Russia: Mandatory Serialization and Aggregation of Medications
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White Paper Serialization in Drug Production in Russia
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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.
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.
Since July 1, 2020, the labelling and reporting of medications to the state information system has been mandatory.
Video: Counterfeit Protection with Serialization and Track & Trace in Russia
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
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
Your Contacts for Serialization of Medications in Russia