Singapore legislation
Regulation 37
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 37
Duty to notify Authority concerning recall
Subregulation 1
For the purposes of section 44(1) of the Act, every manufacturer, importer, supplier or registrant of a CTGT product who recalls or intends to recall a CTGT product must immediately, but in any case no later than 24 hours before the start of the recall or intended recall, notify the Authority of, and the reasons for, the recall or the intended recall.
Subregulation 2
The notice in paragraph (1) must be made in the form and manner specified on the Authority’s website.
Subregulation 3
Where the Authority has been notified of the recall or the intended recall of a CTGT product under paragraph (1), the Authority may by notice require the manufacturer, importer, supplier or registrant of the CTGT product to do either or both of the following:
investigate the matter occasioning the recall of the CTGT product and provide a report of the findings of the investigation to the Authority;
take any other measures that the Authority thinks necessary.
Subregulation 4
A person to whom a notice in paragraph (3) is given must comply with the notice at the person’s own cost and within the time specified in the notice or, if no time is specified in the notice, within a reasonable time after the date of the notice.
Subregulation 5
A person who fails to comply with paragraph (4) 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.