RAC DRUGS TEST BANK 2026 EXAM REVIEW
WITH SOLVED QUESTIONS 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
◉ Qualified Person (QP) in charge of?. Answer: Pharmacovigilance,
scientific service in charge of each medicinal products scientific info
◉ How many months prior to expiration should MA renewal be
submitted?. Answer: 6 months
,◉ ASMF, what are the two parts. 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
,◉ PSUR. Answer: Periodic Saftey Update Report is a
pharmacovigilance document intended to provide an update of the
worldwide safety experience of a medicinal product to regulatory
authorities at defined time points post-authorization.
◉ PBRER. Answer: Periodic benefit-risk evaluation reports (formerly
PSUR format)
◉ DSUR. Answer: Development Safety Update Report
◉ RMP. Answer: Risk management plan
◉ ICH primary basis of assessment for antihypertensive drugs?.
Answer: High systolic and diastolic blood pressures
◉ DHCP. Answer: Direct Healthcare professional communication, or
Dear Doctor letter is correspondence in the form of a mass mailing from
the MA intended to alert doctors and other health care providers about
important new or updated information regarding a marketed medicine or
biologic.
◉ SPC. Answer: Supplementary protection certificate is an extension
granted to compensate for the patent protection period list between filing
the patent and authorization to place the product on to the market.
, ◉ What information must appear in braille?. Answer: Product name on
pack
◉ T or F. European Scientific guidelines do not have legal force.
Answer: True
◉ Purpose of ICH?. Answer: To discuss and establish common
guidelines for safe, effective, and high quality medicines for ICH
regions
◉ What method is used for stability retest period?. Answer: Long term
data and case by case assessment
◉ FOB. Answer: Follow on Biologics or biosimilars
◉ ICH Q10. Answer: Pharmaceutical Quality System
◉ Biosimilar. Answer: New versions of existing biologics whose patents
have expired. Fobs or SEBs
◉ SEB. Answer: Subsequent Entry Biologic (Canada)
◉ monoclonal antibodies. Answer: Structurally complex substances that
can locate and bind to specific molecules
WITH SOLVED QUESTIONS 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
◉ Qualified Person (QP) in charge of?. Answer: Pharmacovigilance,
scientific service in charge of each medicinal products scientific info
◉ How many months prior to expiration should MA renewal be
submitted?. Answer: 6 months
,◉ ASMF, what are the two parts. 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
,◉ PSUR. Answer: Periodic Saftey Update Report is a
pharmacovigilance document intended to provide an update of the
worldwide safety experience of a medicinal product to regulatory
authorities at defined time points post-authorization.
◉ PBRER. Answer: Periodic benefit-risk evaluation reports (formerly
PSUR format)
◉ DSUR. Answer: Development Safety Update Report
◉ RMP. Answer: Risk management plan
◉ ICH primary basis of assessment for antihypertensive drugs?.
Answer: High systolic and diastolic blood pressures
◉ DHCP. Answer: Direct Healthcare professional communication, or
Dear Doctor letter is correspondence in the form of a mass mailing from
the MA intended to alert doctors and other health care providers about
important new or updated information regarding a marketed medicine or
biologic.
◉ SPC. Answer: Supplementary protection certificate is an extension
granted to compensate for the patent protection period list between filing
the patent and authorization to place the product on to the market.
, ◉ What information must appear in braille?. Answer: Product name on
pack
◉ T or F. European Scientific guidelines do not have legal force.
Answer: True
◉ Purpose of ICH?. Answer: To discuss and establish common
guidelines for safe, effective, and high quality medicines for ICH
regions
◉ What method is used for stability retest period?. Answer: Long term
data and case by case assessment
◉ FOB. Answer: Follow on Biologics or biosimilars
◉ ICH Q10. Answer: Pharmaceutical Quality System
◉ Biosimilar. Answer: New versions of existing biologics whose patents
have expired. Fobs or SEBs
◉ SEB. Answer: Subsequent Entry Biologic (Canada)
◉ monoclonal antibodies. Answer: Structurally complex substances that
can locate and bind to specific molecules
