Russian President signs the Federal Law on introduction of drug labeling

Print 18 January 2018
GMP News

Russian President Vladimir Putin signed the Federal Law “On amendments to the Federal law “On Circulation of medicines.”

The law provides for the establishment of state information system to monitor the movement of medicinal products for human use from the manufacturer to the final consumer by using the means of identification with regard to medicinal products in order to ensure the quality control of medicinal products for human use, that are in circulation, and protect the legal trade from falsified, counterfeit, and substandard medicines.

From January 1, 2020, the legal entities and individual entrepreneurs will be liable in accordance with the laws of the Russian Federation for manufacturing or sale of medicinal products without the means of identification or in violation of the procedure established for application of such means, as well as for late entry of information into the monitoring system.

The Government of the Russian Federation is granted the right to establish the particular characteristics for the implementation of movement monitoring system with regard to medicinal products for human use included in the list of vital and essential drugs, as well as medicinal products intended for people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, haematopoietic and related tissue, multiple sclerosis, persons after organ and/or tissue transplantation, and other medicinal products.

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