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Corrective measures in relation to contravening trade descriptions or failure to provide prescribed information

Health Products (Therapeutic Products) Regulations 2016

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—(1) Where any manufacturer, importer, supplier or registrant of a therapeutic product has applied a trade description in contravention of regulation 19, the Authority may order that manufacturer, importer, supplier or registrant, as the case may be, to do all or any of the following:(a)to stop disseminating, publishing or using the trade description with immediate effect;(b)to stop applying the trade description to the therapeutic product, or to stop supplying the therapeutic product applied with the trade description, with immediate effect;(c)to take such measures as may be reasonable and necessary in the circumstances to discontinue or remove any trade description that may already have been applied, disseminated, published or used;(d)to apply, disseminate or publish a corrective trade description in such manner and containing such information as the Authority may require.(2) Where any manufacturer, importer, supplier or registrant of a therapeutic product fails to provide any information required by regulation 20 to accompany the supply of the therapeutic product, the Authority may order that manufacturer, importer, supplier or registrant, as the case may be, to take such corrective measures as the Authority may require, including —(a)to stop supplying the therapeutic product with immediate effect; or(b)to take such measures as may be reasonable and necessary in the circumstances to ensure that the therapeutic product is only supplied with the required information.(3) A person to whom an order under paragraph (1) or (2) is directed must comply with the order at the person’s own cost and within the time specified in the order or, if no time is specified in the order, within a reasonable time after the date of the order.(4) A person who fails to comply with paragraph (3) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.(5) Without prejudice to paragraph (4), the Authority may take such steps as the Authority thinks reasonable and necessary to implement the requirements of an order directed to any person under paragraph (1) or (2), and recover any costs and expenses reasonably incurred by the Authority in so doing from the person.

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