Encyclopedia
Serious adverse reaction
Serious adverse reaction — an unfavorable reaction of a human body that is associated with the use of a biomedical cell product in accordance with its instructions for use, resulting in death, congenital anomalies or developmental defects, or representing a threat to human life requiring hospitalization, or leading to temporary loss of working capacity or disability1.
Federal Law No. 180-FZ of June 23, 2016 "On Biomedical Cell Products". 2016, as amended on January 1, 2017, Article 2, subpara. 22. ↩