Art. 62 TPO in conjunction with Art. 63 para. 3 TPO stipulate the applicable reporting timelines. The following applies:
Reporting timelines | |
---|---|
Deaths, clusters of events | Immediately on becoming known (an initial report can also be made orally) and within a maximum of 15 days |
Serious transfusion reactions, observations of serious events, quality defects | As soon as possible, within a maximum of 15 days |
All other reports |
As soon as possible, within a maximum of 60 days |
For further details, please consult the relevant information sheets - available under Forms / Classification.
Report as early as possible, even if the results of analyses are still outstanding when you submit your report. Additional information and results can be submitted at any time subsequently.