# The Human Medicines Regulations 2012, Regulation 256M: Offences: breach of regulations and false information


(1) A person is guilty of an offence if the person—
(a) contravenes regulation 256B(1); or
(b) offers medicinal products for sale at a distance otherwise than in accordance with the conditions in regulation 256H.
(2) A person is guilty of an offence if the person knowingly gives false information in—
(a) an application to be entered on the list in accordance with regulation 256C(2);
(b) an application for a variation in accordance with regulation 256L(2); or
(c) response to a notice under regulation 256L(4).
(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 256F(3) or 256L(4).
(4) A person is guilty of an offence if that person fails to inform the licensing authority—
(a) of a falsified medicinal product in accordance with regulation 256F(1); or
(b) about a material change of circumstances in accordance with regulation 256F(2).
(5) It is a defence for a person charged with an offence under paragraph (4) to show that the person exercised all due diligence to avoid committing the offence.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/256M (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-256M
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.