RAC DRUGS 2025/2026 Exam Questions
with 100% Correct Answers | Latest
Update
(EU) MA - 🧠 ANSWER ✔✔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 - 🧠 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
1
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
, 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
2
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
with 100% Correct Answers | Latest
Update
(EU) MA - 🧠 ANSWER ✔✔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 - 🧠 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
1
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
, 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
2
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
