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Exam (elaborations)

RAC DRUGS exam 2023/2024 with 100% correct answers

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(EU) MA - correct 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 - correct answer National, centralised, mutual recognition, decentralized procedures MAH - correct 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? - correct answer Active substance international non-proprietary name, trade name. SmPC - correct answer Summary of Product Characteristics PIL - correct answer Product Information Leaflet 6 months - correct answer How many months prior to expiration should MA renewal be submitted? Qualified Person (QP) in charge of? - correct answer Pharmacovigilance, scientific service in charge of each medicinal products scientific info ASMF - correct 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 - correct answer Certificate of Suitability EDQM - correct answer European Directory for the Quality of Medicines CTD Mod

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