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Control and Checks To be Performed According to Regulations

A draft of order by the Russian Ministry of Health “On Approval of Administrative Regulation of the Federal Service for Surveillance in the Field of Healthcare on Public Function for Selective Drug Quality Control for Medical Use” has been developed.

That document defines the rules for selective drug quality control for audit checks in regions. Terms and sequence, as well as rights and responsibilities of public officials in exercising the activity are defined.

Selective check is based on the information submitted to Roszdravnadzor on the risk of harm to life and health of persons and provided by subjects of drug circulation of information about batches, lots of drugs entering the public circulation.

The administrative regulation presents a flow-chart demonstrating a procedure of public function and a list of local compliance authorities of Roszdravnadsor, addresses and telephones.

The proposed Administrative regulation will replace two currently effective regulations describing the functions specified. It will significantly extend the authority of Roszdravnadzor on surveillance  of drug quality audit.

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