The Windsor Framework: Centralised Products and Northern Ireland

The EMA has recently published a Q&A guide on the implementation of Regulation (EU) 203/1182.

There is a potential need by Marketing Authorisation Holders to prepare in advance any regulatory, labelling and/or supply changes required for its implementation to help ensure the continuous supply of the product.

Regulation (EU) 2023/1182 of 14 June 2023 has introduced relevant changes as regards to medicinal products intended to be placed on the market in Northern Ireland in the ‘Protocol on Ireland/Northern Ireland’ (the ‘Protocol’)/Windsor Framework. The regulatory implications on the marketing authorisations of (CAPs) for human use include the need to remove the reference to local representative in Northern Ireland in the package leaflet or on labelling aspects for CAPs where multi-country packs including Northern Ireland/UK and an EU/EEA member state are in place.

Medicinal products that are eligible for the centralised procedure (CAPs) placed on the market in Northern Ireland will be in accordance with the law of the United Kingdom and under the terms of the authorisation granted by them as of the date on which Regulation (EU) 2023/1182 becomes applicable. This is expected as of 1st January 2025

To support the preparation of any regulatory, labelling and/or supply changes required, on 5th January 2024, the Agency published a Q&A to Stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use.

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James Hall