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THERAPEUTIC GOODS ACT 1989 - SECT 42DLB

Civil penalty relating to advertisements--general

  (1)   A person contravenes this subsection if:

  (a)   the person:

  (i)   advertises, by any means, therapeutic goods; or

  (ii)   causes the advertising, by any means, of therapeutic goods; and

  (b)   subsection   (2), (3), (4), (5), (6), (7), (8) or (9) applies to the advertisement.

Maximum civil penalty:

  (a)   for an individual--5,000 penalty units; and

  (b)   for a body corporate--50,000 penalty units.

Contravening provisions

  (2)   This subsection applies to the advertisement if it contains a prohibited representation (whether in express terms or by necessary implication) about the goods and either of the following applies:

  (a)   no permission under section   42DK is in force in relation to the prohibited representation;

  (b)   a permission under section   42DK is in force in relation to the prohibited representation but the use of the prohibited representation is not in accordance with the permission or a condition of the permission.

  (3)   This subsection applies to the advertisement if it does not contain a required representation about the goods.

  (4)   This subsection applies to the advertisement if it contains a restricted representation (whether in express terms or by necessary implication) and either of the following applies:

  (a)   neither an approval under section   42DF nor a permission under section   42DK is in force in relation to the restricted representation;

  (b)   an approval under section   42DF or a permission under section   42DK is in force in relation to the restricted representation but the use of the restricted representation is not in accordance with the approval or permission or a condition of the approval or permission.

  (5)   This subsection applies to the advertisement if it contains a reference to this Act, other than in a statement of the registration number, listing number or device number of the goods.

  (6)   This subsection applies to the advertisement if it contains a statement, pictorial representation or design 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)   a statement of the availability of the goods as a pharmaceutical benefit; or

  (b)   a statement, pictorial representation or design authorised or required by a government or government authority (not including a foreign government or foreign government authority); or

  (c)   a statement, pictorial representation or design prescribed by the regulations for the purposes of this paragraph.

  (7)   This subsection applies to the advertisement if it refers to substances, or goods containing substances, included in Schedule   3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

  (8)   This subsection applies to the advertisement if it refers to a biological, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

  (9)   This subsection applies to the advertisement if it refers to therapeutic goods that are not entered in the Register and that are prescribed by the regulations for the purposes of this subsection, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

Exception

  (10)   Subsection   (1) does not apply if:

  (a)   the person is a broadcaster, a datacaster, the SBS or a person of a kind prescribed by the regulations for the purposes of this paragraph; and

  (b)   as a result of steps taken by the person, it was reasonable for the person to assume that subsections   (2) to (9) did not apply to the advertisement.

  (11)   In this section:

"broadcaster" has the meaning given by clause   3 of Schedule   2 to the Broadcasting Services Act 1992 .

"datacaster" means a person who holds a datacasting licence (within the meaning of the Broadcasting Services Act 1992 ).

"SBS" has the same meaning as in the Special Broadcasting Service Act 1991 .


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