Complex requirements and a broad scope make for a challenging market.
Pharmaceutical companies have been closely monitoring developments in Russia for the last several years. While the final requirements have yet to be completely nailed down, we do know that Russia promises to have some of the more complex serialization and reporting requirements that the industry has seen. In addition, the regulations will cover not only prescription medicines, but also over-the-counter drugs, and will likely impact manfacturers, wholesale distributors, dispensers, and disposal organizations.
For serialization, both a requirement to serialize at multiple packaging levels and an aggregation mandate add complexity. On the reporting side, there are more than 20 transactional events that--depending on a company's business operations--might potentially need to be reported to FSIS MDC, the Russia government system for monitoring and tracking. And data for each event is extensive, with several Russia-specific elements like pricing. In addition, compliance reports are not only in .xml format rather than .csv, but they must be encoded with electronic signatures, calling for significant technical sophistication.
Deadlines for different phases are as follows:
- Feb. 1 – Dec. 31, 2017 (Voluntary Pilot
- Q1 2018: 7HCN drugs (hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid and hematopoietic tissues, multiple sclerosis, organ/tissue transplantation)
- Q2 2018: Medicines >500 Rubles in cost
- Q3 2018: Medicines >100 Rubles in cost
- Dec. 31, 2018: All medicines
Managing Russia regulations within your global compliance solution.
TraceLink customers who do business in Russia will be able to address these requirements through the same TraceLink platform that handles their track and trace and serialization needs for other markets. TraceLink is working closely with industry associations and customers to fully understand and meet the market requirements, and associated business needs, for Russia compliance.