Cell culture inactivated influenza vaccines - annex to note for guidance on harmonisation of requirements for influenza vaccines (CPMP/BWP/2490/00)

We have adopted this International Scientific Guideline - CPMP/BWP/2490/00.

Last updated

3 June 2024

About this guideline

Overseas effective date: August 2022

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

TGA annotations

Effective 1 November 2014: the Quality aspects of this Guideline are replaced by EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines - Quality Module.

The nonclinical and clinical aspects of this Guidelines continue to apply.

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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