Countdown to Russian pharma serialization

26.01.2018
Serialization

Servicepoint has been closely watching the developments of the Russian pharmaceutical serialization. As the Federal law on the circulation of medicines has now been approved, signed by the president, and published Dec 29, 2017, it is time to wrap up the developments so far.

I have been covering the development during the design and pilot phases of lawmaking with articles and blog posts, as well as an interview last December.

Summed up, the law is about quite normal serialization, but with a boosted track & trace with extra functionality for the government. The government wants to use the system to watch at pricing and availability of drugs around Russia and provide the consumers a possibility to use a mobile app to search which pharmacists have the drug they are looking for and check the prices, too.

The data matrix should contain, in addition to the normal GTIN (Application Identifier AI=01), serial number (21), batch number (10), and expiry date (17); imported medicines require also a TH-number (240), which is the four first digits of the TN VED (ТН ВЭД), namely 3001 (e.g. blood products such as heparin), 3002 (blood or serum), 3003 (medicines not packaged in dosage forms), or 3004 (dosage forms).

Aggregation is thus required. Official deadline is Jan 1, 2020, but earlier deadlines for the seven high-spending disease classes (7 ВЗН, such as treatment of haemophilia) and medicines on the list of vital and essential medicines (ЖНВЛП, comprising about 40% of medicine packages or 35% of value), are most probably getting earlier deadlines that will be (soon?) decided by Roszdravnadzor (Federal Service for Surveillance in Healthcare). Tamper evidence is still in the air, depending on later acts.

The government also wants to have some visibility to the industry readiness. They are going to set up a working group to monitor the implementation and is going to call for hearings in July 2018 to review the progress. I would assume there will be further reviews as the deadline draws closer.

Several of the European manufacturers who have done minimal implementation of serialization just to comply with the EU FMD needs (serialization, tamper evidence, and data upload to repository), have now found out that they need to do further investment to aggregation. This is all well if the original system has been purchased and implemented so that adding aggregation is feasible and cost-efficient.

Servicepoint has collected a wide experience in packaging automation projects as well as machine vision and inspection systems. We offer services of an experienced full-service packaging, device assembly, and serialization and track & trace automation integration company. In the last few years, Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Greece.

As we are a Finnish service provider located near the Russian border, we are able to travel to Russian customer sites easily, most of our field engineers have long-term visas. We can also travel on short notice, as in addition to flying to Russia, we have easy train connections to e.g. St. Petersburg and Moscow area. We have Russian-speaking personnel, too. Call us for professional help!

Servicepoint Oy — the reliable partner for the manufacturing industry

Iiro Jantunen
CTO, Chief Technology Officer
Servicepoint Oy
iiro.jantunen@servicepoint.fi
+358 44 7868 215