12 March 2019

Testing equipment for mandatory labeling of drugs.


In December 2018, the new equipment was tested for labeling identification marks on manufactured drugs. From January 1, 2020, in accordance with Federal Law No. 425-FZ dated December 28, 2017 “On Amendments to the Federal Law “On Circulation of Drugs”, all manufacturers of medicinal products shall be obliged to label identification marks on the packaging of drugs for medical use.

It is planned that these measures will reduce the risk of counterfeit drugs appearing on the market, and the pharmaceutical market will benefit from reduced losses from counterfeit, increased logistics efficiency, and the access to foreign markets by compliance with international requirements. Today in PHARMACOR PRODUCTION one production line of the three is supplied with additional equipment. In the near future, the rest lines will have to be equipped with serialization equipment, the work on installation, debugging and validation of software, including at the logistics hub, will be carried out. “We work according to the plan approved by the company, and by January 1, 2020 we will provide all our production lines and units with the necessary equipment for drug labeling. But, at present, it is not enough bylaws and regulatory technical documentation specifying the volume and manner of information provision to the drug circulation monitoring system; the question remains about the procedure and rules for synchronizing our equipment with the equipment of system operator and regulatory bodies, ” said Igor Smorodinov, the Deputy General Director for Production.