Digital labeling of medical devices

Digital labeling of drugs

Main Article: FGIS MDLP Monitoring Drug Movement

History

2024

Russia and Uzbekistan agree on a single digital labeling of drugs

In September 2024, Russia and Uzbekistan agreed on a single digital labeling of drugs. Minister of Health of the Russian Federation Mikhail Murashko and Chairman of the Tax Committee of Uzbekistan Sherzod Kudbiev signed an intergovernmental agreement on information interaction in order to transfer information on the labeling codes of drugs (medicines) for human use.

In addition, Murashko and Acting Minister of Health of Uzbekistan Asilbek Khudayarov signed a protocol between ministries in the field of training, retraining and advanced training of medical personnel.

Mandatory digital labeling of medical gloves introduced in Russia

On July 1, 2024, it became known that the government of the Russian Federation approved a decree on the introduction of mandatory digital labeling of medical gloves. This decision is aimed at combating counterfeit products and unscrupulous market participants who sell goods of inadequate quality or issue imported products for domestic ones.

According to TASS, medical gloves have become the seventh type of medical devices included in the state marking system "Honest Sign." Previously, mandatory labeling was introduced for recirculators, orthopedic shoes, hearing aids, tomographs, coronary stents and sanitary and hygienic products.

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Yegor Zhavoronkov, head of the group of socially significant goods of the Center for the Development of Advanced Technologies (CRPT), noted that manufacturers and importers can begin voluntarily applying labeling codes to medical gloves now. He stressed that the initiative to label gloves came from the industry community itself.

The volume of illegal turnover of medical gloves can reach 40%, and in monetary terms only under state contracts - more than 10 billion rubles. The introduction of mandatory labeling is designed to solve this problem and create equal competitive conditions in the market.

Samara Medical Devices Plant, one of the largest manufacturers of nitrile gloves in Russia, has already begun preparations for work with the Honest Sign system. The executive director of the plant, Vyacheslav Egupov, expressed support for the innovation, noting that the company has repeatedly faced counterfeits of its products and price dumping by unscrupulous market participants.

The introduction of a marking system for medical gloves will increase market transparency, protect consumers from low-quality products and support bona fide manufacturers. Participants in the turnover are given enough time to prepare for the new rules, and the CRPT is ready to provide comprehensive support in this process.^[1]

Mandatory digital marking of crutches and other means of rehabilitation is launched in Russia

On May 31, 2024, the Russian government approved the mandatory digital labeling of technical means of rehabilitation. Products will be monitored using the Honest Sign system - its operator is the Center for the Development of Advanced Technologies (CRPT).

It is reported that the registration stage in the monitoring information system begins on September 1, 2024, and a month later the marking codes in relation to technical means of rehabilitation become mandatory. The list of such products includes: supporting and tactile canes, crutches, supports, handrails, orthoses, functional units of prostheses, anti-decubitus mattresses and pillows, special means in case of disorders of discharge functions (urinary and calorific), as well as chairs-chairs with sanitary equipment.

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The application of identification means to goods is carried out by the manufacturer or importer, including using the services of the service provider. In this case, the marking should be located in such a way that the integrity of the information applied to the product or consumer packaging is not violated. The ID is executed as a two-dimensional barcode in Data Matrix format.

According to Yegor Zhavoronkov, head of the group of socially significant goods of the CRPT, technical means of rehabilitation subject to labeling are goods that are mainly subsidized by the state and distributed by government agencies on a budgetary basis. Mandatory labeling is expected to improve control over budget spending. In addition, it will be possible to track the provision of socially unprotected groups of the population with such products online. Plus, according to Zhavoronkov, a mechanism will be created to prevent theft and resale of rehabilitation funds.^[2]

Approval of digital labeling of syringes, infusion systems and incubators for newborns

In May 2024, the Government of the Russian Federation approved a decree on conducting an experiment in the country to label a number of medical devices, including condoms and syringes. The pilot project starts on September 1, 2024 and will last until December 31, 2025.

The list of goods that will be labeled as part of the experiment includes: condoms, medical masks, syringes, infusion systems, incubators for newborns, test tubes, therapeutic breathing equipment, cosmetic fillers and threads, as well as disposable and non-repeated wipes.

