EU ambassadors today agreed on the mandate for the proposed Directive and Regulation to ensure continued supply of medicines to Northern Ireland, and to Cyprus, Ireland and Malta. On the basis of this position, an agreement will now need to be reached with the European Parliament so that this Directive can enter into force as soon as possible.
The aim of the Directive is to preserve the uninterrupted supply of medicinal products for human use in Northern Ireland after the withdrawal of the United Kingdom, within the Protocol on Ireland/Northern Ireland. It will also, exceptionally and for a transitional period of three years, allow medicinal products from the United Kingdom to be placed on the market in Ireland, Malta and Cyprus under derogations from the requirement for authorisation holders to be established in the European Union. The Regulation is closely linked to the Directive and aims to ensure the supply of investigational medicinal products to the same markets.
With these proposals, the European Union intends to facilitate the implementation of the Protocol on Ireland/Northern Ireland on the ground, in line with the measures for Northern Ireland presented by the Commission on 13 October 2021.