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

Ce que fait l'acte

PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union entered into force on 1 February 2020. The Protocol on Ireland/Northern Ireland forms an integral part of the Withdrawal Agreement. The provisions of Union law listed in Annex 2 to the Protocol apply, under the conditions set out in that Annex, to and in the United Kingdom in respect of Northern Ireland. That list includes, but it is not limited to, Directive 2001/83/EC of the European Parliament and of the Council lays down the rules for medicinal products for human use and Regulation (EC) No 726/2004 of the European Parliament and of the Council lays down Union procedures for the authorisation of medicinal products for human use. Therefore, medicinal products placed on the market in Northern Ireland are required to comply with those provisions of Union law. The European Parliament adopted by 617 votes to 3, with 2 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland. The European Parliament adopted its position at first reading under the ordinary legislative procedure. The proposal provides for specific rules on the placing on the market in Northern Ireland of medicinal products for human use. The UK will provide the Commission with written guarantees that the placing on the market of medicinal products does not lead to an increase in risk to public health in the internal market and that such medicinal products will not be moved to a Member State. In the event that those written guarantees are provided earlier than 1 January 2025 or later than that date, this Regulation will apply from the first day of the month following the month during which the United Kingdom provides those written guarantees. Within one month of reception of those written guarantees, the Commission will provide a report to the European Parliament and to the Council with its assessment of those written guarantees. LEGISLATIVE ACT: Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 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. CONTENT: with this Regulation, the Union is continuing to put in place the Windsor framework, which was the subject of a political agreement between the Commission and the United Kingdom Government on 27 February 2023, to address, in a definitive manner, the challenges concerning Northern Ireland following the UK’s withdrawal from the EU. The Regulation aims to implement the joint solutions agreed with the UK on medicinal products. It establishes specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland. The new…

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