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Two licenses have been granted; a third is in the works
As logistics services providers expand their scope, both geographically and technically, around the globe, more detail emerges on the complexity of managing the clinical supply chain emerges. In this most recent example, Marken, a subsidiary of UPS, has announced that it has received licenses from the Argentina Ministry of Health and from the National Administration of Drugs, Foods and Medical Devices (known by its Spanish acronym, ANMAT). The licenses enable Marken to provide full supply chain services in that country, including receiving, storing and distributing medications, lab kits and ancillary supplies. Another license, enabling secondary packaging services, is in the works. Among other things, secondary packaging allows for the logistics practice of postponement--making shipments of the same product and packaging to multiple locations globally, then tailoring the final packaging to the requirements of each location.
"Marken is proud to be a part of the Argentina pharmaceutical industry,” commented Wes Wheeler, CEO for Marken, in a statement. “We are now a fully independent logistics provider in the country with our own legal entity and all required licenses which enable us to provide services to all of our clinical research clients.” He adds that the company’s ability to win these licenses grew from its internal GMP practices already in place.
For years now, clinical trial work has been expanding globally; at the same time, the regulations for both clinical and commercial drug distribution have been growing as well. One example is for traceability through item-level serialization. For commercial distribution in Argentina, ANMAT adopted a national standard several years ago, but 100% compliance for all products is still unresolved.