{
  "url": "https://openlegislation.uk/medicines-products-for-animal-usefees-amendment-no-2-regulations-2001/schedule-2/paragraph-1",
  "json_url": "https://openlegislation.uk/medicines-products-for-animal-usefees-amendment-no-2-regulations-2001/schedule-2/paragraph-1.json",
  "legislation": "uksi/2001/3751",
  "legislation_title": "Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-animal-usefees-amendment-no-2-regulations-2001",
  "path": "schedule/2/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": null,
  "text": "The application fee for a minor variation (Type 1) to a marketing authorisation (other than a mutually recognised marketing authorisation) as referred to in Annex 1 to Commission Regulation (EC) No. 541/95 (concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a member State ) shall be as follows:—\nFee\nType of application\n£\n1.\nChange following modification(s) to the manufacturing authorisation\n560\n2.\nChange in the name of the medicinal product (either invented name or common name)\n560\n3.\nChange in the name and/or address of the marketing authorisation holder\n220\n4.\nReplacement of an excipient with a comparable excipient (excluding adjuvants for vaccines and biologically derived excipients)\n560\n5.\nChange in the colouring system of the product (addition, deletion or replacement of colourant(s))\n560\n6.\nChange in the flavouring system of the product (addition, deletion or replacement of flavour(s))\n560\n7.\nChange in coating weight of tablets or change in weight of capsule shells\n560\n8.\nChange in the qualitative composition of immediate packaging material\n560\n9.\nDeletion of an indication\n560\n10.\nDeletion of a route of administration\n560\n10a.\nAddition or replacement of measuring device for dosage forms\n560\n11.\nChange in the manufacturer(s) of active substance\n560\n11a.\nChange in name of manufacturer of active substance\n220\n11b.\nChange in supplier of intermediate compound used in the manufacture of the active substance\n560\n12\nMinor change of manufacturing process of the active substance\n560\n12a.\nChange in specification of starting material or intermediate used in the manufacture of the active substance\n560\n13.\nBatch size of active substance\n560\n14.\nChange in specification of active substance\n560\n15.\nMinor change in manufacture of the medicinal product\n560\n15a.\nChange in in-process controls applied during the manufacture of the product\n560\n16.\nChange in the batch size of finished product\n560\n17.\nChange in specification of the medicinal product\n560\n18.\nSynthesis or recovery of non-pharmacopoeial excipients which had been described in the original dossier\n560\n19.\nChange in specification of excipients in the medicinal product (excluding adjuvants for vaccines)\n560\n20.\nExtension of shelf life as foreseen at time of authorisation\n560\n20a.\nExtension of the shelf life or retest period of the active substance\n560\n21.\nChange in shelf life after first opening\n560\n22.\nChange in shelf life after reconstitution\n560\n23.\nChange in the storage conditions\n560\n24.\nChange in test procedure of active substance\n560\n24a.\nChange in test procedure for a starting material or intermediate used in the manufacture of the active substance\n560\n25.\nChange in the test procedures of the medicinal product\n560\n26.\nChanges to comply with supplements to pharmacopoeias\n560\n27.\nChange in test procedures of non-pharmacopoeial excipients\n560\n28.\nChange in test procedure of immediate packaging\n560\n29.\nChange in test procedure of administrative device\n560\n30.\nChange in pack size for a medicinal product\n560\n31.\nChange in container shape\n560\n32.\nChange of imprints, bossing or other markings (except scoring) on tablets or printing on capsules, including addition or changes of inks used for product marking\n560\n33.\nChange of dimensions of tablets, capsules, suppositories or pessaries without change of quantitive composition and mean mass\n560\n34.\nChange in the manufacturing process of a non proteinaceous component due to the subsequent introduction of a biotechnology step\n560",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "M",
      "label": "M1",
      "text": "OJ No. L55, 11.3.95, p. 7 as last amended by Commission Regulation (EC) No. 1146/98, OJ No. L159, 3.6.98, p.31."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2001/3751/schedule/2/paragraph/1",
    "retrieved_at": "2026-10-29T07:21:45.338251+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."
}