Paragraph 9 Active substance registrations

(1)

Except in the case of an inspection where sub–paragraph (2) applies, the fee payable in connection with the grant, variation or review of an active substance registration where the inspection relates to—

(a)

a manufacturer of an active substance, is—

(i)

F1£3,975 if the time taken to make the inspection is not more than 1 day; and

(ii)

if the time taken is 1 day or more, F2£3,975 for the first day and F3£1,988 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection;

(b)

an importer or distributor of an active substance, is—

(i)

F4£2,898 if the time taken to make the inspection is not more than 1 day; and

(ii)

if the time taken is 1 day or more, F5£2,898 for the first day and F6£1,449 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection.

(2)

This paragraph applies where an application or variation of an active substance registration is considered under paragraph 10 but it is necessary to carry out a site inspection before the registration is granted or varied.

(3)

If sub-paragraph (2) applies—

(a)

a fee of F7£949 is payable in addition to any fee under paragraph 10 where the inspection relates to a manufacturer of an active substance;

(b)

a fee of F8£697 is payable in addition to any fee under paragraph 10 where the inspection relates to an importer or distributor of an active substance.

Annotations

Textual amendments

F1: Sum in Sch. 3 para. 9(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), 28(7)(a)(i)
F2: Sum in Sch. 3 para. 9(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), 28(7)(a)(i)
F3: Sum in Sch. 3 para. 9(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), 28(7)(a)(ii)
F4: Sum in Sch. 3 para. 9(1)(b)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(b)(i)
F5: Sum in Sch. 3 para. 9(1)(b)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(b)(i)
F6: Sum in Sch. 3 para. 9(1)(b)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(b)(ii)
F7: Sum in Sch. 3 para. 9(3)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(c)(i)
F8: Sum in Sch. 3 para. 9(3)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(c)(ii)