International scientific guideline: Scientific data requirements for a vaccine antigen master file

About this guideline

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Mar 2003

Categories: Multidisciplinary | Vaccines (multidisciplinary)

Access this international scientific guideline

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.