Regulation (EU) 2023/1182 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC

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Series Details L 157, Pages 1-7
Publication Date 20/06/2023
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Summary:

Regulation (EU) 2023/1182 - adopted by the co-legislators on 14 June 2023 - reflecting a political agreement seeking to ensure a permanent solution for access to all medicine by people in Northern Ireland (NI). This is a text with EEA relevance.

Further information:

This Regulation lays down specific rules relating to medicinal products for human use intended to be place on the market in Northern Ireland in accordance with Directive 2001/83/EC. It also lays down rules regarding the suspension of the application of the specific rules laid down in the Regulation. It seeks to complement the solution already introduced by Directive (EU) 2022/642 which introduced derogations from certain obligations to ensure uninterrupted supply of medicines.

Despite the derogations, the UK raised concerns that the need for separate marketing authorisations for Great Britain (GB) and NI in respect to novel medicines and the application of the EU unique identifier requirement for medicines subject to prescription impose unnecessary administrative burdens for medicines that are only for NI. In accordance with the Withdrawal Agreement signed by the European Union (EU) and the United Kingdom (UK), and in particular the Protocol on Ireland/Northern Ireland, certain EU legislative acts apply to and in Northern Ireland after the end of the transition period provided for in the Agreement. Medicines placed on the market in NI must be covered by a valid marketing authorisation issued by the European Commission or by the UK in respect of Northern Ireland in accordance with those acts. Despite the transition period provided for in the Agreement, it proved difficult for certain economic operators based elsewhere in the UK to adapt and move relevant regulatory compliance functions to NI or the EU in respect of nationally authorised medicines.

The draft law was adopted by the European Commission on 27 February 2023. It followed up on a political agreement announced in February 2023 - the so-called Windsor Framework - whereby the two sides agreed a comprehensive set of joint solutions to ensure legal clarity, predictability and prosperity of communities in Northern Ireland, whilst also protecting the integrity of both the EU and UK internal markets. The plenary of the European Parliament adopted the proposal on 9 May, followed by the Council of the European Union on 30 May. The Act was signed by the co-legislators on 14 June 2023 and published in the Official Journal on 20 June 2023.

Source Link http://data.europa.eu/eli/reg/2023/1182/oj
Related Links
Commentary and Analysis
The British Medical Journal (BMJ): News, 01/03/2023: “Massive relief” as Northern Ireland’s health sector embraces Windsor framework https://doi.org/10.1136/bmj.p501
Bristows: News, 07/03/2023: EU and UK reach new agreement on medicines regulation in Northern Ireland https://www.bristows.com/news/eu-and-uk-reach-new-agreement-on-medicines-regulation-in-northern-ireland/

Official
EUR-LEX: COM(2023)122: Proposal for a Regulation on specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2023:122:FIN
European Parliament: Legislative Observatory: Procedure File for Proposal on Specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland (2023/0064(COD)) https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2023/0064(COD)
European Commission: Protocol on Ireland and Northern Ireland https://commission.europa.eu/strategy-and-policy/relations-non-eu-countries/relations-united-kingdom/eu-uk-withdrawal-agreement/protocol-ireland-and-northern-ireland_en
European Commission: Press Release, 27/02/2023: A new way forward on the Protocol on Ireland/Northern Ireland: political agreement in principle on the Windsor Framework https://ec.europa.eu/commission/presscorner/detail/en/ip_23_1268
UK Government: Policy Papers, 17/04/2023: EM on medicines supply to Northern Ireland (COM(2023)122) https://www.gov.uk/government/publications/em-on-medicines-supply-to-northern-ireland-com2023122
Council of the European Union: Press Release, 30/05/2023: EU-UK relations: EU takes further steps to implement the Windsor Framework https://www.consilium.europa.eu/en/press/press-releases/2023/05/30/eu-uk-relations-eu-takes-further-steps-to-implement-the-windsor-framework/

ESO Records
UK Government: The Windsor Framework. A new way forward https://www.europeansources.info/record/the-windsor-framework-a-new-way-forward/

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