What is drug serialization?
Serialization of drugs was introduced to increase supervision over their sale and distribution.
Each country, or in in case of EU, block of countries introduced their own regulations related to verification of drugs authenticity.
In EU, the Falsified Medicines Directive (FMD) aims to create a European database system through which pharmacies, wholesalers and other entities that provide medicines to patients will be able to verify the authenticity of medical products before they are issued.Drug manufacturers will be required to add unique identifiers to the European database system that will allow pharmacies to verify the authenticity of each issued drug packaging using the National Medicines Verification System (NMVS).These national systems will be linked together by the European Medicines Verification System (EMVS). Its task will be to transfer data on serialized medical products between EU Member States.
In Russia, the Federal Law no. 425-FZ requires all pharmaceuticals to be serialized, whether it’s prescription or over the counter drug. Russia’s regulations track all products imported into the country and those which are manufactured inside of Russia. The compliance reporting is required at each step of the product’s lifecycle, each logistics step to the point to its final dispensation must be reported to the central government system MDLP. In addition to that, all products at a saleable level must include a cryptographic key and code in their 2D barcodes along with the serial numbers. Crypto keys and codes are provided by the government’s remote emission registrar that ties each code to a separate serial number. The aggregation across 2 levels of packaging hierarchy is also mandatory. The deadline for this Law is July 1st, 2020. After this date, all supply chain participants, including hospitals, manufacturers, importers, retail pharmacies and others must be compliant, otherwise the penalties will be issued. Recent change to the Law allows to import and distribute products that were manufactured and not serialized until December 31st, 2020.
In US, the Drug Supply Chain Security Act (DSCSA) manufacturers are obliged to add serialization data on the packaging at the saleable unit and case level. These should include the serial numbers, which are verified when investigated or sold back into the commercial supply chain. Trade partners need to pass the transaction data at each ownership change including 3Ts; Transaction Information (TI), Transaction History (TH) and Transaction Statement (TS).
In China, the Essential Drugs Lists (2009, 2012) already need to be serialized in China following unique China requirements for serial number acquisition, serial number and product data formatting, and barcode labeling. All drug products will need to be serialized, both domestically manufactured and imported medicines. The Government is targeting 2020 to be the year of most likely phased approach mandate of a track and trace system, which most likely will not be one single system, but multiple ones, with government regulatory agencies having access to all of them to monitor and verify.
In Brazil, the 11.903 law for SNCM (National Medicines Control System) updated with the new las 13.410 set the stage for a full track and trace responsibilities for all drug manufacturers in Brazil. It assumed a phased roll-out between 2017 and 2022.
In India, the DGFT announced the new updated regulations for the aggregation reporting in the Dava portal. Existing regulations pertain to the medicinal products produced in India for export, the proposal for domestic drugs was published, but the dates are not yet confirmed. Serialization is done at the tertiary (case), secondary (saleable unit), and mono-carton packaging levels.
All the above countries, as well as others introduced, or are introducing now some type of serialization of medicinal products.
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Serialization of medicines - our services
We offer consulting and IT services related to drug serialization, helping to find and implement the best solutions. We support our customers throughout the whole serialization process or at its individual stages: