Draft Guidance on the use of the term 'Quantified by Input' for Listed complementary medicines
This consultation closed on 4 November 2009.
Consultation
8 October 2009
Introduction
Since the implementation of the original QBI guidance document 'Guidance on the Use of the Term 'Quantified by Input' for Listed Complementary Medicines' in January 2007, it has become evident that a number of issues central to its application require further clarification. Therefore, after extensive consultation between TGA and industry, revised documents have now been prepared. To assist stakeholders in identifying key issues, an explanatory note has been provided in addition to the new guidance document and the associated 'Quantified by Input - Questions and Answers'.
It is hoped that the changes made to the original QBI guidance document will assist manufacturers, in consultation with the relevant sponsor, in determining situations where the assay an active ingredient in a finished listed complementary medicine product may not be required.
Consultation documents
- Explanatory note to assist in the implementation of the principles outlined in the new draft of 'Guidance on the Use of the Term 'Quantified by Input' for Listed Complementary Medicines'
- Questions & answers on the use of 'Quantified by Input'
Submissions should be submitted to the TGA by 4 November 2009.
Submissions may be sent by post and/or email and should, where possible, contain relevant evidence, and/or examples, to support the views expressed.
Content of submissions
It would be helpful if your submission included:
- 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, at 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.
Note on submissions
A list of names of parties making submissions will be published on the TGA website.
All submissions will be placed on the TGA's website unless marked confidential. 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 website.
Confidential material should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the submission coversheet.
Public submissions
Draft Guidance on the Use of the term 'Quantified by Input' for Listed Complementary Medicines
16 December 2009
All submissions received during the consultation are published below, except those that were marked confidential. Feedback on these comments will be summarised and made available to the Australian public by January 2010.
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