Paragraph 7 Marketing authorisation: derivatives
Unless paragraph 8 applies, where a marketing authorisation is held in respect of a derivative of a new active substance, the fee payable under regulation 38(1) is—
(a)
F1£11,627 where the medicinal product to which the authorisation relates has a different route of administration from that of the new active substance; or
(b)
F2£7,847 in any other case.
Annotations
Textual amendments
- F1
Sum in Sch. 4 para. 7(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(4)(a)
- F2
Sum in Sch. 4 para. 7(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(4)(b)