Encyclopedia

Unforeseen adverse reaction


An unexpected adverse reaction is an unfavorable response of a human organism that is associated with the use of a biomedicinal cellular product in accordance with the protocol of a clinical study of a biomedicinal cellular product, the investigator's brochure or instructions for its use, and the nature, severity, and outcome of which do not correspond to the information about the biomedicinal cellular product contained in these documents1.

  1. Federal Law No. 180-FZ of June 23, 2016 "On Biomedicinal Cellular Products". 2016, as amended on January 1, 2017, Article 2, Subparagraph 23. ↩

Laws with commentary

Codes and federal laws