GVP – Module VII: Periodic safety update report

REVISION 1 in force from: 13. 12. 2013

MODULE - FULL TEXT

VII.A Introduction

MODULE - DETAILS

VII.A Introduction

VII.B.1. Objectives of the periodic update safety report (PSUR)

VII.B.2. Principles for the evaluation of the risk-benefit balance within PSURs and scope of the information to be included

VII.B.3. Principles for the preparation of PSURs

VII.B.4. Reference information

VII.B.5. Format and contents of the PSUR

VII.B.6. Quality systems for PSURs at the level of marketing authorisation holders

VII.B. Structures and processes

VII.C.1. PSUR process in the EU – General process

VII.C.2. Standard submission schedule of PSURs

VII.C.3. List of European Union reference dates and frequency of submission of PSURs20

VII.C.4. Processes for PSUR Assessment in the EU network

VII.C.5. EU-specific requirements for periodic safety update reports

VII.C.6. Quality systems and record management systems for PSURs in the EU network

VII.C.7. Transparency

VII.C.8. Renewal of marketing authorisations

VII.C.9. Transition and interim arrangements