A Global View of Serialization Requirements
Counterfeit medicines have long been a very real threat to the pharmaceutical industry at all levels – from global suppliers through to contract manufacturers and distributors. Global government agencies have taken steps to strengthen protection against counterfeiting in response, adopting legislation aimed at making it more difficult for counterfeit drugs to enter the supply chain.
Each country has its own set of laws, based upon the specific concerns regarding counterfeiting in the country – and the way each country manages its supply chains. This white paper sets out the various different requirements for serialization across the globe, including:
- Compliance – Explain the ways serialization requirements can differ depending on region
- Traceability – Outline the basic requirements for track and trace
- Data Management – Review challenges in managing large datasets and the approaches available to address them
- Supply Chain – Understand the way in which supply chain management ties into the overall track & trace process.
Most governments have already implemented serialization laws – and those laws have come into effect, but other track & trace topics are still up in the air – particularly aggregation requirements. It is important to stay up-to-date with the latest information.