22 April 2022


On 12 April, the Council adopted legislation to ensure continued supply of medicines to Northern Ireland, and to Cyprus, Ireland and Malta, as part of the Commission's package of measures proposed in October 2021 to facilitate the implementation of the protocol on Ireland/Northern Ireland on the ground. The new directive and regulation 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 UK, under the Protocol on Ireland/Northern Ireland. It will also, exceptionally and for a transitional period of three years, allow medicinal products from the UK to be placed on the market in Ireland, Malta and Cyprus under derogations from the requirement for authorisation holders to be established in the EU. The regulation is closely linked to the directive and is aimed at ensuring the supply of investigational medicinal products to the same markets.

Source and legal acts: EU Council