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The main goals of the project are to test the mechanisms for marking medical products to counter their illegal circulation, including counterfeiting, as well as to increase the collection of taxes and customs payments. In addition, during the experiment, the initial filling of the subsystem of the national catalog of labeled goods with information about these medical products will be carried out.

The functions of the operator of the marking information system will be performed by the "Operator-CRPT." Participation in the pilot project for manufacturers and distributors is voluntary and free - marking codes will be provided free of charge.

Thanks to the experiment, Roszdravnadzor will have access to the traceability of the entire range of goods subject to labeling, the Operator-CRPT explained to TASS.

The Center for the Development of Promising Technologies noted that following the results of the experiment, proposals will be developed to improve legislation in the field of circulation of medical devices, taking into account mandatory labeling. Previously, mandatory labelling was introduced for a number of other categories of medical devices, including hearing aids, computed tomographs and wheelchairs.^[3]

Approval of blocking the sale of illegal medical products using the digital labeling system

On March 18, 2024, Russian Prime Minister Mikhail Mishustin signed a government decree blocking sales of illegal and expired medical devices. The innovation excludes the technical possibility of selling such products based on data from the state marking system "Honest Sign."

The mechanism applies only to retail market participants who already have experience working with locks at cash desks for other groups of labeled goods. The program includes wheelchairs, as well as all kinds of medical devices. In particular, it will not be possible to sell expired goods if they have a shelf life: this applies to recirculators, orthopedic shoes, hearing aids, computer tomographs, coronary stents and sanitary and hygienic products. Blocking will be carried out according to a number of criteria:

• Marking information is not available in the monitoring information system;
• The item has not been entered into circulation;
• The article is withdrawn from sales;
• The goods are prohibited for sale by decision of the state control bodies;
• The verification code does not meet the requirements;
• The item has expired.

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The Center for the Development of Advanced Technologies (CRPT), which is the operator of the Honest Sign system, said that when scanning the marking code, cash software will access the marking platform in real time and receive information about the requested product from it. If any of the listed criteria works, it will not be possible to sell the product. The measure is aimed at protecting consumers from products that do not meet the established requirements for quality and safety. In addition, the mechanism will help reduce the illegal circulation of medical products. The approved rules come into force on March 1, 2025.^[4]

Introduction of digital labelling of condoms

On March 1, 2024, it became known about the decision of the Ministry of Industry and Trade of the Russian Federation to increase the list of medical devices subject to labeling. It includes condoms, among other things.

It is said that the first phase of the project will be implemented from September 1, 2024 to August 31, 2025. Labeling will help consumers verify product quality. Condoms are one of the most common methods of contraception, and therefore affect a person's health. According to DSM Group estimates, in 2023, 19 million packages of condoms totaling 6.8 billion rubles were purchased through pharmacies in Russia alone.

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In addition to condoms, the list will include syringes, test tubes, medical masks, wipes (including non-daily ones), incubators for newborns, as well as implants for plastic surgery and cosmetology in the form of fillers and cosmetic threads. In addition, the list includes equipment for ozone, oxygen and aerosol therapy, artificial respiration or other therapeutic breathing equipment.

The project operator is the Center for the Development of Advanced Technologies (CRPT). He will develop requirements for the appropriate information system and for ensuring the protection of the data stored in it. At the same time, the Ministry of Industry and Trade will coordinate the creation and functioning of the platform.

Revaz Yusupov, Deputy General Director of the CRPT, notes that the prompt introduction of labeling will make it possible to start cleaning markets from counterfeit and counterfeit products as quickly as possible. And this will protect citizens from unsafe products. In turn, the state, thanks to the introduction of labeling, will receive additional management capabilities. Legal business will be able to increase revenue and profit by increasing sales after unscrupulous suppliers leave the market.^[5]

2023

Pharmaceutical companies in Russia began to transfer data on the origin of raw materials for drugs to a single IT system

At the end of December 2023, an experiment was launched in Russia to trace raw materials and drugs for drugs. The corresponding decree was signed by Russian Prime Minister Mikhail Mishustin.

Pharmaceutical station manufacturers will transmit to the Honest Sign system data on the raw materials received and the finished products released. The list of traceable raw materials for the production of drugs and drugs for human use includes, including:

• propylene glycol (propane-1,2-diol);
• menthol;
• ethyl acetate;
• salts and esters of citric acid;
• salicylic acid and its salts;
• O-acetylsalicylic acid, its salts and esters; antibiotics.

