Paragraph 33 Active substance registrations

(1)

The fee payable under regulation 12(1)(a) in connection with an application for an active substance registration is—

(a)

F1£3,763 where the application includes the manufacture of active substances; or

(b)

F2£2,159 where the application only concerns the importation or distribution of active substances.

(2)

The fee payable under regulation 12(1)(a) in connection with a change of ownership application is F3£439.

Annotations

F1: Sum in Sch. 2 para. 33(1)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(10)(a)
F2: Sum in Sch. 2 para. 33(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(10)(b)
F3: Sum in Sch. 2 para. 33(2) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(11)(b)