Guideline on good pharmacovigilance practices (GVP): module xv - safety communication (rev 1)

We have adopted this International Scientific Guideline - EMA/118465/2012 Rev 1.

Last updated

4 June 2024

About this guideline

Adopted by the TGA: 15 July 2019

Overseas effective date: 13 October 2017

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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