Near the end of 2019, there were rumors that the Russian Federation would extend its regulatory deadlines for pharmaceutical serialization and traceability past its initial January 1, 2020 deadline, which called for full serialization using Russian Crypto Codes and government reporting...
The new decree mandates the addition of seven distinct new clauses to the original decree, all of which contain adjustments to the original deadlines. The reasons for the adjustments could be due to readiness issues with the CRPT and/or the track and trace system provider chosen by the Russian Federation. None of the amendments affect the technical requirements of the original decree. Although originally published in Russian, Decree #1954 (Amendment to the Regulation on the track and trace system for medicine) has been translated into English and is available for review. It’s not an official translation, but there’s no apparent reason to question its legitimacy. Below is my interpretation of the document, but please be sure to use your own judgment when making business decisions.
Requirements of the Russian regulation are more complex than those of any other market. There are two reasons for that. One is that the Datamatrix barcode applied to product packaging must encode a “crypto-code,” and the other is that so many supply chain activities must be reported.
Companies and individuals participating in the pharma supply chain in the Russian Federation must self-register in the track and trace system by February 29, 2020. After that date, newcomers will have seven calendar days to register. After registration, applicants have 21 calendar days to submit a request to CRPT (or whoever the current operator is) that specifies their hardware and software vendors and request integration with the track and trace system.
Two months after being ready to integrate, the applicant must undergo integration testing with CRPT. And starting on July 1, 2020, the company or individual must begin submitting information on all supply chain operations performed with medicines covered by the original decree.
For companies that previously registered with CRPT for participation in the pilot, as long as accurate information was provided in that registration, they are now considered registered in the full track and trace system. However, if inaccurate and incomplete information was provided, registration must be updated by July 1, 2020.
Foreign and domestic drug manufacturers that hold registration certificates for manufacturing have 30 calendar days after registration to connect to the track and trace system. They must submit an electronic request for either devices that can generate marking codes, or internet access to a service that generates these codes, by May 1, 2020, or within 7 calendar days from registration in the system for new companies (see Clause 1).
Starting on July 1, 2020, these companies must begin applying the serialized 2D barcode specified in the original decree on the secondary packaging (or the primary package if there is no secondary package) of the consumer package of covered drugs. If the drug company voluntarily begins applying the serialized 2D barcode to drug packages any time after January 1, 2020, they must submit the information about those packages to the system.
The wording I am using for the paragraph above is what I believe the requirement is, but the wording used in this part of the English translation of the new decree is very odd and seems to be a little twisted. That may be indicative of a bad translation. Drug manufacturers might want to refer to the original Russian language version and have a qualified translator provide them with their best interpretation of this section.
Companies or individuals that administer prescribed medicines or otherwise removed them from the supply chain (I call these “dispensers” below) must submit an electronic request for “disposal registrars” (hardware devices with a 2D barcode reader that connect to the track and trace system) no later than February 15, 2020, or within seven calendar days from registering in the track and trace system (see Clause 1).
As the operator of the track and trace system, CRPT must fulfill several specified requirements. They must provide the hardware or remote internet access to manufacturers specified in Clause 3 no later than 45 calendar days from the date of the request. They must provide dispensers with the disposal registrars no later than 45 calendar days after the date of the request and arrange for system integration testing with companies within 30 calendar days.
As the operator of the track and trace system, CRPT must provide marking codes starting January 1, 2020 upon request from registered participants.
The payment for the service of providing marking codes by the operator of the track and trace system will be charged starting July 1, 2020. The wording here is a little odd so I can’t tell if the charge will come from CRPT or the government, and if the charges will include those for any codes that were provided prior to July 2020 (those that were applied voluntarily by drug companies between January 1 and July 1).
Cyrpto-Code Troubles in XML
I’ve heard through GS1 Healthcare about a problem with the character set that CRPT is using for the Crypto Codes they are providing to drug manufacturers. Apparently the character set they are using includes more special characters than XML allows. This means that if you are unlucky enough to be assigned crypto-codes that contain any of those particular special characters, you cannot encode those crypto-codes in an XML document. The document will not pass XML validation and will not work when well-formed XML is required. Having Crypto Codes that were never put into an XML document is the best-case scenario, but many of the global traceability solutions on the market today make extensive use of XML internally. I cannot corroborate that CRPT’s solution has this problem, but if it does it will need to be fixed soon. It might take a long time before some companies receive these non-XML characters in the codes they are given, but if they are possible the odds of receiving one or more are high .
Smartphone Apps for Russian Crypto-Code Verification
CRPT has posted both Android and Apple smartphone apps that allow users to verify any product that contains a valid Russian Crypto Code-based product identifier, including footwear, tobacco, natural fur products, medicines, and many other products on the Russian market in the future.