Mishustin introduced simplified digital labeling of drugs. What has changed

Why drugs are labeled

According to the World Health Organization, about 700,000 people die each year from falsified drugs sold to them. No country is immune to this misfortune. The trade in falsified anti-cancer drugs is especially developed. According to the World Economic Forum, the global cost of counterfeit pharmaceutical products in 2017 exceeded $200 billion.

Labeling is a unique code on each package, the "passport" of the medicine. The buyer can read the code with a smartphone and verify the authenticity of the drug. And the regulatory authorities, using labeling, are able to track the path of the drug from the manufacturer to the wholesaler and to the point of final sale. This will allow you to fight counterfeits and identify gray schemes in the circulation of drugs.

Drug labeling is regulated by Federal Law No. 61-FZ. All market participants need to register in a special section of the Honest SIGN state system - the drug movement monitoring system (MDLP). Without this, Roszdravnadzor will refuse to issue a license for medical activities and will not renew the expiring license (Government Decree No. 687 of 15.05.2020)^[1]."

Ways to switch to drug labeling

Organizations and entrepreneurs should send information about all stages of drug movement to the MDLP:

• putting on the balance sheet of the enterprise (entering into circulation),
• shipment to the recipient,
• coming,
• transportation from one outlet to another,
• A/R and A/R (both considered a retirement).

There are several options for how to fulfill all these requirements. The choice depends on whether the pharmacy has its own accounting system and how difficult it is to change it.

Method 1. With the help of programmers, redo your accounting service or program for labeling.

• Pros. Developers will take into account the features of your business processes, you will receive an individual solution.
• Cons. The work of programmers will require financial costs and time to integrate your system with the HONEST SIGN through the API. Be prepared to pay for technical support of the system during use.

Method 2. Work with marking through a typical commodity accounting system.

• Pros. Setting up a typical solution will take less time and money compared to individual development.
• Cons. You will have to update your accounting system so that it supports labeling. In this case, you need to take into account the changes that were made to the system earlier. This can result in additional costs. If you plan to purchase a new accounting system, take the time to transfer the item master data, balance data and train employees.

2023: Pharmacies in Russia began to automatically block expired and illegal medicines at the box office

In mid-June 2023, it became known that Rigla was the first of a network of pharmacies in the Russian Federation to automatically block expired and illegal medicines at the cash desks through the Honest Sign state labeling system. Read more here.

2022

CRPT is ready to begin labeling antiseptics from April 1, 2023

The national system of digital labeling of goods "Honest Sign" will be fully ready for the start of labeling antiseptics in accordance with the deadlines proposed by the Ministry of Industry and Trade of Russia. The CRPT company announced this on August 17, 2022. Read more here.

Mishustin approved permanent simplified digital labeling of drugs

Prime Minister Mikhail Mishustin signed a decree that approved on an ongoing basis a simplified procedure for working in the system of digital labeling and tracing of drugs. The press service of the Government of the Russian Federation announced this on February 10, 2022.

The simplified mode of work with labeled drugs introduced into civilian circulation assumes that manufacturers and distributors can sell drugs without waiting for confirmation of the supplier. The information is automatically confirmed by the labeling system itself by checking the item code and participant data. This makes it possible to speed up drug operations for all participants, reduce the risks of drug shortages in pharmacies.

Such a regime was temporarily introduced in early November 2020, it was extended first until July 1, 2021, and later until February 1, 2022. Now the simplified drug labeling scheme has become permanent.

For pharmacies and hospitals with the end of the simplified regime, nothing will change, they will continue to work with labeled drugs in the same way as they worked before. Turnover participants will be able to continue to use the capitalization scheme, in which it is not necessary to wait for confirmation of the acceptance of drugs from suppliers for further work, "Yegor Zhavoronkov, head of the Pharma commodity group, Center for the Development of Advanced Technologies (CRPT, labeling system operator), explained to TASS.

At the same time, the simplified procedure does not apply to medicines that are imported into Russia. This functionality has ceased to be in demand by companies. In most cases, importers receive confirmation of the import of drugs on time from holders or owners of registration certificates and can then sell them, the Cabinet said.^{[2] [3][4] [5]}

2021

Mishustin allowed to provide the pharmaceutical business with data from the labeling system to check counterparties

At the end of December 2021, the Prime Minister Mikhail Mishustin signed a decree that Governments of the Russian Federation allowed pharmaceutical companies to provide data from the labeling system. The innovation is primarily intended to check counterparties.

According to the document published on the official Internet portal of legal information, manufacturers and importers who are registered in the Honest Sign digital marking and tracking system will be able to receive information from the system operator (Center for the Development of Advanced Technologies, CRPT) about the current owner of the goods released by them, the number of goods in circulation and sold. They will also have access to information on the amount of goods sold up to the addresses of points of sale and access to data on average retail prices for their goods at the level of subjects.

Thanks to this, the business will be able to work more efficiently:

• in logistics: understanding the effective and highest quality distribution channels;
• in marketing: conducting promotions and productivity programs - owning data makes it possible to eliminate human errors and automate most processes.

According to the Higher School of Economics, access to the system's data will make it possible to replenish the budget annually by 121 billion rubles due to an increase in the production of bona fide companies and an increase in tax revenues. More than 70 billion rubles will amount to additional revenues from excise taxes on tobacco, 13 billion from income tax, 32 billion from personal income tax and social contributions, 6 billion from other taxes, the CRPT said.

Business from access to data can receive up to 200 billion rubles of additional income every year. The industries of dairy products (53 billion rubles annually), tobacco (34 billion rubles), confectionery (32 billion rubles) and medicines (31 billion rubles) will benefit the most^[6][7]

Law passed on fines for violation of digital labeling of drugs

On May 26, 2021, the State Duma in the third, final reading adopted a law on fines for violating the requirements for digital labeling of drugs. The corresponding bill was initiated by the head of the State Duma Committee on the Development of Civil Society, Issues of Public and Religious Associations Sergei Gavrilov (Communist Party of the Russian Federation).

For the production or sale of drugs without applying means of identification will face a fine: officials - 5-10 thousand rubles, legal entities - 50-100 thousand rubles. When an administrative fine is imposed, drugs without labeling will be confiscated.

A similar amount of fines is provided for late entry of data into the monitoring system for the movement of drugs or for entering inaccurate information into it.

Changes are made to Art. 6.34 of the Code of Administrative Offenses (CAO) of the Russian Federation. Responsibility for entering inaccurate data into the monitoring system prescribed in this article of the Code of Administrative Offenses remains. The law will come into force on December 1, 2021.

