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3. Periodic Safety Update Reports (PSURs)
4. WSP: Core Safety Profiles (CSPs)

Core Safety Profiles (CSPs)

The documents published here are Core Safety Profiles (CSPs) from the so-called European work sharing procedure (WSP). It is the aim of the WSP to assess PSURs regarding certain substances on a European level and to synchronise the basic statements in the product informations of these substances.

Please observe the following notes in this connection:

• As a rule, CSPs only encompass Sections 4.3 - 4.9 of the SPC and include merely the minimum statements to be contained in all product informations on the substance concerned. The pharmaceutical entrepreneurs are not permitted to delete additional statements contained in their product informations on the basis of the CSPs.
• Pharmaceutical entrepreneurs are requested to compare their own product informations with the CSPs. Should statements from the CSP be missing, these are to be included in the product informations and this is to be notified by way of a variation.
• The published CSPs regard concluded WSPs and have been edited by the BfArM
• You will find further specific information on the published CSPs here.
• For further information on WSPs as well as the list of substances assessed in the WSP please go to Heads of Medicines Agencies.

CSPs in alphabetical order:

A-B C-D E-F G-J K-L M-P Q-U V-Z