Therapeutic Goods Regulations 1990

ensure that records are kept that include the following information:

the quantities of the goods or biologicals under the person’s control;

how the goods or biologicals are stored before being disposed of;

if a direction under subclause 4(1) has been received—what actions have been taken to dispose of the goods or biologicals as directed and when the actions were taken;

if the goods or biologicals have been exported or supplied—to whom they were exported or supplied and in what quantity; and

retain the records for 7 years after the last entry is made; and

if the Secretary so requests in writing—give to the Secretary a copy of a record mentioned in paragraph (a):

within 14 days after being notified of the Secretary’s request; or

if the information is required to establish whether the goods or biologicals pose imminent risk to the public or the environment—within 24 hours, or any shorter period, specified by the Secretary.