{
  "url": "https://openlegislation.uk/medicines-labelling-and-leaflets-amendment-regulations-1994/regulation-2",
  "json_url": "https://openlegislation.uk/medicines-labelling-and-leaflets-amendment-regulations-1994/regulation-2.json",
  "legislation": "uksi/1994/104",
  "legislation_title": "The Medicines (Labelling and Leaflets) Amendment Regulations 1994",
  "legislation_url": "https://openlegislation.uk/medicines-labelling-and-leaflets-amendment-regulations-1994",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Amendment of regulation 3(1) of the Labelling Regulations",
  "text": "In regulation 3(1) of the Labelling Regulations (interpretation)—\n(a) after the definition of “homoepathic product”, there shall be inserted the following definition—\n““homoeopathic product to which Council Directive 92/73/EEC applies” means a medicinal product for human use (which may contain a number of principles) prepared from products, substances or compositions called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State, other than one—\n(i) prepared in accordance with a magistral or officinal formula as defined in Article 1(4) and (5) of the 1965 Directive, or\n(ii) which satisfies the criteria laid down in Article 2(4) of the 1965 Directive;”;\n(b) in the definition of “product to which Chapters II to V of the 1965 Directive apply” for “and Article 1 of Council Directive 89/381/EEC(e)” there shall be substituted “, Article 1 of Council Directive 89/381/EEC(e) and Article 9(1) of Council Directive 92/73/EEC”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L297, 13.10.92, p. 8."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Definition inserted by regulation 2(4) of S.I. 1992/3273."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1994/104/regulation/2",
    "retrieved_at": "2026-10-29T13:42:47.089255+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."
}