{
  "url": "https://openlegislation.uk/medicines-labelling-amendment-regulations-1992/regulation-2",
  "json_url": "https://openlegislation.uk/medicines-labelling-amendment-regulations-1992/regulation-2.json",
  "legislation": "uksi/1992/3273",
  "legislation_title": "The Medicines (Labelling) Amendment Regulations 1992",
  "legislation_url": "https://openlegislation.uk/medicines-labelling-amendment-regulations-1992",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Amendment of regulation 3(1) of the principal Regulations",
  "text": "(1) Regulation 3(1) of the principal Regulations (interpretation) shall be amended in accordance with the following paragraphs of this regulation.\n(2) After the definition of “business name” there shall be inserted the following—\n““common name” in relation to a relevant medicinal product means the international non-proprietary name, or, if one does not exist, the usual common name;”.\n(3) After the definition of “medicinal products of the same description” there shall be inserted the following—\n““name” in relation to a relevant medicinal product means the name given to the product which may be either an invented name or a common or scientific name, together with a trade mark or the name of the person responsible for marketing the product;”.\n(4) After the definition of “person responsible for the composition of a medicinal product” there shall be inserted the following—\n““product to which Chapters II to V of the 1965 Directive applies” means a medicinal product to which, in accordance with Article 2 of Council Directive 65/65/EEC as amended, Article 34 of Council Directive 75/319/EEC, Article 1 of Council Directive 89/342/EEC, Article 1 of Council Directive 89/343/EEC and Article 1 of Council Directive 89/381/EEC, Chapters II to V of Council Directive 65/65/EEC apply;”.\n(5) After the definition of “quantity” there shall be inserted the following—\n““relevant medicinal product” means a product to which Chapters II to V of the 1965 Directive applies in respect of which a product licence is granted or renewed on or after 1st January 1994;”.\n(6) After the definition of “specified publication” there shall be inserted the following—\n““strength” in relation to a relevant medicinal product means the content of active ingredient in that product expressed quantitatively per dosage unit, per unit volume or by weight, according to the dosage form;”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. 22, 9.2.1965, p.369/65; the relevant amending Directive is Article 1(3) of 89/341/EEC (OJ No. L142, 25.5.1989, p.11)."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ No. L147, 9.6.1975, p.13."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ No. L142, 25.5.1989, p.14."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ No. L142, 25.5.1989, p.16."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "OJ No. L181, 28.6.1989, p.44."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1992/3273/regulation/2",
    "retrieved_at": "2026-10-29T14:08:02.611849+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."
}