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Consultation: Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public

31 May 2013

This consultation closed on Friday 19 July 2013.

The TGA invited comments from interested persons or organisations on this consultation regulatory impact statement (Consultation RIS) before 5pm, Friday 19 July 2013.

Comments were sought on:

  • how your interests may be affected by the proposals outlined in this paper
  • the likely regulatory impacts and costs of the proposals on consumers and businesses
  • matters relevant to the implementation of the proposals.

Consultation documents

How to access a pdf or Word document


Document released for consultation on Friday 31 May 2013.

Interested parties responded before 5pm, Friday 19 July 2013.

Feedback will be released following consideration of submissions.

About the consultation

The purpose of this Consultation RIS was to seek public comment to help inform the Australian Government in decision making on proposed regulatory reforms to improve the management of public health risks in relation to the advertising of therapeutic goods to the general public.

This Consultation RIS:

  • describes the existing regulatory framework
  • documents problems associated with the existing regulatory framework
  • outlines the objectives for reform
  • suggests proposals for reform
  • invites comments on likely impacts of implementation of the suggested proposals.

After consideration of public comment on this Consultation RIS, the TGA intends to prepare a final RIS to assist Government consideration of the next steps.


See: Submissions received

Submissions may address any, or all, of the proposed amendments to the advertising regulatory framework or other identified issues. In addition you may wish to consider in your comments whether the proposals will:

  • Change the number or type of products that businesses can offer as a result of complying with a proposal
  • Alter consumer demand for products as a result of:
    • increasing prices brought about by regulatory requirements
    • changing public information to ensure compliance with regulation.
  • Alter the ability or incentives of businesses to compete in the market.


All submissions received will be placed on the TGA's Internet site, unless marked confidential. Any confidential material contained within a submission should be provided under a separate cover and clearly marked "IN CONFIDENCE". Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet. For submissions made by individuals, all personal details, other than your name, will be removed from your submission before it is published on the TGA's Internet site. In addition, a list of parties making submissions will also be published on the TGA Internet site. If you do not wish to be identified with your submission in this "list of parties" you must specifically request this in the space provided on the submission coversheet.


Enquiries should be directed via email to, or to 02 6232 8560.