Pharmacovigilance: PSUR Worksharing

messages in brief | 05/10/2009

In the interest of a common, Europe-wide use of resources and harmonization, the project Harmonized Birthdates (HBD) was initiated at the suggestion of the Heads of Medicines Agencies (HMA) organization. In this project, Periodic Safety Update Reports (PSUR) on nationally approved medicinal products containing the same active ingredient are submitted to all competent authorities at the same time and reviewed in a worksharing procedure. This results in a joint expert opinion on safety data for all medicinal products considered and a Core Safety Profile (CSP) for subsequent national implementation in all professional information.


Austria is involved in this project with 25 P-RMS(PSUR- Reference Memberstate)ships and has been represented in the coordinating PSUR Worksharing Group since June 2009. Since the beginning of the project, a total of eight CSPs have been successfully implemented into national professional information in Austria. The definitions and procedures practiced by BASG/AGES PharmMed were adopted into the project guidelines in September 2009 in consultation with representatives of all member states and industry.

More information on this topic:

  • AGES Talk, 12.11.2009, 14:00 to 16:00 hrs
  • HBD Project - Core Safety Profiles 2009



Institute Pharmacovigilance

Dr. Bettina Schade



Further inquiry note