Are we all done with Serialization after the EU implementation?

FMD Implementation

Most companies in the pharmaceutical sector have their eyes on EU and have full speed on their FMD implementation. Every week, good news and progress are announced from different partners in the Supply Chain, and more and more countries are getting their national systems connected to the central database EMVO. This is all good news for the sector and patient safety – and a few friends and colleagues in the industry has asked us if we are all done with Serialization after the EU implementations we are part of?

The answer is no –  the industry is fare from done with serialization and track & trace implementations. Many companies are actively using the one-year postponement of DSCSA enforcement by FDA, to complete the first step in their US project. However, there is still a lot of work to be done to achieve 2023 compliance with full track & trace in the US Supply Chain.

Russia

Recently, we saw Russia postpone their Serialization requirements to 1st of January 2020. As the industry is still missing clear guidance from the Russian authorities, many have not yet started any Russian serialization implementation. At the moment, the drafted requirement from Russia is one of the most complex ones with regards to special requirements to the 2D data matrix and data interface. Furthermore, it looks like Russia will adopt similarly requirement as China with special crypto codes on all cartons.  

Other Markets

The above mentioned countries are all huge markets for the industry. But we still need to see regulation and implement serialization in many countries to come. Canada is expecting to adopt the US FDA guidance in 2020. Brazil has postponed the full roll-out to 2022. Requirements in Japan will be from 2021, and Australia has already had serialization requirements for Hemophilia products since January 2017 but further regulations are expected at a later stage and will most likely be based on GS1 and the European model. Currently, there is no common standard in the Middle East but towards 2020, a new GCC (Gulf Cooperation Council) standard is expected with Saudi Arabian in front and will most likely contain a full track & trace system.

At Pharma IT, we have profound experience in serialization, and would be pleased to help you and your organization in this journey towards better patient safety and compliance. We offer services within SAP ATTP, EMVO connection, 3PL integration, CMO integration, Supply Chain- optimization and analysis, regulatory intelligence and project management both with IT and process experience.

Feel free to contact us if you need sparring on your Serialization Project. PEEI@Pharmait.dk

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