Russian Crypto Code Regulation

New Challenge for Manufacturers

Since Russian Federal Act N^o 488-FZ came into force on January 1, 2019, drug manufacturers have just one year to implement the serialization regulations of the Crypto-Code Act. This challenge should not be underestimated, as the Data Matrix Codes to be used increase significantly with the same module size as a result of the higher data density of up to 44 x 44 modules.

Markirovka Includes Numerous Product Groups

Labeling for medicinal products forms part of a uniform national system for serialization of different products groups with different implementation deadlines. Among other items these include shoes, tobacco, perfume, clothing, alcohol, and milk. The body operating the system known as IS MDLP or Markirovka has been the Center for Research in Perspective Technologies (CRPT) since November 1, 2018. This Center is responsible for implementing the individual timelines, generating the crypto-code, and managing the data.

Crypto-Code for Verification

The new code will consist of two parts, i.e. an identification part and a verification part. As the name suggests, the identification part is intended to ensure unique identification and contains a GTIN and the unique serial number. The second part is for review and verification purposes. It consists of a crypto number and a crypto code produced through the relevant combination of the GTIN and the serial number. The CRPT plans to introduce devices known as “Issue Recorders” for data transmission purposes. These are incorporated into the cloud. This way, manufacturers transmit the GTIN and serial number for the product and in return receive the crypto code and crypto number associated with this pairing. The plan is to charge a fee for issuing this cryptographic information.

Compliance with Russian laws using Laetus systems

Manufacturers may not have much time to find the right solutions and implement these in their packaging lines if they are to meet the tight deadline. Drawing on established solutions is therefore an advantage here. With our systems, we managed to provide the conditions for securely implementing the requirements of the Crypto-Code Act some time ago.