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Schedule 5 Fees for certificates of registration

Column 1Column 2Column 3
Type of applicationFees for applications in respect of products prepared from not more than 5 homoeopathic stocksFees for other applications
1An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation.F1£194F2£479
2An application in respect of a product which is either—F3£582F4£857
(a)prepared solely from repeat stocks; or
(b)is of a repeat formulation.
3A mutual recognition procedure incoming application.F5£610F6£777
4A mutual recognition outgoing application (regulatory assistance).£287£374
5A decentralised procedure application where the UK is a concerned member State.F7£524F8£686
6A decentralised procedure application where the UK is the reference member State.£813£1,063
7Any other application.F9£962F10£1,259

Annotations

Textual amendments

F1

Sum in Sch. 5 Table Item 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(a)(i)

F2

Sum in Sch. 5 Table Item 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(b)(i)

F3

Sum in Sch. 5 Table Item 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(a)(ii)

F4

Sum in Sch. 5 Table Item 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(b)(ii)

F5

Sum in Sch. 5 Table Item 3 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(a)(iii)

F6

Sum in Sch. 5 Table Item 3 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(b)(iii)

F7

Sum in Sch. 5 Table Item 5 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(a)(iv)

F8

Sum in Sch. 5 Table Item 5 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(b)(iv)

F9

Sum in Sch. 5 Table Item 7 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(a)(v)

F10

Sum in Sch. 5 Table Item 7 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(b)(v)