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Paragraph 11 Offences

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

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.