{
  "url": "https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1998/note",
  "json_url": "https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1998/note.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": "note",
  "kind": "note",
  "number": null,
  "heading": "Explanatory note",
  "text": "(This note is not part of the Regulations)\nThese Regulations revoke and re-enact with modifications the Medicines (Products for Animal Use—Fees) Regulations 1997. As in the case of the 1997 Regulations, they prescribe fees in connection with applications and inspections relating to:\n(a) marketing authorisations granted under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142);\n(b) licences and certificates granted under the Medicines Act 1968 insofar as they apply to medicinal products for animal use; and\n(c) the registration of homoeopathic veterinary medicinal products.\nIn prescribing fees in relation to the 1994 Regulations, these Regulations continue to supplement the 1994 Regulations in implementing Council Directive 93/40/EEC (OJ No. L214, 24.8.93, p.31) which contains amendments to Council Directive 81/851/EEC (OJ No. L317, 6.11.81, p.1).\nThe average level of fees payable under the Regulations is increased by 10% in comparison with the 1997 Regulations.\nThe changes in these Regulations include–\n(a) the introduction of a separate fee for variations to marketing authorisations which have been mutually recognised and which relate to medicinal products (primarily immunological) falling within the scope of introductory statement A to Annex 1 of Commission Regulation 541/95/EC;\n(b) a reduction in the fee payable for a variation which is additional, consequential and in identical terms to the first variation of a mutually recognised marketing authorisation;\n(c) a reduction in the fee payable for manufacturers' licences and wholesale dealers' licences.\nThe Regulations also provide for:\n(a) the method and time for payment of fees (regulations 16 to 18);\n(b) the suspension of licences and certificates where fees remain unpaid (regulation 19);\n(c) the waiver, reduction or refund of fees (regulation 20 and Schedule 7); and\n(d) transitional provisions (regulation 22).\nA Regulatory Impact Assessment has been prepared and a copy has been placed in the library of each House of Parliament. Copies may be obtained from the Veterinary Medicines Directorate, Woodham Lane, Addlestone, Surrey, KT15 3LS.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1998/2428/note",
    "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."
}