# The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, Paragraph 12: Offences


Where, in relation to a relevant medicinal product—
(a) the labelling of the product, or any package leaflet accompanying the product, does not comply with; or
(b) the product is not accompanied by a package leaflet required to be provided by virtue of,
the applicable requirements of Council Directive 92/27/EEC or Schedule 5, any person, other than the holder of the marketing authorization for that product, who in the course of a business carried on by him, sells or supplies or procures the sale or supply of that product knowing, or having reasonable cause to believe, that the labelling does not so comply or, as the case may be, that the product is not so accompanied, shall be guilty of an offence.

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Source: https://www.legislation.gov.uk/uksi/1994/3144/schedule/3/paragraph/12 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.