Consultation: Draft therapeutic goods advertising code 2018 and associated guidelines

29 March 2018

This consultation closed on Friday, 27 April 2018.

The TGA sought comments from interested parties on the proposed draft Therapeutic Goods Advertising Code 2018 (the Code) and associated guidance document.

Consultation documents

How to access a pdf or Word document

Draft Therapeutic Goods Advertising Code 2018

Draft Therapeutic Goods Advertising Code 2018 - Guidance

Comparison between the Therapeutic Goods Advertising Code 2015 and the proposed 2018 Code

Timetable

Documents released for consultation on Thursday, 29 March 2018.

Interested parties should respond by close of business Friday, 27 April 2018.

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

Once the TGA has considered feedback from this consultation and from the Therapeutic Goods Advertising Code Council (TGACC), final amendments will be made to the proposed draft Code and guidance document. At this stage it is anticipated the new Code will come into effect from 1 July 2018.

About the consultation

The purpose of this consultation is to seek stakeholder feedback on the proposed draft Code and associated guidelines. It builds on the 2017 Code consultation which canvased broad proposals for development of the new Code (including a proposed framework for advertising Pharmacist-Only (Schedule 3) medicines to the public).

Feedback from the 2017 Code consultation, targeted stakeholder workshops and from the TGACC has helped inform the development of the proposed draft Code.

Stakeholders should note that, once the guidance content is finalised, it is likely to be published in a different style and format to that used for the consultation in order to meet accessibility requirements. There are currently some areas of the guidance document that still under development and we welcome your comments and views on these areas and any other suggested changes.

Background

The Code is a legislative instrument made under section 42BAA of the Therapeutic Goods Act 1989 (the Act) by the Minister or their delegate. It is the key advertising compliance standard that sets out minimum requirements and underpins the regulatory framework for the advertising of therapeutic goods to the public. The last major update of the Code was completed in 2007. However, it was remade with minimal changes in November 2015 to avoid it being automatically repealed (sunsetted) under the Legislation Act 2003 while the Expert Panel Review of Medicines and Medical Devices Regulation (the Review) was ongoing.

The 2015 Code needs to be remade to address several Review recommendations agreed to by Government. These include providing increased clarity and objectivity in order to support the new enforcement compliance powers in the Act (Review Recommendation 57) and to improve consistency between the requirements for medicines and medical devices (Review recommendation 54).

Content of submissions

Submissions may address any, or all, of the proposed amendments to the draft Therapeutic Goods Advertising Code 2018, the draft guidance document or any other identified issues.

In addition, submissions might include:

  • Suggested improvements to the proposed provisions.
  • An assessment of how the proposed draft Code 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.
  • Any suggestions for development of further education and guidance material.

Enquiries

Any questions relating to submissions should be directed by email to advertising.consultation@health.gov.au or by telephone to 02 6232 8560.

What will happen

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (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.