175.—(1) A person to whom this paragraph applies is guilty of an offence if the person provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of a medicinal product that is false or misleading in a material particular.
(2) Paragraph (1) applies to any person who for the purposes of regulation 167 (special patient needs)—
(a)sells or supplies the product; or
(b)provides a specification for the product.
(3) A person is guilty of an offence if the person fails to—
(a)maintain any record required by regulation 170(1) (records in connection with special medicinal products etc);
(b)make any record available as required by regulation 170(2); or
(c)notify the licensing authority of any suspected serious adverse reaction as required by regulation 170(3).
176.—(1) A person guilty of an offence under regulation 175 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.
(2) It is a defence for a person charged with an offence under regulation 175(1) to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of that offence.
(3) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (2), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.