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RAC DRUGS FINAL EXAM 2025| BRAND NEW ACTUAL
EXAM WITH 100% VERIFIED QUESTIONS AND
CORRECT SOLUTIONS| GUARANTEED VALUE PACK|
ACE YOUR GRADES.
1. (EU) MA - correct answer - Market Authorization or product license
issued by health authority. Valid for 5 years and subject to 1 renewal.
2. 4 EU procedures to obtain an MA - correct answer - National,
centralised, mutual recognition, decentralized procedures
3. MAH - correct answer - A legal person or legal entity who must be
established in the European Economic Area comprising of 28 member
states.
4. What does an MA include? - correct answer - Active substance
international non-proprietary name, trade name.
5. SmPC - correct answer - Summary of Product Characteristics
6. PIL - correct answer - Product Information Leaflet
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7. 6 months - correct answer - How many months prior to expiration should
MA renewal be submitted?
8. Qualified Person (QP) in charge of? - correct answer -
Pharmacovigilance, scientific service in charge of each medicinal
products scientific info
9. ASMF - correct answer - Active Substance Master File, info regarding
the drug substance consists of one Applicants Part (AP), and one
Restricted Part (RP), or proprietary information.
10. CEP - correct answer - Certificate of Suitability
11. EDQM - correct answer - European Directory for the Quality of
Medicines
12. CTD Module 1 - correct answer - Region specific administrative data
13. CTD Module 2 - correct answer - Quality Overall Summary
RAC DRUGS FINAL EXAM 2025| BRAND NEW ACTUAL
EXAM WITH 100% VERIFIED QUESTIONS AND
CORRECT SOLUTIONS| GUARANTEED VALUE PACK|
ACE YOUR GRADES.
1. (EU) MA - correct answer - Market Authorization or product license
issued by health authority. Valid for 5 years and subject to 1 renewal.
2. 4 EU procedures to obtain an MA - correct answer - National,
centralised, mutual recognition, decentralized procedures
3. MAH - correct answer - A legal person or legal entity who must be
established in the European Economic Area comprising of 28 member
states.
4. What does an MA include? - correct answer - Active substance
international non-proprietary name, trade name.
5. SmPC - correct answer - Summary of Product Characteristics
6. PIL - correct answer - Product Information Leaflet
, Page |2
7. 6 months - correct answer - How many months prior to expiration should
MA renewal be submitted?
8. Qualified Person (QP) in charge of? - correct answer -
Pharmacovigilance, scientific service in charge of each medicinal
products scientific info
9. ASMF - correct answer - Active Substance Master File, info regarding
the drug substance consists of one Applicants Part (AP), and one
Restricted Part (RP), or proprietary information.
10. CEP - correct answer - Certificate of Suitability
11. EDQM - correct answer - European Directory for the Quality of
Medicines
12. CTD Module 1 - correct answer - Region specific administrative data
13. CTD Module 2 - correct answer - Quality Overall Summary
