In the U.S., the Food and Drug Administration (FDA) has defined standards to secure the drug supply chain. Standardized numerical identification for prescription drug packages is now required. This is serialization.
Serialization entails marking packages with a product identifier (GTIN), a unique serial number, a lot number and an expiration date. The serialization must be done to the smallest packaging level of a product, should it be a box, a vial or a bottle, and all data must be included in a 2D Data Matrix (GS1) data carrier. Learn more about the serialization requirements by reading the HCP Serialization Playbook.
Aggregation is the next logical step and requirement of the DSCSA. All companies that have just finished implementing the serialization process are expected to implement this next critical step by 2023.
Understanding the EU FMD is no easy task, but this impending law will have a significant impact throughout the pharmaceutical and healthcare industries, affecting operations from one end of the supply chain to the other, from manufacturing to dispensing.
Pharmaceutical manufacturers, parallel importers and contract manufacturing organisations (CMOs) will have the obligation to guarantee the authenticity of all prescription drugs by identifying individual packs and checking whether the outer packaging of medicines has been tampered with.
Wholesalers and distributors are obligated to guarantee the authenticity of prescription drugs and identify whether or not the outer packaging of medicines has been altered.
European hospitals and retail pharmacies will then be required to decommission prescription medications using unique identifiers before distributing them to patients.
In Brazil, Law No. 13.410 of 28 December 2016, together with RDC 157 (Resolução da Diretoria Colegiada, Resolution of the Board of Directors No. 157), lays down that the pharmaceutical industry has until April 2022 to implement traceability in its chain of prescribed drugs. This system must be connected to the central database named the Sistema Nacional de Controle de Medicamentos (National Drug Control System, SNCM), created by the Agência Nacional de Vigilância Sanitária (Brazilian Health Regulatory Agency, ANVISA), in order to deliver better quality and safety to the final consumer.
The implementation of traceability occurs through the serialization and aggregation of the products. This means that drugs will receive a unique identification printed on the packaging, known as the “Identificador Único de Medicamentos” (“Unique Drugs Identifier”, IUM). The IUM is made up of:
The Russian Federal Law No. 425-FZ (decree No 1556) states that in order to track supply chain activity, certain pharmaceutical products must be serialized by January 1, 2020. Unlike the EU’s serialization requirements under FMD, Russian regulations apply to a wider range of pharmaceutical products. These include:
Reporting of serialized products takes place through a centralized database called the Federal State Information System for Monitoring Drug Circulation (FSIS MDC). Manufacturers must onboard with the FSIS MDC and report all serial numbers and batch numbers to the centralized system. Along with the information required by U.S. and European regulations (a GTIN and serial number), the Russian regulations call for a crypto key (4 characters from the GS1 characters set 82) and crypto code (44 characters: Symbols, numbers, lower and upper-case letters from the Latin alphabet).
Each individual unit must be serialized with a 2D barcode that is placed on the box or bottle. This 2D code contains the following information:
The Drug Administration Law tasked the National Medical Products Administration (NMPA) with establishing unified traceability standards and specifications for drug products. China has then adopted 10 drug traceability standards and specifications to guide relevant parties to jointly build a national Drug Traceability Information System.
The move helps to break down barriers between various independent systems and companies by unifying drug traceability code requirements, standardizing the basic technical requirements for drug traceability systems, defining the content and format of information companies are required to record during the traceability process, and outlining data exchange requirements.
The Fast Track to Serialization Compliance
Requirements and Challenges of Aggregation in the United States.
The Fast Track to Serialization Compliance
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