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Analysis of Noncompliances with Legislative Requirements in Pharmacovigilance Materials of Registration Dossiers

Since 1 January 2021 the authorisation of medicines in the Russian Federation has to be performed according to the Eurasian Economic Union (EAEU) procedure. The Pharmacovigilance System Master File (PSMF) is the main document describing the pharmacovigilance system of the marketing authorisation hol...

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Furkejuvvon:
Bibliográfalaš dieđut
Váldodahkkit: E. O. Zhuravleva, N. Yu. Velts, G. V. Kutekhova
Materiálatiipa: Artigo
Giella:Russo
Almmustuhtton: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2021-12-01
Ráidu:Безопасность и риск фармакотерапии
Fáttát:
Liŋkkat:https://www.risksafety.ru/jour/article/view/235
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