RAC Drugs Final Exam 2024 | 40 Questions with 100% Correct Answers | Verified | Latest Update | Graded A+
(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 recog...
RAC Drugs Final Exam 2024 | 40 Questions with 100% Correct Answers | Verified | Latest Update | Graded A+ (EU) MA - ✔✔Market Authorization or product licen se 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 Europ ean 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, inf o 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
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