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Pharmacovigilance information for pharmaceutical companies Electronic exchanges of individual case safety reports (Cars) with ANSM (National Agency of Medicine and Health Product safety) This document
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What is reporting icsrs in Russia?
Reporting ICSRs in Russia refers to the mandatory reporting of individual case safety reports related to adverse drug reactions and the comprehensive monitoring and reporting of safety information for medicinal products in Russia.
Who is required to file reporting icsrs in Russia?
Marketing authorization holders (MAHs) or their authorized representatives are required to file reporting ICSRs in Russia.
How to fill out reporting icsrs in Russia?
Reporting ICSRs in Russia should be filled out using the specified electronic format provided by the Russian competent authority.
What is the purpose of reporting icsrs in Russia?
The purpose of reporting ICSRs in Russia is to monitor and ensure the safety of medicinal products by collecting and analyzing information on adverse drug reactions.
What information must be reported on reporting icsrs in Russia?
Reporting ICSRs in Russia should include information such as the patient's demographics, details of the adverse drug reaction, suspected medicinal product, and concomitant medications.
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