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Quality of medicines Q&A

We have adopted this International Scientific Guideline - Quality of medicines Q&A 

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Access this international scientific guideline

About this guideline

Provided for information: 1 August 2014

Categories: Quality | Quality of medicines Q and A - Introduction

TGA annotations:

Answers amended after 1 August 2014 are excluded until such time as they have been considered by TGA.

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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