Russia’s latest serialization regulations give pharma companies until July 1st 2020 for complete unit- and batch-level traceability. Originally, the deadline was January 2020, however this was pushed back last year. While this extra time will be beneficial to pharma companies, it may still not be enough due to the complexity of Russia serialization requirements.
At Excellis, we recognise that Russia’s complex serialization and traceability requirements can be difficult to understand. We have years of experience in helping pharma companies reach compliance within tight deadlines.
Like the EU Falsified Medicines Directive (FMD), Russia serialization requires a way of tracking all pharmaceutical products as they travel through the supply chain. This includes a 2D barcode with a GTIN, serial number, batch number, and expiration date.
However, Russian regulations are significantly more complicated as they also require two cryptographic elements encoded on all 2D barcodes that need to be sourced from CRPT, the organisation operating the Russia system. Furthermore, there is a complex series of compliance events that need to be reported, time critical and following the correct choreography.
What presents an additional challenge for pharma companies supplying Russia is that leading providers of Serialisation / EPCIS compliance solutions are struggling to provide all the required reports in time.
To close the potential gap in reporting capability, Excellis have developed a reporting engine which can interface directly with Russian systems. The Russia Reporting engine enables manufacturers who make products inside of Russia to upload crypto code consumption to the OMS and transactional track and trace data to the MDLP.
The solution we have developed jointly with our Russian partner, Korus Consulting, is vendor-agnostic and works with TraceLink, SAP-ATTP and other solutions. The Reporting Engine retrieves the necessary information from the core L4/L5 serialization solution, enriches it with master data and other transactional information, to create the necessary reports and facilitates the upload to the OMS and the MDLP. The solution is validated and already operational with a number of customers.
What differentiates the Excellis Reporting Engine from the basic stop-gap solutions is it is also available as a managed service by the Excellis Service Bureau Helpdesk. We are providing this solution to several of our clients and it is enabling them to upload the specific reports to ensure they are 100% compliant for the quickly approaching compliance deadline.
Let Excellis help you to reach Russian compliance by July 2020. Get in touch with our expert team at firstname.lastname@example.org to find out more.