List of Abbreviations
ABBREVIATION | WORD |
---|---|
CP | Centralized Procedure |
DCP | Decentralized Procedure |
MRP | Mutual Recognition Procedure |
RMS | Reference Member State |
MS | Member State |
GCP | Good Clinical Practices |
GLP | Good Laboratory Practices |
CRO | Contract Research Organization |
ASMF | Active Substance Master File |
DMF | Drug Master File |
CEP | Certificate of suitability of Monographs of the European Pharmacopoeia |
DACS | Detailed and Critical Summaries |
LoA | Letter of Access |
PV | Pharmacovigilance |
QPPV | Qualified Person for Pharmacovigilance |
PSUR | Periodic Safety Update Report |
VNeeS | Veterinary Non-eCTD electronic Submission |
Eudralink | A secure message transfer application for communication between EMA, EU Member States agencies and the pharmaceutical industry. |
EMA | European Medicines Agency (formerly known as EMEA) |