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Russia: Serialization and Aggregation of Medications Becoming Mandatory

Arvato Systems Is Your Strong, Experienced Track & Trace Partner | White Paper Download

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Serialization of drugs

Counterfeit products naturally pose a major problem in the pharmaceutical sector. This affects brand-name and generic products as well as OTC (over the counter) products. Counterfeiters not only bring imitation medication into circulation through non-authorized pharmacies and online portals, but also successfully plant them in the legal distribution chain via wholesalers and the pharmacy network. To this end, counterfeiters falsify sales and supplier documents so that the “medications” are sold to legal wholesalers. Beyond the EU, this dilemma also affects Russia and other countries in the Eurasian Economic Union (EAEU). EAEU member states Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan have currently united to form a domestic market with a customs union. Similarly to the EU nations and the United States, Russia has also developed a system for serializing medication to meet the serialization requirements and regulations.

Fighting Counterfeit Medications in Russia

On January 1, 2019, the law on serializing medication with crypto coding entered into force. This stipulates that serialization will be mandatory by law. The legislation stipulates that legal persons who carry out the manufacturing, import, storage and distribution, sales, use, or disposal of medication in Russia must provide information about these processes in the system designed for this purpose.

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The latest version of the Federal Law “On the Circulation of Medicines” No. 61-FZ with the amendments of 425-FZ and 462-FZ (the later from December 27, 2019) together with the stated resolutions introduced a federal state information system for monitoring the circulation of medicines for medical use within Russian Federation. In order to meet the governmental requirements, pharmaceutical products must have a unique identifier on the packaging. The unique identifier in data matrix format contains next to GTIN and Serial Number centrally provided verification information (“crypto code”). Unlike serialization systems in other countries, such as those in the EU, the Russian system not only requires unique identification codes for labeling each individual package of medication, but also tracks the packages’ every movement across the entire value chain. Aggregating packages in shipping cartons is a crucial prerequisite for making this possible.


With regard to the timeline the transitional period for the mandatory marking and reporting of pharmaceuticals to the state information system is extended  from January 1, 2020 until July 1, 2020.  However, on January 1, 2020 (previously October 1, 2019) marking became already mandatory for preparations from the list of high-cost nosologies.

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White Paper Download: "Serialization of Medications in Russia"

The MDLP system operated by the Russian company CRPT is the only one of its kind in the world in terms of its scope and complexity. The Russian legislature and the numerous guidelines it stipulates pose a great challenge to manufacturing and selling companies. Download our latest White Paper and learn, among other things, details on how crypto code works, helpful background information, and how you can draw on our many years of expertise and proven IT solutions to implement the serialization of medication for the Russian market by the applicable deadline.

Mandatory field

We Support You in Implementing the Russian Track & Trace Requirements

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Implementing the Russian legislation within a company is a complex undertaking. Moreover, the deadline set by the Russian government places companies that want to export goods to countries in the EAEU under enormous pressure. Companies that cannot make changes in line with the currently applicable schedule will no longer be able to export to Russia and the other countries in the Eurasian Economic Union that are taking part in the Markirovka Project. That is why thorough knowledge of the Russian requirements for processes and reporting is necessary to ensure successful compliance.

Arvato Systems Provides It and Process Consulting That Makes Your Medication Counterfeit-Proof

In the healthcare segment, our serialization experts cover the entire process chain with our own, proven serialization solutions. Our standardized, modular IT solutions support the professional implementation of the required processes. Arvato Systems offers the Arvato Corporate Serialization Database (Arvato CSDB), an IT solution that combines the various elements of serialization in the pharmaceutical industry. The solution can be integrated into existing ERP systems and offers interfaces to production lines, suppliers, production facilities, and various verification systems.

The Arvato CSDB maps out a whole range of scenarios particular to medication serialization for Russia, including:

  • Production as a CMO for the Russian market
  • Exporting with and without a representative office in Russia
  • Exporting with a proprietary import and sales organization in Russia
  • International customers with production in Russia

In order to cover the various business models, Arvato Systems offers an IT solution architecture that supports reporting, manufacturing, and logistics processes. The Arvato CSDB represents the core of the Arvato CSDB Russian Pharma Track & Trace Package.

Arvato CSDB Solution Landscape

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Depending on the business model (or combination of business models) used by a pharmaceutical company active on the Russian market, Arvato Systems can combine the various modules into a customer-specific solution package. Each module maps specific processes within the supply chain and supports them. Find out how we use the expertise gained by our international teams from numerous completed projects to support companies in the area of medication protection with the Arvato CSDB serialization solution.


Arvato Systems has also been selected as a National Blueprint Service Provider by the European Medicines Verification Organization (EMVO). Our National Verification Systems have already been successfully put into operation in 17 EU states.

Benefit from Our Experience When It Comes to Successfully Implementing Healthcare Projects in the Russian Market

One of the market leaders in Europe for corporate solutions and national verification systems
Implementation experience: systems for 17 countries and over 70 pharmaceutical manufacturers
Projects completed in Russia
Proven serialization solution Arvato CSDB, which can be adapted to your business model
Can be customized to fit specific requirements
Integrated communication to Russian platforms
Comprehensive implementation of reporting requirements

Press release

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Arvato Systems has been officially named as integration, software and tested solution partner for the Russian Center for Research in Perspective Technologies (CRPT) and was recently added to the CRPT website. We are looking forward to the continued good cooperation!

References (extract)

Serialization

Aenova Group implements the requirements of the Falsified Medicines Directive with the help of the Arvato CSDB IT serialization solution

Safety for patients

Aristo Pharma serializes with Arvato CSDB.

FMD-compliant

Application of the serialization solution Arvato CSDB at Basic Pharma.

Serialization: Efficient & Secure

Bausch & Lomb uses Arvato CSDB for serialization.

Serialization: Each pack is unique

Bluepharma based in Portugal serializes with Arvato CSDB.

Implementation in Record Time

BRIZ Ltd with the help of Arvato Systems compliant with the EU Falsified Medicines Directive regulations in record time.

For health

Protection of medicines at Cesra by serialization solution from Arvato Systems.

Traceability of medicines

Chanelle Pharma serializes with Arvato CSDB.

Serialization in the pharmaceutical industry

Drug protection with the Arvato CSDB with Dr. Falk.

Protection for end users

Serialization for counterfeit protection: Arvato CSDB at Dr. Kade.

Counterfeit proof medicines

Implementation of Arvato CSDB - IT solution for successful drug serialization according to the Falsified Medicines Directive

EU-FMD compliant

Genericon relies on serialization solution Arvato CSDB.

Safe Medicines

Serialization solution Arvato CSDB in use at Gerot Lannach.

Accurate Traceability of Medicines

medac with Arvato CSDB against counterfeit drugs.

Knowing where the drugs come from

Mylan successfully implemented serialization solution from Arvato Systems.

Drug Protection

Pharma Stulln serialized with the Arvato CSDB.

Against product piracy

At the heart of the Netherlands: Royal Herkel serializes with Arvato Systems

Medication safety

Successful serialization in medicine production with the help of Arvato CSDB

Wörwag Pharma

With IT expertise and software solutions, Arvato Systems supports Wörwag Pharma in the implementation of drug serialization for Russia.

Solution for Pharmaceutical Logistics

Arvato Systems uses logistics solution to fulfill FMD at Yusen Logistics.

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Serialization in the pharma industry

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Your Contact for Serialization of Medications in Russia

MA_Carl-Rainer_Stetter_Commerce
Carl-Rainer Stetter
Expert for Counterfeit Protection in the Pharmaceutical Industry