CHMP recommendations for the pharmacovigilance plan as part of the Risk Management Plan to be submitted with the marketing authorisation application for a pandemic influenza vaccine

We have adopted this International Scientific Guideline - EMEA/359381/2009.

Last updated

3 June 2024

About this guideline

Overseas adoption date: 24 September 2009

Categories: Pharmacovigilance

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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