Proposal for a Regulation on specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland

Summary:

Legislative initiative tabled by the European Commission on 27 February 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:

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. To ensure uninterrupted supply of medicines, the EU adopted Directive (EU) 2022/642, which introduced derogations from certain obligations. This allowed economic operators to maintain batch testing and release and manufacturing or regulatory functions elsewhere in the UK.

However, 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. Following several rounds of negotiations, 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. This became generally known as the Windsor Framework, politically agreed in February 2023.

This draft seeks to allow permanent access to all medicine by people in NI, including novel medicines. It complements the solution already adopted by the in April 2022 for the supply of generic medicines to NI. It provides for new safeguards, notably labelling, designed to ensure that the medicines do not enter the EU's Single Market. It was adopted by the European Commission on 21 March 2023.

• Primary Source

Official

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

---

ESO Records

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

---