Commonwealth Numbered Regulations

1990 No. 394 THERAPEUTIC GOODS REGULATIONS - REG 6

6. (1) A person must not publish an advertisement about goods for therapeutic
use:

   (a)  that contains a prohibited representation (whether in express terms or
        by necessary implication) about those goods; or

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

   (c)  that is in contravention of a notice referred to in regulation 7 or 9:

        (i)    that was served on that person; or

        (ii)   of which the person was aware when the advertisement was
               published; or

   (d)  that contains:

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

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

   (e)  that refers to goods included in Schedule 3, 4 or 8 to the Poisons
        Standard; or

   (f)  that are not registered or listed, unless the goods are exempt goods.
Penalty: $1,000.

(2) Subject to subregulation (3), in a prosecution under subsection (1), it is
a defence if the defendant establishes that the contravention of that
subregulation in respect of which the proceeding was instituted was due:

   (a)  to a reasonable mistake; or

   (b)  to reasonable reliance on information supplied by another person; or

   (c)  to the act or default of another person, to an accident or to some
        other cause beyond the defendant's control, and the defendant took
        reasonable precautions and exercised due diligence to avoid the
        contravention.
(3) In paragraphs (2) (b) and (c), "another person" does not include a person
who was:

   (a)  a servant or agent of the defendant; or

   (b)  if the defendant is a body corporate - a director, servant or agent of
        the defendant, at the time when the contravention occurred.

(4) If a defence provided by subregulation (2) involves an allegation that a
contravention was due to reliance on information supplied by another person,
the defendant is not, without leave of the Court, entitled to rely on that
defence unless he or she has, not later than 7 days before the day on which
the hearing of the proceeding commences, given the person by whom the
proceeding was instituted a notice in writing setting out such information
that would identify or assist in the identification of the other person as was
then in his or her possession.

(5) In a proceeding under this regulation, it is a defence if the defendant
establishes that:

   (a)  he or she is a person whose business it is to publish or arrange for
        the publication of advertisements; and

   (b)  that he or she received the advertisement for publication in the
        ordinary course of business; and

   (c)  that he or she did not know and had no reason to suspect that its
        publication would amount to a contravention of subregulation (1).