Serialization of medical products: man and law
On February 14, 2018 in Moscow (Marriott Royal Aurora Hotel), a business-brunch "Serialization of medical products: man and law" was held. Publishing House Kommersant was the event organizer.
In connection with the growth of the world market of illegal pharmaceutical products, mandatory serialization of medicinal products is adopted in the Russian Federation (from January 1, 2020 - 100% of all medical products should have special identification codes).
The implementation of mandatory serialization of medical products in such a short time will inevitably raise a large number of issues related to legislation that regulates all stages of the process; with the way how communication between market participants and the state database will be organized; how mandatory serialization will affect the cost of medicines (especially inexpensive). These and many other issues related to the introduction of serialization were discussed at the business-brunch of the publishing house «Kommersant».
Among the speakers were: Konstantin Belanov, deputy head of the department for the organization of state control over the quality of medical products of Roszdravnadzor; Deputy Head of the Federal Service for Intellectual Property of Rospatent – Lyubov Kiriy; President of the National Association "APF" Sergey Kolesnikov; Executive Director of SPFO Lilia Titova; Director General of the ARPF Viktor Dmitriev and other persons known in the pharmaceutical community.
Alexei Martynov, X-TECH, answered on one of the important posed questions: who should put serialization data in the state database?
In his opinion, this can be done both by the customer of the goods and by the manufacturer of the medicinal product. But, more logically, it should be done by the manufacturer, because serialization data is applied at the factory and, and Manufacturer owns all the data on the composition of the applied codes. In addition, from the point of view of fiscal requirements, this obligation lies with the organization that owns the goods at the time of the logistics operation.
During the discussions at the business lunch, a lot of important issues were discussed, the solution of which is necessary for the introduction of a mandatory system of and all-encompassing serialization of medicines in the Russian Federation.
In connection with the growth of the world market of illegal pharmaceutical products, mandatory serialization of medicinal products is adopted in the Russian Federation (from January 1, 2020 - 100% of all medical products should have special identification codes).
The implementation of mandatory serialization of medical products in such a short time will inevitably raise a large number of issues related to legislation that regulates all stages of the process; with the way how communication between market participants and the state database will be organized; how mandatory serialization will affect the cost of medicines (especially inexpensive). These and many other issues related to the introduction of serialization were discussed at the business-brunch of the publishing house «Kommersant».
Among the speakers were: Konstantin Belanov, deputy head of the department for the organization of state control over the quality of medical products of Roszdravnadzor; Deputy Head of the Federal Service for Intellectual Property of Rospatent – Lyubov Kiriy; President of the National Association "APF" Sergey Kolesnikov; Executive Director of SPFO Lilia Titova; Director General of the ARPF Viktor Dmitriev and other persons known in the pharmaceutical community.
Alexei Martynov, X-TECH, answered on one of the important posed questions: who should put serialization data in the state database?
In his opinion, this can be done both by the customer of the goods and by the manufacturer of the medicinal product. But, more logically, it should be done by the manufacturer, because serialization data is applied at the factory and, and Manufacturer owns all the data on the composition of the applied codes. In addition, from the point of view of fiscal requirements, this obligation lies with the organization that owns the goods at the time of the logistics operation.
During the discussions at the business lunch, a lot of important issues were discussed, the solution of which is necessary for the introduction of a mandatory system of and all-encompassing serialization of medicines in the Russian Federation.