19 October 2020

A new era of the pharmaceutical industry

OpenBio-2020: a new era of the pharmaceutical industry

At OpenBio-2020, the problems of introducing a new system of labeling medicines, regulation and combating the import of counterfeit drugs into the Russian Federation will be discussed. The annual industry complex of events will be held in the Koltsovo science city of the Novosibirsk region from October 27 to 30.

The OpenBio platform for open communications in the field of biotechnology, biopharmaceutics and virology will be held in the Koltsovo Science City from October 27 to 30. The event will begin with a three-day scientific conference, and on the final day a business forum and the Siberian Venture Fair will be held. The Organizing Committee of OpenBio informs that it will take all measures to ensure the epidemiological safety of participants at the forum sites.

An important part of the forum – the round table "Pharmaceutical circulation: a new era of the pharmaceutical industry" will become a platform for discussing topical issues in the field of pharmaceutical circulation, regulation and drug labeling.

Since July 1, 2020, mandatory labeling of medicines has come into force in the Russian Federation. According to the decree on the specifics of the introduction of a system of digital labeling and tracing of medicines, from that moment a ban on the production and import of unmarked medicines came, and the transfer of information about the turnover of labeled medicines to the labeling system became mandatory for all participants in the turnover. The sale of unmarked medicines that entered circulation before July 1, 2020 is allowed until their expiration date.

"At the same time, at the moment in the Novosibirsk region, more than 40% of the subjects of circulation of medicines have not connected to the system of monitoring the movement of medicines, that is, they automatically become violators of the legislation of the Russian Federation. In the future, organizations and individual entrepreneurs who have not connected to the monitoring system for the movement of medicines (MDLP) may be penalized or deprived of a license for medical or pharmaceutical activities, production, wholesale storage of medicines," explained Elena Khrustaleva, moderator of the discussion, Candidate of Medical Sciences, head of the territorial body of Roszdravnadzor in the Novosibirsk region.

According to the expert, the situation is acute and may affect the availability of medical care and medicines for the population.

"Our task within the framework of the forum is to discuss the problematic situation at all levels: the level of government, supervisory and customs authorities, the developer and curator of the MDLP system, directly organizations that are subjects of the circulation of medicines. It is necessary to jointly work out solutions aimed at correcting problematic issues," Khrustaleva shared.

Representatives of relevant ministries, manufacturers of medicines, heads of large retail and wholesale pharmacy chains will take part in the open dialogue. They will also discuss measures of state support for companies at the stage of transition to labeling and control of the import of counterfeit products.

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