Consultation: Therapeutic Goods Advertising Code

Proposed improvements including proposed framework for Schedule 3 medicine advertising

31 August 2017

This consultation closes on 13 October 2017.

Invitation to comment

The TGA is seeking comments from interested parties on proposed changes to improve the Therapeutic Goods Advertising Code (the Code) and a possible framework for the advertising of pharmacist-only (Schedule 3) medicines to the public.

Consultation documents

How to access a pdf or Word document

Timetable

Documents released for consultation on Thursday, 31 August 2017.

Interested parties should respond by close of business Friday, 13 October 2017.

Feedback will be released following consideration of submissions. (see 'What will happen').

A further round of public consultation on the new draft Code is planned for late 2017/early 2018.

About the consultation

The Government has agreed to reform and simplify the processes by which the advertising of therapeutic goods to the public is regulated. This agreement sees the continuation of advertising controls under the TGA's legislative framework including the Code and the alignment of advertising requirements for medicines and medical devices (where possible). The Government has also agreed to review the Schedule 3 medicines advertising guidelines.

The purpose of this consultation is to provide an opportunity for interested parties to provide their views on proposed changes to the Code to support the implementation of related Review recommendations and a possible framework for advertising of Schedule 3 medicines to the public.

Background

In October 2014 the establishment of the Expert Review of Medicines and Medical Devices Regulation was announced.

The Panel made seven recommendations in relation to advertising of therapeutic goods to the public (Recommendations 52-58) and two recommendations relating to reviewing the Scheduling policy framework, including a review of the Schedule 3 advertising guidelines (Recommendations 11 and 12).

The Australian Government has accepted the Review's specific advertising Recommendations. Further, following consultation with stakeholders in late 2016 on the preferred design of a new advertising complaints handling process, the Government agreed that the TGA take on the role of the single body responsible for handling advertising complaints from 1 July 2018. Consultation with stakeholders in April 2017on the Scheduling Policy Framework and advertising of pharmacist-only medicines identified that further consultation on a possible framework for the advertising of Schedule 3 medicines to the public was required.

To continue development of these reforms, the Department of Health now seeks feedback from interested or affected parties.

Content of submissions

Submissions may address any, or all, of the [proposed amendments to the title of consultation document] or other identified issues.

In addition, submissions might include:

  • Suggested improvements
  • An assessment of how the proposed change will impact on you.
  • What do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please quantify these costs and benefits.

How to submit

Complete the online consultation submission form to upload your submission in either pdf or word format.

Consultation submission form

Alternatively, hardcopy submissions with a printed cover sheet may be mailed to:

Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

How to access a Word document

Enquiries

Any questions relating to submissions should be directed by email to or by telephone to 02 6232 8861.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.