{
  "url": "https://openlegislation.uk/medicines-data-sheet-amendment-regulations-1996/regulation-2",
  "json_url": "https://openlegislation.uk/medicines-data-sheet-amendment-regulations-1996/regulation-2.json",
  "legislation": "uksi/1996/2420",
  "legislation_title": "The Medicines (Data Sheet) Amendment Regulations 1996",
  "legislation_url": "https://openlegislation.uk/medicines-data-sheet-amendment-regulations-1996",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Amendment of regulation 1 of the principal Regulations",
  "text": "Regulation 1 of the principal Regulations shall be amended so that—\n(a) in paragraph (2) after the definition of “monograph” the following definitions are inserted—\n““product information compendium” has the meaning it bears in regulation 2A(1)(b);\n“summary of product characteristics” has the meaning it bears in regulation 2(1) of the Medicines (Advertising) Regulations 1994;”, and\n(b) after paragraph (2) the following paragraph is inserted—\n“(2A) In these Regulations unless the context otherwise requires “product licence” includes a marketing authorisation in respect of medicinal products intended for use by being administered to human beings and granted under Council Regulation (EEC) No. 2309/93 or under the Medicines for Human Use (Marketing Authorisations, Etc.) Regulations 1994;”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 1994/1932."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ no. L214, 24.8.93, p. 1."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "S.I. 1994/3144."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1996/2420/regulation/2",
    "retrieved_at": "2026-10-29T12:35:11.357297+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."
}