International scientific guideline: Guideline on influenza vaccines - Quality module

About this guideline

Overseas effective date: 1 February 2018

Categories: Biological medicines | Drug substance | Vaccines (drug substance)

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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.

For more information see International scientific guidelines adopted in Australia.

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.