{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-2/paragraph-1",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-2/paragraph-1.json",
  "legislation": "uksi/1995/1116",
  "legislation_title": "The Medicines (Products for Human Use — Fees) Regulations 1995",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995",
  "path": "schedule/2/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": "Interpretation",
  "text": "(1) In this Schedule—\n“major inspection” means an inspection at a site at which 60 or more, but fewer than 250, relevant persons are employed;\n“minor inspection” means an inspection at a site at which fewer than 10 relevant persons are employed;\n“relevant person” means any person directly or indirectly engaged in, or assisting in, the manufacture or assembly of medicinal products and includes any person connected with such production who is involved in management, quality control, site maintenance, packing, storage or distribution;\n“standard inspection” means an inspection at a site at which 10 or more, but fewer than 60, relevant persons are employed;\n“supersite inspection” means an inspection at a site at which 250 or more relevant persons are employed.\n(2) In calculating the number of relevant persons for the purposes of this Schedule, any person partly engaged in or assisting in the manufacture or assembly of medicinal products (whether as a part-time employee or by virtue of being only partly employed in such work) shall be included in the calculation but only as a fraction calculated by reference to the amount of time spent by that person engaged or assisting in the manufacture or assembly of medicinal products or, where such a calculation is inappropriate, by reference to the percentage of his job which relates to the manufacture or assembly of such products and, in either case, by comparison with the average working week of a relevant person engaged in full-time employment at the same site.\n(3) Any reference in sub-paragraphs (1) and (2) to the manufacture or assembly of medicinal products includes a reference to the preparation of substances which are used in the manufacture of an immunological product or a blood product.",
  "extent": null,
  "status": null,
  "version": "current",
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  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1995/1116/schedule/2/paragraph/1",
    "retrieved_at": "2026-10-29T13:10:38.932521+00:00"
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  "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."
}