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About this guideline
Overseas effective date: April 1997
Replaces: III/3188/91 (adopted by TGA July 1994)
Note: To be read in conjunction with Cell culture inactivated influenza vaccines - annex to note for guidance on harmonisation of requirements for influenza vaccines (CPMP/BWP/2490/00214/96) (CPMP/BWP/2490/00).
Categories: Multidisciplinary | Vaccines
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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For more information see International scientific guidelines adopted in Australia.