An experiment on tracing raw materials and drugs for drugs has started

Manufacturers, importers and sellers of these types of raw materials and drugs participate in the traceability experiment on a voluntary basis. The powers of the information system operator providing information support for the experiment are assigned to Operator-CRPT LLC.

According to the results of the experiment, which will last until the end of 2024, a decision will be made on the advisability of introducing mandatory traceability of raw materials for the production of drugs and drugs for medical use.

Earlier in 2023, the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (AFPEAES) proposed introducing a traceability system for the origin of active pharmaceutical substances. We are talking about the main active substances - the very basis of the drugs. Such a system should confirm that drug manufacturers who receive certain benefits and advantages for localizing full-cycle production in Russia really produce drugs from scratch. If we are talking about the purchase of ingredients abroad in order only to release the finished form and pack it at a Russian plant, then the manufacturer will not receive additional support measures. These include, first of all, the advantage in state orders.

Government of the Russian Federation Resolution of December 22, 2023 No. 2261

Launch of the experiment on the labeling of veterinary products

On December 1, 2023, an experiment on digital labeling of drugs for veterinary use will start in Russia. The press service of the Ministry of Industry and Trade announced this on November 15, 2023.

The department noted that participation in the experiment is voluntary and will not require additional funding for participants. On the calculations of the Higher School of Economics and the NIFI of the Ministry of Finance of Russia, the introduction of subsequently mandatory labeling of veterinary drugs will not have a significant impact on their cost, the press service added.

Experiment on digital labeling of drugs for veterinary use starts

About 20% of manufacturers of veterinary drugs, as well as a significant number of wholesale and retail organizations, are simultaneously subjects of circulation of drugs for human use already subject to labeling, registered with the Federal State Drug Monitoring Information System [Federal State Information System] and successfully carry out business processes for labeling goods, the Ministry of Industry and Trade said in mid-November 2023.

The Rosselkhoznadzor said that the introduction of labeling on veterinary drugs will not have a significant impact on their retail value. Taking into account the costs of introducing labeling from the manufacturer to the counter, the price of such products increased by only 0.6-0.75.

This decision will help reduce the spread of all types of illegal products - counterfeit, counterfeit, smuggling. And it will stop various fraudulent schemes, - noted in the service.

The Ministry of Industry and Trade adds that the introduction of labeling of veterinary drugs will also further ensure the traceability of ethyl alcohol used in production, taking into account integration with the EGAIS. And this will reduce the risks of using alcohol intended for the production of veterinary drugs in the illegal production of alcoholic beverages.^[6]

A law has been adopted giving Rospotrebnadzor the authority to control the labeling of pharmacy products

At the end of July 2023, the State Duma adopted a law empowering Rospotrebnadzor to control the labeling of pharmacy products. Amendments are made to the Law on the Protection of Consumer Rights and the Law on the Basics of State Regulation of Trade Activities in the Russian Federation (Federal Law No. 318-FZ of 28.12.2009).

In accordance with the document, which will enter into force on September 1, 2023, Rospotrebnadzor will receive control powers (supervision) over compliance by sellers and owners of aggregators with mandatory requirements for labeling goods by means of identification, for transferring information to the state information system for monitoring the turnover of goods subject to mandatory labeling by means of identification, and other requirements related to the turnover of goods, information about which is subject to entry into the specified state information system in accordance with the current legislation.

Rospotrebnadzor received authority to control compliance with labeling requirements

Anton Gushchansky, director of control activities at the Center for the Development of Advanced Technologies (CRPT, is the operator of the labeling system), explained to Kommersant that the state is thus strengthening control over compliance with labeling requirements.

In fact, before the adoption of such a law, there was no responsible labeling control body, the CRPT explains.

In this regard, it was not applied in practice of Art. 15.12.1 of the Code of Administrative Offenses of the Russian Federation, which implies responsibility for failure to provide information (violation of the procedure or deadlines for their transfer) or submission of incomplete and inaccurate information to the operator of the system for monitoring the turnover of goods subject to labeling in the form of fines from 50 thousand to 100 thousand rubles.

