Guideline on conduct of pharmacovigilance for medicines used by the paediatric population

We have adopted this International Scientific Guideline - EMEA/CHMP/PhVWP/235910/2005 - rev.1.

Last updated

4 June 2024

About this guideline

Overseas effective date: 26 January 2007

Replaces: EMEA/CHMP/PhVWP/235910/2005 (adopted by TGA 16 March 2009)

Categories: Multidisciplinary | Paediatrics | Clinical efficacy and safety

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.
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