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Explanatory note to GVP module VII
[PDF, 245.2 KB]
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.
- 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.