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To Reduce the Packaging

A text of draft of order “On approval of requirements to the size of tare, packaging and package contents of drugs for medicinal use” developed by the Ministry of Health of the Russian Federation, has been uploaded to the regulation.ru website for public discussion.

The document aims to influence the current situation with non-medical use of drugs. The information about such use of drugs comes from executive authorities in regions of the Russian Federation. Director of Department of Medicine Provision and Regulation of Medical Devices Circulation Elena Maximkina, commenting on that document, remarked, that by decreasing the size of packaging of alcohol-containing drugs, it will no longer be practical to buy them at small volumes (25-50 mL), at a practically the same cost.

According to the draft of document, drugs with the volume of alcohol above 50%, with a course dose of drug on no more than 75 mL inclusive, and availability of information from over 60 regions of the Russian Federation about the use of the drug off-label, the drug should be filled in containers of no more than 25 mL. If the alcohol volume is 30% to 50%, the course dose does not exceed 200 mL inclusively, and availability of information from over 30 regions of the Russian Federation about the use of the drug off-label, the drug should be filled in containers of no more than 50 mL. If the volume of alcohol is less than 30%, the course dose of the drug does not exceed 200 mL inclusively, and information on the use of the drug off-label is available from over 30 regions of Russia, the volume of container  shall not exceed 100 mL.

Public discussion of the document will continue until October 6, 2016.

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