Filenews 20 December 2021 - by Theano Thiopoulou
A package of measures to ensure the continued long-term supply of medicines to Cyprus, Malta and Northern Ireland from Great Britain was unveiled on Friday by the European Commission. The European Commission and the UK Government have held extensive talks to find a long-term solution to medicines.
According to the European Commission, historically, many medicines in Cyprus, Ireland and Malta were supplied through or from Great Britain. The UK's withdrawal from the EU has made it a challenge for operators in these Member States to fully comply with EU law. In order to address this situation, avoid shortages of medicines and ensure a high level of protection of public health, Cyprus, Ireland and Malta will benefit from certain derogations for a period of three years.
For example, during this period in these three countries, importers of medicines from the UK will not need to have manufacturing authorisations, nor will these medicines have to undergo batch testing again if they have already been tested in the UK. In addition, Cyprus and Malta will be able, under certain conditions, and for justified reasons of public health, to authorise the placing on their national market of a medicine authorised in the UK. This will give operators more time to adapt. Work on a long-term permanent solution is ongoing in the context of the EU's pharmaceutical strategy.
In parallel, work is ongoing on finding a long-term permanent solution in the context of the EU's pharmaceutical strategy.
The notice requires the competent authorities in the United Kingdom and the Member States concerned to publish a list of the medicinal products concerned. This is one way to increase transparency about the functioning of the special solution for Northern Ireland and the specific derogations for Cyprus, Ireland and Malta, with the ultimate aim of protecting public health in the EU and ensuring that these medicines are not further distributed to other parts of the single market. For reasons of stability and predictability, there will be an extension of the Commission's interpretative note to ensure the continuation of the supply of medicines to Northern Ireland as well as to Cyprus, Ireland and Malta. Therefore, the existing arrangements will last until the end of 2022, unless the legislative process is finalised earlier.
Veterinary medicinal products
Legislative proposals do not cover veterinary medicinal products. Discussions on veterinary medicinal products will continue in the coming months in order to gather information, identify any outstanding implementation issues and find the most appropriate way to ensure the long-term continuity of the supply of veterinary medicines in Northern Ireland, as well as in Cyprus, Ireland and Malta.
Next steps
The legislative proposals will be sent to the European Parliament and the Council as soon as all language versions are available. The Commission invites the co-legislators to start working on these proposals as soon as possible, in the interests of the citizens and businesses of Northern Ireland and the three Member States concerned.
In order to ensure the stability and predictability of the system, the Commission's interpretative note will be extended to ensure the continued supply of medicines in Northern Ireland, as well as in Cyprus, Ireland and Malta. As a result, the existing regime will continue to apply until the end of 2022, unless the legislative process is completed earlier.
