The logistics contractor opened the depot in August telling us at the time that the site was part of a wider expansion in Latin America that will also see it open similar sites in Peru and Chile in the next six to eight weeks.
As yet no further announcements about the Peru and Chile sites have been made. However, at the Brazil depot, Marken is on track to being storing and shipping clinical trial suppliers in the next few weeks according to spokeswoman Christine Noble.
She told Outsourcing-pharma.com that: “First clinical trial products are scheduled to arrive in our depot the last week of September.
“Many of our clients had been following the Marken depot progress closely and so were immediately ready to start shipments as soon as the licenses and approvals became final.”
In Brazil – which is where around half of all the clinical trials that are conducted in Latin America take place – assessment of supply depots and warehouses is conducted by municipal authorities in each city.
In Sao Paolo a health surveillance organisation called COVISA makes sure depots are up to standard according to Nobel, who told us that: “A very specific series of licences must be acquired in correct sequence order to open and operate a clinical trial depot in Brazil, beginning with the various construction and fire code permits.
“Ultimately, the final step is the very important COVISA inspection that provides approval to operate pharmaceutical products. Application and registration for the ANVISA license can only be obtained if the COVISA inspection was successful.”
She added that Marken passed the COVISA inspection in July and was authorised to begin operations on August 1, despite the fact that “authorities may not publish the approvals for up to 3 months in the official register.”