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.
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.
More information can be found under 'Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance'.
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 the European Commission's Volume 2A: Procedures for marketing authorisation: Chapter 2: Mutual recognition.
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.
More information can be found under 'Handling competing interests'.
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).
More information can be found under 'Paediatric investigation plans'.
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.