Commonwealth Consolidated Acts

[Index] [Table] [Search] [Search this Act] [Notes] [Noteup] [Previous] [Next] [Download] [Help]

THERAPEUTIC GOODS ACT 1989 - SECT 42DL

Advertising offences

             (1)  A person must not publish or broadcast an advertisement about therapeutic goods:

                     (a)  that contains a prohibited representation (whether in express terms or by necessary implication) about those goods, the use of which has not been permitted under subsection 42DK(2); or

                     (b)  that does not contain a required representation about those goods; or

                     (c)  that contains a restricted representation, about those goods, the use of which has not been approved under subsection 42DF(1) or permitted under subsection 42DK(1); or

                     (d)  that is in contravention of a notice referred to in section 42DKB that was given to the person; or

                     (e)  that contains:

                              (i)  a reference to the Act other than in a statement of the registration number, listing number or device number of the goods; or

                             (ii)  a statement suggesting or implying the goods have been recommended or approved by or on behalf of a government or government authority (including a foreign government or foreign government authority), other than a statement of their availability as a pharmaceutical benefit or a statement authorised or required by a government or government authority (including a foreign government or foreign government authority); or

                      (f)  that contains a statement referring to goods, or substances or preparations containing goods, included in Schedule 3, 4 or 8 to the current Poisons Standard, other than a statement authorised or required by a government or government authority (including a foreign government or foreign government authority); or

                    (fa)  that contains a statement referring to a biological, other than a statement authorised or required by a government or government authority (including a foreign government or foreign government authority); or

                     (g)  that are not entered in the Register; or

                     (h)  if the goods are therapeutic goods, or come within a class of therapeutic goods, that:

                              (i)  are exempt goods or exempt devices prescribed in the regulations for the purposes of this provision; or

                             (ii)  have been approved under subsection 19(1) or section 41HB of this Act for importation into, exportation from, or supply within, Australia.

Penalty:  60 penalty units.

             (2)  For the purposes of an offence against subsection (1), strict liability applies to the following physical elements:

                    (aa)  that the use of a prohibited representation, as referred to in paragraph (1)(a), has not been permitted under subsection 42DK(2);

                     (a)  that the use of a restricted representation, as referred to in paragraph (1)(c), has not been approved under subsection 42DF(1) or permitted under subsection 42DK(1);

                     (b)  that the notice referred to in paragraph (1)(d) is a notice referred to in section 42DKB;

                     (c)  that goods, substances or preparations referred to in paragraph (1)(f) are included in Schedule 3, 4 or 8 to the current Poisons Standard;

                     (d)  that the therapeutic goods, or class of therapeutic goods, referred to in paragraph (1)(h):

                              (i)  are exempt goods or exempt devices prescribed in the regulations made for the purposes of subparagraph (1)(h)(i); or

                             (ii)  have been approved under subsection 19(1) or section 41HB of the Act for importation into, exportation from or supply within, Australia.

             (3)  It is a defence to a prosecution under subsection (1) if:

                     (a)  in relation to an advertisement mentioned in paragraph (1)(a), (c) or (f)--the advertisement is made by, or on behalf of, the Commonwealth; and

                     (b)  in relation to an advertisement mentioned in paragraph (1)(f)--the goods, substances or preparations are mentioned in Appendix H of the current Poisons Standard; and

                     (c)  in relation to goods mentioned in paragraph (1)(g)--the goods are exempt goods or exempt devices other than goods of a kind mentioned in paragraph (1)(h).

Note:          A defendant bears an evidential burden in relation to the matters mentioned in subsection (3) (see section 13.3 of the Criminal Code ).



AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback