{
  "url": "https://openlegislation.uk/eu-regulation-2012-1027/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-1027/introduction.json",
  "legislation": "eur/2012/1027",
  "legislation_title": "Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2012-1027",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Regulation (EU) No 1027/2012 of the European Parliament and of the Council\nof 25 October 2012\namending Regulation (EC) No 726/2004 as regards pharmacovigilance\n(Text with EEA relevance)\nTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,\nHaving regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,\nHaving regard to the proposal from the European Commission,\nAfter transmission of the draft legislative act to the national parliaments,\nHaving regard to the opinion of the European Economic and Social Committee,\nAfter consulting the Committee of the Regions,\nActing in accordance with the ordinary legislative procedure,\nWhereas:\n(1)\nIn order to ensure transparency on the surveillance of authorised medicinal products, the list of medicinal products subject to additional monitoring established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, should systematically include medicinal products that are subject to certain post-authorisation safety conditions.\n(2)\nIn addition, voluntary action by the marketing authorisation holder should not lead to a situation where concerns relating to the risks or benefits of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, the marketing authorisation holder should be obliged to inform the European Medicines Agency of the reasons for withdrawing or interrupting the placing on the market of a medicinal product, for requesting that a marketing authorisation be revoked, or for not renewing a marketing authorisation.\n(3)\nSince the objective of this Regulation, namely to provide for specific rules on pharmacovigilance and improve the safety of medicinal products for human use authorised pursuant to Regulation (EC) No 726/2004, cannot be sufficiently achieved by the Member States and can therefore 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 that objective.\n(4)\nRegulation (EC) No 726/2004 should therefore be amended accordingly,\nHAVE ADOPTED THIS REGULATION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(v) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ C 181, 21.6.2012, p. 202."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Position of the European Parliament of 11 September 2012 (not yet published in the Official Journal) and decision of the Council of 4 October 2012."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ L 136, 30.4.2004, p. 1."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2012/1027/introduction",
    "retrieved_at": "2026-11-01T14:49:02.299424+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}