International scientific guideline: Harmonisation of requirements for influenza vaccines

About this guideline

Overseas effective date: 12 Feb 2002

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

Replaces: III/3188/91 (Adopted by TGA July 1994)

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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.

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.