That is, today you can make fake labeling and for this the violators avoid responsibility in both administrative and criminal order. Therefore, the bill provides for the introduction of responsibility for this act. I think it's very necessary. Because, unfortunately, those goods that are made with fake labeling are dangerous for citizens. And the next big omission: all these goods are not taxed, which is why our budget suffers, - explained Zarif Baiguskarov, a member of the Committee on State Construction and Legislation.

According to him, earlier neither the Administrative Code nor the Criminal Code provided for liability for the use of deliberately fake means of identifying means of labeling goods.^[8]

90% of pharmacies switched to drug labeling

It was planned to switch to the drug labeling system back in 2020. However, the transition had to be postponed. In June 2021, all pharmacy centers should work according to the updated scheme. The Pharmedu portal on February 9, 2021 published the results of a survey of pharmacists and pharmacists, in which 5 thousand specialists from 6 federal districts of Russia took part.

The respondents were asked whether they are ready for the full use of the labeling system and how it affects the entry of drugs into pharmacies.

90% of respondents are already working according to the updated scheme. More than half (65.35%) noted that there were interruptions in the supply of drugs to the pharmacy, but this issue was resolved. However, 32% assure that the problem persists.

The same number (32%) of pharmacists said that it is very difficult to work with labeling, certain problems constantly arise. 65% of respondents are more positive: they said that there are difficulties, but you can work. The main inconvenience, which was noted by 99% of the survey participants, is that the sale process is delayed, which, in turn, unnerves buyers.

No one noted an increase in the range of pharmacies with the introduction of labeling. But the decrease was emphasized by 59.41% of pharmacists. 37.65% did not notice the changes.

When asked how the labeling affected the work of pharmacies, 39% answered that there was no help from it to anyone, but there was no harm either, however. Half of the respondents were divided in opinion: 25% consider the introduction of labeling a mistake, and the other 25% are convinced that it helps manufacturers and distributors. But 13% of pharmacists say that the updated scheme helps the buyer.

The introduction of labeling coincided with the pandemic, and pharmacists had to take the whole blow, "said Tatyana Khodanovich, director of the Pharmedu service. - To the consumer frightened by the epidemiological situation, it seemed that it was the pharmacy and the pharmacist who were personally to blame for the queues and long service. The system is debugged. Hopefully, in February, as promised by the developers of the MDLP system (monitoring the movement of drugs), there will be no more failures.

2020

Customs blocked deliveries of 1.5m Stada products due to labelling system failure

On November 25, 2020, it became known that Russian customs blocked the supply of 1.5 million products Stada due to a system failure. markings More. here

Mishustin simplified the system of digital labeling of drugs after criticism

In early November 2020, Prime Minister Mikhail Mishustin signed a decree of the Government of the Russian Federation, which simplifies the system of digital labeling of drugs. The order of operation became easier after the system was criticized due to constant failures.

Now in pharmacies and medical institutions it will be possible to withdraw drugs from circulation through cash registers immediately after notification of the receipt of drugs. Previously, it was necessary to wait for confirmation of the registration of drugs in the system.

Until July 1, 2021, simplified mechanisms for "reverse drug administration" are additionally introduced when they are imported into Russia and circulated within the country:

• when circulating, participants are not required to wait for confirmation of drug acceptance from suppliers and can independently apply them and carry out further actions with drugs;

• similarly, when importing drugs into Russia, importers may not expect from the holders or owners of the marketing authorization for import confirmation drugs.

This information will be automatically confirmed by the system itself by checking the product code and participant data. This will increase the speed of drug operations for all participants, as it reduces the dependence on delays on the side of drug providers.

The simplified labeling regime applies to all drugs, with the exception of drugs from the category of 12 high-cost nosologies.

In addition, until February 1, 2021, manufacturers will apply codes to drugs, pharmacies must scan them, and operations within the country will become easier. All information will need to be entered into the system, but you can take further action with the drugs without waiting for a response if it is not received within 15 minutes.

Given the increased demand for medicines and the epidemiological situation, the simplified regime will function until all industry participants are fully ready, the press service of the Cabinet of Ministers reports.[9]

A drug crisis is brewing in Russia due to a labeling system failure

A drug crisis is brewing in Russia due to a labeling system failure. Companies cannot supply more than 40 million packages of drugs, including "vital," the Association of International Pharmaceutical Manufacturers (AIPM) said.

According to RBC, citing an AIPM survey, two-thirds of the association members complained about the failures - in total, there are more than 60 companies that produce more than 80% of all drugs in the world. Problems arise with supplies to pharmacies and medical institutions.

According to experts from the Institute of State and Municipal Administration of the Higher School of Economics, by the end of October 2020, the supply of 4.5 million drugs was delayed for a total of 216 days. According to Konstantin Golovschinsky, Deputy Director of the Institute of State and Municipal Administration of the Higher School of Economics, the main reasons for the shortage of medicines, in addition to the failure of the labeling system, are problems with public procurement.

In the drug supply market, both in the hospital and outpatient segments, right now we are witnessing an ideal storm: a combination of short-term and medium-term negative trends and problems, "Golovschinsky's words are quoted by Vedomosti.

On October 27, 2020, the Ministry of Industry and Trade transferred the labeling system to a notification mode of operation until market participants are fully ready for it.

As the head of the department Denis Manturov admitted, drug distributors and a number of pharmacy organizations were technically not ready to work with labeled drugs, which, against the background of increased demand, led to the disappearance of drugs from pharmacy shelves. The notification procedure significantly softened the situation.

Yusupov, deputy general director of the labeling system operator CRPTRevaz, told the publication that they have already reduced the interaction time between their own and customs systems. According to him, from October 27, 2020, errors in the system are automatically corrected.^[10][11]

Business complained to Mishustin about the drug monitoring system

In October 2020, the Association of International Pharmaceutical Manufacturers (AIPM), the Association of Russian Pharmaceutical Manufacturers (ARFP), Rosmedprom, the Association of Manufacturers of Pharmaceutical Products and Medical Devices (ACE), the All-Russian Union of Public Associations, the National Pharmaceutical Chamber, Infarma, SoyuzPharma, the Association of Independent Pharmacies and the Russian Association of Pharmacy Chains sent a letter to Prime Minister Mikhail Mishustin, Chairman of the Federation Council Valentina Matvienko and Chairman of the State Duma Vyacheslav Volodin, in, in which complained about the failure of the information system for monitoring the movement of drugs for medical use MDP)

Business, as Forbes writes with reference to this document, pointed to the "catastrophic inoperability" of the drug tracking system and demanded operational solutions to "prevent the collapse of the drug supply system," which is fraught with "the most negative consequences."

The functioning of the distribution chain is actually paralyzed, failures in the acceptance of goods, their release and movement to the end user increase avalanche-like. Warehouses of distributors and manufacturers, quarantine zones of pharmacy organizations are overcrowded, many manufacturers are forced to stop supplies, products stand without movement along the entire chain, all participants bear additional significant costs, and pharmacies cannot issue labeled drugs to patients, the authors of the appeal note.

On October 24, 2020, the head Ministry of Industry and Trade Russia Denis Manturov announced that the digital drug labeling system in Russia is temporarily being transferred to a notification mode of operation in the pharmacy and distribution line. Changes in the rules for the sale of drugs are being introduced temporarily due to "insufficient technical readiness of distributors and a number of pharmacy organizations to work with labeled drugs," he said.^[12]

Moscow pharmaceutical plants have introduced mandatory labeling systems

Pharmaceutical plants in Moscow completed testing in a timely manner and introduced drug labeling systems, which became mandatory from July 1, 2020. This was announced on July 6, 2020 by the Moscow DIiPP.

Since the beginning of 2020, the Moscow pharmaceutical industry, which employs 15 large and medium-sized enterprises, has shown significant growth. From January to April, pharmaceutical plants produced and sold drugs and medical materials for 54 billion rubles, which is 52% more than in the same period in 2019. From July 1, all pharmaceutical enterprises are obliged to work according to the new rules, while large players have introduced a mandatory labeling system even ahead of schedule, "said Vladimir Efimov, Deputy Mayor of Moscow for Economic Policy and Property and Land Relations.

Labeling is necessary for the transfer of data on the movement of drugs - putting drugs into circulation, moving them from the manufacturer to the supplier and then to the pharmacy, temporary withdrawal from circulation and other operations.

{{quote 'The changes will allow patients to track the origin of the drug product and be sure of its quality, manufacturers, distributors and pharmacy chains will be able to optimize the procurement process, healthcare organizations will be able to increase the effectiveness of drug provision to the population. Moscow pharmaceutical plants meet all the requirements of modern and high-quality production of drugs, most of them began preparations for the introduction of the system back in 2019, "said Alexander Prokhorov, head of the Moscow Department of Investment and Industrial Policy. }}

The international independent pharmaceutical company Servier has timely completed a series of testing and validation procedures for traceability systems for the movement of medicines produced at the plant in Russia: since the launch of the system, the company has already produced more than 1 million labeled packages, most of which are drugs for the treatment of cardiovascular diseases and diabetes.

Mandatory digital labeling of drugs entered into force in Russia

On July 1, 2020, the mandatory digital labeling of drugs in Russia came into force. The circulation of unmarked drugs is possible only for special cases after coordination with Roszdravnadzor.

Exceptions may only be made for medicinal products with the exception of medical products intended to provide individuals with hemophilia, cystic fibrosis, pituitary nanism, Gaucher's disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, individuals after organ and tissue transplantation. Such drugs must be produced outside the Russian Federation by October 1, 2020.

To determine whether to allow the circulation of unmarked drugs, a special interdepartmental commission is being created under Roszdravnadzor. It will include representatives of the Ministry of Health, the Ministry of Industry and Trade, the Federal Customs Service, the FAS and the monitoring system operator.

It will be possible to obtain permission to enter into civil circulation in the personal account of the holder or owner of the registration certificate in the automated information system of Roszdravnadzor. It will be necessary to attach a justification to the package of documents for the impossibility of applying identification means to the packaging of the drug product, including at the customs warehouse, as well as an action plan for the implementation of the monitoring system with an indication of the final date of the manufacturer's readiness.^[13]

According to the general director of the ARFP Viktor Dmitriev, manufacturers fear the accompanying introduction of labeling of the shortage of drugs in the country.

We still cannot finish commissioning due to the fact that foreign specialists whose equipment we use cannot come to the country. Until now, we do not understand when the borders will be opened. That is why we asked to move the timing of the introduction in order to calmly start, "Dmitriev explained.

Ministry of Health of the Russian Federation: vaccines against coronavirus will be subject to digital labeling

Vaccines against coronavirus COVID-19 Russia in will be subject to digital labeling. This was announced on Center for the Development of Promising Technologies June 25, 2020 by the deputy head of the digital development department information technology Ministry of Health and Evgenia Merkulova. More. here

In the system of digital labeling of drugs may introduce a moratorium on violations

On June 24, 2020, it became known that a moratorium on prosecution for violations may be introduced for participants in the digital labeling system, which will become mandatory for medicines, shoes and tobacco from July 1. This was stated by Vera Volkova, Director of the Department of General Business Analysis of the Center for the Development of Advanced Technologies (CRPT), during an online conference on labeling organized by the Chamber of Commerce and Industry of the Russian Federation. Read more here.

Servier has completed testing of the drug movement labeling and traceability system

On June 18, 2020, Servier announced that, together with its logistics and information systems partner, Santance Service, it had completed validation of the processing and distribution of serialized drugs on the 3PL (Third Party Logistics) platform. During PQ testing in the production environment, the processes of acceptance, in-house operations and shipment were checked. As a result, Servier delivered a batch of medicines to the warehouse of the distributor FC PULSE.

According to the company, at each stage, including acceptance by the distributor, data on drugs were transferred to the MDLP system thanks to the CHECK, TRACK&TRACE (CTT) IT solution used. Read more here.

Pharmaceutical Company Norman has introduced an integration module with FSIS MDLP in the warehouse

On June 16, 2020, the company InStock Technologies announced that it had introduced an pharmaceutical LLC "Norman" integration module with MDLP to the company's warehouse to InStock FSIS work with Mandatory labeling. drugs More. here

The Russian division of Italfarmaco is ready to send messages to the IS MDLP

On June 9, 2020, Utrace announced the completion of the implementation of a cloud solution for integrated product labeling management L4 Utrace Hub in ITF LLC (Russian division of Italfarmaco). The launch of the first batches is expected in September 2020, the system is fully ready for their processing and sending messages to the IS MDLP. Read more here.

Small Business Mobile Application Development

On May 27, 2020, the Center for the Development of Advanced Technologies (CRPT) announced its investment in the development of a mobile application designed to work in the drug labeling system. This was reported by TASS with reference to the press service of the company.

The CRPT has invested in creating a service that allows you to work in the drug labeling system through the web interface, as well as smartphone replaces a 2D scanner with its mobile application. How much money was spent on this project is not specified.