According to Anton Gushchansky, although Rospotrebnadzor saw violations in the market, it could not stop them due to the lack of authority and the presence of a moratorium on inspections. De facto, the operation of the article is "unfrozen," since after obtaining authority, Rospotrebnadzor will be able not only to carry out checks based on risk indicators (the indicators themselves are now being discussed - their approval is expected soon), but also to punish violators under this article of the Administrative Code.^[7]

Approval by the Ministry of Industry and Trade of digital labeling of rehabilitation means

In June 2023, it became known about the decision of the Ministry of Industry and Trade to conduct an experiment in Russia to label certain types of technical means of rehabilitation. It will begin on October 1, 2023 and will last until the end of February 2028.

The list of technical means of rehabilitation for which labeling will be introduced includes:

• televisions with teletext for receiving programs with hidden subtitles (with a diagonal of at least 80 cm)
• functional nodes of prostheses;
• special means in case of violations of the extraction functions (in terms of single-component caloretes).

Manufacturers, importers and sellers of these technical means of rehabilitation participate in the labeling experiment on a voluntary basis.

The powers of the information system operator providing information support for the experiment are assigned to Operator-CRPT LLC. Based on the results of the experiment, a decision will be made on the feasibility of introducing mandatory labeling of technical means of rehabilitation. If you are working with a branded retail item, you may need to upgrade your software. The cost of this upgrade depends on the software vendor.

According to TASS, the Ministry of Industry and Trade will be instructed to ensure by December 1, 2023 the development and approval, in agreement with the authorized bodies, of methodological recommendations for the experiment, as well as the development and approval of a schedule for the experiment. In addition, the ministry may be instructed, in agreement with the authorized bodies, to ensure that a report on the results of the experiment is sent to the government by March 1, 2025. Earlier in Russia, experiments were carried out on the labeling of certain types of medical devices, dietary supplements, antiseptics and wheelchair seats.^[8]

Approval of mandatory labeling of medical products

At the end of May 2023, Prime Minister Mikhail Mishustin signed a decree on mandatory digital labeling of medical devices. It should be introduced from September 1, 2023.

From this day, the system of mandatory labeling of goods will be extended to biologically active additives (dietary supplements), a number of medical devices and wheelchair seats.

From September 1, the system of mandatory labeling of goods will be extended to dietary supplements (dietary supplements), a number of medical devices and wheelchair seats

According to the government decision, from October 1, 2023, markings will be applied to orthopedic products and recirculators, from March 1, 2024 - to other products. The Ministry of Health explained that labeling will free the market from falsified products.

The prompt introduction of labeling will make it possible to quickly start cleaning markets from counterfeit and counterfeit products, and will protect citizens of our country from unsafe products. The labeling of such goods will give the state additional management capabilities. Legal business will be able to increase revenue and profit by increasing sales volumes after leaving the counterfeit and counterfeit market, "said Revaz Yusupov, deputy general director of the Center for the Development of Advanced Technologies (operator of the Honest Sign digital marking system).

According to him, by the beginning of June 2023 there is enough equipment on the market, mandatory labeling will not affect the cost of goods.

We have formed our own stocks at a warehouse in the Moscow region. Applicators, printers, vision cameras, ribbons, print heads, cartridges, self-adhesive material and others - more than 10 thousand units. They will last for 6 months of uninterrupted support for industries and stocks are constantly replenished. I note that 11 product categories are already being marked. In none of them, the marking affected prices, this will not happen with new goods, "Yusupov added (quoted by TASS).

Government of the Russian Federation Resolution of May 31, 2023 No. 894

Initiation of coronary stent labeling

In January 2023, coronary stents in Russia began to be digitally labeled. The introduction of labeling will help contain the illegal circulation of medical products and protect consumers from falsification, since counterfeit products are often found on the market, which are illegally imported into Russia without proper control, the press service of the Center for the Development of Advanced Technologies (CRPT, operator of the Honest Sign labeling system) reported.

As explained in the CRPT, the coronary stent is a medical device used by surgeons to dilate blood vessels and normalize the blood flow of patients. The head of the CRPT project, Petr Novikov, also noted that the labeling system will become an effective tool in the fight against illegal products on the medical device market.

