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Consultation: Boxed Warning guidance

10 August 2018

This consultation closed on 31 August 2018.

The TGA sought comments from interested parties on the proposed guidance for the use of Boxed Warnings for prescription medicines.

The public consultation paper sought written submissions from interested individuals and representatives from industry, consumer and health professional groups.

Consultation documents

How to access a pdf or Word document


Documents released for consultation on Friday, 10 August 2018.

Interested parties should respond by close of business Friday, 31 August 2018.

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

About the consultation

The purpose of the consultation paper is to:

  • Outline the objectives for introducing a Boxed Warning to a Product Information (PI) document
  • Provide proposed guidance on how and when to use a Boxed Warning
  • Seek feedback from individuals, healthcare professionals and industry on the proposed requirements for Boxed Warnings

This consultation focuses on aspects of the Boxed Warning that will inform guidance for industry sponsors intending to, or requested to, include a Boxed Warning statement as part of the Product Information (PI) document. In implementing guidance, we will assist sponsors with determining when a Boxed Warning is required and what it should look like, with a view to ensuring consistency across the prescription medicines regulatory framework.


Boxed Warnings have not only been used in Australia, but are used internationally to draw attention to the most serious of safety issues. Different international regulatory agencies have taken varying approaches to the use of Boxed Warnings and they are not used consistently across jurisdictions, adding to the importance of providing guidance in the Australian context.


Submissions may address specific questions which are included in the proposal. Opportunity to provide additional comment is provided.

Please specify:

  • Whether or not you support the proposed Boxed Warning guidance. If you do not support the changes, you may make suggestions for an alternative.
  • An assessment of how the proposed change will impact on you, and what you see as the likely benefits or costs to you (financial or non-financial).


Any questions relating to submissions should be directed to the Transparency Reforms and Evaluation Management Section by email to or by telephone to 02 6232 8942.

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.

Following consultation and consideration of stakeholder feedback the finalised guidance is proposed to be published later in 2018 and will take effect immediately.

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.