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16. After regulation 95 (offences in connection with marketing authorisation application) insert—
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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