RAC DRUGS CERTIFICATION EVALUATION
COMPLETE QUESTIONS AND VERIFIED
SOLUTIONS
●● 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
COMPLETE QUESTIONS AND VERIFIED
SOLUTIONS
●● 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
