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A law was adopted on the phased introduction of GIS for monitoring the movement of drugs

The State Duma at a meeting on December 22 adopted a law that involves the development and phased introduction of the state information system for monitoring the movement of drugs (GISMDL).

The document “will almost 100% protect the population from counterfeit medicines,” said Alexander Petrov, a member of the Duma’s committee on health protection, recalling that the initiative was developed in accordance with the order of President Vladimir Putin. “After the introduction of this system, it will be possible to trace which medicine is given to any grandmother in any corner of the Russian Federation,” he assured.

According to the accompanying materials, monitoring will be carried out "from the manufacturer to the final consumer using identification means in relation to medicines for medical use." Manufacturers in the order established by the government of the Russian Federation will apply identification means on the primary and secondary (consumer) packaging.

The law provides for free-of-charge receipt by pharmaceutical companies of information on series and consignments of medicines produced by them and in civil circulation in the Russian Federation contained in the GISMDL. There is a liability (administrative fine) for legal entities and individual entrepreneurs for the production or sale of drugs without identification means, in violation of the established procedure for their application, as well as for late entry of data into the GISMDL or entering inaccurate data into it:

• for officials in the amount of five thousand to 10,000 rubles;
• for legal entities - from fifty thousand to 100,000 rubles;
• for individual entrepreneurs - from 50,000 to 100,000 thousand rubles.

According to the document, the government will establish the specifics of GISMDL implementation, including the timing of implementation, for medicines for medical use included in the list of vital and essential medicines, as well as medicines designed to provide patients with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, individuals after transplantation of organs and (or) tissue her other medications.

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