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Core Safety Profiles (CSPs)

The documents published here are Core Safety Profiles (CSPs) from the so-called European work sharing procedure (WSP). The WSP was initiated in 2002 with the aim of assessing PSURs regarding certain substances on a European level and to synchronise the basic statements in the product informations of these substances.
The new pharmacovigilance legislation (Directive 2010/84/EC) created new a new legal framework regarding the submission of PSURs and introduced the principle of the EU single assessment with an evaluation by the Pharmacovigilance Risk Assessment Committee (PRAC). The new rules regarding PSURs will be implemented on a step-by-step basis. Against this background, the EMA Management Board has decided not to start the EU single assessment principle yet for substances for which there are no centralised marketing authorisations. The WSP will be continued until introduction of the EU single assessment for substances for which there are only national marketing authorisations; however, CSPs are no longer updated nor newly adopted. Submission of CSPs is no longer required since it has become obligatory to submit PSURs in accordance with GVP Module VII (1/2013).