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TGA medicine labelling and packaging review

Consultation

24 May 2012

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Have your say

This consultation paper has been prepared for a wide range of stakeholders; however care has been taken to develop a paper that can also be easily understood by a consumer audience. It is hoped that this approach will encourage consumer engagement and response and will enhance understanding of medicine labels and labelling requirements. To assist this further, a collection of animations has been developed to illustrate the proposed changes, to show more clearly what the proposed regulatory changes would mean for their medicines.

The TGA is seeking feedback on each of the proposed regulatory changes under each issue. Interested stakeholders are encouraged to provide a response to the general questions at the end of each section relating to the proposed regulatory changes. Stakeholders may respond to as many or as few of the questions as they wish and may provide additional information on issues not asked in the questions.

In addition to responses to the general questions for the proposed changes, the TGA is seeking industry specific information on each of the key issues of this consultation. In particular for each of the issues, industry and other interested stakeholders are invited to review and comment on the relevant recommendations. Responses should include:

  • Whether or not you support the proposed changes. If you do not support a change, you may make suggestions for an alternative acceptable to you and provide rationales for the commentary.
  • An assessment of how the proposed change will impact on you or your business. That is, what are the likely benefits or costs to you or your business (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

Submissions to the general questions and industry specific information should be lodged electronically to labellingreview@tga.gov.au. Or if hardcopy is preferred please mail your submissions to TGA Labelling and Packaging Review, PO Box 100, Woden, ACT, 2606.

The closing date for submissions is close of business 24 August 2012.

What will the TGA do with your comments

Submissions will be acknowledged as they are received. All submissions received will be placed on the TGA's Internet site, unless marked confidential. Any confidential material contained within your 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.

How to access a Word document

Consultation submission coversheet (Microsoft Word,40kb)

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 be published. If you do not wish to be identified with your submission, you must specifically request this in the space provided on the submission coversheet.

At the close of the consultation period, the TGA will collate and analyse submissions on matters that are within the scope of this review. An update on progress of the review and expected timeframes for the TGA response to the comments received will be provided on the TGA website during the consultation period.

The TGA will make any refinements or amendments of the proposed regulatory options as appropriate. The outcomes of these considerations will be published on the TGA website. At this stage, the TGA will also consider appropriate transition arrangements for the medicines industry, health care professionals and consumers.

The TGA will draft a Therapeutic Goods Order that reflects the outcomes of this consultation and, in accordance with the Best practice regulation handbook1, will conduct a consultation to determine the economic impact of the proposed changes on the medicines industry.

At the completion of the required consultation processes, which also includes the Therapeutic Goods Committee, the revised Therapeutic Goods Order will be released. It will be determined at this time if any other regulatory amendments or instruments are required.

From the time the new Therapeutic Goods Order is registered as a legislative instrument there will be a transition period, at this stage proposed to be three years, for industry to comply with the revised requirements. New medicines that are approved once the new requirements come into force will be required to comply immediately.


  1. The Best practice regulation handbook is a publication of the Department of Finance and Deregulation and describes consultation processes that Australian government agencies must conduct when implementing regulatory changes that are not minor or routine. For more information visit https://www.dpmc.gov.au/office-best-practice-regulation.

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