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Russian President Vladimir Putin signed bill № 488-FZ requesting implementation of the serialisation code with a cryptographic part on December 25, 2018. The law became effective on January 1, 2019. The bill was enacted despite concerns expressed by representatives of the AIPM (Association of International Pharmaceutical Manufacturers) about the introduction of the crypto-code in an open letter to the Chairman of the State Duma, Vyacheslav Volodin, on December 12, 2018. AIPM requested a bill content modification to declare the cryptographic part in the datamatrix code as optional, referring to technical difficulties as a main reason. The crypto-code, in its current form, contains much more data than comparable datamatrix codes that affects exports to the EU or states of the Eurasian Economic Union EAEU. However, the bill was approved unchanged. Serialisation will be mandatory for all medicines as of January 1, 2020.
MORE PRODUCT GROUPS TO BE SERIALISED
In the course of the coming year, various product groups are to be serialised for traceability purposes. The new law requires implementation of serialisation activities in a uniform national system. At present, this system provides for 12 different product groups which will require serialisation. In addition to pharmaceutical products, the system also covers shoes, clothing, tobacco, and alcohol. In the long term, the system will cover all products.
Russian serialisation code will consist of two parts. The first part is used for unique identification, "identification part", and consists of a GTIN and a serial number. The second part is for control and verification, "verification part", and is a sequence of characters formed as a result of a cryptographic transformation of an identification code. These cryptographic characters are intended to expose counterfeit codes during their verification. The challenge lies in the size of the verification part. Due to the cryptographic transformation, the data set to be coded more than doubles compared to the GS1 datamatrix used in the European Union.
The system provider is responsible for successful introduction of serialisation and clarification of any details as well as administration and evaluation of the resulting data. Until November 2018, the system was operated by the Ministry of Taxation of the Russian Federation. Since then, the new operator has been the Center for Advanced Technology Development (CRPT). CRPT provides for allocation of crypto characters and transfer of the required data, as well as installation of Issue Recorders at the respective production sites. These devices will be connected to the national cloud. The pharma producer transmits serial numbers together with the GTIN to the cloud and in return receives the corresponding cryptographic key for the code to be printed and verified. The model provides for a fee to be charged for each cryptographic key; in addition, annual maintenance costs for the Issue Recorder are under discussion.
The process of aggregation of serialised products, which includes aggregation into cartons and further into pallets, will be the same as in other countries. For this purpose SSCC codes with GS1-128 data structure will be utilized. No changes from the Russian side are to be expected here so far.
WIPOTEC-OCS has closely followed the developments in Russia in order to prepare the necessary extensions in advance. Thus, the required solutions are already available. It is possible to upgrade all new as well as existing TQS systems with little effort to meet the requirements of the Russian legislation. The specifications of particularly small and sophisticated packaging formats are also taken into account.
Author: Eugen Held, Technical Sales Track&Trace at WIPOTEC-OCS