{
  "url": "https://openlegislation.uk/medicines-products-for-animal-usefees-amendment-regulations-1999/schedule",
  "json_url": "https://openlegislation.uk/medicines-products-for-animal-usefees-amendment-regulations-1999/schedule.json",
  "legislation": "uksi/1999/2512",
  "legislation_title": "The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 1999",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-animal-usefees-amendment-regulations-1999",
  "path": "schedule",
  "kind": "schedule",
  "number": null,
  "heading": "SUBSTITUTION OF FEES",
  "text": "Column (1)\nColumn (2)\nColumn (3)\nColumn (4)\nProvision in the principal Regulations\nSubject matter\nOld fee\nNew fee\nregulation 12\nManufacturer’s licences: annual fees\n£190\n£200\nregulation 13\nWholesale dealer’s licences: annual fees\nregulation 13(1)\nTurnover of £40,000 or more\n£380\n£400\nregulation 13(2)\nTurnover of less than £40,000\n£185\n£200\nregulation 14\nRegistration of Homoeopathic Veterinary Medicinal Products\nregulation 14(2)\nRenewal of registration\n£75\n£80\nregulation 14(3)\nAlteration of dossier\n£85\n£90\nSCHEDULE 1, PART II\nFEES RELATING TO APPLICATIONS FOR THE GRANT OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES\nparagraph 1, Table A, Column (2)\nFee for an application for a type A marketing authorisation\nentry 1\nMajor application\n£18,120\n£19,115\nentry 2\nComplex application\n£10,515\n£11,095\nentry 3\nStandard application\n£4,540\n£4,790\nentry 4\nAbridged standard application\n£3,545\n£3,740\nentry 5\nSimple application\n£1,260\n£1,330\nparagraph 1, Table A, Column (3)\nFee for an application for a type B marketing authorisation\nentry 1\nMajor application\n£10,000\n£10,550\nentry 2\nComplex application\n£6,000\n£6,330\nentry 3\nStandard application\n£3,000\n£3,165\nentry 5\nSimple application\n£800\n£845\nparagraph 1, Table A, Column (4)\nFee for an application for a product licence\nentry 1\nMajor application\n£18,120\n£19,115\nentry 2\nComplex application\n£10,515\n£11,095\nentry 3\nStandard application\n£4,540\n£4,790\nentry 5\nSimple application\n£1,260\n£1,330\nparagraph 2, Table B, Column (2)\nFee for an application for an Article 15.2 marketing authorisation\nentry 1\nMajor application\n£10,515\n£11,095\nentry 2\nComplex application\n£4,540\n£4,790\nparagraph 3\nApplication for a marketing authorisation by holder of Article 15.2 marketing authorisation\nparagraph 3(a)\nMajor application previously made\n£7,605\n£8,020\nparagraph 3(b)\nComplex application previously made\n£5,975\n£6,305\nparagraph 6\nManufacturer’s licences\nparagraph 6(1)(a)\nApplications in respect of which paragraph 6(2) applies\n£95\n£100\nparagraph 6(1)(b)\nOther cases\n£2,040\n£2,150\nparagraph 7\nWholesale dealer’s licences\nparagraph 7(1)\nApplication fee where anticipated turnover £40,000 or more\n£1,185\n£1,250\nparagraph 7(2)\nApplication fee where anticipated turnover less than £40,000\n£480\n£505\nparagraph 8\nAnimal test certificate applications in relation to biological products or for administration to non food-producing animals\n£250\n£265\nparagraph 8\nOther animal test certificate applications\n£600\n£635\nparagraph 9\nMarketing authorisation (parallel import)\n£1,415\n£1,495\nSCHEDULE 1,PART III\nFEES RELATING TO APPLICATIONS FOR ASSISTANCE IN CONNECTION WITH MUTUAL RECOGNITION APPLICATIONS\nparagraph 4, Table C, Column (2)\nBasic fee\nentry 1\nMajor\n£3,250\n£3,430\nentry 2\nComplex\n£2,175\n£2,295\nentry 3\nStandard\n£940\n£990\nentry 4\nSimple\n£315\n£330\nparagraph 4, Table C, Column (3)\nAdditional fee for the sixth and each additional member State\nentry 1\nMajor\n£700\n£740\nentry 2\nComplex\n£340\n£360\nentry 3\nStandard\n£175\n£185\nentry 4\nSimple\n£60\n£65\nparagraph 5, Table D, Column (2)\nBasic fee\nentry 1\nCategory I application\n£7,975\n£8,415\nentry 2\nCategory II application\n£5,320\n£5,615\nentry 3\nCategory III application\n£4,255\n£4,490\nparagraph 5, Table D, Column (3)\nAdditional fee for the sixth and each additional member State\nentry 1\nCategory I application\n£1,000\n£1,055\nentry 2\nCategory II application\n£665\n£700\nentry 3\nCategory III application\n£530\n£560\nSCHEDULE 1, PART IV\nFEES RELATING TO APPLICATIONS FOR THE VARIATION OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES\nparagraph 1\nMarketing authorisations (other than mutually recognised marketing authorisations) and product licences—complex application for variation\n£2,000\n£2,110\nparagraph 2, Table E, Column (2)\nMarketing authorisations (other than mutually recognised marketing authorisations) and product licences—application for variation other than complex application\nentry 1\nVariation requiring assessment\n£500\n£530\nentry 2\nVariation not