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 (Text with EEA relevance)
Regulation (EU) 2023/1182 of the European Parliament and of the Councilof 14 June 2023on 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(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4), point (c), thereof,Having regard to the proposal from the European Commission,After transmission of the draft legislative act to the national parliaments,Having regard to the opinion of the European Economic and Social CommitteeOpinion of 27 April 2023 (not yet published in the Official Journal).,After consulting the Committee of the Regions,Acting in accordance with the ordinary legislative procedurePosition of the European Parliament of 9 May 2023 (not yet published in the Official Journal) and decision of the Council of 30 May 2023.,Whereas:(1)The Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (the "Withdrawal Agreement") was concluded on behalf of the Union by Council Decision (EU) 2020/135Council Decision (EU) 2020/135 of 30 January 2020 on the conclusion of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ L 29, 31.1.2020, p. 1). and entered into force on 1 February 2020. The transition period referred to in Article 126 of the Withdrawal Agreement, during which Union law continued to apply to and in the United Kingdom in accordance with Article 127 of the Withdrawal Agreement, ended on 31 December 2020.(2)The Protocol on Ireland/Northern Ireland (the "Protocol") forms an integral part of the Withdrawal Agreement.(3)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 Directive 2001/83/EC of the European Parliament and of the CouncilDirective 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). and Regulation (EC) No 726/2004 of the European Parliament and of the CouncilRegulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).. Therefore, medicinal products placed on the market in Northern Ireland are required to comply with those provisions of Union law.(4)Directive 2001/83/EC lays down rules for medicinal products for human use and Regulation (EC) No 726/2004 lays down Union procedures for the authorisation of medicinal products for human use.(5)In order to take account of the specific situation of Northern Ireland, it is appropriate to adopt specific rules relating to the placing on the market in Northern Ireland of medicinal products for human use.(6)It is appropriate to clarify that the provisions of Union law listed in Annex 2 to the Protocol should apply in respect of medicinal products for human use intended to be placed on the market in Northern Ireland, unless specific rules are laid down in this Regulation. Where specific rules of this Regulation apply, and there is an inconsistency between those specific rules of this Regulation and the provisions of Union law listed in Annex 2 to the Protocol, those specific rules of this Regulation should take precedence.(7)Furthermore, it is important to ensure that the application of the specific rules laid down in this Regulation does not lead to an increased risk to public health in the internal market.(8)The specific rules should include a prohibition against displaying the safety features referred to in Directive 2001/83/EC on the outer packaging or, where there is no outer packaging, on the immediate packaging of medicinal products for human use intended to be placed on the market in Northern Ireland and a prohibition against placing on the market in Northern Ireland new and innovative medicinal products that have been granted a marketing authorisation in accordance with Regulation (EC) No 726/2004. Furthermore, the specific rules should include certain labelling requirements for medicinal products for human use intended to be placed on the market in Northern Ireland. As a consequence, Commission Delegated Regulation (EU) 2016/161Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1). should not apply to medicinal products for human use intended to be placed on the market in Northern Ireland.(9)In respect of new and innovative medicinal products, the competent authorities of the United Kingdom should be able to authorise the placing of those medicinal products on the market in Northern Ireland provided that certain conditions are fulfilled, namely that the authorisation is granted in accordance with the law of the United Kingdom and that the medicinal products are placed on the market in Northern Ireland under the terms of the authorisation granted by the competent authorities of the United Kingdom, that those medicinal products comply with certain labelling requirements, and that written guarantees have been provided by the United Kingdom to the Commission.(10)Furthermore, appropriate safeguards for the Union should be put in place in order to ensure that the application of the specific rules does not increase risks to public health in the internal market. Such safeguards should include continuous monitoring by the competent authority of the United Kingdom of the placing on the market in Northern Ireland of medicinal products for human use subject to specific rules laid down in this Regulation and a total prohibition against the movement to or placing on the market in a Member State of medicinal products subject to the specific rules laid down in this Regulation.(11)The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of suspending the application of some or all of the specific rules laid down in this Regulation where there is evidence that the United Kingdom is not taking appropriate measures to tackle serious or repeated infringements of those specific rules. In such an event, it is appropriate to provide for a formal information and consultation mechanism with clear time limits within which the Commission should act. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-MakingOJ L 123, 12.5.2016, p. 1.. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.(12)Where the specific rules for the placing on the market in Northern Ireland of medicinal products for human use are suspended, the relevant provisions of Union law listed in Annex 2 to the Protocol should apply again to such medicinal products.(13)In order to ensure an effective and swift reaction to any increased risk for public health, this Regulation should provide for the possibility for the Commission to adopt delegated acts in accordance with an urgency procedure.(14)Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.(15)It is appropriate to provide for a transitional period for the application of the specific rules laid down in this Regulation to medicinal products for human use which are already on the market in Northern Ireland.(16)As a consequence of the adoption of this Regulation, Directive 2001/83/EC should be amended accordingly,HAVE ADOPTED THIS REGULATION: