Paragraph 57A F1
The fee payable under regulation 19D(1) in connection with the carrying out of a major safety review is—
F2£61,408, where one or two active ingredients, or combinations of active ingredients, are included in the assessment;
F3£71,357, where three active ingredients, or combinations of active ingredients, are included in the assessment;
F4£81,305, where four active ingredients, or combinations of active ingredients, are included in the assessment; or
F5£91,254, where five or more active ingredients, or combinations of active ingredients, are included in the assessment.
Annotations
Textual amendments
- F1
Sch. 2 Pts. 6-6B, substituted for Sch. 2 Pt. 6 (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(13) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ix)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Sum in Sch. 2 para. 57A(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(29)(a)
- F3
Sum in Sch. 2 para. 57A(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(29)(b)
- F4
Sum in Sch. 2 para. 57A(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(29)(c)
- F5
Sum in Sch. 2 para. 57A(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(29)(d)