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Regulation 47 Fees for variations of certificates

(1)

The fee payable by an applicant in connection with an application for an administrative variation of a certificate of registration shall be—

(a)

where more than one application for an administrative variation is made at the same time by the same applicant and the applications are for identical variations—

(i)

in respect of the first application considered by the licensing authority, a fee of F1£149, and

(ii)

in respect of each other application so considered, a fee of F2£75;

(b)

in any other case, a fee of F3£149.

(2)

The fee payable by an applicant in connection with an application for a standard variation of a certificate of registration shall be—

(a)

where more than one application for a standard variation is made at the same time by the same applicant and the applications are for identical variations—

(i)

in respect of the first application considered by the licensing authority, a fee of F4£296;

(ii)

in respect of each other application so considered, where further medical, technical or scientific assessment is required, a fee of F5£296;

(iii)

in respect of the second to thirtieth applications so considered, where no further medical, technical or scientific assessment is required, a fee of F6£149;

(iv)

in respect of each other application so considered, where no further medical, technical or scientific assessment is required, a fee of F7£75;

(b)

in any other case, a fee of F8£296.

Annotations

Textual amendments

F1

Sum in reg. 47(1)(a)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(a)(i)

F2

Sum in reg. 47(1)(a)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(a)(ii)

F3

Sum in reg. 47(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(b)

F4

Sum in reg. 47(2)(a)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(c)(i)

F5

Sum in reg. 47(2)(a)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(c)(ii)

F6

Sum in reg. 47(2)(a)(iii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(c)(iii)

F7

Sum in reg. 47(2)(a)(iv) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(c)(iv)

F8

Sum in reg. 47(2)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(d)