268.—(1) This regulation applies to the holder of a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product who sells or supplies, offers to sell or supply, or possesses for the purpose of sale or supply, a medicinal product to which the authorisation, certificate or registration relates.
(2) A person to whom this regulation applies is guilty of an offence if—
(a)a package or package leaflet relating to the product does not comply with the applicable requirements of this Part or Article 28 or 32 of the Paediatric Regulation; or
(b)the product is not accompanied by a package leaflet when one is required by virtue of this Part.