{
  "url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-amendment-regulations-1977/regulation-2",
  "json_url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-amendment-regulations-1977/regulation-2.json",
  "legislation": "uksi/1977/675",
  "legislation_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1977",
  "legislation_url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-amendment-regulations-1977",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Amendment of regulation 2(1) of the principal regulations",
  "text": "Regulation 2(1) of the principal regulations (interpretation) shall be amended by adding—\n(a) immediately after the definition of “advertisement” the following definitions:—\n““BCG” means the bacillus of Calmette and Guerin;\n“BCG vaccine” means a vaccine that is a preparation of the bacteria in a living pure culture of a strain of the bacillus of Calmette and Guerin; ”;\n(b) immediately after the definition of “medicinal product” the following definitions:—\n““parenteral administration” means administration by breach of the skin or mucous membrane;\n“serum” means a fluid fraction of coagulated blood;\n“smallpox vaccine” means a vaccine that is a preparation of an infective vaccinia virus;\n“toxins” means substances used in the diagnosis, prevention or treatment of disease consisting wholly or partly of poisonous substances derived from specific micro-organisms, plants or animals;\n“vaccines” means antigenic substances which consist wholly or partly of—\n(i) any micro-organisms, viruses or other organisms in any state,\n(ii) any toxins of microbial origin which have been detoxified (toxoids), or\n(iii) any extracts or derivatives of any micro-organisms or of any viruses,\nbeing substances which, when administered to human beings or animals, are used for the prevention or treatment of specific diseases;”",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1977/675/regulation/2",
    "retrieved_at": "2026-10-29T20:03:34.145499+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."
}