Encyclopedia
Regulatory Documentation for a Biomedical Cellular Product
Regulatory documentation for a biomedicinal cell product — a document developed by the manufacturer of a biomedicinal cell product containing a list of quality parameters of the biomedicinal cell product determined based on the results of relevant expert evaluations, and information on methods for controlling the quality of the biomedicinal cell product1.
Federal Law No. 180-FZ dated June 23, 2016 "On Biomedicinal Cell Products". 2016, as amended on January 1, 2017, Article 2, subpara. 12. ↩