Spring Intro 2023

Online Resources

EMA: http://www.ema.europa.eu/ema/ Home/Human regulatory/Post-authorisation/Variations

Home/Human regulatory/Post-authorisation/Post-authorisation procedural Q&A Home/Human regulatory/Marketing authorisation/Submission dates/Timetables Home/Human regulatory/Research and development/Scientific guidelines

Heads of Medicines Agencies http://www.hma.eu/ Home/Human Medicines/CMDh/Procedural Guidance/Variation Home/Human Medicines/CMDh/Questions & Answers

National Licences – refer to national websites

The Organisation for Professionals in Regulatory Affairs

43

List of abbreviations

AR

Assessment Report



CA

Competent Authority



 CMD(h) Coordination Group of Mutual Recognition and Decentralised Procedures (Human)

CMS Concerned Member State



CP

Centralised procedure



DCP Decentralised Procedure



 DDPS Detailed Description of the Pharmacovigilance

DMF Drug Master File



E

Efficacy



EEA European Economic Area



EMA European Medicines Agency



EU European Union



MA 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



S

Safety



44