# The Human Medicines Regulations 2012, Regulation 207: Offences


(1) A person is guilty of an offence if the person commits a breach of a provision in this Part, other than Schedule 12A (further requirements in respect of pharmacovigilance activities) and regulation 199(2) or (6) (submission of draft study protocols for required studies).
(2) A breach of a provision in this Part includes any—
(a) failure by a holder to comply with any requirement or obligation in this Part; or
(b) contravention by any person of any prohibition in this Part.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/207 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-207
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.