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Regulation 119 Offences in connection with applications

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.