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THERAPEUTIC GOODS REGULATIONS 1990 - REG 16AB Specified periods

THERAPEUTIC GOODS REGULATIONS 1990 - REG 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.