RAC- Pharmaceuticals EU Regulations-
Test Questions with Solved Solutions.
ADR - Answer Adverse Drug Reaction
AESGP - Answer Association of the European Self-medication Industry
AIFA - Answer Italian Medicines Agency
ATMP - Answer Advanced Therapy Medicinal Products
CA - Answer Competent Authority
CAT - Answer Committee on Advanced Therapies
CD-P-PH/ PHO - Answer European Committee on Pharmaceuticals and Pharmaceutical Care
CEN - Answer European Committee for Standardization
CHMP - Answer Committee for Medicinal Products for Human Use
CMD(h) - Answer Coordination Group for Mutual Recognition and Decentralised Procedures
for human medicines
CMS - Answer Concerned Member State
COMP - Answer Committee on Orphan Medicinal Products
CP - Answer Centralized Procedure
CTA - Answer Clinical Trial Application
CTD - Answer Common Technical Document
CTFG - Answer Clinical Trials Facilitation Group
, CVMP - Answer Committee for Veterinary Medicinal Products
DAR - Answer Draft Assessment Report
DCP - Answer Decentralized Procedure
DG - Answer Directorate Generals
DLP - Answer Data Lock Point
DSUR - Answer Development Safety Update Report
DTCA - Answer Direct To Consumer Advertising
EC - Answer European Commission
EC-REP or AR - Answer European Authorized Representative
EDQM - Answer European Directorate for the Quality of Medicines
EEA - Answer European Economic Area - 28 Member States plus Iceland, Lichtenstein and
Norway
EFPIA - Answer European Federation of Pharmaceutical Industries and Associations
EFTA - Answer European Free Trade Association
EMA - Answer European Medicines Agency
EMEA - Answer European Agency for Evaluation of Medicinal Products
ENCePP - Answer European Network of Centres for Pharmacoepidemiology and
Pharmacovigilance
Test Questions with Solved Solutions.
ADR - Answer Adverse Drug Reaction
AESGP - Answer Association of the European Self-medication Industry
AIFA - Answer Italian Medicines Agency
ATMP - Answer Advanced Therapy Medicinal Products
CA - Answer Competent Authority
CAT - Answer Committee on Advanced Therapies
CD-P-PH/ PHO - Answer European Committee on Pharmaceuticals and Pharmaceutical Care
CEN - Answer European Committee for Standardization
CHMP - Answer Committee for Medicinal Products for Human Use
CMD(h) - Answer Coordination Group for Mutual Recognition and Decentralised Procedures
for human medicines
CMS - Answer Concerned Member State
COMP - Answer Committee on Orphan Medicinal Products
CP - Answer Centralized Procedure
CTA - Answer Clinical Trial Application
CTD - Answer Common Technical Document
CTFG - Answer Clinical Trials Facilitation Group
, CVMP - Answer Committee for Veterinary Medicinal Products
DAR - Answer Draft Assessment Report
DCP - Answer Decentralized Procedure
DG - Answer Directorate Generals
DLP - Answer Data Lock Point
DSUR - Answer Development Safety Update Report
DTCA - Answer Direct To Consumer Advertising
EC - Answer European Commission
EC-REP or AR - Answer European Authorized Representative
EDQM - Answer European Directorate for the Quality of Medicines
EEA - Answer European Economic Area - 28 Member States plus Iceland, Lichtenstein and
Norway
EFPIA - Answer European Federation of Pharmaceutical Industries and Associations
EFTA - Answer European Free Trade Association
EMA - Answer European Medicines Agency
EMEA - Answer European Agency for Evaluation of Medicinal Products
ENCePP - Answer European Network of Centres for Pharmacoepidemiology and
Pharmacovigilance
