Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41EWD

  (1)   If an Australian corporation:

  (a)   is an Australian conformity assessment body; and

  (b)   is required by a condition referred to in subsection   41EWA(5) to keep records relating to certification - related activities carried on by the corporation;

the Australian corporation must keep the records at all times while the corporation is an Australian conformity assessment body.

  (2)   If the Australian corporation ceases to be an Australian conformity assessment body, the corporation must keep the records referred to in subsection   (1) for 15 years after that cessation.

Offences

  (3)   An Australian corporation commits an offence if:

  (a)   the corporation is subject to a requirement under this section; and

  (b)   the corporation contravenes the requirement.

Penalty:   1,200 penalty units.

  (4)   An Australian corporation commits an offence if:

  (a)   the corporation is subject to a requirement under this section; and

  (b)   the corporation contravenes the requirement.

Penalty:   300 penalty units.

  (5)   An offence against subsection   (4) is an offence of strict liability.