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Guideline on key aspects for the use of pharmacogenomics in the pharmacovigilance of medicinal products

We have adopted this International Scientific Guideline - EMA/CHMP/281371/2013.

Last updated

About this guideline

Overseas effective date:  1 April 2016

Categories: Multidisciplinary | Pharmacogenomics

TGA annotations:

Where applicable, reference to parts of the EU SPC should correspond to the analogous section of the Australian Product Information.

  • 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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