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RAC DRUGS LATEST 2023 ALREADY PASSED
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RAC DRUGS LATEST 2023 ALREADY PASSED (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 m...

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  • September 17, 2023
  • 6
  • 2023/2024
  • Exam (elaborations)
  • Questions & answers

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  • rac drugs latest 2023 already passed

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  • RAC DRUGS
  • RAC DRUGS

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RAC DRUGS LATEST 2023 ALREADY PASSED (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 6 months ✔✔How many months prior to expiration should MA renewal be submitted? 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 inform ation. 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

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