{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-34",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-34.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/34",
  "kind": "paragraph",
  "number": "34",
  "heading": "Outgoing mutual recognition applications",
  "text": "(1) The fee payable under regulation 16 (application to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in another EEA State or in other EEA States) is the fee specified in sub-paragraphs (2) to (5).\n(2) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom (the application relating to that authorization is referred to in this paragraph as the “original application”) and the original application had been a major application or would fall within the meaning of a major application, in respect of—\n(a) the first application for regulatory assistance (“the first application”), the fee is £44,934;\n(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;\n(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £29,516; and\n(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.\n(3) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom and the original application had been a complex application or would fall within the meaning of a complex application, in respect of—\n(a) the first application for regulatory assistance (“the first application”), the fee is £11,623;\n(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;\n(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £7,709; and\n(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.\n(4) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom and the original application had been a standard application or would fall within the meaning of a standard application, in respect of—\n(a) the first application for regulatory assistance (“the first application”), the fee is £4,628;\n(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;\n(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £3,855; and\n(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.\n(5) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom and the original application had been a simple application or would fall within the meaning of a simple application, in respect of—\n(a) the first application for regulatory assistance (“the first application”), the fee is £2,769;\n(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;\n(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £2,769; and\n(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.\n(6) The condition referred to in sub-paragraphs (2) to (5) is that all applications fall within the meaning given to a set of applications in regulation 15.",
  "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/34",
    "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."
}