Seasonal influenza vaccines - quality module

This guidance supports manufacturers and sponsors submitting quality modules for influenza vaccine registration. This may be 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).

We adopted the EMA Guideline on Influenza Vaccines - Quality Module (EMA/CHMP/BWP/310834/2012) on 1 November 2014. The quality modules submitted to us need to meet this EMA guideline.

If you have any questions about this guidance, please contact us via email at Vaccines@health.gov.au

Contents

• Introduction
• Scope
• Legal basis and relevant guidelines
• Quality requirements for influenza vaccines
• Appendix 1: Procedural and sampling requirements for Annual Seasonal Update (ASU) submissions for seasonal influenza vaccines
• Appendix 2: Seasonal verification of the Single Radial Immunodiffusion – Advice on the annual update submissions for seasonal influenza vaccines
• Appendix 3: Quadrivalent SRID – An example of qualification of a bivalent reference for the SRID assay of B virus antigen Content
• Appendix 4: Control of contamination with extraneous agents

Documents