Biomedical Cell Product Regulation

Biomedical cell product – introduction and main information.

| Regulation:

  • Order of the Ministry of Health of Russia № 567n – in Russian and in English;
  • Order of Ministry of Health of Russia dated 31.05.2017 № 281n – in Russian and in English;
  • The Rules of transportation of biological material, cells for the preparation of cell lines and cell lines themselves (Order of Ministry of Health dated 28.08.2017 №564n) – in Russian and in English;
  • The procedure of marking of the primary and secondary packaging for the autologous BMCP and combined BMCP (Order of Ministry of Health dated 13.10.2017 №800n) – in Russian and in English;
  • Safety monitoring, conducted by the holder of the registration certificate (RC) – in Russian and in English;
  • Form of the statement for the BMCP document changing process (Order of Ministry of Health dated 20.10.2017 №837n) – in Russian and in English;