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Draft Guidance on the use of the term 'Quantified by Input' for Listed complementary medicines
This consultation closed on 4 November 2009.
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, became 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.
- 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'
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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