RAC DRUGS ACTUAL EXAM PAPER 2026
QUESTIONS WITH SOLUTIONS GRADED A+
◉ 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
◉ DLP. Answer: Data lock point is cut off date for data to be included in
PSUR
QUESTIONS WITH SOLUTIONS GRADED A+
◉ 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
◉ DLP. Answer: Data lock point is cut off date for data to be included in
PSUR
