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Draft Guidance on the use of the term 'Quantified by Input' for Listed complementary medicines

Consultation

8 October 2009

This consultation closed on 4 November 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, 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.

Consultation document

How to access a pdf document

Draft Guidance on the use of the term 'Quantified by Input' for Listed complementary medicines (pdf,112kb)

Explanatory documents

Public submissions

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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