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Changes Proposed

Changes will be introduced into the administrative regulation of public function of licensing control of activity for manufacture of drugs, approved by the Ministry of industry and trade in October, 2013.  The corresponding suggestions have already been prepared.
According to the suggested modifications, the inspector should provide to the head of the licensee or other responsible person documents and information obtained within the interdisciplinary information exchange.  It implies, that the Russian Ministry of industry and trade makes enquiries  and freely obtains within interdisciplinary information exchange, including in electronic form, information from public list of medicinal drugs, from accounting reports, and from the Uniform State Register of Legal Entities . Besides, an extract from the Uniform State Register of Legal Entities confirming real property titles, and information on average staffing number of employees for the previous calendar year.

Scheduled inspection may be suspended by the head of the Ministry of Industry and Trade or his deputy for a period required for interdepartmental interaction, but no more than by ten working days. Repeated interruption of inspection is  not allowed.

All suggested changes are conditioned by the need to bring the Administrative regulation in compliance with legislative and regulatory acts of the Russian Federation.

Public discussion of the project of law will continue till August 6, 2016.

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