{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-21",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-21.json",
  "legislation": "nisr/2012/134",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2012",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012",
  "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 authorization 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); or\n(p) a change following modification to the manufacturing authorization referred to in Article 40 of the 2001 Directive.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/nisr/2012/134/schedule/2/paragraph/21",
    "retrieved_at": "2026-10-29T01:16:38.443269+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."
}