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PSUR/PSUSA and Referral Recommendations

The purpose of this document is to provide recommendations arising from Work Package 8 (WP8) – Lifecycle Pharmacovigilance (PV) – benefit/risk assessment in the context of Periodic Safety Update Report (PSUR) and referral. The recommendations include key considerations and useful advice for PV assessors, such as practical guides in support of PSUR/ Single assessment of Periodic Safety Update Reports (PSUSA) and referral assessments.

What does this document cover?

1. Introduction

2. Recommendations

 - General recommendations

 - PV procedure – specific (PSUR/PSUSA and referral) recommendations

Annexes: WP8 Practical Guide on PSUR-PSUSA; WP8 Practical guide on Safety-related Referrals

Target audience

The target audience is primarily pharmacovigilance assessors working at National Competent Authorities.


14 pages PDF.

Click here to access this document. 

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