Serialisation and Aggregation Requirements in Russia

Introduction and definition

On 25.12.2018, Russian President V. Putin signed Federal Law No. 488-FZ, which deals with the amendments to Federal Law No. 381-FZ (28.12.2009) on the “Principles of State Regulation of Trading Activities in the Russian Federation”.

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)
TQS serialization systems enable printing of crypto codes
  • 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.

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. 

The regulations are stipulated for primary packaging (e.g. blister packs for tablets), secondary packaging (e.g. boxes) and tertiary packaging (in the sense of aggregation in shipping cases). The 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.

Management of Track & Trace data

In addition, Executive Order No. 1556 defines how the system for tracking pharmaceuticals works and how to access it (registration with the operator, evidence of licences for medicines, etc.). Access for producers outside the Russian Federation is to be by means of a cloud system. For production sites within the Russian borders, the system operator CRPT (Centre for the Development of Advanced Technologies) will provide a technical apparatus “Issue Recorder” which will facilitate exchange of the data. The necessary contracts for use and maintenance will be negotiated directly with the system operator. Depending on various production scenarios, deadlines between 5 and 45 working days will apply to entering production data in the Russian system for pharmaceuticals which are manufactured outside the territory of the Russian Federation and therefore are imported. With the Russian method, each serial number is combined with a GTIN and this unique combination is assigned to a unique (crypto-) signature consisting of verification key and electronic signature.

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 and 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

Facts

Deadline 01.01.2020

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.

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.

WIPOTEC-OCS has prepared itself for this scenario with a large signature containing 88 characters and already has appropriate solutions ready for both existing and new machines.

Serialisation

Data matrix code (DMC) in accordance with GS1 standard

Error correction: ECC 200

Contents: ​​​​​​​

No.NameApplication Identifier (AI)Number of symbols charactersType of symbol (Latin alphabet) Remarks
1GTIN 0114NumbersStatic
2Serial number2113Numbers, lower and upper case letters Dynamic
3Verification key 914Numbers, lower and upper case letters Static, (assignment of a goods unit/group)
4Electronic signature (crypto-key/verification code)9288Numbers, lower and upper case letters & special charactersDynamic cryptographically transformed GTIN and serial number
5Batch/LOT10>20Numbers or alphanumeric combinationsStatic
6Expiry date/EXP176NumbersStatic YYMMDD
  • Data groups nos. 1-4 are a mandatory part of the DMC to be applied 
  • Group no. 5 Batch/LOT and no. 6 Expiry date/EXP must be included in the data matrix code as additional components
  • The requirement for the structure of the data matrix code is that the GTIN always comes first and data groups 3-4 (AI91 & 92) always come at the end
  • GTIN and serial number must be printed on the packaging in readable form
  • AI91 and AI92 are not printed in plain text
  • 40x40 modules or 44x44 modules are required for the data volume
  • Data matrix code min. module size: 10 mil = 0.255 mm
  • Carton quality: at least GC2/GT2 or better
  • Grading: at least grade C (ISO 15415 & 16022)
  • Tamper-evident closure is not currently required

Print layout example:

DMC with 44 x44 modules

Aggregation

Aggregation to carton/case level (tertiary packaging)

Barcode 128 in accordance with GS1 standard

Contents: ​​​​​​​

No.NameApplication Identifier (AI)Number of symbols charactersType of symbol (Latin alphabet) Remarks
1SSCC0018NumbersDynamic
  • Barcode min. module size: 10 mil = 0.255 mm
  • Additional content on the label: manufacturer’s no., product no., verification logo

Print layout example:

The solution from WIPOTEC-OCS

With software version 1.23, it is possible to print a data matrix code via both print heads. The offset in the printed Datamatrix code is detected by the camera and readjusted at the print head. After several prints, the data matrix code is printed correctly without offset; the checking and readjustment takes place continuously during operation.
THE VIO 1 60/12 camera installed does not have sufficiently high resolution to detect a classification of the grading at less than 15 mil module size. With an upgrade kit, which among other things includes a new higher resolution VIO 1 60/32 camera, it is possible to verify a grading from a module size of 10 mil.
In addition, an ink with more black pigments is required for better and higher contrast of the printing: Black Eagle CS or Black Eagle HD. It is up to the operator to test the inks to determine which delivers the best results depending on the folding box material. It goes without saying that only high-quality folding box material will lead to a good printing result.

ResolutionField of viewField of viewSmallest module size DM Read / GradingSmallest font height
Model XY
VIO3 600/16016 Mpix600 mm400 mm15 mil / --
VIO3 450/16016 Mpix450 mm300 mm10 mil / --
VIO3 600/29029 Mpix600 mm400 mm10 mil / --
VIO 1 60/121,2 Mpix60 mm45 mm8 mil /15 mil2 mm
VIO 1 60/323,2 Mpix60 mm45 mm5 mil / 10 mil1,4 mm

The crypto code with AIs 91 & 92 can be processed with software version 1.23 and can also be printed via both print heads – release is planned for end of Q1/beginning of Q2 2019.

Quotes for conversion can be requested via our service department, indicating the machine number. We will check how many MVGs the machine has, as one conversion kit is required for each MVG. It is also necessary to ensure that two print heads are already installed for each MVG, otherwise a second print head will have to be retrofitted.

An update from Windows 7 Embedded to Windows 10 IoT is required in addition to the TQS software update for TQS machines with software version 1.19 or lower. In this case, it is necessary to order the TQS licence package for Update Windows 10 IoT and Matrix MIL 10 (46500430) in addition to the TQS software update. This is why we need the software version currently installed in the TQS machine before preparing a quote.

Solution options

Version 1

Serialisation:

  • Printing of the data matrix code with module size 10 mil (DMC size 12x12 mm)
  • Upgrade kit with VIO 1 60/32 required, software update 1.23

Aggregation:

  • Upgrade kit with VIO 3 600/290 required, software update 1.23

 

Version 2

Serialisation:

  • Printing of the data matrix code with module size 15 mil (DMC size 17x17 mm)
  • Printing via two print heads
  • Upgrade kit with VIO 1 60/32 required, software update 1.23

Aggregation:   

  • Standard VIO 3 600/160 remains available, software update 1.23

Version 3

Serialisation:

  • Printing of the data matrix code with module size 10 mil (DMC size 12x12 mm)
  • Upgrade kit with VIO 1 60/32 required, software update 1.23

Aggregation:  

  • Standard VIO 3 600/160 remains available
  • Reduction of the field of view to 450 x 300 mm, software update 1.23

 

All versions depend on the customer’s situation, the size of the folding boxes and the case or carton size and must be checked on a case-by-case basis. The overview is intended to help you decide on the best possible solution.

Precision stripper plate for two print heads: 

Precision stripper plate for two print heads: 

Standard stripper plate:

VIO 1 60/12:

VIO 1 60/32:

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