Reports of adverse blood products reactions and risky situations
- Permit or other obligation
- Public service
Transfusion centre must report to Fimea without delay situations that form a serious risk possible effecting the quality and safety of the blood or parts of the blood, or serious adverse reactions observed during or after transfusion possibly caused by a quality deviation of the blood or parts of the blood. Reports shall be submitted on forms adopted by the Ministry of Social Affairs and Health’s decree (258/2006).
Do the following
The reports shall be made on forms made available on the website of Fimea and submitted to Fimea.
To whom and on what terms
The obligations concern the transfusion centres.
As soon as an adverse reaction or risky situation has been observed.