5/6 October 2022
In the course of the Brexit negotiations, the role of Northern Ireland was always in focus. The aim of the EU in particular was to avoid a hard border on the island of Ireland. The result was the so-called Protocol on Ireland and Northern Ireland. But it is and remains complicated and there have been a number of renegotiations without much agreement and also follow-up documents. Now there are further announcements and publications.
On 17 December, the EU Commission presented proposals to ensure the long-term supply of medicines from Great Britain to Northern Ireland and to solve the remaining supply problems in Cyprus, Ireland and Malta. In the context of the Ireland/Northern Ireland Protocol, this means that the same medicines will continue to be available in Northern Ireland at the same time as in the rest of the UK, while specific conditions will ensure that medicines authorised in the UK do not enter the internal market.
What does this mean in detail?
The EU will amend its own legislation on medicines to ensure the following:
Under the proposals, the UK will also have to comply with certain conditions:
The points are summarised and explained in a corresponding Q& document (Questions and Answers on Commission Proposal to ensure continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta).
The most important change here is the extension (by three years) of the exemption from the obligation of wholesalers to decommission the unique identifier of medicinal products exported to the United Kingdom. Again, the aim is to ensure the continued supply of medicines to Cyprus, Ireland, Malta and Northern Ireland.
Introduction of an additional alarm type ("Non-Union pack"): this is triggered when a medicinal product has been manufactured and labelled for the UK market but verification has not taken place in Northern Ireland, Cyprus, Ireland or Malta.
"The Commission would like to hear your views" it says on two web portals set up by the EU Commission. From 20 December 2021 - 16 February 2022, feedback can be given on the following two topics: