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Biomedical Cell-Based Products: Control and Licensing

A draft of law “On amendments to individual legislative acts of the Russian Federation related to the Federal Law “On biomedical cell-based products” prepared by the RF MoH in connection with approval of Federal Law of 23.06.2016 No 180-FZ “On Biomedical Cell-Based Products” has been presented for public discussion.

The new document established public control in the field of biomedical cell-based products circulation, and licensing of their production.

The draft of law specifies the notion “medical wastes” as all types of wastes, including anatomic, pathology-anatomic, biochemical, microbiological, physiological and other types of waste products.

Besides the draft of law specifies amendments and additions to Federal Law of November 21, 2011 No 323 FZ “On fundamental healthcare principles in the Russian Federation” and of May 4, 2011 No 99-FZ “On Licensing of specific types of activities”.

Public discussion of the draft of law will continue until August 2, 2016.

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