Regulatory Requirements

Russia : Authorities confirm reduction of crypto code to 44 characters

The Adents Team Written by The Adents Team
11-Sep-2019

Crypto code requirements in Russia have been amended. The Russian Government has finally ratified and published the long-awaited Decree No. 1118, confirming the reduction of the crypto code length to 44 characters.

Furthermore, the option of adding batch number and expiry date has been removed. This and the decrease in the length of the crypto code will considerably decrease the density of the data matrix to be put on medicine packaging.

Payment terms for crypto codes: What is required?

The terms of payment for the crypto codes were another clarification eagerly awaited by the pharmaceutical industry. Upon reception of crypto key and signature, licence holders have 180 days to pay and report used crypto codes. However, if product enters into circulation or arrives on Russian territory before, licence holders will have to have paid a reported used crypto codes beforehand.

Decree No. 1118: What else?

Decree No. 1118 details a list of reasons why a licence holder might not get marking codes, for example if there is no information about the drug in question registered in the Russian Track & Trace system or if a serial number (sGTIN) for which a crypto code is requested has already been used. Furthermore, it lists reasons why Marking codes might be canceled or invalidated, i.e. if they have not been reported back as used.

Russian crypto code and Datamatrix: Increased risks of rejection

While above mentioned amendments clarify the situation, complexities remain. According to Viktor Dmitriev, Director of the Association of Russian Pharmaceutical Manufacturers, the reduction to 44 characters will not fundamentally improve the current situation. In an interview with Pharmvestnik, he states that a crypto code length of more than 20 characters can lead to up to 89% of packages to be rejected, while the norm is less than 1%. This means loss of productivity and might ultimately be reflected in price.

The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.

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