On February 1, 2017, the experiment to label drugs will start on the territory of the Russian Federation
On January 30, 2017, the Government of the Russian Federation published its resolution dated January 24, 2016, bearing No. 62 “On performance of the experiment for labeling with control (identification) signs and monitoring of the turnover of certain types of medications destined for medical usage.”
Main goals of the labeling of packs of medications with the 2D bar code is to provide each buyer with the possibility to check its legality with the help of a smart phone or generally available scanner in the pharmacy as well as ensure the automatic protection of the legal turnover from low-quality and fake preparations.
Labeling has clear “strong sides” for business circles, that is: decreasing direct losses from fake and adulterate goods, decrease of costs due to more efficient logistic management, compliance with requirements to labeling, which are intensely introduced abroad, for entering external markets.
When 100% produced medications is labeled, the monitoring system will trace about 6 billion packs of medications per annum and will cover over 350,000 participants of the market turnover, which includes about 1,000 foreign and Russian pharmaceutical producers, over 100,000 medical entities and 250,000 pharmacies.
In connection with the fact that this project is a large-scale arrangement, the Government of the Russian Federation made a decision to conduct the (pilot) experiment to label medications, given whose results the project will be developed further.
The Resolution of the Russian Government dated January 24, 2016, No.62 “On performance of the experiment for labeling with control (identification) signs and monitoring of the turnover of certain types of medications destined for medical usage” sets forth that this experiment will start on February 1, 2017. During four months (until June 2017), the software will be finished, commissioned in the industry and become accessible to the experiment participants.
At the early stage, the labeling will embrace over 60 items of medications, including 10 trade names of pharmaceuticals, designed for treatment of high-cost nosology, and over 30 trade names of medications put on the list of vital and most essential preparations. The total amount of preparations to be labeled at the start of the experiment will make up about 10% of the market.
A total of 23 pharmaceutical producers, four major pharmaceutical distributors, above 30 medical entities and above 250 retailers of medications, including pharmacy networks of federal and regional levels expressed readiness to participate. As the experiment progresses, the number of participants will boost.
At the initial stage, the experiment will be carried out in six subjects of the Russian Federation (Moscow, the Moscow region, St. Petersburg, the Nizhny Novgorod region, and Belgorod region), then, after the software refinement and technical possibilities extension, it will be stage by stage expanded to all Russian subjects, as well as at hardly accessible settlements with non-sustained communications with information system resources.
In the course of the experiment, the preliminary approbation and assessment of efficiency of major organizational and technological solutions of the to-be-created system of monitoring of the medications’ flow will be carried out; optimal technological requirements and solutions will be determined, as well as the required amendments and addenda to regulations of the Russian Federation, governing the sphere of pharmaceuticals turnover, will be defined. Given the results of the experiment, further decisions concerning the introduction of the system of monitoring of the medications’ flow on the territory of the Russian Federation will be made.
Source – http://www.roszdravnadzor.ru/news/5908