18. Any holder of a traditional herbal registration who sells or supplies or procures the sale or supply of a traditional herbal medicinal product to which the traditional herbal registration 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 Title V of the 2001 Directive or of Schedule 5 to these Regulations, shall be guilty of an offence.