Regulation 95 Offences in connection with application

A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a marketing authorisation for a relevant medicinal product, the person—

(a)

fails to provide the licensing authority with any information that is relevant to the evaluation of the safety, quality or efficacy of the product; F1or

(b)

provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of the product but that is false or misleading in a material particular;

F2(c)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3(d)

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Annotations

Textual amendments

F1: Word in reg. 95 inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 67(a)
F2: Reg. 95(c) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 67(b)
F3: Reg. 95(d) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 67(b)