Belgium, (Brussels Morning Newspaper) The EU Council has adopted rules to protect supply of medicines to Ireland, Northern Ireland, Cyprus and Malta.
The new rules will come into effect one day after publication in the Official Journal of the EU, which should take place in the coming days, the Council noted in a statement on Tuesday.
The body stressed that the new rules will apply retroactively from the start of this year.
“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 Council pointed out.
“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 EU.”
The European Commission welcomed the Council’s move and reminded that the EU Parliament voted in favour of new rules last week.
The EC proposed the move at the end of 2021 after “extensive talks with the UK government to find this long-lasting solution.”
Maroš Šefčovič, Vice-President of the EC for Interinstitutional Relations, described the new rules as “a lasting solution, which was delivered in record time.”
He announced plans to continue cooperating with the UK government “to ensure predictability, legal certainty and the prosperity of all communities in Northern Ireland.”
European Commissioner for Health and Food Safety Stella Kyriakides pointed out that “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.”
She concluded that the EC has found a solution to the problem and secured uninterrupted supply of medicines.
The EC stressed that the solution is temporary and predicted that the markets in question will gradually decrease their dependence on supply of medicines from or through the UK other than Northern Ireland.
The body announced plans to propose changes to EU’s pharmaceutical legislation at the end of the year with the aim of finding long-term structural solutions.