Clever Leaves, a vertically-integrated Colombian licensed producer of pharmaceutical-grade medical cannabis and hemp extracts, has become authorized by the Colombian National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos or INVIMA) to be Good Manufacturing Practices (GMP) certified to produce medical cannabis. GMP certification by INVIMA allows Clever Leaves to produce phytotherapeutic medicines derived from cannabis which can be prescribed through a medical distribution channel.
“This is a crucial milestone for the medical cannabis industry in Colombia. GMP certification by INVIMA demonstrates that the industry is achieving pharmaceutical-grade standards recognized by regulators throughout the world,” said Andres Fajardo, CEO of Clever Leaves.
“INVIMA’s GMP certification is formal recognition of Clever Leaves’ operational excellence and adherence to international pharmaceutical standards. In a rapidly-emerging industry where patients and regulators have a lack of internationally-recognizable quality standards on which to rely, GMP certification is a difficult-to-obtain but easy-to-recognize symbol of quality,” said Kyle Detwiler, CEO of Northern Swan Holdings, the financial sponsor and strategic partner of Clever Leaves.
INVIMA is a regulatory agency within Colombia’s Ministry of Health. INVIMA is responsible for inspecting and supervising the marketing and manufacturing of health products, as well as providing medical approval for the import and export of various products. INVIMA performs many tasks which are akin to functions of the U.S. Food and Drug Administration (FDA). GMP certification from INVIMA is a quality assurance validation system which allows pharmaceutical distribution channels to evaluate the quality and safety of manufactured products and is generally considered to be a prerequisite in the process of obtaining final market authorization in highly regulated markets.