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Guideline on the content, management and archiving of the clinical master file (paper and/or electronic)

We have adopted this International Scientific Guideline - EMA/INS/GCP/856758/2018 

About this guideline

Adopted by the TGA: 15 July 2019

Overseas effective date: 6 months after publication (published 6 December 2018)

Categories: Good clinical practice

TGA Annotations: Nil
 

  • 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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