The Human Medicines (Amendment) (No. 2) Regulations 2014
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Change 1
16 Insertion of regulation 95A
After regulation 95 (offences in connection with marketing authorisation application) insert— Offences in connection with parallel import licence application 95A. 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.
16 Insertion of regulation 95A
After regulation 95 (offences in connection with marketing authorisation application) insert— Offences in connection with parallel import licence application 95A. 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.
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