Submission of Periodic Safety Update Reports (PSURs)
The European Medicines Agency has published the list of European Union (EU) reference dates and frequency of submission of periodic safety update reports (PSURs) known as the 'EURD list'.
Due to legal provisions (Reg. (EC) 726/2004, Article 25a), the EMA is obliged to set up a database for periodic safety update reports (PSUR) and the associated expert opinions.
- All PSUR procedures must be submitted electronically (according to Reg. 726/2004, Article 107b §1 and Article 28(2)).
The PSUR Repository website and the FAQs Pharmacovigilance https://www.basg.gv.at/en/companies/pharmacovigilance/faqs-pharmacovigilance are available for detailed information.