Minimum criteria for reporting

For the purpose of reporting cases of suspected adverse reactions, the minimum data elements for a case are: an identifiable reporter, an identifiable patient, an adverse reaction and a suspect medicinal product (see GVP Annex IV, ICH-E2D Guideline).

In the case of expedited reporting, the individual case safety report shall include at least an identifiable reporter, an identifiable patient, one suspected adverse reaction and the medicinal product(s) concerned [IR 520/2012 Art 28(1)].

See also Individual case safety report