On the 24th of March 2023, the United Kingdom and the European Union formally adopted the Windsor Framework agreement concerning Brexit for Northern Ireland. This agreement sets out arrangements to solve problems and challenges following the exit of Great Britain from the EU. The new version of the document introduces solutions that will make the protocol work more effectively.
From 01.01.2025 the following changes to be introduced include:
The British Medicines Agency (MHRA) will approve/issue marketing authorizations for all the medicinal products across the UK market (including Northern Ireland). This will allow to supply all types of medicinal products in single packs, within the UK supply chains, with a single authorization. Previously, the original Northern Ireland Protocol applied to all the EU rules and marketing authorization requirements. This meant, that in the case of new medicinal products, including innovative ones, the European Medicines Agency (EMA), and not the MHRA, had to approve the medicinal products for the Northern Ireland market which significantly hampered the supply between these two islands.
All medicinal products in order to be sold in the UK must have a “UK Only” label on their packaging.
The EU Falsified Medicines Directive (FMD) will not apply to the medicinal products provided to Northern Ireland anymore. The features previously included to comply with EU FMD requirements may now be removed. The UK law on safety requirements, such as the placement of the expiry date and batch number on packaging, remains unchanged.
In terms of providing innovative medicines to patients, Northern Ireland will be re-integrated into a UK-only regulatory environment, with the EMA playing no role.
In conclusion, Northern Ireland will be reintegrated into a UK-only regulatory environment, excluded from the EMA Agency.
Medicines already placed on the market in Northern Ireland and Great Britain (in accordance with the relevant legislation in Northern Ireland or Great Britain; i.e. released by the QP) by the date of applying the Windsor Framework, may continue to be supplied to patients until their expiry date.
All new medicines and existing medicines in Northern Ireland that are currently centrally authorized by the EMA will be nationally authorized by the MHRA for the UK market.