Reporting timelines: When to report?

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.