{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-2/paragraph-2",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-2/paragraph-2.json",
  "legislation": "uksi/1991/1474",
  "legislation_title": "The Medicines (Products for Human Use — Fees) Regulations 1991",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991",
  "path": "schedule/2/paragraph/2",
  "kind": "paragraph",
  "number": "2",
  "heading": "Fees",
  "text": "Subject to paragraphs 3 to 5, the fee payable in respect of an inspection under these Regulations shall be—\n(a) except in the case of an inspection falling within sub-paragraphs (b) to (d) below—\n(i) in respect of a minor inspection, £1,350;\n(ii) in respect of a standard inspection, £2,700;\n(iii) in respect of a major inspection, £5,100;\n(iv) in respect of a supersite inspection, £10,200;\n(b) where the site inspected is wholly or partly concerned with the manufacture of sterile products or the filling of the containers directly in contact with such products—\n(i) in respect of a minor inspection, £1,500;\n(ii) in respect of a standard inspection, £5,500;\n(iii) in respect of a major inspection, £8,500;\n(iv) in respect of a supersite inspection, £17,000;\n(c) except in the case of an inspection falling within sub-paragraph (b) above or subparagraph (d) below, where the site inspected is concerned only with the assembly of medicinal products—\n(i) in respect of a minor inspection, £500;\n(ii) in respect of a standard inspection, £1,350;\n(iii) in respect of a major inspection, £2,700;\n(iv) in respect of a supersite inspection, £5,400;\n(d) where the site inspected is limited solely to the manufacture or assembly of medicinal products, the sale or supply of which does not require a product licence and to which Article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies, £100.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "added",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1992/756",
      "affecting_title": "The Medicines (Products for Human Use– Fees) Amendment Regulations 1992"
    },
    {
      "type": "amended",
      "affecting": "uksi/1992/756",
      "affecting_title": "The Medicines (Products for Human Use– Fees) Amendment Regulations 1992"
    },
    {
      "type": "amended",
      "affecting": "uksi/1992/756",
      "affecting_title": "The Medicines (Products for Human Use– Fees) Amendment Regulations 1992"
    },
    {
      "type": "added",
      "affecting": "uksi/1992/756",
      "affecting_title": "The Medicines (Products for Human Use– Fees) Amendment Regulations 1992"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1991/1474/schedule/2/paragraph/2",
    "retrieved_at": "2026-10-29T14:42:17.847283+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."
}