Glossary of MHRA terms - E

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EAG
Expert Advisory Group.

EC
See: EU.

ECPHIN
European Community Pharmaceutical Information Network.

e-CTD
Electronic common technical document

EDQM
European Department for Quality of Medicines.

EEA
European Economic Area. This includes the Member States of the EU together with Iceland, Leichtenstein and Norway.

EEC
European Economic Community.
See: EU

EFTA
European Free Trade Association.

EFPIA
European Federation of Pharmaceutical Industries Associations. This is the European equivalent of the ABPI.

EFQM
European Foundation for Quality Management. This Foundation promotes quality management within European business.

EMACOLEX
A group of European lawyers from health departments and regulatory agencies.

EMEA
European Medicines Agency. This is a decentralised body of the European Union. With headquarters in London, its aim is to protect and promote public health through the evaluation and supervision of medicines for human and veterinary use.

EP
European Pharmacoepia.

EPAR
European Public Assessment Report.

EPID
Extended (also Expanded) Public Information Document. This provides information about their products, provided by the pharmaceutical industry to the public.

EQA
European Quality Award. This is an award given to business organisations by the EFQM for practicing quality management in their area of business. See also: EFQM.

ETSI
European Telecommunications Standards Institute.

EU
European Union.

EUDRA
European Union Drug Regulatory Authorities.

EudraCT
The Clinical Trial application and database, which is hosted by the EMEA.

EudraGMP
The Community database containing information on all pharmaceutical manufacturers. It also includes details of those manufacturers' Manufacturing and Importation Authorisations and GMP Certificates. EudraGMP is typically accessed by Inspectorates. Write access to EudraGMP requires user authentication.

Eudralex
Web server for the on-line dissemination of Community guidelines, Notice to Applicants and pharmaceutical legislation.

Eudralink
As EudraNet II can only be accessed and used by the National Competent Authorities, the EudraLink secure communication service has been developed allowing secure information exchange with pharmaceutical industry, research institutes and pharmaceutical experts via the Public Internet.

Eudramail
A dedicated secure e-mail system based on functional mailboxes, which allow working groups to exchange messages relevant to their specific group.

Eudranet
A European human and veterinary pharmaceuticals telecommunication network allowing scientific experts, those working on pharmaceutical business processes and policy makers to have a secure and well structured electronic environment to 'meet', exchange information and work together on a pan-European scale.

Eudranet II
EudraNet II is a managed virtual private IP network (IP VPN) based on encrypted tunnels over the public Internet. It uses the IPSec protocol and 3DES encryption. EudraNet II is a star shaped network with the EMEA being the central site. A second star network has been implemented to allow access to the CTS database, which is hosted at DIMDI in Cologne, Germany.

Eudrapharm
The central European database providing core data on all centrally authorised medicinal products, including MRLs for veterinary medicinal products and nationally authorised products from Member States ready to supply data as part of a pilot exercise.

Eudraportal
The central entry point for all the Eudra applications. The portal will evolve to become a communications platform for the Eudra community.

Eudratrack
A tracking and communication system for Mutual Recognition and decentralised applications for member states.

EudraVigilance
A data processing network and management system for reporting and evaluating suspected adverse reactions during the development and following the marketing authorisation of medicinal products in the European Economic Area (EEA).