Get the free PSUR Repository user guide for NCA users
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6 August 2015 EMA/52448/2015 User Guidance for National Competent Authorities for POUR Repository 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 8427 Facsimile
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What is psur repository user guide?
PSUR repository user guide provides instructions on how to submit Periodic Safety Update Reports to the repository.
Who is required to file psur repository user guide?
Marketing authorization holders are required to file the PSUR repository user guide.
How to fill out psur repository user guide?
PSUR repository user guide can be filled out electronically or manually as per the instructions provided in the guide.
What is the purpose of psur repository user guide?
The purpose of PSUR repository user guide is to ensure standardized submission of safety update reports to the repository.
What information must be reported on psur repository user guide?
Information such as adverse events, safety data, and risk management activities must be reported on the PSUR repository user guide.
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