Serialization and aggregation in Russia from 2020
MADO SYSTEMY TOGETHER WITH WIPOTEC-OCS IS READY FOR SCENARIO WITH A LARGE SIGNATURE CONTAINING 88 CHARACTERS.
Federal Law No. 381-FZ is thereby supplemented with regard to the mandatory labelling of goods for unique identification. A labelling code in machine-readable form, presented as a data matrix code/barcode or recorded in an RFID tag, is stipulated as the identification means. It also lists the definitions for its essential components:
• Labelling code (a unique sequence of characters, consisting of an identification code and a verification code; AI01 GTIN, AI21 SN, crypto code AI91&92)
• Identification code (a sequence of characters representing a unique number of units of goods; AI01 GTIN, AI21 SN)
• Verification code (a sequence of characters generated by the cryptographic transformation of the identification code and enabling the identification of forged identification codes when it is verified using a control data module and/or with verification code verifiers; AI 91, AI 92)
• Verification code verifiers (checking of the authenticity or forgery of the identification code as a result of verifying it using the verification code and the key document for verification of the identification code)
• Technical means for generating a check code – hardware-software encryption (cryptographic) information security tools, which ensure the generation of a check code as the result of a cryptographic conversion of an identification code and for which a security agency has issued a document.
Products that are placed on the market up to the deadline have to be serialised and aggregated, so for imports the regulations must be implemented even before the deadline. As a result, registration, contracts and verification (test) with the system operator (CRPT) must take place in advance.
SPECIFICATIONS OF THE LABELLING REQUIREMENT
Furthermore, Executive Order No. 1556 – “Directive governing the system for monitoring the movement of pharmaceuticals for medical purposes” – of 14.12.18 defines further details concerning the specific appearance and operation of the Russian system for tracking medicines and labelling the packaging of pharmaceuticals. The Executive Order came into force on the day of its publication. Regulations are stipulated for primary (e.g. blister packs for tablets), secondary (e.g. boxes) and tertiary packaging (in the sense of aggregation in shipping cases). Identification means is to be represented as a 2D data matrix conforming to the standard ISO/IEC 16022-2008 with error correction ECC-200. Its grading according to ISO/IEC 15415-2012 should have at least classification C or higher.
The identification means may be applied by printing on the packaging or by means of a label. In conjunction with Federal Law No. 488-FZ, 6 data groups are specified for identification and verification parts which are listed in the following table (Serialisation). In line with international standards and in accordance with ISO/IEC 15417-2013, the aggregation code for consolidating serialised products in a third packaging level for transport and storage is generated in the form of a one-dimensional barcode as SSCC 128. Information contained in the aggregation code can be printed in readable form. The aggregation code can be printed on the tertiary packaging or can be applied using a label.
The process of assigning the electronic signatures and verification keys is carried out in four steps according to the (simplified) procedure shown:
1. The registered pharmacist/distributor sends its generated serial numbers, linked to the GTIN, to the system operator (CRPT)
2. The system operator (CRPT) uses the data received to create the cryptographically generated electronic signature. Furthermore sends it back to the pharmacist/distributor together with the verification key
3. Application of the data matrix code to the products
4. Sending of reports and the data of correctly applied data matrix codes
POTENTIAL FUTURE DEVELOPMENT
In December 2018, the system operator CRPT signalled its willingness to talk to market participants. It may be possible to shorten the cryptographic electronic signature of the Application Identifier (91) which currently has 88 characters (numbers, lower/upper case letters and special characters). At present there is no more detailed official information available about the final number of characters planned. For this purpose, CRPT is carrying out a series of tests with participants of the Russian pilot project. Should a reduction of the AI (91) be possible, it might be expected to take several months until any changes are made to the Russian legislation. This will not alter the deadline for the mandatory serialisation of pharmaceuticals on 01.01.2020.
Mado Systemy together with WIPOTEC-OCS has prepared itself for this scenario with a large signature containing 88 characters. We already have appropriate solutions ready for both existing and new machines.
We encourage you to contact us and to familiarize yourself with our Track & Trace devices. We’ll be happy to advise you on a specific project.
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