serious adverse reaction
as defined in Directive 2002/98/EC of the European Parliament and of the Council of 27…, Article 3, point (h)
an unintended response in donor or in patient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity
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Also defined in
- Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on… 32014R0536, Article 2(1)
set out in points (2), (6), (11), (12), (23) and (24), respectively, of Article 1 of Directive 2001/83/EC apply - Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and… 32004L0023, Article 3, point (n)
an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity - Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to… 32001L0083, Article 1, point (12)
An adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.