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RAC DRUGS Exam Questions And Answers 100% Solved Correct (A+ Solution Guide)

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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

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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

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