Paragraph 57B F1F2
The fee payable under regulation 19F(1) in connection with the submission of a sample of a batch of a medicinal product is £5,093 for each day taken to examine the sample for testing, the appropriate documentation (as defined in regulation 60A of the Human Medicines Regulations) or both (as the case may be), and the fee payable is to be adjusted pro rata for each period taken of less than 1 day.
In this paragraph, a “day” means a period of 8 hours and 30 minutes.
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
Sch. 2 para. 57B substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(30)