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This glossary gives definitions for the main regulatory terms used on this website and in European Medicines Agency (EMA) documents.

Click on a letter below to see terms beginning with that letter.

Disclaimer: EMA has developed the definitions in this glossary to help this website's users understand regulatory terminology. Definitions may differ from those given in European Union legislation.


vaccine antigen master file

Documentation containing information on the biological, pharmaceutical and chemical nature of an antigen included in a vaccine.

For more information, see vaccine antigens.


A change to the terms of a marketing authorisation.