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Guideline on good pharmacovigilance practices (GVP): product or population-specific considerations i: vaccines for prophylaxis against infectious diseases

We have adopted this International Scientific Guideline - EMA/488220/2012.

Last updated

About this guideline

Overseas effective date:   13 December 2013

Replaces: EMEA/CHMP/PhVWP/503449/2007 Guideline on the Conduct of Pharmacovigilance for Vaccines for Pre- and Post-Exposure Prophylaxis Against Infectious Diseases (adopted by TGA 17 December 2010)

Categories: Pharmacovigilance

TGA annotations:

P.I.C.2.1.Reporting of vaccination failures: Lack of efficacy of a vaccine, as signified by the occurrence of breakthrough infection, is considered to fall within the definition of a serious adverse drug reaction (ADR) and is therefore subject to the expedited reporting requirement as stated in the Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines.

  • 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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