Guideline on the scientific data requirements for a vaccine antigen master file (VAMF)

We have adopted this International Scientific Guideline - EMEA/CPMP/BWP/3734/03

Last updated

27 August 2024

About this guideline

Overseas effective date: 1 March 2004

Categories: Biologicals | Active substance

Multidisciplinary | Vaccines

TGA Annotations: Nil

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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