THERAPEUTIC GOODS REGULATIONS 1990 - REG 9A Information about certain therapeutic goods to be supplied

THERAPEUTIC GOODS REGULATIONS 1990 - REG 9A

  (1)   The sponsor of therapeutic goods that are specified in Part   1 of Schedule   10 and are included in the Register 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 consumer medicine 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)   approved for registration on or after 4   July 1995; and

  (c)   included in the Register;

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 consumer medicine 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.