Russia Pharmaceuticals Traceability – update on 1st July 2020 deadline

The Russia Serialization deadline has been confirmed by the Duma this week:

Despite strong advocating from the industry, the Duma confirmed the application date of the 1^st of July 2020 with a 6 months flexible period for penalties (soft launch) even if there are still several areas unclear to fully implement the system.

The implications are the same as before:  get ready, test your processes, test the multiple reports needed by the authorities and mandatory to move the products and make sure that the interactions with your downstream partners are running seamlessly.

Our review of the situation and how we can support you by de-risking this complex challenge:

Speculations that Russia’s serialization deadline of 1^st July 2020 might be moved have been going circulating for some time now. Recent updates have added more clarity but some uncertainties – and therefore risks – remain.

AIPM, the association representing leading global pharmaceutical manufactures, had spelled out the concerns about the impact of the supply of medicines in Russia, especially against the background of COVID-19, if the deadline of 1st July for full-scale implementation of the T&T process was maintained. AIPM’s suggestion was for a 6-month transition period from 1^st July that would not require the project to be stopped but allow for a smooth implementation of the complex Track and Trace process. This was aligned with a submission signed by the 11 largest Industry Associations who also advocated for the prolongation of transition period.

The meeting of the State Duma on 3^rd June 2020, with participation of all involved Federal authorities, CRPT and industry, considered this suggestion, with the following conclusion:

• Despite the industry submissions, all authorities and deputies agreed that 1st July deadline for the implementation should not be changed.
• However, it was agreed that a transition period would be required for smooth implementation. The suspension of penalty activities for the issues with reporting to the system was discussed.
• Discussing the issue with focus on the import of the medicines, deputies agreed on the necessity to amend Federal Law FL-425 to allow the import of medicines manufactured before 1^st July 2020 after this date without carrying DataMatrix codes.

This news goes some way towards easing the pressure on manufacturers but there still remain a number of questions, such as: 

• Definition of Manufacturing Date, i.e. is this the date of the CoA or of final packaging?
• Scope of products and applicability of transition period, i.e. imported vs. domestic manufacture; what this means for products in the high cost nosologies; what about manufacturers that have already started data uploading
• Penalties: The suspension of penalty activities for the issues with reporting to the system was discussed but as yet no concrete details were presented by the Federal authorities at this time.

While this news will be welcomed by many manufacturers who have been increasingly concerned about their compliance readiness, the remaining uncertainties and need for clarification so close to the formal compliance date of 1^st July 2020 will keep the pressure on MAHs to do what they can to advance their Russia readiness and to also consider all possible steps to de-risking their program, including closing the functional gaps that still exist in the solutions offered by the main traceability system suppliers.

Close the gap in reporting with our Russia Readiness Programme

To close the potential gap in reporting capability, Excellis have developed a reporting engine to support the data exchange for crypto code consumption to the OMS and transactional track and trace data to MDLP.

The solution we have developed jointly with our Russian partner, Korus Consulting, is vendor-agnostic, customer-specific 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 for the upload to the OMS and the MDLP. The solution is validated and operational with a number of customers.

Contact us for more information on Russia reporting and to find out how we can help: getsecured@excellishealth.eu