Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 16AB

                   For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:

                     (a)  if the information relates to an event or occurrence that represents a serious threat to public health--within 48 hours after the person first becomes aware of the event or occurrence;

                     (b)  if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person--within 10 days after the person first becomes aware of the event or occurrence;

                     (c)  if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person--within 30 days after the person first becomes aware of the event or occurrence.