State Institute for Drug Control

GVP Module VI part VI.B.3 places special emphasis on reporting ADRs related to suspect MP of biological origin. In the case of these reports MAH and SUKL shall make efforts to obtain the precise brand name of the suspect MP, including the batch number. Information about the effort to obtain this information (or FU) must be recorded in the “Case narrative” part of the report, and this includes cases that this information could not be obtained.