Last-minute update around the requirements for mandatory serialization in Russia for medicines
As of July 1, 2020, the requirements for mandatory serialization (marking and labeling) of medicines, shoes, and tobacco products had to come into force.
According to Decree of the Government of the Russian Federation № 955 from 30.06.2020, non-serialized medicines manufactured or imported in Russia from the period 1st of July to 1st October, 2020, will be released on the basis of a decision of a special Interdepartmental Commission.
The approval will be issued within 8 days and requires a list of documents, including a justification for the impossibility to serialize and the deadline for the manufacturer’s readiness to serialize.
(last updated 09/07/2020)
Prior to the deadlines, SoftGroup provided several pharmaceutical companies in Russia, the CIS, and the EU with full-stack solutions for serialization.
Besides the high customer satisfaction of the user-friendly solution, SoftGroup has been scored with the highest assessment from the General Manager of the CRPT – Mr. Dmitrii Alhazov.
Additionally, just before the COVID-19 crisis, SoftGroup has been awarded the 6th CEE Pharmaceutical Manufacturing Excellence Award for a full-stack serialization solution for the Russian market for a project in Poland.
Coronavirus vaccines updates
Just from the last month, the Ministry of Health in Russia announced that the coronavirus vaccines, which several major Russian research institutes are exploring simultaneously, will also have a unique product identification code.
The system so far
According to the Chestny Znak system, 230 000 companies have already been registered to their system. The statistics show that about 16 billion codes have been issued.
Serialization: Mission possible
“We are working in-depth on every single customer’s project, we did a lot of innovation and enhancements in the all-in-one product. I can proudly say that SoftGroup® SaTT solutions have already provided a smooth production for the Russian market of our customers. However, we are in constant contact with them to answer questions, provide additional training, and help in unforeseen situations. We do understand that some of the pharmaceutical companies still have not completed the implementation of the serialization solution or were unsatisfied with their current choice. That is why we will be happy to provide them with a working alternative. ” says Venelin Dimitrov, Founder and CEO of SoftGroup.