The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025
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Change 1
3 New regulation 3A
After regulation 3 (interpretation of Part 2), insert— Fee for scientific or other advice 3A (1) Unless regulation 5 applies, the fee specified in paragraph (2) is payable by a person with whom the licensing authority holds a meeting in order to provide scientific or other advice relating to a medicinal product. (2) The fee payable by a person in relation to a meeting referred to in paragraph (1) is— (a) £17,516, if the advice provided at that meeting is on a matter of high complexity; (b) £13,137, if the advice provided at that meeting is on a matter of medium complexity; (c) £8,758, if the advice provided at that meeting is on a matter of low complexity; (d) £986, if the advice provided at that meeting is on a matter of simple complexity. (3) In paragraph (2), a matter is of— (a) high complexity if it requires more than twelve assessor days; (b) medium complexity if it requires more than seven, but not more than twelve, assessor days; (c) low complexity if it requires more than three, but not more than seven, assessor days; (d) simple complexity if it requires not more than three assessor days. (4) If the person paying the fee in accordance with paragraph (1) consents, the licensing authority may provide any advice in writing instead of at a meeting. (5) In this regulation— “assessor day” means— in the case of an assessor who is a member of the senior civil service, one assessor working for one day; in the case of an assessor who is not a member of the senior civil service, one assessor working for two days. “medicinal product”, in paragraph (e) of the definition of scientific or other advice in this regulation, includes a substance incorporated in a device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive; “scientific or other advice” includes— scientific advice on an application for an EU marketing authorisation, or an application for the variation of an EU marketing authorisation, in relation to a medicinal product; advice before the publication of advertising of a medicinal product by the holder of a marketing authorisation for that product on whether that advertising conforms to the requirements of the Human Medicines Regulations; pharmacovigilance advice; regulatory advice; advice in relation to— scientific or regulatory issues relating to the development of a medicinal product or a type of medicinal product; the design of pharmaceutical or pre-clinical tests, or clinical trials, for a medicinal product or a type of medicinal product; the management of risk in relation to a medicinal product or a type of medicinal product which is under development, or is being marketed; other scientific or regulatory issues relating to a medicinal product or a type of medicinal product after an EU marketing authorisation has been granted for that product or a product of that type. .
3 New regulation 3A
After regulation 3 (interpretation of Part 2), insert— Fee for scientific or other advice 3A (1) Unless regulation 5 applies, the fee specified in paragraph (2) is payable by a person with whom the licensing authority holds a meeting in order to provide scientific or other advice relating to a medicinal product. (2) The fee payable by a person in relation to a meeting referred to in paragraph (1) is— (a) £17,516, if the advice provided at that meeting is on a matter of high complexity; (b) £13,137, if the advice provided at that meeting is on a matter of medium complexity; (c) £8,758, if the advice provided at that meeting is on a matter of low complexity; (d) £986, if the advice provided at that meeting is on a matter of simple complexity. (3) In paragraph (2), a matter is of— (a) high complexity if it requires more than twelve assessor days; (b) medium complexity if it requires more than seven, but not more than twelve, assessor days; (c) low complexity if it requires more than three, but not more than seven, assessor days; (d) simple complexity if it requires not more than three assessor days. (4) If the person paying the fee in accordance with paragraph (1) consents, the licensing authority may provide any advice in writing instead of at a meeting. (5) In this regulation— “assessor day” means— in the case of an assessor who is a member of the senior civil service, one assessor working for one day; in the case of an assessor who is not a member of the senior civil service, one assessor working for two days. “medicinal product”, in paragraph (e) of the definition of scientific or other advice in this regulation, includes a substance incorporated in a device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive; “scientific or other advice” includes— scientific advice on an application for an EU marketing authorisation, or an application for the variation of an EU marketing authorisation, in relation to a medicinal product; advice before the publication of advertising of a medicinal product by the holder of a marketing authorisation for that product on whether that advertising conforms to the requirements of the Human Medicines Regulations; pharmacovigilance advice; regulatory advice; advice in relation to— scientific or regulatory issues relating to the development of a medicinal product or a type of medicinal product; the design of pharmaceutical or pre-clinical tests, or clinical trials, for a medicinal product or a type of medicinal product; the management of risk in relation to a medicinal product or a type of medicinal product which is under development, or is being marketed; other scientific or regulatory issues relating to a medicinal product or a type of medicinal product after an EU marketing authorisation has been granted for that product or a product of that type. .
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