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Guideline on good pharmacovigilance practices (GVP): module xvi - risk minimisation measures: selection of tools and effectiveness indicators (rev 2)

We have adopted this International Scientific Guideline - EMA/204715/2012 Rev 2.

Last updated

About this guideline

Overseas effective date:   31 March 2017

Categories: Pharmacovigilance

TGA annotations:

XVI.C. Operation of the EU Network. This section of the guidance has not been adopted by the 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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