The solution is intended primarily for market participants who do not have equipment, including 2D scanners and commodity accounting systems, or commodity accounting systems are not integrated with the drug movement monitoring system (MDLP).

The CRPT described the principle of operation of the service. The web application opens in a browser and performs several functions: receiving documents from other participants of the FSIS MDLP, forming, signing and sending documents. Documents are created in a human-readable form, and values ​ ​ can be selected from reference books, so you can fill in documents in literally one click. Most importantly, you can download a mobile application with a 2D scanner function: it scans Data Matrix codes on drugs that are substituted into the desired document.

According to the press service of the CRPT, a request for such a service was received from medical organizations with a relatively small volume of drug turnover, including dentistry, small medical organizations and sanatoriums.

There will be no additional burden on these representatives of small businesses - the service is free, operations are as simplified as possible, - the press service quotes the words of the head of the Pharma group of the CRPT Sergei Kholkin.[14]

Postponement of mandatory drug labeling

On May 28, 2020, it became known about the postponement of the introduction of mandatory labeling of medicines Russia due to the coronavirus pandemic., And COVID-19 Ministry of Health Roszdravnadzor Ministry of Industry and Trade sent a document to the State Duma, from which it follows that the departments are working on a proposal for a new date for the launch of the project.

According to the authors of the document, by the end of May 2020, due to the difficult epidemiological situation, there is a risk that the subjects of circulation of drugs will not be able to prepare for the introduction of labeling on time, RIA Novosti reports.

One of the main reasons is the delay in the adjustment of equipment and software due to the impossibility of the arrival of technical specialists, as well as the delay in the supply of the equipment itself for marking by means of identification, the Ministry of Health says.[15]

The circulation of drugs without digital codes should be prohibited in Russia from July 1, 2020, while unmarked drugs that entered circulation before that time can be sold before the expiration date.

The CRPT (labeling system operator) does not discuss postponing the mandatory labeling of drugs, said Revaz Yusupov, deputy general director of the CRPT. According to him, no such letters or proposals have been received from regulators to the company. The system is ready for traceability of all drugs from July 1, which was proved by recent testing with a load 10 times higher than the annual turnover of drugs, Yusupov said.

It makes no sense to postpone the deadlines: most of the participants in the turnover are ready, 98% of Russian and 83% of foreign manufacturers are connected to the system, almost all budget medical organizations, pharmacies and distributors, he continues. The CRPT believes that the next transfer will be discrimination for most market participants.

Pharmaceutical and medical companies in Russia will be able to obtain licenses only after connecting to the digital labeling system

On May 18, 2020, the Government of the Russian Federation approved a decree according to which pharmaceutical and medical companies in Russia will be able to obtain licenses only after connecting to the digital labeling system.

Even if you use just one drug in your activities, you are a subject of drug circulation and must be connected to the system. And you must work in this system, receive medicines, promote them through the system, withdraw them from the system, "explained Valentina Kosenko, deputy head of Roszdravnadzor.

The document of the Cabinet of Ministers of the Russian Federation, published on the official Internet portal of legal information, supplements the list of licensing requirements for the licensee in the implementation of activities for the production of medicines with the following paragraph: "registration in the system for monitoring the movement of drugs for human use." The decree will enter into force on July 1, 2020, when mandatory labeling of drugs should work (it has been repeatedly postponed).

Earlier, the Association of Russian Pharmaceutical Manufacturers sent a letter to the Chairman of the State Duma Vyacheslav Volodin with a request to postpone the launch of the introduction of mandatory labeling of drugs. The restrictive measures introduced against the background of the spread of coronavirus (COVID-19) infection make it difficult to complete equipment testing and train specialists, market participants say.

By May 19, 2020, drug manufacturers supplying products to the Russian market have labeled more than 1 billion goods since the beginning of the labeling experiment in the industry. Since the beginning of 2020 , 3.3 times more codes have been issued than  in three years since the start of the system, the press service of the labeling operator Center for the Development of Advanced Technologies (CRPT) told TASS. From ^[16]

Increase in the number of participants in the circulation of drugs by 21%

On March 27, 2020, it became known that the Center for the Development of Promising Technologies, the operator of the drug labeling and tracing system (MDLP), reported a significant increase in the rate of registration of pharmaceutical and medical organizations in the MDLP system.

Since the beginning of 2020, 9,691 drug turnover participants have joined the MDLP system, an increase of 21%.

As of March 2020, more than 56,000 organizations with a license for medical or pharmaceutical activities, including more than 14,000 pharmacies, have been registered in the MDLP system in all regions of Russia.

The average rate of registration in the MDLP system is from 200 to 500 organizations per week. As the date of mandatory drug labeling approaches, the pace is increasing. In February 2020, the CRPT recorded a fivefold jump in registrations - up to 2000 thousand organizations per week.

Together with Roszdravnadzor, we are actively working on connecting medical institutions to the system, " said Sergey Kholkin, head of the Pharma commodity group[17]

Biocad implemented drug labeling system and set up interaction with FGIS MDLP

On March 25, 2020, SAP CIS announced that Biocad has implemented the SAP Advanced Track and Trace for Pharmaceuticals (ATTP) SAP Track & Trace system for labeling and tracking the movement of medicines in accordance with the requirements of Russian legislation. The implementation partner was 3Keys.

The implementation of the system allowed the company to ensure the daily formation of regular reports on the production and movement of serialized products, set up interaction with the FSIS MDLP/GIS "Marking" to request and receive marking codes, and implement integration with partners in tracking serialized products. Read more here.

72% of drugs in Russia are registered in the Honest Sign labeling system

The data of the Honest Sign digital labeling and product tracking system confirm the high readiness of the pharmaceutical industry to introduce mandatory drug labeling. This became known on February 10, 2020.

As of February 5, 2020, 6872 names of drugs were registered in the drug labeling system, which is 72.4% of the average number of names of drugs that applied to the Russian Federation in 2018 and 2019, according to Roszdravnadzor.

According to the open online catalog of drugs of Roszdravnadzor - ESCLP - a total of 15,824 registration certificates for various names of drugs were issued in Russia. However, according to the information service of Roszdravnadzor "Information on medicines received in civil circulation in the Russian Federation" for 2018 and 2019, only 9482 items were applied (produced and imported) from this number in Russia.

Four months are left before the mandatory labeling of drugs comes into force. At this time, the CRPT plans to hold a series of training events for the industry together with partners. Our task is to ensure that labeling simplifies the handling and accounting of drugs for pharmacies and medical institutions and gives patients confidence in the originality and quality of drugs. Together with the Ministry of Health and Roszdravnadzor, the CRPT will conduct explanatory work with manufacturers and importers in order to ensure 100% registration of drugs in circulation in the labeling system, said Dmitry Alkhazov, General Director of the CRPT operator

The pilot project for monitoring the movement of drugs started on February 1, 2017. A phased transition to the labeling of all drugs was established from January to July 2020. From July 1, 2020, drug manufacturers and importers must apply a digital code to each package. and all participants in the turnover are obliged to transfer data on the movement of labeled drugs at each stage of their passage along the distribution chain to the labeling system.

Drugs manufactured before July 1, 2020 are allowed for storage, transportation, issue, sale and transfer without marking until their expiration date^[18].

2019

Implementation of the Marking project in Nanolek

• Potential use of MDLP data
• Main article: Nanolek

Sanofi Experience Implementation of Reporting System in IS MDLP

The purpose of the local project is comprehensive automation of the reporting process in IS MDLP, including import, domestic production, organization of data exchange with 3PL and CMO.

Organization of project work in Sanofi

• Cross functional local project involving Supply Chain, IT, Regulatory, Quality.
• Global Core Model T&T covering L1 L4 levels
• Global program to implement Core Model T&T at all manufacturing sites.
• Interaction with CMO through the global service provider.

Main article: Sanofi Russia (Sanofi)

Servier Rus launched a drug labeling and traceability system

On December 26, 2019, the company SERVIER RUS"" announced that it had launched marking system the traceability of medicinal drugs. The launch took place earlier than the deadline established by law - the first batches of labeled drugs will be produced in December 2019. More. here

Kurgan plant "Synthesis" completed integration with the labeling system

On December 25, 2019, OAO Sintez announced that, together with Italian developers of marking equipment, Antares Vision had introduced the DataMatrix digital drug labeling system into the production process. The equipment was launched at the packaging area of ​ ​ the ready-made dosage forms workshop, the labeling was applied to the batch of Ibuprofen. Read more here.

Digital labeling of drugs reduced their illegal circulation by 2.5 times

Digital labeling of drugs has significantly reduced their illegal circulation, Deputy Minister of Industry and Trade Viktor Yevtukhov said in December 2019 at a press breakfast at the Rossiyskaya Gazeta media center.

In the process of the experiment, market experts and Roszdravnadzor said that thousands of companies have already registered for medicines, millions of codes have been received, and they already see a 2.5-fold decrease in illegal circulation. And, according to the estimates of the Biocad company, for important oncological drugs, they significantly noted a decrease in the appearance of uncertified drugs, "he said.

According to him, there will be no fee for labeling drugs related to vital and costing less than 20 rubles for packaging.

Viktor Yevtukhov also noted that thanks to this project, it will be possible to control the entry into the market of medicines that are received as part of public procurement by state institutions. The circulation of such falsified and counterfeit medicines will not be possible, he assured.

Mandatory labeling of all medicines in Russia, as previously assumed, will begin on January 1, 2020.

At the same time, on December 11, 2019, the State Duma approved in the second reading a bill on the stage of introducing mandatory labeling of drugs, extending the transition period for six months - until July 1, 2020.

On October 1, 2019, digital labeling and tracking of drugs started in Russia: a unique digital code is applied to each package of drugs intended for the treatment of high-cost nosologies, information on the movement of these drugs along the commodity chain is transmitted to the system at each stage. This will guarantee the authenticity of drugs and trace them from production to dispensing to the patient.^[19]

Testing IS MDLP with solutions of the "First BIT" for clinic automation

The international integrator of IT solutions "First Bit" on November 22, 2019 announced that it had tested its software products for clinics with the participation of the Center for the Development of Advanced Technologies (CRPT) - a single operator of digital marking "Honest Sign." CRPT experts confirmed that the systems "BIT. Management of the medical center" and "BIT. Tomatology" are guaranteed to work with the state system for monitoring the movement of drugs (MDLP). Read more here.

Drug labeling system not ready for full launch

The Russian Union of Industrialists and Entrepreneurs (RSPP) appealed to Prime Minister Dmitry Medvedev and State Duma Speaker Vyacheslav Volodin with letters stating that the drug labeling system was not ready for implementation on January 1, 2020. Both letters were signed by the President of the Russian Union of Industrialists and Entrepreneurs Alexander Shokhin, RBC reported on October 8, 2019.

According to the Russian Union of Industrialists and Entrepreneurs, by September 1, 2019, more than 28 million packages of 5370 drugs were marked. Upon completion of the implementation, the labeling system will have to track about 6.5 billion packages of drugs and cover over 1,000 manufacturers.

Despite the "large amount of work" on the preparation for the implementation of labeling from January 1, 2020, the letter notes "objective circumstances" that prevent the completion of its implementation. Among them are a significant increase in labeling defects, a "sensitive increase" in the cost of drugs, the imperfection of a single directory of drugs, the unresolved exchange of data from labeling participants with the federal information system, negative test results for labeling with 44 crypto code signs from enterprises and other problems.

The above factors do not allow assessing the degree of readiness as high, the letter says.

At the same time, the RSPP declares a "high degree of readiness" for labeling drugs included in the 7 Nosologies program. We are talking about the most expensive drugs for the treatment of genetic and oncological diseases.

In the RUIE, there was "serious concern" about the number of participants registered in the system (about 15% of the planned number), as well as the number of drugs introduced into the system (8% of the estimated volume). This situation, the letters say, speaks of "high risks" for the full implementation of all stages of the system's functioning at the same time from January 1, 2020.

According to information from 228 Russian drug manufacturers cited by the Russian Union of Industrialists and Entrepreneurs, out of 788 production lines, only 45% are fully equipped with labeling equipment.

Among the problems faced during the experiment are manufacturers producing drugs worth up to 20 rubles, applying an identifier with a crypto code of 44 characters.

In this case, the problem can be solved by embedding a code of 20 characters, the letter suggests.

RSPP notes that this will allow the use of existing equipment without replacement or revision.

Refinement, according to the Union of Industrialists and Entrepreneurs, is also required by the Unified Directory of Medicines. It does not contain some drugs contained in the State Register of Medicines, which led to the impossibility of their registration.

Among other problems, the letter cited the lack of regulatory legal acts that would provide for a mechanism to include payment for the provision of labeling codes, the unresolved exchange of data with the information system and the lack of IT solutions to eliminate this problem.

Roszdravnadzor explained that as of October 2019, a scheme has been developed for the interaction of monitoring the movement of drugs and the Unified Classifier of Drugs.

The labeling system will receive correct information, and the time for the establishment of data on drugs will be significantly reduced, says advisor to the head of Roszdravnadzor Olga Maleva

According to her, market participants insist on strict compliance with the deadlines and "oppose the postponement of the launch of the project."

Dmitry Alkhazov, general director of Operator-CRPT (operator of the digital labeling system), also announced the proposed scheme of interaction between the labeling system and a single classifier of drugs. According to him, direct integration will remove current inconsistencies. Alkhazov rejected the problem of raising marriage beyond the norm, which the RSPP speaks about in a letter.

The sites are located both in Russia and abroad, 1.8 million packages of drugs have already been released with a cryptographic part of 44 characters, - explained the general director of the labeling operator, adding that the company is responsible for its implementation on time.

The Ministry of Industry and Trade said that they are constantly working with drug manufacturers, including about the difficulties and problems in introducing a monitoring system. The ministry noted that according to the results of testing, the crypto code was reduced to 44 characters and manufacturers achieved high print quality and low scrap levels.

The deadline for the implementation of the monitoring system is established by law as January 1, 2020. Until October 2019, the issue of changing the deadlines was not discussed, the ministry stressed.

Chief information officer of Protek CV Viktor Gorbunov announced the technological readiness of the company. According to him, the level of readiness of large networks is quite high. Viktor Gorbunov believes that it is not worth postponing the marking period.

The project has been going on for three years, the industry is tired of expectations. It should be launched from January 1. In the first six months, all issues will be resolved in working mode, and everything will work as it should, - he is optimistic.

Evgeny Nifantyev, general director of the Neopharm network, agrees with him.

Still, they knew that January 2020 would come. Who has not yet had time to connect - hands in feet, and turn on. There is no need to deceive yourself by postponing, you need to prepare a sled in the summer, "he said.

Another market participant, President of Akrikhin Denis Chetverikov, sees a negative scenario if the date of the introduction of labeling is postponed.

After all, then it turns out that all those costs, both financial and temporary, that we incurred, will be unjustified. And we are not the only Russian company that is at a high level of readiness. If there are market participants who did not have time to do everything on time, it is their fault. The postponement will create an unfair situation[20], concludes Chetverikov

MDLP IE testing with 1C solutions

On February 4, 2019, the Center for the Development of Advanced Technologies (CRPT) and 1C announced joint testing of updated versions of 1C: Retail software products . Pharmacy, "" 1C: Pharmacy network management "and products of the" 1C: Medicine "line with support for the information system for monitoring the movement of drugs (IS MDLP).

In order to develop the IS of MDLP, the current versions of the software as of February 4 were optimized and new business processes implemented in the system were improved, including taking into account the proposals of participants in the circulation of medicines.

The most important update is the possibility of unhindered movement of drugs between registered and unregistered participants in the turnover. Now registered participants do not need to wait for their counterparties and partners to register in the system, and it is possible to fully automate their business processes taking into account labeling. This opportunity significantly reduces the timing of the introduction of the marking and traceability system both in individual companies and in the industry as a whole, the CRPT emphasized.

1C solutions use a dedicated library to integrate with MDLP. It allows you to ensure the unity of methodological and interface solutions, as well as timely support for changes. Based on the documents warehousing generated in program 1C, documents are created for data transfer to the FGIS MDLP system. This allows you to organize data exchange with FGIS MDLP without double input. data

This integration library can be used by all developers on the 1C:Enterprise 8 platform, which will allow them to quickly support FGIS MDLP not only in the solutions produced by 1C itself, but also in numerous developments for the pharmaceutical market offered by 1C partners and independent developers, the CRPT said.

Now registered participants in the experiment, thanks to the appropriate functionality, can report that they are selling drugs to a turnover participant who is not registered in the system. The presence of a wide range of domestic software specially designed to automate the drug labeling process gives participants in the pharmaceutical market all the possibilities for successful preparation for the start of mandatory labeling, "said Anton Kharitonov, head of the Pharma product department of the CRPT.

2018

How will the drug labeling system work in Russia

In December 2018, the Prime Minister Dmitry Medvedev signed four documents - three decrees and one executive order - which defined the procedure for implementation Russia marking systems in and tracking. medicines The documents will make it possible to implement the changes made in December 2017 to the Law "On the Circulation of Medicines." The resolutions are dated December 14, the order - December 18. The texts of the documents can be found on the website. governments

The first decree enshrines the provision on the drug monitoring system. In accordance with the document, drug manufacturers must apply special identification tools to their primary and secondary packaging, and their carriers, distributors, sellers, etc., must enter information about drugs into the system for monitoring the movement of these goods. Such labeling becomes mandatory from January 1, 2020.

According to another decree, the data contained in the monitoring system for the movement of drugs should be published on the Internet "including in the form of open data." The resolution comes into force on October 1, 2019.

According to a government order, LLC "" became the operator of the drug movement monitoring system. Operator-CRPT The CRPT should become the operator of a unified system for labeling goods, which is planned to be created in Russia by 2024.

The latest decree concerns the peculiarities of creating a system for monitoring the movement of drugs. In accordance with the document, all legal entities and those SP involved in the circulation of drugs against hemophilia, cystic fibrosis, pituitary cord, Gaucher's disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis as well as those used after transplantations organs or tissues, must register in the monitoring system from 1 to 8 July 2019. In the future, if a new legal entity begins to participate in the circulation of such drugs, it will have seven days to register.

As explained on the government website, vital and essential medicines, as well as medicines for the treatment of rare diseases, should be included in the monitoring system in the first place. As the prime minister noted at a meeting of the government commission on digital development, these are quite expensive drugs, in addition, there are not very many of them.

Within 21 days after registration in the monitoring system, these legal entities ensure their readiness for information interaction with the system and send an application to the system operator to undergo appropriate testing. Then, within two months after testing, they enter drug information into the monitoring system - starting from October 1, 2019.

According to the same decree, drug manufacturers who are engaged in their packaging, and other owners of registration certificates of medicines, must send an application to the monitoring system operator for a device for registering the issue of drug identification devices and gaining remote access to these devices. This should be done within 21 days of registration with the monitoring system.

In the same period, those participants in the circulation of drugs who do not sell them at retail, but release them for free or at a discount, thus withdrawing them from circulation, must apply for disposal registrars.

