EMA: Q&A on Brexit Rules for Centrally Authorized Medicinal Products in Northern Ireland
The European Medicines Agency (EMA) has answered nine questions on the application of revised Brexit rules to centrally authorised medicinal products for human use in Northern Ireland (Regulation (EU) 2023/1182).
The original Brexit agreement maintained EU pharmaceutical legislation in Northern Ireland, leading to trade challenges and licensing inconsistencies within the UK. The Windsor Framework and subsequent EU regulations, which will apply from 1 January 2025, set out the rules for medicinal products for human use in Northern Ireland. The EMA clarifies that the rules apply to all human medicines, excluding veterinary medicines.
Human medicines will need to be authorised by the UK authorities to enter the Northern Ireland market, and the temporary process for UK authorisation of products without EU authorisation will end with the new regulations. Centrally Authorised Products (CAPs) and multi-country packs that were CAPs in Northern Ireland before the regulations came into force will be able to remain on the market without having to comply with the new conditions.
With the applicability of Regulation (EU) 2023/1182, the reference to the local representative for Northern Ireland in the product information of CAPs will become obsolete and marketing authorisation holders should update the information during variation or renewal procedures. Parallel distribution notices for CAPs with the UK (including Northern Ireland) as the only destination or source country will become invalid. If the UK is one of several destinations/sources, the notices must be amended to remove the UK.
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