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Draft Guideline for Levels and Kinds of Evidence for Listed Medicines with Indications and Claims for Weight Loss

Consultation paper

This consultation closed on 3 April 2009.

Introduction

This Guideline has been developed to assist sponsors of Listed complementary medicines in determining the level and kind of evidence to support indications and claims for weight loss. It should be applied as an addition to the Guidelines for Levels and Kinds of Evidence to Support Indications and Claims for Non-Registerable Medicines, including Complementary Medicines and other Listable Medicines <http://www.tga.gov.au/docs/html/tgaccevi.htm> (the Guidelines).

This Guideline will also help ensure consistency in the type and level of evidence required to support indications and claims for weight loss in Listed medicines and give consumers confidence in the medicines they choose for self-care.

Consultation paper

Content of submissions

It would be helpful if your submission included:

  • your name and full contact details including: address, telephone number and, if applicable, facsimile and email address
  • information and data concerning the impact of proposed changes on affected parties
  • in the case of organisations; the level at which the submission was authorised.

In addition, submissions might:

  • include any other relevant information eg. scientific and technical, economic, international obligations, business and consumer information
  • identify and discuss any perceived omissions or alternative approaches, in addition to those already included in the consultation paper.

Confidentiality of submissions

If you wish any information contained in a submission to be treated as confidential, please clearly identify the information and outline the reasons why it is confidential.

Electronic submissions should be emailed to:

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