For its part, the monitoring system operator must provide applicants with devices for registering the emission of drug identification tools. This can be done by providing remote access to such a registrar located in the infrastructure of the operator himself. The operator is also responsible for providing applicants with disposal registrars. Registrars must be provided within 30 days from the date of receipt of applications. Applicants conclude agreements with the operator "containing, among other things, the conditions for the provision of such equipment and its scheduled maintenance free of charge."^[21]

Transfer of FGIS MDLP to Honest Sign platform

On November 1, 2018, the information system for monitoring the movement of drugs (IS MDLP) passed from the Federal Tax Service of the Russian Federation into a single national system for labeling and tracing goods "Honest Sign." The system operator was the Center for the Development of Advanced Technologies (Operator-CRPT).

As told in the CRPT, the services necessary for the participants of the drug labeling experiment were transferred and opened to the Честныйзнак.рф website at 00:00 (Moscow time) on November 1 from the FTS website. The migration of the system was carried out in accordance with amendments to the Decree of the Government of the Russian Federation of 24.01.2017 No. 62 "On Conducting an Experiment on Labeling with Control (Identification) Signs and Monitoring the Circulation of Certain Types of Drugs for Human Use."

Thanks to the well-organized interaction with the Federal Tax Service, we are confident that the transition to a single national system will take place seamlessly and imperceptibly for market participants. After the transition, the interface, the functionality of the personal account of the participants in the experiment, as well as the algorithms for working in it have not changed. All information in the participant's personal account is also completely saved, - noted in the CRPT.

CRPT is the operator of a single national system of digital labeling and traceability of goods "Honest Sign" and, as of November 6, 2018, is already conducting pilot projects for labeling tobacco products and shoes.

At the same time, the CRPT is in constant dialogue with the pharmaceutical business, holds meetings with pharmaceutical associations, arranges educational webinars and seminars. The center has already developed and launched a deployed testing program for equipment, technological and business processes of enterprises. Its purpose is to ensure full compliance with the requirements for the serialization and aggregation of medicinal products in production.

Project dates: October-November 2018

5.5 thousand participants and 700 drugs registered

As the deputy head of Roszdravnadzor Valentina Kosenko said on May 15, 2018 in St. Petersburg within the framework of the Russian Pharmaceutical Forum, the labeling of drugs already at the pilot project stage confirmed its effectiveness. In particular, individual labeling at the pilot project stage made it possible to identify offenses totaling over 500 million rubles. In addition to identifying "re-stuffing," the introduction of labeling provides counteraction to the illegal production of medicines, their illegal import and circulation, prevents unfair competition in the field of drug trafficking, and also allows you to standardize and unify procedures for accounting for the supply and distribution of drugs.

In total, as of May 2018, more than 5.5 thousand participants and 700 drugs were registered.

Vladislav Shestakov, Director of the State Institute of Medicines and Good Practices of the Ministry of Industry and Trade of the Russian Federation, commented on the interim results of the transition to drug labeling: "By 01.01.2020, 99% of licensees are expected to be connected to the monitoring system. 5 enterprises (1% of the total) do not have time by the deadline and plan to connect the system during 2020. It is obvious that the introduction of labeling will continue after 2020, however, according to the manufacturers, all drugs of paramount importance from the lists of 7VZN and HLVLNP will be in the monitoring system exactly by the end of the Pharma-2020 program.

The number of poor-quality drugs in the network has halved

In January 2018, the head of Roszdravnadzor, Mikhail Murashko, said that in 2017 the number of poor-quality products and drugs on the network more than halved.

Offenses were identified that are related to illegal sale on the Internet. A large number of criminal cases were opened both for falsified and poor-quality, unregistered products: medical devices and drugs, - RIA Novosti[22] quoted Murashko as[23] of[24].

Earlier in January, he also reported that thanks to labeling, it was possible to identify crimes in the field of circulation of drugs in the amount of more than 100 million rubles^[25].

Mikhail Murashko also predicted that by the end of 2020 in Russia counterfeit and falsification in the licensed network of pharmacies will not fall at all.

According to the Federal Tax Service (FTS), since the beginning of the experiment in February 2017, as of January 2018, about 1,000 of the largest representatives of the pharmaceutical industry have been registered in the drug labeling system and about 3.5 million packages of drugs have been labeled^[26]

Prolongation of drug labeling experiment

In January 2018, the chairman Government of the Russian Federation Dmitry Medvedev signed a decree extending the experiment on labeling certain types of drugs until December 31, 2018.

Later, the head of Roszdravnadzor Mikhail Murashko explained that an increase in the time for an experiment on drug labeling would allow drug manufacturers to better prepare^[27] of ^[28] on^[29].

Deputies of the State Duma considered it necessary to extend the implementation period (marking system) by one year... this, of course, will give an additional time period for the preparation of all manufacturers and pharmacy organizations, - RIA Novosti quotes Murashko.

2017

Postponement of mandatory labeling to 2020

In December 2017, State Duma deputies changed the term for mandatory labeling of drugs - from 2019 to 2020. Manufacturers asked for time until 2023^[30]. Earlier in November, ten manufacturers of inexpensive drugs appealed to the speaker of the lower house of parliament Vyacheslav Volodin with a request to postpone the introduction of labeling.

They insisted that its introduction from 2019 will lead to the disappearance of inexpensive drugs, since they do not have time to purchase special equipment, and many of them do not have enough funds for it.

Rostec launch of drug labeling equipment

As part of the development of "digital" healthcare, Rostec State Corporation announced on October 16, 2017 the launch of serial production of equipment for labeling drugs. The Center for the Development of Advanced Technologies has been appointed the project operator. The volume of investments in the project, according to the industrial director of the radio electronic cluster of the State Corporation Rostec Sergei Kulikov, exceeded 20 million euros.

The production process involves the capacities of two enterprises of the Avtomatika concern, where 8 types of equipment will be produced, designed for serialization, aggregation and application of control signs. In the future, it is planned to deploy a service and repair base on the basis of these plants.

As explained in Rostec, the equipment being created is still focused only on the drug market. It is expected that it will allow you to control the origin of drugs and identify poor-quality, counterfeit products on the shelves of pharmacies - using a special protective mark on the packaging. However, the technical competencies that the Avtomatika concern will receive during the localization process will further allow creating similar equipment for other product groups.

As you know, foreign equipment used for labeling drugs is more expensive and costly to operate. In localized equipment, a significant part of the technical elements and components will be of Russian production, which will reduce its price and cost of ownership. In particular, according to Sergei Sakhnenko, General Director of Avtomatika, the solutions produced by the concern will be about 40% cheaper than their foreign counterparts.

He also pointed out that as of October 16, 2017, the process of creating and testing pilot samples, as well as formalizing design documentation, has been completed, while the start of mass production is scheduled for December 2017.

