Singapore legislation
Regulation 25
Regulation 25
Duty to notify Authority concerning recall
Subregulation 1
Every manufacturer of an active ingredient who intends to recall the active ingredient due to a defect or suspected defect in the active ingredient must immediately, but in any case no later than 24 hours before the start of the intended recall, notify the Authority of, and the reasons for, the intended recall.
Subregulation 2
Where the Authority has been notified of the intended recall of an active ingredient under paragraph (1), the Authority may by written notice require the manufacturer of the active ingredient to do all or any of the following:
investigate the matter occasioning the recall of the active ingredient and provide a report of the findings of the investigation;
issue or cause to be issued to any persons that the Authority may specify or to the general public a statement informing them of the recall of the health product and any other matter that the Authority considers necessary;
take any other measures that the Authority thinks necessary in respect of the recall.
Subregulation 3
A person to whom a notice in paragraph (2) 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 4
For the purposes of paragraph (1), an active ingredient has a defect if the active ingredient —
is adulterated;
is counterfeit;
has been tampered with;
is unwholesome; or
is of an inadequate quality or is unsafe for the purpose for which the active ingredient was manufactured.