Coronary stent

The system helps clear the market of counterfeit and falsified products. In the field of medicines, for example, labeling already ensures the transparency of the pharmaceutical market and protects it from the appearance of illegal drugs. In 2022, thanks to her, low-quality drugs worth more than 1 billion rubles were identified. We apply this experience when introducing labeling of medical devices, - the press service of the CRPT quoted Novikov as saying.

Anastasia Demina, head of the quality department of the company-manufacturer of stents "RK Group," emphasized that the company is testing the application of identification tools on coronary stents in advance in order to debug everything and smoothly enter the process by the start of mandatory labeling.

By January 2023, 2,689 companies are participating in the experiment on the labeling of medical devices: 67 manufacturers, 257 importers and others. In addition to coronary stents, the experiment includes certain types of medical devices: air purifier disinfectants, hearing aids, orthopedic shoes, etc.^[9]

2022: Launch of digital marking of CT scanners and hearing aids

In February 2022, Prime Minister Mikhail Mishustin signed a decree approving the launch of an experiment on digital labeling of several types of medical devices, namely:

Digital labeling of CT scanners is launched in Russia

• air purifier disinfectants;
• orthopaedic shoes;
• hearing aids;
• coronary stents;
• CT scanners;
• sanitary and hygienic products used in incontinence.

According to TASS at the Center for the Development of Advanced Technologies (CRPT, labeling system operator), it is ready for a pilot project, by February 11, 2022, a working group of industry representatives is being formed. The experiment will take place from February 15, 2022 to February 28, 2023.

According to Yegor Zhavoronkov, head of the Pharma commodity group of the CRPT, the pilot project will not require costs from the participants, marking codes will be provided free of charge.

Business is interested in including medical devices in labeling, it was the companies that voiced the initiative about this. The Ministry of Industry and Trade, the Ministry of Health and the operator supported the proposal, he said.[10]

The CRTP was instructed to develop requirements for the information system by April 1, 2022, which the Ministry of Industry and Trade will have to approve by the end of the same month. By the same time, guidelines for conducting the experiment should be ready. They will prescribe the procedure for participation, after which manufacturers will be able to declare their desire to join the pilot.

Among the goals of the experiment are to increase the collection of taxes and customs payments, to counter the illegal import, production and circulation of certain types of medical products. Therefore, the Federal Tax and Customs Services, Roszdravnadzor, the Federal Accreditation Service and the Social Insurance Fund of the Russian Federation (FSS RF) must ensure the interaction of their IT systems with the labeling platform for medical products.

2019: Ministry of Health decides to digitally label nappies and coronary stents

In December 2019, it became about the digital labeling of medical devices planned by the Government of the Russian Federation. From February 1, 2020 to September 1, 2021, it is planned to conduct a pilot project to control the supply of diapers and coronary stents.

According to the TASS Information Agency of Russia, the labeling of new products is stated in the corresponding draft government decree, which is posted by the Ministry of Health of the Russian Federation on the federal portal of draft regulatory legal acts.

It became about the digital labeling of medical devices planned by the Government of the Russian Federation

According to the document, the federal executive bodies authorized to ensure the experiment are Ministry of Industry and Trade Ministry of Health Ministry of Finance,,,,,,. Ministry of Digital Development, Communications and Mass Media Federal Health Surveillance Service Ministry of Economic Development Federal Customs Service

The national system of digital labeling and tracking of goods has been created and is successfully functioning, says a representative of the labeling operator, the Center for the Development of Advanced Technologies (CRPT). - In mandatory or pilot mode, 15 groups of goods are already marked - from medicines and cigarettes to fur coats and bicycles. The system traces more than 6 billion codes. The CRPT is ready to scale the project to medical devices, if the government makes such a decision.

It is assumed that diapers and coronary stents (more precisely, on the packaging of goods or on the product label) will be applied a two-dimensional code in the format Data Matrix (Date Matrix), which will contain detailed information about the product (name, manufacturer, date, time and place of release, etc.).

By December 12, 2019, the labeling of medical products confirms the quality and legality of the goods, informs consumers about its purpose and other properties, but does not allow controlling the supply of products in Russia.

For the experiment, Operator-CRPT LLC will need to develop requirements for the information system, as well as requirements for ensuring the protection of information contained in the IT system, and for ensuring information security when using information and communication technologies during the experiment, by March 1, 2020.^[11]

Notes