Earlier this month the Russian Federation finally amended Decree #1556 to cut the length of the Signature portion of the crypto-code element of their pharmaceutical unique identifier in half. Will that solve the problems the industry uncovered, like the barcode taking up so much space and slow read performance? Let’s take a closer look at it, but first, a review.
Russian Federation Decree #1556 published in December, along with several others related to their pharma serialization and traceability requirements (see “Mixed Signals From Russia”). It specified the details of the unique identifier to be required on all drugs as of January 1, 2020. It specified that the unique identifier must be composed of the following data elements:
- A GTIN-14
- A 13 character unique serial number
- A 4 character “verification key”
- An 88 character “signature”
- An optional batch code
- An optional expiry date
But companies participating in the Russian Federation pilot had already complained that the datamatrix barcode that resulted from this set of data took too much package real estate and it also took printers too long to encode it, and barcode readers too long to decode it (see “More Details On The Russian Crypto-Code”). Right around the time of the government published Decree #1556, their contractor, CRPT, LLC posted an announcement indicating that they were “willing” to reduce the length of the code. It has taken this long to get the government to amend Decree 1556 with the reduced length. Here is the amending document.
But the changes introduced by the new amendment goes farther than just cutting the “signature” field in half (88 to 44 characters). It also eliminates the mentioning of the batch code and expiry date fields, which means they are not even optional now. The effect of these changes will be to reduce the barcode contents from a maximum of 147 alphanumeric characters to just 76 alphanumeric characters. That should go a long way toward reducing the real estate necessary on packages and speeding up the read operations. It will also eliminate the ability to perform recall and expiration date checks with a single read.
I am not an expert on all pharmaceutical regulations, but I assume the batch code and expiration date are still required on drug packages by some other Russian Federation regulation/decree, but they should no longer be encoded in the traceability barcode. If they are encoded into a second barcode on the package, that’s a bad idea because healthcare professionals won’t know which barcode to scan for which reason, adding confusion and delays that can negatively impact health outcomes.
Since I’ve listed the old set of data elements above, here are the revised data elements that must be in the barcode by October 1, 2019 for drugs targeting a list of nosologies, and by January 1, 2020 for all other drugs:
- A GTIN-14
- A 13 character unique serial number
- A 4 character “verification key”
- An 44 character “signature”
Using my favorite barcode generator from Terry Burton, here are the old maximum barcode and the new maximum barcode side-by-side, using comparable nonsense data:
The new barcode should be faster for both printing and reading. Will it be enough? We’ll just have to wait to see as companies adopt the new format on their packaging lines.
Besides these barcode changes the amendment adjusts some text and adds some new clarifying text. In fact, there are lots of tweaks included, but it’s hard for a non-Russian language reader to fully understand the impact of those changes because we are dealing with translated modifications to a translated original document. It’s very hard to follow. The language doesn’t always get translated right because some of the changes are not complete sentences (Google Translate doesn’t do very well with sentence fragments). One of the additions appears to be to clarify the number of days a drug manufacturers has to use and pay for crypto-codes after they are issued. See if you can figure it out from this translation snippet:
“On approval of the size fees for the provision of marking code services necessary for the formation of means of identification and security monitoring the movement of goods subject to mandatory labeling means of identification, as well as the procedure for its collection service to provide the marking code is payable, the issuer of funds identification makes payment of such a service to the system operator monitoring within 180 calendar days from the date of receipt of the code marking, but no later than the date of putting into circulation of the drug, on the packaging (label) of which the identification means is applied, converted from the corresponding marking code, or not later dates of delivery of the drug to the place of arrival in the territory Russian Federation in the manufacture of a medicinal product outside the territory of the Russian Federation (with the exception of medicinal preparations imported from Member States of the Eurasian Economic Union), or until the date of import into the territory of the Russian Federation to pharmaceutical warehouse in the manufacture of medicinal drugs outside the territory of the Russian Federation in relation to medicines imported from member states of the Eurasian Economic Union. At the same time, the operator of the monitoring system registers (contributes) information on application to the monitoring system means of identification indicated by the issuer of means of identification in information on applying the means of identification, after receiving payment marking code services converted to appropriate means of identification. Labeling code service is recognized as provided monitoring system operator at the time of registration (entry) the operator of the monitoring system in the information monitoring system, contained in the information on applying the means of identification, converted from the corresponding marking code.”
My attention to this amendment document was raised through GS1 Healthcare’s Public Policy work group, and thanks to Brian Daleiden of Tracelink, who provided the link to that group. This group is a very valuable source of timely serialization and traceability regulatory information for companies and solution providers, and Tracelink, through Brian, is a frequent provider of information like this. I’d like to recognize both for their work and their generous contributions.
I’ll have more to say about the crypto-code in a future essay. I’ve recently learned the official reason it was created and it wasn’t the reason I thought it was. Watch for that in the next few weeks.
Dirk.
