UK Updates – Windsor Framework and Regulation (EU) 2023/1182 for Centralised Products

What it means for your company

• Batches of medicinal product, authorised through the centralised procedure (CAP), that are currently lawfully on the market in Northern Ireland may remain so until their Expiry Date
  • However, these medicinal products cannot be moved from Northern Ireland to an EU/EEA Member State or be placed on the market in an EU/EEA Member State.
• No new batches of authorised CAPs can be released on the market in Northern Ireland after Regulation (EU) 2023/1182 becomes applicable (01Jan2025)
  • Therefore the release of CAP medicinal product by your Qualified Person (QP) has to be planned accordingly and cannot be performed after this date.
• It is recommended that companies and MAH’s anticipate any potential issues and resolve them in the next 8 months.
• There is no possibility of multi-country packs for CAPs between Northern Ireland and any other EU/EEA member state after the regulation becomes applicable.
  • Any medicines placed on, or who are currently on the market before this happens may remain so until the expiry date is reached.
• The product information (PI) of the CAPs will no longer require the mention of a local representative in Northern Ireland after the regulation becomes applicable.
  • The PI can be amended by way of an article 61(3) if no regulatory procedure is planned within 36 months.
  • This change should be made at the earliest opportunity.
  • The Q&As to stakeholders states ‘Additionally, it is also acceptable to request the deletion of the local representative for Northern Ireland in any regulatory procedure affecting the Annexes of the Marketing Authorisation submitted after 1 July 2024, provided that this change is only implemented after the date that Regulation (EU) 2023/1182 becomes applicable.’

Do you have a product that this may affect? There are lots of tasks that need to be done if so and these should begin this quarter!

The Legal Jargon behind it all

The Windsor Framework is a legal agreement between the European Union and the United Kingdom that was announced on February 27, 2023. It is a political declaration and a series of legal documents reached by the UK and EU in the Withdrawal Agreement Joint Committee. It covers topics such as trade, goods, services, sanitary and phytosanitary measures, and the democratic consent mechanism. The Framework was formally adopted by both parties on March 24, 2023, and came into effect on October 1, 2023.

Regulation (EU) 2023/1182 is a legal document that was passed by the European Parliament and the Council on June 14, 2023. It contains specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amends Directive 2001/83/EC. The regulation is aimed at ensuring that medicinal products placed on the market in Northern Ireland comply with the provisions of Union law. This has resulted in increased costs and red tape for GB-based pharmaceutical manufacturers and suppliers who are required to meet EU testing and labelling requirements in addition to UK rules.

Regulation (EU) 2023/1182 came into force on June 20, 2023 1. However, it is not applicable until January 1, 2025, provided that the UK has provided the written guarantees referred to in Article 8 of that Regulation.

This can impact centralised procedures (CAPs) as medicines can now only be placed on the market in Northern Ireland if authorised by the UK authorities in accordance with the law of the United Kingdom and under the terms of the authorisation granted by them.

Pursuant to Article 13 of Regulation (EU) 2023/1182, Article 5a of Directive 2001/83/EC is deleted with effect from the date on which the Regulation becomes applicable (01Jan2025). Article 5a allowed for the medicinal products to be temporarily authorised to supply to in Northern Ireland of a medicinal product belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 provided that certain conditions were fulfilled.

If you need assistance with any of the above, contact us.

Written by

Emily Fletcher