Commonwealth Numbered Regulations

THERAPEUTIC GOODS AMENDMENT REGULATIONS 2002 (NO. 5) 2002 NO. 315 - SCHEDULE 2

(regulation 3)

[1] Subregulations 9A (1) and (1AAA)

substitute

(1)

The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a patient information document set out in Schedule 12.

Penalty:
10 penalty units.

(1AAA)

For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.

Note
For strict liability , see section 6.1 of the Criminal Code .