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.
Information on the immediate or outer packaging of a medicine.
A set of questions addressed to a company during a procedure, such as the evaluation of a marketing authorisation application. Lists of outstanding issues are prepared after a company has already responded to a list of questions.
A set of questions addressed to a company during a procedure, such as a marketing authorisation application.