During 2018, it is planned to put on the market up to 1200 different sets of marking equipment for pharmaceutical manufacturers and distributors of labeling products, added Sergei Kulikov.

Mandatory labeling of drugs

Mandatory labeling of 100% of medicinal products will be introduced from January 1, 2019 as part of the priority project "Introduction of an automated system for monitoring the movement of medicines from the manufacturer to the end consumer to protect the population from falsified medicines and promptly remove counterfeit and poor-quality drugs from circulation."

The monitoring system will track about 8 billion packages of medicines per year and, presumably, will cover over 350 thousand participants in the turnover, including about 1 thousand domestic and foreign manufacturers of medicines, more than 100 thousand medical and 250 thousand pharmacy organizations.

Since January 1, 2017, labeling of medical products in Russia has been carried out voluntarily, on an experimental basis.

Start of the program

On January 30, 2017, Prime Minister Dmitry Medvedev, during a meeting with Deputy Prime Ministers, announced the signing of a document that launches the mechanism for labeling drug packages with special codes. According to him, this is part of the work to counter the turnover of counterfeit, counterfeit products.^[31]

It is absolutely obvious how important it is to trust the safety and quality of drugs so that the drugs are real, not fake. Today we initiated the creation of a special automated system that will allow tracking all stages of the movement of these products: from the manufacturer to the pharmacy or hospital. As a result, any person using a special device, a scanner in a pharmacy or his smartphone, if he has such a program installed there, will be able to check the origin of the package, make sure that it is legal, and not some fake products, - said the prime minister.

However, before introducing such a system throughout the country, it is necessary to test its capabilities, identify potential problems, and already based on the results of the experiment, decide on the mandatory labeling for all market participants - manufacturers, distributors, and a pharmacy chain, Medvedev added.

According to Deputy Prime Minister Arkady Dvorkovich, the direct executors of the work are Roszdravnadzor and the Federal Tax Service - in terms of the information system. The participants will ultimately be all medical institutions, all trade organizations, as well as manufacturers of medicines and distributors. 100% of the drugs produced are about 6 billion packages.

The principle is that tracking during the circulation of medicines will be carried out regardless of the nature of the package. That is, for example, you do not have to unpack entire large batches to check each specific drug product. Control will be carried out in large packages when passing through the production line, when delivered to wholesale warehouses, to medical institutions and retail chains.

In total, we are talking about about 350 thousand participants in the turnover. This is about a thousand manufacturers (about half - domestic, half - foreign), about 100 thousand medical institutions and about 250 thousand other organizations.

At the first stage, the system will pass the approbation period. Participation in the system will be voluntary for one year. Already, according to Dvorkovich, key manufacturers of medicines, including vital ones, have announced their readiness to participate in this work. Also, the readiness was confirmed by the main distribution networks and a number of major regions, including Moscow. In Moscow, work will begin with Zelenograd, which is part of Moscow and part of the Moscow region.

It will be possible to read the corresponding marks both with your own phones and scanners. Equipment for municipal pharmacies will be purchased by the city authorities. Private pharmacies, when the mandatory period comes, will have to purchase scanners at their own expense.

The advantages of the project, according to Dvorkovich, are primarily that protection against counterfeit turnover, turnover of falsified products will be provided, which means that the manufacturer will benefit. And due to this win, they will be able to remove from their price an additional mark-up, which is being established today in order to insure against the risk of counterfeit products turnover, which means that ultimately the cost and profit of the relevant organizations should not suffer, the Deputy Prime Minister said.

But all this will be tested during the year during the experiment. Preliminary results will be announced on December 1, 2017, he said.

Dmitry Medvedev added that scanners must be tested in a certain way, sealed so that there is a guarantee that there will be no unauthorized penetration and attempts to sell falsified drugs through these scanners.

This is what will be tested in the coming months. This requires a pilot period, - explained Dvorkovich.

As expected, the information system will be ready by June 2017, respectively, all the main actions will be carried out in the second half of the year. Until that time, it is planned to coordinate the actions of all participants in the turnover so that everyone knows how the system functions, what are the consequences of detecting falsified products.

Citizens, as well as patients of medical institutions, will be informed about how this all works. Thus, we hope for a serious, social, including an effect, - added the Deputy Prime Minister.

The consequences should be clear: if a falsified drug is supplied, which, using this scanner or in another way, is defined as a falsification, as a counterfeit drug, an investigation should be initiated - both administrative and, quite likely, criminal, - concluded Dmitry Medvedev.

The experiment on drug labeling is carried out as part of the implementation of the priority project "Introduction of an automated system for monitoring the movement of drugs from the manufacturer to the end consumer to protect the population from falsified drugs and the prompt removal of counterfeit and poor-quality drugs from circulation," the passport of which was approved at a meeting of the Presidium of the Presidential Council Russia for Strategic Development and Priority Projects on October 25, 2016.

According to the document, in 2017 an experiment will be conducted on a voluntary basis, and in 2018 it is planned to cover 100% of drugs in civilian circulation by labeling.

• By 31.12.2018, it is planned to cover 100% of drugs with individual labeling.
• To meet the requirements, participants in the circulation of medicines must introduce a traceability system at their enterprises with the transfer of information to the FSIS MDLP.
• Functional Customer - Ministry of Health of the Russian Federation
• System Operator - Federal Tax Service of the Russian Federation

1C approach to solving integration problems

A separate library is being developed to support the FGIS MDLP. MDLP support will be added to 1C industry solutions for retail pharmacies, hospital pharmacies, dental clinics, and wholesale organizations.

The library will be available to the entire partner network of 1C, which will make it possible to implement it not only in solutions that 1C itself is being developed, but also in all solutions that are made based on 1C: Enterprise platforms by independent developers.

Total Turnover Control System

• State Information System for Marking Goods
• Counterfeit Goods Monitoring System
• National Commodity Traceability System (NSP)
• CRPT: National Catalogue
• System of accounting (marking) of tobacco products
• Monitoring of Drug Product Movement
• Digital labeling of footwear products
• Mineral and potable bottled water labeling
• Labeling of dairy products
• RFID-labeling of alcohol in Russia
• Perfume labelling
• State system in the field of control over the turnover of precious metals, precious stones and products from them (GIIS DMDK)
• Marking of fur coats and fur products
• Animal labelling

• The Ministry of Health has begun to develop an IT system for controlling drug prices
• 1C: Retail. Pharmacy
• 1C: Pharmacy Chain Management
• 1C: Medicine. Hospital pharmacy
• 1C: Medicine. Dental clinic

• A system of total control of trade turnover is being created in Russia

Notes