EU-UK relations: ensuring uninterrupted supply of medicines
On Thursday, MEPs adopted measures to continue supplying medicines from Great Britain to Northern Ireland, as well as to Cyprus, Ireland and Malta.
Following an urgent procedure, Parliament adopted two Commission proposals to ensure legal certainty and predictability for the long-term supply of medicinal products and investigational medicinal products from the United Kingdom to Northern Ireland, Cyprus, Ireland and Malta.
The exceptional provisions will allow medicines authorised in the UK to be supplied to Northern Ireland through a temporary authorisation, valid for a maximum of six months or until the European Medicines Agency grants or refuses a marketing authorisation in the EU. Specific conditions would be in place to ensure that UK-authorised medicines do not enter the EU single market.
In this context, marketing authorisation holders may be established and/or located in parts of the UK other than Northern Ireland and batch testing may be carried out in parts of the UK other than Northern Ireland. Additionally, investigational medicinal products manufactured in parts of the UK other than Northern Ireland can be imported into Cyprus, Ireland, Malta and Northern Ireland, provided that certain conditions are fulfilled.
These derogations will apply indefinitely to Northern Ireland, while for Cyprus, Ireland and Malta the derogations will be temporary for a period of three years, as these markets are expected to gradually be supplied through EU member states.
Next steps
The new legislation will enter into force as a matter of urgency, following the swift approval of the same amended texts by both Parliament and Council. The measures adopted by member states will apply retroactively from 1 January 2022.
The Commission plans to propose a revision of EU pharmaceutical legislation by the end of 2022. These proposals are expected to provide longer-term structural solutions to the issue of access to medicines, in particular to enhancing security of supply and addressing the risk of shortages in smaller EU markets.
Background
In line with the package of solutions for Northern Ireland tabled on 13 October 2021, the Commission adopted on 17 December 2021 a series of proposals aiming to ensure the supply of medicines to Northern Ireland, as well as to Cyprus, Ireland and Malta.
An additional Commission Notice bridges the gap between 31 December 2021 (deadline for application of previous guidance provided by the Commission) and the entry into force of the proposed legislative measures.