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EMA issues guidance on core requirements for PSURs of vaccines for coronavirus (COVID-19)

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Published on: 09 July 2021
Published by LNB News

LNB News 09/07/2021

Document Information

Issue Date: 09 July 2021

Published Date: 09 July 2021

Jurisdiction(s): European Union

Article summary

The European Medicines Agency (EMA) has released a scientific guideline for periodic safety update reports (PSURs). PSURs are part of the post-marketing safety surveillance requirements for coronavirus (COVID-19) vaccines in addition to Monthly Summary Safety Reports (MSSRs). The guidance assists marketing authorisation holders to prepare PSURs, highlighting requirements when drafting the PSURs of coronavirus vaccines.

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Jurisdiction(s):
European Union

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