Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16ab
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16AB
Character Range: 227850–228874

16AB  Specified periods
  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.

Part 3A—Applications for evaluation

Division 1—Preliminary