{
  "url": "https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1998/schedule-1/part-IV/paragraph-2",
  "json_url": "https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1998/schedule-1/part-IV/paragraph-2.json",
  "legislation": "uksi/1998/2428",
  "legislation_title": "The Medicines (Products for Animal Use—Fees) Regulations 1998",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1998",
  "path": "schedule/1/part/IV/paragraph/2",
  "kind": "paragraph",
  "number": "2",
  "heading": "Marketing authorisations (other than mutually recognised marketing authorisations) and product licences",
  "text": "The fee for an application of a kind described in an entry in column (1) of Table E for the variation of–\n(a) a marketing authorisation, other than a mutually recognised marketing authorisation; or\n(b) a product licence,\nother than a complex application, is that specified in the corresponding entry in column (2) of that Table.\nTable E\nColumn (1)\nColumn (2)\nKind of application\nFee\nVariation requiring veterinary, scientific or pharmaceutical assessment (where the authorisation or licence is not related solely to an emergency vaccine)\n£500 for each individual variation in that application plus £200 for each additional consequential individual variation to other authorisations or licences in identical terms\nVariation not requiring veterinary, scientific or pharmaceutical assessment (where the authorisation or licence is not related solely to an emergency vaccine)\n£200 in respect of each individual variation\nVariation where the authorisation or licence relates solely to an emergency vaccine\n£40 in respect of each individual variation",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "rev in pt",
      "affecting": "uksi/2001/1669",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2001"
    },
    {
      "type": "rev in pt",
      "affecting": "uksi/2001/1669",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2001"
    },
    {
      "type": "rev in pt",
      "affecting": "uksi/2001/1669",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2001"
    },
    {
      "type": "am",
      "affecting": "uksi/2001/3751",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001"
    },
    {
      "type": "am",
      "affecting": "uksi/2001/3751",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001"
    },
    {
      "type": "am",
      "affecting": "uksi/2001/3751",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001"
    },
    {
      "type": "am",
      "affecting": "uksi/2001/3751",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001"
    },
    {
      "type": "replaced (by paras 1, 2, 2A)",
      "affecting": "uksi/2001/3751",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001"
    },
    {
      "type": "am",
      "affecting": "uksi/2001/3751",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001"
    },
    {
      "type": "am",
      "affecting": "uksi/2001/3751",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001"
    },
    {
      "type": "amended",
      "affecting": "uksi/1999/2512",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 1999"
    },
    {
      "type": "amended",
      "affecting": "uksi/2000/2250",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2000"
    },
    {
      "type": "added",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "rev",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "subst",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "am (heading am)",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
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      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
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      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
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      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
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    {
      "type": "am",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "added",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "subst",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
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      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
    {
      "type": "subst",
      "affecting": "uksi/2003/2957",
      "affecting_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003"
    },
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      "affecting": "uksi/2002/2569",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2002"
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      "affecting": "uksi/2002/2569",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2002"
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      "affecting": "uksi/2002/2569",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2002"
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      "affecting": "uksi/2002/2569",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2002"
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      "affecting": "uksi/2002/2569",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2002"
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    {
      "type": "am",
      "affecting": "uksi/2002/2569",
      "affecting_title": "Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1998/2428/schedule/1/part/IV/paragraph/2",
    "retrieved_at": "2026-10-29T11:17:55.596342+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."
}