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RAC DRUGS EXAM SCRIPT 2026 FULL QUESTIONS AND CORRECT ANSWERS ALREADY PASSED

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RAC DRUGS EXAM SCRIPT 2026 FULL QUESTIONS AND CORRECT ANSWERS ALREADY PASSED

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RAC DRUGS EXAM SCRIPT 2026 FULL
QUESTIONS AND CORRECT ANSWERS
ALREADY PASSED



◉ 4 EU procedures to obtain an MA. Answer: National, centralised,
mutual recognition, decentralized procedures


◉ MAH. Answer: 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?. Answer: Active substance international
non-proprietary name, trade name.


◉ SmPC. Answer: Summary of Product Characteristics


◉ PIL. Answer: Product Information Leaflet


◉ 6 months. Answer: How many months prior to expiration should MA
renewal be submitted?

, ◉ Qualified Person (QP) in charge of?. Answer: Pharmacovigilance,
scientific service in charge of each medicinal products scientific info


◉ ASMF. Answer: Active Substance Master File, info regarding the
drug substance consists of one Applicants Part (AP), and one Restricted
Part (RP), or proprietary information.


◉ CEP. Answer: Certificate of Suitability


◉ EDQM. Answer: European Directory for the Quality of Medicines


◉ CTD Module 1. Answer: Region specific administrative data


◉ CTD Module 2. Answer: Quality Overall Summary


◉ CTD Module 3. Answer: Drug Substance and Drug Product
Information


◉ CTD Module 4. Answer: Nonclinical Study Reports


◉ CTD Module 5. Answer: Clinical study reports
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