| ADR Adverse Drug Reaction |
| ADSL Asymmetric Digital Subscriber Line |
| CHMP Committee for Medicinal Products for Human Use |
| CVMP Committee for Veterinary Medicinal Products |
| DBMS Database Management System |
| DIA Drug Information Association |
| DTD Data Type Definition |
| E2B Clinical Safety Data Management: Data Elements for Transmission of ICSRs |
| EC European Commission |
| EDI Electronic Data Interchange |
| EEA European Economic Area |
| EFPIA European Federation of Pharmaceutical Industries and Associations |
| EMA European Medicines Agency |
| ESTRI Electronic Transfer of Regulatory Information Gateway |
| EU European Union |
| EV EudraVigilance |
| EVCTM EudraVigilance Clinical Trials Module |
| EVMPD EudraVigilance Medical Product Dictionary |
| EV PM EudraVigilance Post-Authorisation Module |
| EWG Expert Working Group |
| ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use |
| ICSRs Individual Case Safety Reports |
| ICT Information and Communications Technologies |
| IDA Interchange of Data between Administrations |
| IMP Investigational Medicinal Product |
| JIG The Joint Implementation Group |
| M2 Electronic Standards for Transmission of Regulatory Information (ESTRI) |
| MAH Marketing Authorisation Holder |
| MedDRA Medical Dictionary for Regulatory Activities |
| MedDRA MSSO MedDRA Maintenance and Support Services Organization |
| MR Mutual Recognition |
| MS EU Member State |
| NCS Non Commercial Sponsor of clinical trials |
| PASS Post-authorisation Safety Study |
| PMS study Post-Marketing Safety study |
| PSUR Periodic Safety Update Report |
| RAS Rapid Alert System |
| SAR Serious Adverse Drug Reaction |
| SGML Standard Generalised Markup Language |
| SMEs Small and Medium Size Enterprises |
| SPC Summary of Product Characteristics |
| SUSAR Suspected Serious Unexpected Adverse Reactions |
| TIG Telematic Implementation Groups |
| TMC Telematic Management Committee |
| TSC Telematic Steering Committee |
| VICH International Co-operation on Harmonization of Technical Requirements of Veterinary Medicinal products |
| XML Extensible Markup Language |
General
