Paul-Ehrlich-Institut

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Glossary

The Paul-Ehrlich-Institut has developed the definitions in this glossary to help users understand regulatory and biomedical terminology. Definitions may differ from those given in German and European Union legislation and medicine. Many definitions correspond to the glossary entries on the pages of the European Medicines Agency (EMA).

National Competent Authority

A regulatory medicines authority in a European Union Member State or European Economic Area.

Updated: 21.11.2019

Nationally Authorised Product

A medicine authorised in a Member State in accordance with its national authorisation procedure.

Updated: 21.11.2019

Notified Bodies

Notified bodies are federally authorised bodies that are designated and supervised in Germany by the Central Office of the Länder for Health Protection of Medicinal Products and Medical Devices (ZLG).

They examine and evaluate medical devices – depending on the risk class of the device – as part of the conformity assessment that manufacturers are required to complete. Manufacturers may apply to the notified body of their choice for the conformity assessment, provided that the chosen body is designated for the procedure and product category concerned. If all information is correct and meets the requirements, the notified bodies then certifies the application in accordance with uniform assessment standards. The manufacturer will receive a CE marking for the assessed product.

Updated: 09.11.2022