Already in 2009, the Russian government built the basis for Track and Trace by releasing the law no. 381-FZ. This law regulates the fundamentals for governmental regulatory and trading activities in Russia. In 2018, Russian President Wladimir Putin signed the additional law no. 488-FZ, which mentions that serialization for all drugs and a so-called “Crypto Code” will be mandatory starting January 1, 2020. Additionally to the laws, the Russian government released an edict at the end of 2018, which includes definitions about the functionality of the system to track and trace the pharmaceutical supply chain.
Every single saleable unit has to be serialized and the identification must be realized by a data matrix code or a RFID tag. Furthermore, the law contains definitions regarding the look of the code and what has to be included. It also regulates the measurements the code has to be generated with. Regarding Track and Trace, the Russian code regulatory includes requirements for:
- Russian T&T Code is a code sequence consisting of an “Identification Code” and a “Verification Code”. This means the code includes the Application Identifiers AI01 for GTIN, AI21 for Serial Number, AI91 and AI92 for the crypto code.
- Identification Code is a code sequence consisting of GTIN and Serial Number. This means this code includes AI01 GTIN and AI21 Serial Number.
- Verification Code is a code sequence, which is generated by cryptographic transformation of the Identification Code. The corresponding Application Identifiers are AI91 and AI92.
- Verification Code Verifier: Check of authenticity as a result of the combined verification by using Identification Code and Verification Code
Regarding all information above, the Russian code will include the following details as shown in the table below.
GTIN and Serial Number have to be printed in human readable text in contrast to the keys. Depending on the content of the code (amount of sequence positions) the code requires a module size of 40×40 modules or 44×44 modules.
This leads to the following special requirements because of the data included in the code:
- The required module sizes are 40×40 modules (228 numeric characters / 169 alphanumeric characters) and 44×44 modules (288 numeric characters / 214 alphanumeric characters)
- The module size of the data matrix code is 10 mil = 0,255 mm
- Good carton quality
- High quality ink with a good contrast
- Minimum C Grading according to ISO/IEC
The edict mentioned above is valid for all primary packaging (e.g. bottles or blisters for tablets), secondary packaging (e.g. cartons) and tertiary packaging (e.g. cases).
The identification feature for the serialized secondary packaging shall be a 2D data matrix code according to ISO/IEC 16022-2008 with an error correction of ECC-200 and it shall have a C grading minimum according to ISO/IEC 15415-2012. It´s up to customers if they will print directly on the secondary packaging product or apply a label.
For aggregation purpose at the tertiary case packaging, the edict includes the definition to use a SSCC 128 code according to international standards by using ISO/IEC 15417-2013 norm. Also for tertiary packaging, it is up to customers if they print the code directly or apply a label.
The process for crypto generation in four steps
The process behind generating the crypto code is not as complicated as it seems at first glance. There are four steps that have to be fulfilled:
- First, the registered pharmaceutical company sends self-generated serial numbers to the system operator CRPT
- Based on this data, CRPT generates cryptographic signatures and sends them together with the keys back to the pharmaceutical company
- The pharmaceutical company prints or applies the data matrix codes onto the products
- Reports and data about successfully printed or applied codes are transferred back to CRPT
Resumed there are the following challenges that have to be solved by pharmaceutical companies and their partner:
- Tight timeline till implementation in January 2020
- Data exchange between different systems
- Information density inside the code and the resulting code sizes
- Challenges for software, printers and cameras
T&T solutions by Bosch Packaging Technology
Bosch Packaging provides several solutions to fulfill the T&T challenges of the Russian market. Especially software, printer and camera topics are critical to ensure a smooth and compliant implementation. Bosch provides several camera and printer types. No matter if one or two print heads, Bosch can provide a solution. The new baseline software is flexible to fulfill every task. The table below shows which combination of print heads and cameras are possible. Please do not hesitate to provide us a format list and we will consult you how to handle the topic in a fast and easy way. Each customer format must be analyzed to specify the best technical solution. Analysis have to be done by carton sizes, carton material, print layout, camera field of view, machine speed etc. Bosch is able and willing to support you with your challenges.
Bosch is prepared to fulfill Track and Trace requirements of the Russian market. Contact us!
Product Management Pharma
Phone: +49 711 811-57172