Singapore legislation
Regulation 28
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 28
Corrective measures in relation to contravening trade descriptions or failure to provide prescribed information
Subregulation 1
Where any manufacturer, importer, supplier or registrant of a CTGT product has applied a trade description in contravention of regulation 24, the manufacturer, importer, supplier or registrant must, upon receiving an order from the Authority, do one or more of the following as specified in the order:
stop disseminating, publishing or using the trade description with immediate effect;
stop applying the trade description to the CTGT product, or stop supplying the CTGT product applied with the trade description, with immediate effect;
take any measures that 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;
apply, disseminate or publish a corrective trade description in the manner and containing the information that the Authority requires.
Subregulation 2
Where any manufacturer, importer, supplier or registrant of a CTGT product fails to provide any information required by regulation 25 to accompany the supply of the CTGT product, the manufacturer, importer, supplier or registrant must, upon receiving an order from the Authority, take the corrective measures that the Authority requires in the order, which may include any of the following:
stop supplying the CTGT product with immediate effect;
take any measures that may be reasonable and necessary in the circumstances to ensure that the CTGT product is only supplied with the required information.
Subregulation 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.
Subregulation 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.
Subregulation 5
Without affecting paragraph (4), the Authority may take any steps that 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.