Drug companies who serve markets within the European Union (EU) have until February 9, 2019 to add serial numbers within a Data Matrix barcode to their drug packages, among many other specific requirements (see “The ‘Unique Identifier’ in the EU Delegated Act”). The specific requirements are outlined in the EU Delegated Regulation (EUDR). I’ve written a lot about the EUDR over the last few years (see RxTrace: Delegated Regulation). Today I want to highlight and explain a problem that may be brewing in the implementation of the system of repositories as established by the non-profit European Medicines Verification Organization (EMVO). The potential problem is related to the way the EMVO Continue reading Pharma Serial Number Randomization Under The Falsified Medicines Directive
This is the second of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:
- GS1 Serial Number Considerations
- Properties of Randomization (this essay)
- Threat Analysis
- Algorithmic Approach
- Other Approaches to Randomization
This week Ken introduces three properties of randomization. — Dirk.
Continue reading Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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