RAC DRUGS Exam Questions And
Answers 100% Solved Correct (A+
Solution Guide)
(EU) MA - Answers -✔✔ Market Authorization or product license issued by health
authority. Valid for 5 years and subject to 1 renewal.
4 EU procedures to obtain an MA - Answers -✔✔ National, centralized, mutual
recognition, decentralized procedures
MAH - Answers -✔✔ a legal person or legal entity who must be established in the
European Economic Area comprising of 28 member states.
What does an MA include? - Answers -✔✔ Active substance international non-
proprietary name, trade name.
SmPC - Answers -✔✔ Summary of Product Characteristics
PIL - Answers -✔✔ Product Information Leaflet
6 months - Answers -✔✔ How many months prior to expiration should MA renewal be
submitted?
Qualified Person (QP) in charge of? - Answers -✔✔ Pharmacovigilance, scientific
service in charge of each medicinal products scientific info
ASMF - Answers -✔✔ Active Substance Master File, info regarding the drug substance
consists of one Applicants Part (AP), and one Restricted Part (RP), or proprietary
information.
CEP - Answers -✔✔ Certificate of Suitability
EDQM - Answers -✔✔ European Directory for the Quality of Medicines
CTD Module 1 - Answers -✔✔ Region specific administrative data
CTD Module 2 - Answers -✔✔ Quality Overall Summary
CTD Module 3 - Answers -✔✔ Drug Substance and Drug Product Information
CTD Module 4 - Answers -✔✔ Nonclinical Study Reports
Answers 100% Solved Correct (A+
Solution Guide)
(EU) MA - Answers -✔✔ Market Authorization or product license issued by health
authority. Valid for 5 years and subject to 1 renewal.
4 EU procedures to obtain an MA - Answers -✔✔ National, centralized, mutual
recognition, decentralized procedures
MAH - Answers -✔✔ a legal person or legal entity who must be established in the
European Economic Area comprising of 28 member states.
What does an MA include? - Answers -✔✔ Active substance international non-
proprietary name, trade name.
SmPC - Answers -✔✔ Summary of Product Characteristics
PIL - Answers -✔✔ Product Information Leaflet
6 months - Answers -✔✔ How many months prior to expiration should MA renewal be
submitted?
Qualified Person (QP) in charge of? - Answers -✔✔ Pharmacovigilance, scientific
service in charge of each medicinal products scientific info
ASMF - Answers -✔✔ Active Substance Master File, info regarding the drug substance
consists of one Applicants Part (AP), and one Restricted Part (RP), or proprietary
information.
CEP - Answers -✔✔ Certificate of Suitability
EDQM - Answers -✔✔ European Directory for the Quality of Medicines
CTD Module 1 - Answers -✔✔ Region specific administrative data
CTD Module 2 - Answers -✔✔ Quality Overall Summary
CTD Module 3 - Answers -✔✔ Drug Substance and Drug Product Information
CTD Module 4 - Answers -✔✔ Nonclinical Study Reports
