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: | , , , , |
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| Format: | Book |
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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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| Summary: | 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 returned to them for correction. The purpose of this article is to present the standard forms of PSUR, which will allow you to adequately prepare this reporting document. |
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| Item Description: | 2312-7821 2619-1164 |