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Guideline-on-Influenza-vaccines-quality-module
[PDF, 345.62 KB]
About this guideline
Overseas effective date: 1 February 2018
Replaces: Guideline on Influenza Vaccines - Quality Module (EMA/CHMP/BWP/310834/2012) (adopted by TGA 1 November 2014).
Categories: Biologicals | Active substance | Vaccines Multidisciplinary | Vaccines
TGA annotations:
The TGA has published an explanatory document to support the submission of quality modules as part of registration applications for influenza vaccines (Category 1 applications), and/or variation applications for annual strain updates to seasonal influenza vaccines (Category 3 applications), in reference to EMA/CHMP/BWP/310834/2012.
This document also applies to relevant sections in EMA/CHMP/BWP/310834/2012 Rev. 1.
- 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.