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.
Urgent regulatory action triggered by the marketing authorisation holder, a national regulatory authority or by the European Commission in the event of, or to prevent, a risk to human or animal health or to the environment.