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