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.
A country outside the European Union and European Economic Area.
A medicine containing engineered cells or tissues, which is intended to regenerate, repair or replace a human tissue.
For more information, see advanced therapies.
A change to a marketing authorisation where the ownership of a marketing authorisation is moved from one marketing-authorisation holder to another.
For more information, see transfer of marketing authorisation: questions and answers.
An agreed plan issued by the sponsor of a clinical trial giving details of the objectives, design and organisation of the study.
A minor change to a marketing authorisation that has a minimal or no impact on the quality, safety or efficacy of the medicine and does not require prior approval before implementation by the marketing authorisation holder.
For more information, see type IA variations: questions and answers.
A minor change to a marketing authorisation that the marketing-authorisation holder must notify to the regulatory authority before implementation, but which does not require formal approval.
For more information, see type IB variations: questions and answers.
A major change to a marketing authorisation that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration. Type II variations require a formal approval.
For more information, see type II variations: questions and answers.