Glossary

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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.

Glossary

data exclusivity

The period of eight years from the initial authorisation of a medicine during which the marketing-authorisation holder benefits from the exclusive rights to the results of preclinical tests and clinical trials on the medicine. After this period, the marketing authorisation holder is obliged to release this information to companies wishing to develop generic versions of the medicine.

For more information, see European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications.

decentralised procedure

The procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State.

For more information, see Volume 2A: Procedures for marketing authorisation: Chapter 2: Mutual recognition.

declaration of interests

The provision of information on all potential conflicts of interests by an individual, including recent work activities, investments and family connections with the pharmaceutical industry.

For more information, see Handling conflicts of interests.

deferral (paediatric)

The possibility to defer a measure in a paediatric investigation plan until after studies in adults have been conducted. This ensures that research in children is done only when it is safe and ethical to do so. Deferrals are adopted by the Paediatric Committee (PDCO).

For more information, see Paediatric investigation plans.

direct healthcare-professional communication

A letter sent directly to individual healthcare professionals by a marketing authorisation holder or a regulatory authority, containing information or advice regarding the use of a medicine.