EU-UK relations: the Council adopts legislation to ensure continued supply of medicines

EU-UK relations: the Council adopts legislation to ensure continued supply of medicines

The Council today adopted a directive and a regulation to ensure continued supply of medicines to Northern Ireland, and to Cyprus, Ireland and Malta. These texts will enter into force on the day of their publication in the Official Journal of the European Union, which is expected in the next few days. The measures will apply retroactively from 1 January 2022.

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, under 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 is aimed at ensuring the supply of investigational medicinal products to the same markets.

Background

With this legislation, 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.

Source: EU-UK relations: the Council adopts legislation to ensure continued supply of medicines – Consilium (europa.eu)

%d bloggers like this: