Review of the Certification Procedure for Qualified Persons of Manufacturers of Medicines for Human Use in Russia

Review of the Certification Procedure for Qualified Persons of Manufacturers of Medicines for Human Use in Russia

Scientific relevance. In December 2020, the Russian Federation adopted the Eurasian Economic Union (EAEU) requirements. This has significantly changed the certification procedure for qualified persons (QPs) of manufacturers of medicinal products for human use in the Russian Federation. To accommodat...

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Bibliographic Details
Main Authors: Zh. I. Aladysheva, N. V. Pyatigorskaya, V. V. Beregovykh, G. E. Brkich, A. P. Meshkovskiy, M. M. Marshalova, V. V. Belyaev, N. S. Nikolenko, E. I. Nesterkina, A. A. Kamaletdinova, M. F. Lutfullin
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 (FSBI ‘SCEEMP’) 2023-09-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
qualified person responsible for quality
medicines
manufacturing of medicines
certification
Online Access:https://www.vedomostincesmp.ru/jour/article/view/540
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