Guidelines for the Preparation of a Document Containing the Drug Safety Monitoring Results

Recommendations for the Marketing Authorisation Holders for the preparation of the document containing the results of the monitoring of safety of the drug, which is presented as part of the dossier at the state registration confirmation in 5 years after the initial registration of the drug in Russia...

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Bibliographic Details
Main Authors: Yu. V. Olefir, B. K. Romanov, R. N. Alyautdin, S. V. Glagolev
Format: Article
Language:Russian
Published: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation  2018-02-01
Series:Безопасность и риск фармакотерапии
Subjects:
Online Access:https://www.risksafety.ru/jour/article/view/49