{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-21",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-21.json",
  "legislation": "uksi/2016/190",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2016",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016",
  "path": "schedule/2/paragraph/21",
  "kind": "paragraph",
  "number": "21",
  "heading": "Standard variation application for a homoeopathic medicinal product",
  "text": "A standard variation application for a homoeopathic medicinal product is an application for a variation of a marketing authorisation for a national homoeopathic product which requires—\n(a) the replacement of an excipient used in the manufacture of the product;\n(b) the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;\n(c) a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;\n(d) a change to the method of manufacture of a homoeopathic stock included in the product;\n(e) a change to the specification of any reagent or excipient used in the manufacture of the product;\n(f) a change to the finished product specification of the product;\n(g) a change to the test procedure for any raw material used in the manufacture of the product;\n(h) a change to the test procedure for the product;\n(i) a change to the test procedure for the container or other form of packaging immediately in contact with the product;\n(j) a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a member State;\n(k) a change to the shape of the container in which the product may be placed on the market;\n(l) an additional pack size in which the product may be placed on the market;\n(m) a change to the approved storage conditions for the product;\n(n) a change to the shelf life of an unopened container of the product after the container has been opened for the first time;\n(o) a change to the dimensions of an approved dosage form of the product (for example, tablets); ...\n(p) a change following modification to the manufacturing authorisation referred to in Article 40 of the 2001 Directive; or;\n(q) a change to any packaging of the product, including the container or other form of packaging immediately in contact with the medicinal product, any packaging into which the container or other form of packaging immediately in contact with the product is placed, or to a leaflet that accompanies the product and contains information for the user of the product.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in Sch. 2 para. 21(o) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(2)(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Sch. 2 para. 21(p) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(2)(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sch. 2 para. 21(q) inserted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(2)(c)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/21",
    "retrieved_at": "2026-10-28T23:27:13.215121+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."
}