Pharmacovigilance
Guidance documents on pharmacovigilance - Regulation (EU) 2019/6
Q&A on transitional arrangements from Directive 2001/82 to Regulation (EU) 2019/6
Best practice guide
Best practice guide for the CMDv tasks related to pharmacovigilance
Further guidance on pharmacovigilance and signal detection (EMA website)
Guidance documents on pharmacovigilance - Directive 2001/82/EC
Periodic Safety Update Reports (PSURs)
Best practice guide on handling of PSURs in MRP/DCP
Best practice guide on handling of PSURs in EU PSUR worksharing (February 2021)
PSUR-algorithm