Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.
How to submit your periodic benefit risk evaluation report (PBRER), previously a periodic safety update report (PSUR).
You must submit a periodic benefit risk evaluation report (PBRER) for all approved medicinal products.
The PBRER is a periodic assessment of the risk-benefit balance of the product. You need to do this irrespective of the marketing status of the product (whether it is placed on the market or not). The PBRER provides an analysis of the safety, efficacy, and effectiveness of the product over its lifecycle.
Most information will likely be related to safety, but you should include information on any new limitations of the medicine and alternative treatment areas.
You must not wait for the PBRER submission to notify us of significant new information relating to the safety and efficacy of your product. Follow the good pharmacovigilance practices for guidance on how to report this urgent safety information.