The European Union Council has adopted legislation to ensure medicines can continue to flow unimpeded from Great Britain into Northern Ireland.
The issues surrounding medicines stem from the outworkings of the Northern Ireland Protocol, a part of the Brexit deal which means Northern Ireland remains covered by the EU’s pharmaceutical regulations.
As Northern Ireland receives most of its medicines from suppliers in Great Britain, there had been concerns that their movement could be impeded when grace periods end.
Instead, European Commission vice president Maros Sefcovic announced proposed new legislation last year to tackle the issue.
The EU Council said on Tuesday it has now adopted the directive and regulations to ensure the continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta.
A statement said: “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 January 1 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.
The council said the move would “facilitate the implementation of the protocol on Ireland/Northern Ireland on the ground”.
The EU law change will allow GB-based pharma suppliers to maintain their current regulatory arrangements.
It will mean companies in Great Britain can continue to act as a hub for the supply of generic medicines to Northern Ireland, without the need to establish bases in the region.
