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Guideline on good pharmacovigilance practices (GVP): module v - risk management systems (Rev 2)

We have adopted this International Scientific Guideline - EMA/838713/2011 Rev 2.

Last updated

About this guideline

Overseas effective date:   31 March 2017

Replaces: EMA/838713/2011 Guideline on good pharmacovigilance practices (GVP) Module V - Risk management systems. (adopted by TGA 10 April 2014)

Categories: Pharmacovigilance

TGA annotations:

Risk management plans updates: an updated EU RMP (accompanied by an Australian-specific annex) should be submitted at the request of the TGA and whenever the EU RMP is modified as a result of new information which may change the risk-benefit balance of the product or as a result of an important pharmacovigilance or risk minimisation milestone being reached. Refer to the TGA guidance 'Risk management plans for medicines and biologicals - Australian requirements and recommendations' for more 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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