19A. Duty to report defects

For the purposes of section 42(1)(a) of the Act, every manufacturer, importer or supplier of any clinical research material must report any defect in the clinical research material to the Authority within the following period after the manufacturer, importer or supplier (as the case may be) first becomes aware of the defect:

if the defect represents a serious threat to persons or public health, within 48 hours;

in all other cases, within 15 days.