MARKET AUTHORIZATION BY NETWORK SUBMISSION AND EVALUATION

Objective

The aim of MANSEV is the design and implementation of a novel electronic submission system adapted to new EU drug regulatory procedures. Using the network infrastructure of the EU regulatory authorities, the system will be designed as an interchange module between pharmaceutical companies and the authorities with whose application tracking facilities it will be integrated. Implemented by means of Internet Web technologies, the project is expected to result in a fully functional pilot system for initially limited verification and, following its completion, possibly extensive use in pharmaceuticals production. MANSEV participates in the project cluster entitled: ACTION for Telematics Applications for Cooperative work of Healthcare Professionals.

Programme(s)

• FP4-TELEMATICS 2C - Specific programme of research and technological development and demonstration in the area of telematic applications of common interest, 1994-1998

Topic(s)

• C.7 - Telematics Applications for Healthcare

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

European Communities - Commission of the European Communities - Joint Research Centre (JRC)

Address

Via E. Fermi 1
21020 Ispra
Italy

Participants (10)

AGENCE DU MEDICAMENT

France

Address

143-145,Boulevard Anatole France
93200 Saint-denis

Artificial Intelligence Software Spa

Italy

Address

Via Esterle 9
20132 Milano

BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE

Germany

Address

10,Seestra_e
13353 Berlin

Glaxo Wellcome Research and Development Ltd

United Kingdom

Address

Greenford Road
UB6 0HE Greenford

HOECHST AKTIENGESELLSCHAFT

Germany

Address

50,Brueninger Strasse, Building H 790
65926 Frankfurt Am Main

JANSSEN PHARMACEUTICA NV

Belgium

Address

30,Turhnoutseweg
2340 Beerse

Medicines Control Agency

United Kingdom

Address

1 Nine Elms Lane
SW8 5NQ London

PHARMACIA AB

Sweden

Address

15,Frosundaviks Alle
17197 Solna Stockholm

SmithKline Beecham plc

United Kingdom

Address

New Frontiers Science Park Third Avenue
CM19 5AW Harlow

ZENTRUM FUER GRAPHISCHE DATENVERARBEITUNG

Germany

Address

7,Wilhelminenstrasse
64283 Darmstadt