List of Abbreviations

CPCentralized Procedure
DCPDecentralized Procedure
MRPMutual Recognition Procedure
RMSReference Member State
MSMember State
GCPGood Clinical Practices
GLPGood Laboratory Practices
CROContract Research Organization
ASMFActive Substance Master File
DMFDrug Master File
CEPCertificate of suitability of Monographs
of the European Pharmacopoeia
DACSDetailed and Critical Summaries
LoALetter of Access
QPPVQualified Person for Pharmacovigilance
PSURPeriodic Safety Update Report
VNeeSVeterinary Non-eCTD electronic Submission
EudralinkA secure message transfer application
for communication between EMA, EU
Member States agencies and the
pharmaceutical industry.
EMAEuropean Medicines Agency
(formerly known as EMEA)