Glossary for E
EDQM – European Directorate for the Quality of Medicines
A European organisation involved in harmonisation and co-ordination of standardisation, regulation and quality control of medicines, blood transfusion, organ transplantation, pharmaceuticals and pharmaceutical care.
EEA – European Economic Area
Member States of the EU together with Iceland, Liechtenstein and Norway.
EMA – European Medicines Agency
An agency of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The IMB is represented on the scientific committees which conduct the main scientific work of the EMA.
Studies of populations which attempt to identify the cause or causes of particular health effects or outcomes.
The central European database created to capture data relating to medical devices that are registered with competent authorities across the EU, typically Class I and in-vitro diagnostic devices. It also includes national Competent Authority reports associated with vigilance information.
A database of information on the content, commencement and termination of all clinical trials in the European Union (from 1 May 2004 onwards). It was established in accordance with Directive 2001/20/EC, and is managed by the European Medicines Agency.
The central database of information on all medicinal products for human or veterinary use that have been authorised in the EU. It currently holds data on medicines authorised by the European Commission and will be extended over time to all nationally-authorised products. The database is accessible to the public at http://eudrapharm.eu.
The data management system for reporting and evaluating suspected adverse reactions experienced by patients during clinical trials and from use of medicines once approved.
Exempt medicinal product
Unauthorised products which are supplied to the order of registered doctors or dentists for use by their individual patients under their direct personal supervision.