Standard form of a periodic safety update report
The results of evaluating information in the Periodic safety update reports (PSUR) submitted by marketing-authorisation holder indicate a lack of understanding of regulatory requirements for the preparation of this document. As a result PSURs submitted by some marketing authorisation holders are ret...
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Main Authors: | B. R. Romanov (Author), R. N. Alyautdin (Author), M. A. Darmostukova (Author), S. V. Glagolev (Author), V. A. Polivanov (Author) |
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Format: | Book |
Published: |
Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»,
2018-02-01T00:00:00Z.
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Online Access: | Connect to this object online. |
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