The Human Medicines Regulations 2012

Provisions relating to offences U.K.

Offences in connection with applications U.K.

119.  A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a certificate of registration for a registrable homoeopathic medicinal product, the person—

(a) fails to provide the licensing authority with any information that is relevant to an evaluation of the quality of the product; or

(b) provides to the licensing authority any information that is relevant to an evaluation of the quality of the product that is false or misleading in a material particular.

Provision of false or misleading information U.K.

120.—(1) The holder of a certificate of registration for a medicinal product is guilty of an offence if the person provides the licensing authority with any information that is relevant to the quality of the product but that is false or misleading in a material particular.

(2) Paragraph (1) is without prejudice to the operation of regulation 119.

General offence of breach of provision of this Part U.K.

121.—(1) A person is guilty of an offence if that person commits a breach of a provision in this Part.

(2) A breach of a provision in this Part includes any—

(a) failure by the holder of a certificate of registration to comply with any requirement or obligation in this Part;

(b) contravention by any person of any prohibition in this Part; or

(c) failure to comply with any requirement imposed on a person by the licensing authority pursuant to this Part.

(3) Paragraph (1) is without prejudice to any offence established by any other provision in this Part.

Penalties U.K.

122.  A person guilty of an offence under this Part 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.

Persons liable U.K.

123.  If an offence under regulation 119 (offences in connection with applications) is committed by a person acting as employee or agent, the employer or principal of that person is guilty of the same offence and is liable to be proceeded against and punished accordingly.

Defences U.K.

124.—(1) Paragraph (2) applies if the holder of a certificate of registration is charged with an offence under this Part in respect of anything that—

(a) has been manufactured or assembled to the holder's order by another person; and

(b) has been so manufactured or assembled as not to comply with the terms of the certificate.

(2) It is a defence for the holder to prove that—

(a) the holder communicated the terms of the certificate to the other person; and

(b) the holder did not know and could not by the exercise of reasonable care have known that those terms had not been complied with.

(3) It is a defence for a person charged with an offence consisting of a breach of regulation 113(3) or 118 or an offence under regulation 119 or 120 to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of that offence.

(4) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (3), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.