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Note for guidance on harmonisation of requirements for influenza vaccines

We have adopted this International Scientific Guideline - CPMP/BWP/214/96 

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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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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