Paragraph 30 Manufacturer's licences and authorisations

(1)

The fee payable under regulation 12(1)(a) in connection with an application for a manufacturer's licence or a manufacturing authorisation is—

(a)

F1£245 in a case to which sub-paragraph (2) applies;

(b)

F2£461 in the case of a change of ownership application; and

(c)

F3£4,209 in any other case.

(2)

This sub-paragraph applies to the case of an application for a manufacturer's licence which is limited solely to the manufacture or assembly of medicinal products which are to be sold or supplied in circumstances to which regulation 169 (mixing of general sale medicinal products) of the Human Medicines Regulations applies.

Annotations

Textual amendments

F1: Sum in Sch. 2 para. 30(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(8)(a)
F2: Sum in Sch. 2 para. 30(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(8)(b)
F3: Sum in Sch. 2 para. 30(1)(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(8)(c)