Pills – Photo by qimono on Pixabay
(LUXEMBOURG) – The EU Council adopted legislation Tuesday to ensure continued long-term supply of medicines from the UK to Northern Ireland and to address outstanding supply concerns in Cyprus, Ireland and Malta.
The texts are set to 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.
The agreement was welcomed by the European Commission. “The continuous supply of medicines is essential for hundreds of thousands of patients in Northern Ireland – as well as Cyprus, Ireland and Malta, whose markets are historically dependent on medicines from the UK,” said the Health Commissioner Stella Kyriakides: “We have now fulfilled our commitment to find a solution to ensure that all citizens can continue to get the medicines they need, at all times.”
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.
Proposal to ensure continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta - background guide
