Encyclopedia

Biomedical Cell Product


Biomedical cell product - a complex consisting of a cell line (cell lines) and auxiliary substances, or a cell line (cell lines) and auxiliary substances in combination with medicinal products for medical use that have undergone state registration (hereinafter - medicinal products), and/or pharmaceutical substances included in the state register of medicinal products, and/or medical devices. Biomedical cell products do not include transplantation objects, as well as high-tech medicinal products, including gene therapy medicinal products, subject to registration in accordance with the law of the Eurasian Economic Union and/or state registration in accordance with Federal Law No. 61-FZ dated April 12, 2010 "On Circulation of Medicinal Products"1.

  1. Federal Law No. 180-FZ of June 23, 2016 "On Biomedical Cell Products". 2016, as amended on April 1, 2024, Article 2, paragraph 1. ↩

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Codes and federal laws