{
  "url": "https://openlegislation.uk/eu-regulation-2013-198/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-198/introduction.json",
  "legislation": "eur/2013/198",
  "legislation_title": "Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-198",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Regulation (EU) No 198/2013\nof 7 March 2013\non the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to 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, and in particular Article 23(4) thereof,\nWhereas:\n(1)\nSome medicinal products for human use are authorised subject to additional monitoring for reasons of their specific safety profile. Pursuant to Article 23 of Regulation (EC) No 726/2004 this includes medicinal products with a new active substance, biological medicinal products and products for which post-authorisation data are required.\n(2)\nPatients and healthcare professionals should be able to easily identify medicinal products that are subject to additional monitoring in order to allow them to share with the competent authorities and the marketing authorisation holder any information they have from the use of the medicinal product and in particular to report suspected adverse reactions.\n(3)\nTo ensure transparency, all medicinal products that are subject to additional monitoring are included in a list that is set up and maintained by the European Medicines Agency in accordance with Article 23(1) of Regulation (EC) No 726/2004. Additionally, they are labelled with a black symbol.\n(4)\nOn 3 October 2012 the Pharmacovigilance Risk Assessment Committee adopted a recommendation stating that the black symbol should be an inverted equilateral black triangle. The recommendation took into account the views of patients and healthcare professionals as expressed by the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Group established by the European Medicines Agency.\n(5)\nHolders of marketing authorisations that were granted before 1 September 2013 should be given sufficient time to adapt the product information of the products concerned.\n(6)\nIn addition, competent authorities should be given the possibility to grant a longer period of time for that adaptation where exceptional circumstances so require.\n(7)\nThe introduction of the black symbol should not cause difficulties on the market and in the supply chain. In order to avoid any disruptions, marketing authorisation holders should not be obliged to recall or repackage products which have been already placed on the market,\nHAS 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(y) (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 L 136, 30.4.2004, p. 1."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/198/introduction",
    "retrieved_at": "2026-11-01T14:48:48.856706+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."
}