CRED Managing Variations Effectively

List of abbreviations

AR CA

Assessment Report Competent Authority

CMD(h)

Coordination Group of Mutual Recognition and Decentralised Procedures (Human)

CMS

Concerned Member State Centralised procedure Decentralised Procedure

CP

DCP

DMF EEA

Drug Master File

European Economic Area European Medicines Agency

EMA

EU MA

European Union

Marketing Authorisation MAH Marketing Authorisation Holder MRP Mutual Recognised Procedure PI Product Information PRAC

Pharmacovigilance Risk Assessment Committee

Q

Quality

RMS

Reference Member State

RSI

Request for Supplementary Information