Offences in connection with applicationU.K.
95. 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;
(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;
(c)[F1, in relation to an EU marketing authorisation for a product for sale or supply in Northern Ireland,] fails to provide the EMA with any information that is relevant to the evaluation of the safety, quality or efficacy of the product as required by paragraph (7) or (11) in the “Introduction and general principles” of Annex 1 to the 2001 Directive as applied by Article 6(1) of Regulation (EC) No 726/2004; or
(d)[F2, in relation to an EU marketing authorisation for a product for sale or supply in Northern Ireland,] provides to the EMA any information of the kind described in sub-paragraph (c) that is false or misleading in a material particular.
Textual Amendments
F1Words in reg. 95(c) inserted (31.12.2020) by S.I. 2019/775, reg. 92(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 69)
F2Words in reg. 95(d) inserted (31.12.2020) by S.I. 2019/775, reg. 92(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 69)