Replaces: Guideline on Influenza Vaccines - Quality Module (EMA/CHMP/BWP/310834/2012) (adopted by TGA 1 November 2014).
Categories: Biologicals | Active substance | Vaccines Multidisciplinary | Vaccines
TGA annotations:
The TGA has publishedan explanatory document to support the submission of quality modules 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), in reference to EMA/CHMP/BWP/310834/2012.
This document also applies to relevant sections in EMA/CHMP/BWP/310834/2012 Rev. 1.
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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