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Roszdravnadzor defined the responsibilities of owners of certificates of registration of biomedical cell products (BMCP) in the process of reported side effects and adverse reactions when applied. The respective departmental order from 02.08.2018 No. 5071 registered Ministry of justice of Russia on August 15.
the Owners of certificates of registration of biomedical cell products, the organizers of clinical trials required to:
– receiving, accounting, processing, analysis and storage coming to their address from the subjects of circulation of biomedical cell products and state authorities of reports of adverse reactions in compliance with the legislation of the Russian Federation on personal data, medical and commercial secret, and may authorize other legal entities to carry out reception, registration, processing, analysis and storage of reports of adverse reactions;
is to organize the reception and registration of reports of adverse reactions, including information published in specialized journals, received from the subjects of circulation of biomedical cell products and bodies of state power, post, email, telephone or Fax;
– to assign responsible persons for work with reports of adverse reactions;
– keep on the territory of the Russian Federation in electronic or paper form processes for the receipt, registration, processing, analysis of reports of adverse reactions.
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