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)