Global Serialization Landscape
Serialization is already required in countries as diverse as Argentina, Saudi Arabia, Iran, and South Korea. One of the earliest adopters of the serialization was Turkey, requiring serialization at all levels of packaging. It is also mandatory in the US since November 2017, with Aggregation to follow from November 2023.
As per the EU Falsified Medicines Directive (FMD), serialization and tamper-evident packaging are required since February 2019 for all prescription drugs entering the European supply chain, unless included in the FMD white-list. Some non-member countries such as Switzerland, Norway, and Iceland have decided to apply the FMD incl. its deadline as well.
Aggregation (in addition to serialization) is obligatory in Saudi Arabia from March 2020; serialization is also mandatory. The EU (EMVO) is currently undertaking a study to determine the most effective way to support the concept of aggregation/consolidation within the overall EMVS system.
Pakistan seems to have pushed back the serialization deadline to 2021 although the latest draft amendment from late August mentions a deadline extension of 6 rather than 2 years.
In Russia, serialization and aggregation had to become mandatory from July 2020, but the deadline is postponed for October 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.
Based on Saudi Arabia’s first experiences with serialization, other members of the Cooperation Council for the Arab States of the Gulf are likely to follow suit, adapting requirements where needed.
Ukraine is currently planning a pilot project for a unified state system for monitoring medicines circulation, starting in November 2020.
The challenges of Track & Trace
The underestimated investment for implementation of serialization into the production processes has led many pharmaceutical companies to unexpected challenges as:
- Lack of unified communication among business network
- Additional investment in IT infrastructure
- Limitation of production efficiency
- Lack of qualified staff
- Manual work on serialization data files
- Insufficient support service
The perfect fit for your serialization needs
Easy Integration with Multiple Vendors on Level 3
Automatic communication with external customer’s interface as ERP, WMS
Automatic Serialization Data Exchange
Unaffected production efficiency
Easy On-Boarding of Partners (CMOs, MAHs, Wholesales)
User-friendly interface
Data auto-publishing function
Automatic conversion of serialization data files
One point of contact for all serialization issues
All participant of the pharmaceutical chain can verify the originality and origin of the products they commercialize
Certified Gateway Provider by the EMVO
Officially Accredited Solution Provider to the Russian regulatory
Certified Partner of GS1
They trust us for a reason
“We have been impressed with the SoftGroup’s team which developed, implemented and validated a complete serialization solution based on the stringent requirements of Antibiotic Razgrad.”
Dimitar Papazov
Executive Director
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