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...
| Main Authors: | , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2021-12-01
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| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/235 |