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Waste Products Formed in the Process of Circulation of BMCBPs Require Legal Regulation

10 may 2017 16:57

A draft of law on regulation of BMCBP-related issues was discussed on April 27 at the meeting of the Government of the Russian Federation.

The document outlines the legal framework of handling waste products formed in the process of circulation of biomedical cell-based products. It is of note, that Federal Law No 180-FZ of June 23, 2016 No 180-FZ on Biomedical Cell-Based Products regulates issues related to BMCBPs (development, preclinical and clinical studies, expertise, state authorization, manufacture etc.). It entails specification into the Federal Law On fundamental healthcare principles in the Russian Federation to define the notion Medical Waste Products, by including, among others, waste products formed in the process of circulation of biomedical cell-based products.

It is also suggested that requirements to licensing of biomedical cell-based product production activity, state control in the field of circulation be established, and details of documents confirming payment of the public fees for expertise, which are part of marketing authorization dossier for the biomedical cell-based product be specified..

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