# The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, Paragraph 11: Offences


Any holder of a marketing authorization who sells or supplies or procures the sale or supply of a relevant medicinal product to which the authorization relates—
(a) the labelling of which, or any package leaflet accompanying which, does not comply with; or
(b) without a package leaflet required to be provided by virtue of,
the applicable requirements of Council Directive 92/27/EEC or of Schedule 5 to these Regulations, shall be guilty of an offence.

---
Source: https://www.legislation.gov.uk/uksi/1994/3144/schedule/3/paragraph/11 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.