Singapore legislation
Regulation 34
Regulation 34
Duty to report defects and adverse effects
Subregulation 1
For the purposes of section 42(1)(a) of the Act, every manufacturer, importer, supplier or registrant of a therapeutic product must, upon becoming aware of any defect in the therapeutic product, report the defect to the Authority —
if the defect represents a serious threat to persons or public health, within 48 hours; or
in all other cases, within 15 days,after the manufacturer, importer, supplier or registrant, as the case may be, first receives notice of the defect.
Subregulation 2
For the purposes of section 42(1)(b) of the Act, every manufacturer, importer, supplier or registrant of a therapeutic product must, upon becoming aware of any serious adverse reaction arising from the use of the therapeutic product, report the serious adverse reaction to the Authority immediately, but in any case no later than 15 days after the manufacturer, importer, supplier or registrant first becomes aware of the serious adverse reaction.
Subregulation 3
In this regulation, “serious adverse reaction” means an adverse effect that is unintended and occurs in association with the use or administration of a therapeutic product at doses normally used in humans for prophylaxis, diagnosis or therapy of a disease or for the restoration, correction or modification of a physiological function, and that —
may result in a person’s death;
may threaten a person’s life;
results in a person being hospitalised or prolongs a person’s existing stay in hospital;
results in a person’s persistent or significant disability or incapacity;
results in a congenital anomaly or birth defect; or
is judged to be medically important even though the effect might not be immediately life-threatening or result in death or hospitalisation, but may jeopardise the person’s health or may require intervention to prevent the person’s death or one of the other outcomes mentioned in sub-paragraphs (c), (d) and (e).