RAC PHARMACEUTICALS EU
REGULATIONS EXAM QUESTIONS &
COMPLETE SOLUTIONS
ATMP - correct answer ✔✔Advanced Therapy Medicinal Products
AESGP - correct answer ✔✔Association of the European Self-medication Industry
ADR - correct answer ✔✔Adverse Drug Reaction
AIFA - correct answer ✔✔Italian Medicines Agency
CA - correct answer ✔✔Competent Authority
CAT - correct answer ✔✔Committee on Advanced Therapies
CD-P-PH/ PHO - correct answer ✔✔European Committee on Pharmaceuticals and
Pharmaceutical Care
CEN - correct answer ✔✔European Committee for Standardization
CHMP - correct answer ✔✔Committee for Medicinal Products for Human Use
CMD(h) - correct answer ✔✔Coordination Group for Mutual Recognition and Decentralized
Procedures for human medicines
, CMS - correct answer ✔✔Concerned Member State
COMP - correct answer ✔✔Committee on Orphan Medicinal Products
CP - correct answer ✔✔Centralized Procedure
CTA - correct answer ✔✔Clinical Trial Application
CTD - correct answer ✔✔Common Technical Document
CTFG - correct answer ✔✔Clinical Trials Facilitation Group
CVMP - correct answer ✔✔Committee for Veterinary Medicinal Products
DAR - correct answer ✔✔Draft Assessment Report
DCP - correct answer ✔✔Decentralized Procedure
DG - correct answer ✔✔Directorate Generals
DLP - correct answer ✔✔Data Lock Point
DSUR - correct answer ✔✔Development Safety Update Report
DTCA - correct answer ✔✔Direct To Consumer Advertising
REGULATIONS EXAM QUESTIONS &
COMPLETE SOLUTIONS
ATMP - correct answer ✔✔Advanced Therapy Medicinal Products
AESGP - correct answer ✔✔Association of the European Self-medication Industry
ADR - correct answer ✔✔Adverse Drug Reaction
AIFA - correct answer ✔✔Italian Medicines Agency
CA - correct answer ✔✔Competent Authority
CAT - correct answer ✔✔Committee on Advanced Therapies
CD-P-PH/ PHO - correct answer ✔✔European Committee on Pharmaceuticals and
Pharmaceutical Care
CEN - correct answer ✔✔European Committee for Standardization
CHMP - correct answer ✔✔Committee for Medicinal Products for Human Use
CMD(h) - correct answer ✔✔Coordination Group for Mutual Recognition and Decentralized
Procedures for human medicines
, CMS - correct answer ✔✔Concerned Member State
COMP - correct answer ✔✔Committee on Orphan Medicinal Products
CP - correct answer ✔✔Centralized Procedure
CTA - correct answer ✔✔Clinical Trial Application
CTD - correct answer ✔✔Common Technical Document
CTFG - correct answer ✔✔Clinical Trials Facilitation Group
CVMP - correct answer ✔✔Committee for Veterinary Medicinal Products
DAR - correct answer ✔✔Draft Assessment Report
DCP - correct answer ✔✔Decentralized Procedure
DG - correct answer ✔✔Directorate Generals
DLP - correct answer ✔✔Data Lock Point
DSUR - correct answer ✔✔Development Safety Update Report
DTCA - correct answer ✔✔Direct To Consumer Advertising
