The Swiss Haemovigilance reporting system

Manufacturers

Art. 59 para. 1 TPA requires any person who manufactures or distributes therapeutic products to put in place a reporting system in compliance with the requirements of Art. 65 TPO. In accordance with Art. 59 para. 1 and 2 TPA in conjunction with Art. 61 ff TPO and Art. 37 ff MPLO, Swissmedic must be notified of quality defects and other findings and evaluations which could influence the basis for assessment and of adverse effects and incidents which:

are or could be due to the therapeutic product itself, its use or incorrect labelling or instructions for use;
could endanger or impair the health of patients.

Under the haemovigilance system, donor reactions, quality defects and protective measures, transfusion reactions and serious incidents associated with the handling of labile blood products, such as transfusion errors and near misses, must be reported to Swissmedic within the timelines stipulated in Art. 62 TPO.

Users

According to Art. 59 para. 3 TPA, any person who professionally dispenses therapeutic products or administers them to humans or who is entitled to do so as medical personnel must notify Swissmedic of any serious or previously unknown adverse effects and incidents, clusters of events, observations of other serious or previously unknown facts and quality defects that are of significance for drug safety within the timelines stipulated in Art. 63 para. 3 TPO.

Under the haemovigilance system this applies to transfusion reactions, quality defects and serious incidents associated with the handling of labile blood products, such as transfusion errors, near misses and other serious incidents.