| Author (Corporate) | Council of the European Union, European Parliament |
|---|---|
| Series Title | Official Journal of the European Union |
| Series Details | L 157, Pages 1-7 |
| Publication Date | 20/06/2023 |
| Content Type | Legislation, Policy-making |
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. |
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| Source Link | Link to Main Source http://data.europa.eu/eli/reg/2023/1182/oj |
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| Subject Categories | Health, Internal Markets, Politics and International Relations |
| Subject Tags | Bilateral Relations, Brexit, External Trade | Trade Agreements, Medicines | Medical Devices, Public Health, Regional Dimension |
| Keywords | Northern Ireland, Post-Brexit |
| Countries / Regions | United Kingdom |
| International Organisations | European Union [EU] |
