Regulation 95A Offences in connection with parallel import licence applicationF1

A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a parallel import licence 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; or

(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.

Annotations

Textual amendments

F1: Reg. 95A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 16 and reg. 95A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 16