Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(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.
Note Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell -- see regulation 9B.
(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 .
(1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.
Note A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code ).
(1A) The sponsor of therapeutic goods that are:
(a) specified in Schedule 3 of the Poisons Standard; and
(b) are approved for registration on or after 4 July 1995;
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 13.
Penalty: 10 penalty units.
(1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A) (a).
Note For strict liability , see section 6.1 of the Criminal Code .
(2) For the purposes of subregulation (1) or (1A), information must be provided:
(a) in the primary pack in which the therapeutic goods are supplied; or
(b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.