The Human Medicines (Amendment) (No. 2) Regulations 2014
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Change 1
15 Insertion of regulation 80A
After regulation 80 (urgent safety restrictions) insert— Urgent safety restrictions: parallel import licences 80A. The holder of a parallel import licence is guilty of an offence if the holder— (a) fails to inform the licensing authority that the holder has taken urgent safety restrictions on the holder’s own initiative; (b) fails to implement an urgent safety restriction imposed on the holder by the licensing authority; or (c) fails to submit an application for variation of the parallel import licence to the licensing authority before the end of a period of fifteen days beginning on the day after— (i) the taking of urgent safety restrictions under paragraph (a) or, as the case may be, (ii) the imposition of urgent safety restrictions under paragraph (b).
15 Insertion of regulation 80A
After regulation 80 (urgent safety restrictions) insert— Urgent safety restrictions: parallel import licences 80A. The holder of a parallel import licence is guilty of an offence if the holder— (a) fails to inform the licensing authority that the holder has taken urgent safety restrictions on the holder’s own initiative; (b) fails to implement an urgent safety restriction imposed on the holder by the licensing authority; or (c) fails to submit an application for variation of the parallel import licence to the licensing authority before the end of a period of fifteen days beginning on the day after— (i) the taking of urgent safety restrictions under paragraph (a) or, as the case may be, (ii) the imposition of urgent safety restrictions under paragraph (b).
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