According to the company, the two licenses allow Marken to receive, store and distribute medication, lab kits and ancillary supplies throughout the country.
The Ministry of Health (MOH) of the Province of Buenos Aires approved the ‘Operator Logistico’ license. The second license, ‘Distribuidora y Operador Logistico de Medicamentos,’ was issued by the National Administration of Drugs, Foods and Medical Devices (ANMAT).
Marken explained the MOH and ANMAT will perform unannounced GMP inspections in order to ensure compliance with all regulations.
"Compliance with country-specific regulations, including the requirements for importation of investigational drug product, is a critical component of the clinical trial process. These regulations and licenses ensure that shipments into Argentina arrive without disruption and with minimal risk to be stored at the licensed depot," Christine Noble a company representative told us.
Marken previously invested in the Argentina market by opening a depot and office in Buenos Aires in 2013.
"Based on the success of our global GMP-compliant depot network and increased client demand for use of the Marken depot in Argentina for global clinical trials, we needed to expand the Argentina depot which took place in December 2016," Christine Noble from Marken, told us.
The company is also pursuing an application for a Secondary Packaging License in the country.