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RAC Drugs Final Exam-with 100% verified solutions
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RAC Drugs Final Exam-with 100% verified solutions
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RAC Drugs Final Exam-with 100% verifiedsolutions 2024-2025
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(EU) MA
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
National, centralised, mutual recognition, decentralized procedures
MAH
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?
Active substance international non-proprietary name, trade name.
SmPC
Summary of Product Characteristics
PIL
Product Information Leaflet
How many months prior to expiration should MA renewal be submitted?
6 months Qualified Person (QP) in charge of?
Pharmacovigilance, scientific service in charge of each medicinal products
scientific info
ASMF
Active Substance Master File, info regarding the drug substance consists of one Applicants Part (AP), and one Restricted Part (RP), or proprietary information.
CEP
Certificate of Suitability
EDQM
European Directory for the Quality of Medicines
CTD Module 1
Region specific administrative data
CTD Module 2
Quality Overall Summary
CTD Module 3
Drug Substance and Drug Product Information
CTD Module 4
Nonclinical Study Reports
CTD Module 5
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