34 Medicines Regulation in the

European Union

Anne-Ruth van Troostenburg de BruynandGiuliana Tabusso

List of abbreviations

ABPI Association of British Pharmaceutical
Industry
CEP European Pharmacopoeia Certificate of
Suitability
CHMP Committee for Human Medicinal Pro-
ducts
CIOMS Council of International Organizations
of Medical Sciences
CMC Chemistry, Manufacturing and Controls
CMS Concerned member state(s)
COMP Committee for Orphan Medicinal Pro-
ducts
CP Centralized procedure
CPMP Committee for Proprietary Medicinal
Products
CTA Clinical trial authorization
CTD Common technical document
CVMP Committee for Veterinary Medicinal
Products
EEA European economic area
EFPIA European Federation of Pharmaceutical
Industries’ Associations
EMEA European Medicines Evaluation Agency
EPAR European Public Assessment Report

EU European Union

FDA Food and Drug Administration

GCP Good clinical practices

GLP Good laboratory practices

GMO Genetically modified organism

GMP Good manufacturing practices

GSL General sales list

HCMP Committee for Herbal Medicinal Pro-

ducts

ICH International Conference of Harmoni-

zation

IM Intramuscular

IMP Investigational medicinal product

IV Intravenous

MA Marketing authorization

MedDRA Medical Dictionary for Drug Regula-

tory Activities

MRFG Mutual Recognition Facilitation Group

MRP Mutual recognition procedure

MS Member state(s)

P Pharmacy

PA Protocol assistance

PAGB Proprietary Association of Great Britain

PIL Patient information leaflet

POM Prescription only medicine

PSUR Periodic Safety Update Report

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9