{
  "url": "https://openlegislation.uk/eu-regulation-2019-5/article-3",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-5/article-3.json",
  "legislation": "eur/2019/5",
  "legislation_title": "Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2019-5",
  "path": "article/3",
  "kind": "article",
  "number": "3",
  "heading": "Amendment to Regulation (EC) No 1901/2006",
  "text": "In Article 49 of Regulation (EC) No 1901/2006, paragraph 3 is replaced by the following:\n‘3. The Commission may, in relation to medicinal products authorised in accordance with Regulation (EC) No 726/2004, impose, in accordance with the procedure laid down in Article 84a of that Regulation, financial penalties in the form of fines or periodic penalty payments for the failure to comply with the obligations set out in this Regulation that are listed in Annex II to Regulation (EC) No 726/2004.’.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regulation revoked in part (31.12.2020) by S.I. 2019/775, Sch. 9 para. 1(jj) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 195)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2019/5/article/3",
    "retrieved_at": "2026-11-01T14:43:40.857236+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."
}