Periodic Safety Update Reports (PSURs)
In accordance with Section 63b AMG (documentation and notification obligations), marketing authorisation holders and pharmaceutical entrepreneurs shall submit a regularly updated report on the safety of medicinal products (Periodic Safety Update Report, referred to as PSUR in the following) (cf. Section 63b sub-sections 5 and 7 AMG).
When submitting such reports please use the appropriate Form for submission of PSURs (file size: 264 KB) together with the corresponding list of medicinal products which covers all formally necessary information. Please only use this rtf form (as of 24 August 2010) for submission of your PSURs.
Should you have any questions regarding the submission of PSURs please observe our FAQs.