Local scientific literature and suspected side effects

messages in brief | 20/11/2012

The "Guideline on good pharmacovigilance practices", Module VI obliges marketing authorization holders, among other things, to monitor the local medical press. Publications relating to any adverse drug reactions are to be identified and fed into the pan-European reporting system.


The further procedure for case reports identified in this way follows the rules of the spontaneous reporting system:

  • Obligation to report exists as soon as the minimum criteria are fulfilled.
  • If several preparations are affected, the obligation to report applies to the preparation for which at least a possible causal relationship is assumed.
  • If the use of the patient's own (identical) preparation can be excluded on the basis of conclusive information (e.g. dosage form, dosage, etc.), there is no obligation to report.
  • A separate case report is prepared for each identifiable patient.


In light of current events, the BASG points out that publications of this type may also be fictitious (or at least highly alienated) cases that are created, for example, for teaching or demonstration purposes.

In order to avoid false reports and false signals, careful follow-up is recommended, especially for cases of this kind.


Further inquiry note