Explanatory note to GVP module VII

We have adopted this International Scientific Guideline - EMA/670256/2017.

Last updated

3 June 2024

About this guideline

Overseas publication date: 31 October 2017

Categories: Pharmacovigilance

TGA annotations:

Any additional safety concerns included in the Australian-specific Annex to the RMP should be included in the summary of safety concerns in the PSUR.

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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