7/8 February 2023
Heidelberg, Germany
The EU Commission has been working for some time to ensure a long-term supply of medicines from Great Britain to Northern Ireland and to solve the remaining supply problems in Cyprus, Ireland and Malta. Among other things, its own legislation on medicines should be changed and, in addition to Northern Ireland, countries that have so far had staked trade relations with Great Britain, such as Malta, Cyprus and Ireland, should benefit from certain exemptions for a certain period of time. Last year, the EU Commission proposed both a Directive and a Regulation. One objective was to ensure the supply of medicines for human use to Northern Ireland under the Ireland/Northern Ireland Protocol. Other points included:
Now both the European Parliament (7 April 2022) and the Council (12 April 2022) have approved the further agreed texts of the Directive and the Regulation. These can enter into force on the day of their publication in the Official Journal of the European Union.
The points are summarised and explained in the corresponding Q&A document "Questions and Answers on Commission Proposal to ensure continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta".