05.01.2022

Brexit and Northern Ireland - what's new?

Recommendation

Tuesday, 12 December 2023 14.00 - 16.00 h

GMP Update 2023/2024 - Live Webinar

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.

Press release on the supply of medicines to Northern Ireland as well as Cyprus, Ireland and Malta

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:

Access for people in Northern Ireland to generic medicines authorised under UK national procedures in compliance with EU rules on medicines.
Access to innovative life-saving medicines (including new cancer drugs) through a 'bridging solution': any new medicine authorised in the UK can be supplied to Northern Ireland until the equivalent marketing authorisation is also granted in the EU.
No repeated batch testing of medicines imported into Northern Ireland from the UK if they have already been tested in the UK or EU.
No manufacturing authorisations or import licences are required for medicines supplied from Great Britain to Northern Ireland, "subject to certain conditions".
UK-based companies can use a single pack and leaflet when supplying markets in Great Britain and Northern Ireland. Separate packaging is not required.
Malta, Cyprus and Ireland will benefit from certain exemptions for a period of three years. For example, during this period, importers of medicines from the UK will not be required to have a manufacturing authorisation in these three countries, nor will these medicines have to undergo batch testing again if they have already been tested in the UK.

Under the proposals, the UK will also have to comply with certain conditions:

Certain packaging requirements to ensure that medicines authorised in the UK do not enter the EU internal market.
The UK will assume sole responsibility for the authorisation of medicinal products for Northern Ireland in compliance with EU legislation on the quality, safety and efficacy of medicinal products for human use.

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).

Adaptation of Delegated Regulation (EU) 2016/161

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.

Feedback on the legal acts

"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: