# The Human Medicines Regulations 2012, Regulation 45U: Offences: breach of regulations and false information


(1) A person is guilty of an offence if the person imports, manufactures or distributes an active substance in breach of regulation 45M(1).
(2) A person is guilty of an offence if the person knowingly gives false information in—
(a) a registration form received by the licensing authority under regulation 45N(1);
(b) a notification to the licensing authority under regulation 45N(2) or 45P(4);
(c) an application for a variation under regulation 45T(2); or
(d) response to a notice under regulation 45T(4).
(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 45P(6) or 45T(4).

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/45U (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-45U
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.