Regulation 175 Offences relating to exceptions

(1)

A person to whom this paragraph applies is guilty of an offence if the person provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of a medicinal product that is false or misleading in a material particular.

(2)

Paragraph (1) applies to any person who for the purposes of regulation 167 (special patient needs)—

(a)

sells or supplies the product; or

(b)

provides a specification for the product.

(3)

A person is guilty of an offence if the person fails to—

(a)

maintain any record required by regulation F1167G(1)(g)(ii) (EAMS medicinal products: pharmacovigilance) F2, 170(1) (records in connection with special medicinal products etc), 170A(1) (MM medicinal products: pharmacovigilance requirements), or 170B(1) (POC medicinal products: pharmacovigilance requirements);

(b)

make any record available as required by regulation F3167G(1)(g)(iii) F4, 170(2), 170A(3) or 170B(3); or

(c)

notify the licensing authority of any suspected serious adverse reaction as required by regulation 170(3) F5, 170A(4) or 170B(4) F6or of any relevant changes as required by regulation 167G(1)(f).

Annotations

Textual amendments

F1: Words in reg. 175(3)(a) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 9(2) (with reg. 19)
F2: Words in reg. 175(3)(a) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 25(2)(a)
F3: Words in reg. 175(3)(b) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 9(3) (with reg. 19)
F4: Words in reg. 175(3)(b) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 25(2)(b)
F5: Words in reg. 175(3)(c) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 25(2)(c)
F6: Words in reg. 175(3)(c) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 9(4) (with reg. 19)