An update on Russian pharmaceutical serialization
I discussed the development of the Russian Pharmaceutical Serialization last March. As the end of the year draws closer, it is time to have a closer look on the developments.
First and foremost lets discuss the deadlines: they will move one year each, so the voluntary pilots (15 companies have sent preliminary applications for participation) will happen during 2017, and the results are to be reported to the Russian government by Feb 1, 2018. The actual deadlines for the different medicine classes will be (source)
- Jan 1, 2018 for 7VZN (7 ВЗН), the seven high-spending disease classes
- Jan 1, 2019 for ZhNVLP (ЖНВЛП), the vital and essential medicines
- Jan 1, 2020 for all other medicines for human use.
This will be of great help to the industry as the projects definitely need time and the simultaneous deadlines in USA and EU add pressure to the few companies, such as Servicepoint, able to implement serialization to packaging lines.
Data Matrix or QR code
Another issue is the form of the machine-readable code. There has been discussion about using RFID or QR codes, but it seems that Russia will end up using the Data Matrix like most other markets, such as EU and USA. This would be another great relief to the whole of industry. There has been calls for use of the RFID but the pharmaceutical industry has firmly opposed the technology, understandably for technical and cost issues (source). Following the regulatory developments is made difficult by the fact that the term ”QR code” is often used when the text of attached picture is clearly about the Data Matrix – QR code seems to be used as a general term for all two-dimensional barcodes. The Ministry of Health of the Russian Federation has formed a working group to define and approve the marking system.
As in Europe, the re-packagers are going to be required to re-serialize the packages. This is understandable, as in another case the anti-counterfeit benefits of serialization would be lost.
FGIS MDLP is in very early stage
The development of the FGIS MDLP (ФГИС МДЛП) is also in very early stage, as the software developer has not been selected yet. The introduction of the MDLP has been tasked to the Federal Tax Service. As we know from the experience in EU, design and building the repositories takes time. Benefits of serialization are also seen on preventing violations on the rules of selling prescription medicines. By linking to Uniform State Information System of Health Care (ЕГИСЗ) and using the patient’s data on the electronic medical card, the sale of drugs which are for some reason inadvisable to this specific buyer could be blocked.
Another issue on the regulation about the packaging of medicines is the use of Braille font (for the visually impaired). This is nothing new: also in EU and USA name of the drug and dosage is required, but in addition to those, the draft regulation for Russia has included requirements for printing the date of release and expiration as well as route of administration.
These additions were rejected, however, during further shaping of the regulation, and for a good technical cause: the name and dosage can be pre-printed to the cartons along with the other artwork, but expiry date changes from batch to batch and should thus be printed on the production/packaging line where Braille printers are not common. Another reason is that a significant portion of the visually impaired people are not able to read Braille, anyhow. One should note that the Data Matrix and a suitable text-to-speech smartphone app could be used to meet the needs of the blind, even though finding the code may take a while.
The pharmaceutical manufacturers catering the Russian market need to keep a constant watch on the developments on the regulations. This is, of course, self-evident. Even already published regulations, such as the EU FMD and the related delegated act, will evolve and differ in details in different parts of the market.
We at Servicepoint are happy to help pharmaceutical manufacturers and packagers to upgrade their production lines to comply with the existing and incoming regulations. We always keep a keen eye on the developments on the regulations – for the benefit of your business.
Iiro Jantunen, D.Sc.
Chief Technology Officer
Servicepoint Ltd in Finland provides serialization and other types of automation systems to pharmaceutical industry as well as other sensitive industries in Europe and Russia.
+358 44 7868 215