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.
One of the two members of a committee or working party who leads the evaluation of an application.
A review of an opinion by a scientific committee of the Agency, triggered at the request of the applicant.
The European Union Member State that leads the review of an application in a mutual recognition procedure or decentralised procedure.
For more information, see volume 2A: Procedures for marketing authorisation: Chapter 2: Mutual recognition.
An evaluation conducted by a European Medicines Agency committee following a referral from the European Commission or a Member State. Referrals are used to address particular issues, such as safety concerns, to resolve disagreements between Member States on issues related to the authorisation of medicines or to give an opinion on an issue of Europe-wide interest.
A document outlining the view of the European Medicines Agency or one of its committees, working parties or other groups on a particular issue.
A body that carries out regulatory activities relating to medicines, including the processing of marketing authorisations, the monitoring of side effects, inspections, quality testing and monitoring the use of medicines.
An extension of the validity of a marketing authorisation, which can be for a fixed or indefinite period of time. Initial marketing authorisations are usually valid for five years.
For more information, see renewals: questions and answers.
A list of questions addressed to a marketing authorisation holder during the evaluation of a variation to an existing marketing authorisation.
A detailed description of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines.
A set of activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines, including the assessment of the effectiveness of those activities and interventions.
A public health intervention intended to prevent or reduce the probability of the occurrence of an adverse reaction associated with exposure to a medicine or to reduce its severity if it occurs.
The way in which a medicine is given, e.g. orally (by mouth), intravenously (into a vein), subcutaneously (under the skin), etc.