# The Human Medicines (Amendment) (No. 2) Regulations 2014, Regulation 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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Source: https://www.legislation.gov.uk/uksi/2014/1878/regulation/16 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-no-2-regulations-2014/regulation-16
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.