requiring assessment\n£200\n£210\nparagraph 3, Table F, Column (2)\nUnited Kingdom acting as the Reference Member State\nentry 1\nType I variation—Administrative\n£530\n£560\nentry 2\nType I variation, Scientific—\n£2,130\n£2,245\nentry 3\nType I variation, Scientific—\n£3,500\n£3,695\nType II procedure\nentry 4\nType II variation\n£7,445\n£7,855\nentry 5\nVariation with extras\n£8,510\n£8,980\nparagraph 3, Table F, Column (3)\nUnited Kingdom not acting as the Reference Member State\nentry 1\nType I variation—Administrative\n£100\n£105\nentry 2\nType I variation—Scientific\n£500\n£530\nentry 3\nType I variation, Scientific-Type II procedure\n£1,000\n£1,055\nentry 4\nType II variation\n£2,000\n£2,110\nentry 5\nVariation with extras\n£3,560\n£3,755\nparagraph 5\nManufacturer’s licences\nparagraph 5(a)\nVariation of manufacturer’s licence referred to in Schedule 1, Part II, paragraph 6(2)\n£95\n£100\nparagraph 5(b)\nVariation in any other case\nparagraph 5(b)(i)\nRequiring assessment\n£360\n£380\nparagraph 5(b)(ii)\nNot requiring assessment\n£120\n£125\nparagraph 6\nWholesale dealer’s licences\nparagraph 6(a)\nVariation requiring assessment\n£360\n£380\nparagraph 6(b)\nVariation not requiring assessment\n£120\n£125\nparagraph 7\nVariation of animal test certificate\n£200\n£210\nSCHEDULE 1, PART V\nFEES RELATING TO APPLICATIONS FOR THE RENEWAL OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES AND ANIMAL TEST CERTIFICATES\nparagraph 1\nMarketing authorisations and product licences\nparagraph 1(b)\nHerbal products\n£300\n£315\nparagraph 1(c)\nOther cases\n£900\n£950\nparagraph 2\nManufacturer’s licences\n£90\n£95\nparagraph 3\nAnimal test certificates\n£90\n£95\nSCHEDULE 2\nFESS REALTING TO SITE INSPECTIONS\nparagraph 2(1), Table A, Column (2)\nentry 1\nSupersite inspection\n£8,390\n£8,850\nentry 2\nMajor inspection\n£4,415\n£4,655\nentry 3\nStandard inspection\n£3,155\n£3,330\nentry 4\nMinor inspection\n£1,705\n£1,800\nparagraph 2(2), Table B, Column (2)\nentry 1\nSupersite inspection\n£13,905\n£14,670\nentry 2\nMajor inspection\n£7,680\n£8,100\nentry 3\nStandard inspection covering immunological Veterinary Medicinal Products\n£5,010\n£5,285\nentry 4\nOther standard inspection\n£3,775\n£3,985\nentry 5\nMinor inspection covering immunological Veterinary Medicinal Products\n£2,580\n£2,720\nentry 6\nOther minor inspection\n£2,525\n£2,665\nparagraph 2(3), Table C, Column (2)\nentry 1\nSupersite inspection\n£6,090\n£6,425\nentry 2\nMajor inspection\n£4,115\n£4,340\nentry 3\nStandard inspection\n£2,015\n£2,125\nentry 4\nMinor inspection\n£1,035\n£1,095\nparagraph 2(4)(b)\nSite limited solely to manufacture and assembly of emergency vaccines\n£100\n£105\nparagraph 3(1)\nEither or both of premises and procedures for quality control of a biological product which is not a dormant product\n£1,210\n£1,275\nSCHEDULE 5, PART II\nFEES RELATING TO APPLICATIONS FOR REGISTRATION OF HOMOEOPATHIC VETERINARY MEDICINAL PRODUCTS\nparagraph 1, Table, Column (2)\nFees for applications in respect of products prepared from not more than 5 homoeopathic stocks\nentry 1\nProduct both prepared solely from repeat stock and being of repeat formulation\n£100\n£105\nentry 2\nProduct which is either prepared solely from repeat stock or is of a repeat formulation\n£300\n£315\nentry 3\nAny other application\n£500\n£530\nparagraph 1, Table, Column (3)\nFees for applications in respect of products prepared from more than 5 homoeopathic stocks\nentry 1\nProduct both prepared solely from repeat stock and being of repeat formulation\n£250\n£265\nentry 2\nProduct which is either prepared solely from repeat stock or is of a repeat formulation\n£450\n£475\nentry 3\nAny other application\n£650\n£685\nparagraph 2\nEquivalent product registered under Part II of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 or in an EEA State\nparagraph 2(i)\nProduct prepared from not more than 5 homoeopathic stocks\n£100\n£105\nparagraph 2(ii)\nProduct prepared from more than 5 homoeopathic stocks\n£250\n£265\nSCHEDULE 6\nMARKETING AUTHORISATIONS, PRODUCT LICENCES AND ANIMAL TEST CERTIFICATES: FEES FOR REFERENCES TO THE VETERINARY PRODUCTS COMMITTEE OR TO THE MEDICINES COMMISSION\nparagraph 1, Table, Column (2)\nentry 1\nMajor application\n£1,420\n£1,500\nentry 2\nComplex application\n£820\n£865\nentry 3\nStandard application\n£380\n£400\nentry 4\nSimple application\n£140\n£150\nparagraph 2\nAnimal test certificate\n£495\n£520",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "M",
      "label": "M1",
      "text": "S.I. 1994/105, amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1999/2512/schedule",
    "retrieved_at": "2026-10-29T09:56:38.047860+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."
}