Serialization, Track & Trace have emerged as a critical tool in the pharmaceutical industry to address the challenges of counterfeiting, diversion, and theft of drugs. This technology involves assigning a unique identification code to each product, packaging it with this code, and tracking it throughout the supply chain until it reaches the patient. Serialization does not only help in combating the illicit trade of drugs but also enables efficient management of the supply chain and improves patient safety. However, the lack of global standardization and of down-stream supply chain transparency poses significant challenges in implementing Serialization 2.0. Different countries and regions have their regulations and requirements, which may not be compatible with each other. As a result, companies must invest in multiple serialization solutions to comply with different standards, leading to higher costs and complexity. Missing supply chain transparency adds complexity and gives room for grey market opportunities.

This presentation covers:

• Global Standards for Serialization Track & Trace
• 2 D Matrix Code with 4 data elements o SSCC code for shippers and pallets
• Global Standards for Data transmission (EPCIS)
• Seamless data exchange between different (Cloud-) Service Providers
• Transparency after the first change of ownership