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.
269.—(1) This regulation applies to a person, other than the holder of a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business sells or supplies, or offers to sell or supply the product, or possesses the product for the purpose of sale or supply.
(2) A person to whom this regulation applies is guilty of an offence if the person sells or supplies, or offers to sell or supply, the product, or possesses the product for the purpose of sale or supply, knowing or having reasonable cause to believe—
(a)that a package or package leaflet relating to the medicinal product does not comply with the applicable requirements of this Part or Article 28 or 32 of the Paediatric Regulation; or
(b)that the product is not accompanied by a package leaflet when one is required by virtue of this Part.
270.—(1) If the holder of a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration fails to comply with a requirement imposed by this Part in relation to a medicinal product, the licensing authority may give a notice to the holder requiring compliance within three months or such other period (which may be less than three months) as may be specified in the notice.
(2) If the holder fails to comply with the notice, the licensing authority may suspend the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration until the holder complies with the requirements of this Part.
(3) A person who fails to comply with a notice under this regulation is guilty of an offence.
271. A person who is guilty of an offence under regulation 268, 269 or 270 is liable—
(a)on summary conviction to a fine not exceeding the statutory maximum; or
(b)on conviction on indictment, to a fine, to imprisonment for a term not exceeding two years, or to both.