Art. 62 TPO in conjunction with Art. 63 para. 3 TPO requires reports to be submitted within the following timelines:
| 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 / Information sheets.
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.