Periodic Safety Update Reports (PSURs)
A Periodic Safety Update Report (PSUR) is the periodical report containing the records referred to in Regulation (EC) 726/2004 and Directive 2001/83/EC, as amended.
PSURs are intended to provide an update of the worldwide safety experience of a medicinal product to companies at defined time points post-authorisation.
The IMB has adopted the guidance on the format, content and periodicity for submission of PSURs as described in Part 1 - Chapter 6 of Volume 9A of The Rules Governing Medicinal Products in the European Union.
Contact Points for PSUR Submission:
PSURs prepared for routine submission (i.e. 6 monthy, yearly, 3-yearly) should be sent to the Receipts and Validation Section of the IMB.
PSURs/bridging reports submitted in support of renewal applications should be sent with relevant renewal documentation, or appropriately cross-referenced.
PSURs requested on an immediate/interim basis, should be sent to the individual staff member requesting the report.
Cover Letter Requirements
The following information should be included in the cover letter accompanying PSURs:
For more information on PSURs, please consult: Part 1 - Chapter 6 of Volume 9A of The Rules Governing Medicinal Products in the European Union (Guidelines on Pharmacovigilance for Medicinal Products for Human Use) and the EMEA guidance document on PSUR Submission.
- The name(s) of the Marketing Authorisation Holder(s)
- The brand name(s) of the products addressed by the PSUR
- The substance (i.e. INN) addressed by PSUR
- The marketing authorisation number(s)
- The authorisation procedure (i.e. nationally authorised/mutual recognition etc.)
- The status of the PSUR, i.e. if part of the EU work-sharing initiative
- The Rapporteur/RMS/PRMS, if applicable
- The date of authorisation
- The number and date of the PSUR
- The period covered by the PSUR