured outside Northern Ireland will also be able to be imported into Cyprus, Ireland, Malta and Northern Ireland.
The derogations will be of indefinite duration for Northern Ireland; for Cyprus, Ireland and Malta, which have so far been heavily dependent on the UK for the supply of medicines, they will last for 3 years, after which these markets will be gradually supplied by the EU.
Link to the adopted texts: https://aeur.eu/f/15l (Original version in French by Solenn Paulic)