On Wednesday 9 March the national ambassadors to the EU adopted the mandate proposed by the Commission on the proposals for a directive and a regulation to ensure the continuity of supply of medicines to Northern Ireland, but also to Cyprus, Ireland and Malta.
Proposed by the Commission in December (see EUROPE 12856/1) after a series of exchanges with the UK, the texts amend existing EU legislation to make it easier to export medicines between Britain and Northern Ireland. A market authorisation could, for example, be issued only in Great Britain and be valid for Northern Ireland, if the medicine in question remains in that territory. An agreement will now have to be found with the European Parliament, which still has to approve its mandate.
The Directive aims to safeguard the uninterrupted supply of medicines for human use in Northern Ireland. It will also allow, exceptionally and for a transitional period of three years, the marketing in Ireland, Malta and Cyprus of medicines originating from the UK under derogations from the requirement that the authorisation holders be established in the EU, the EU Council explains in a statement. The substance of the proposals has not been changed by the Member States, who have only provided some technical clarifications. (Original version in French by Solenn Paulic)