The Colombian government issued a new regulation that establishes the regulatory framework to commercialize master cannabis preparations for Colombian medicinal cannabis, a market estimated to comprise some 5 million patients.
On March 2, the Ministry of Health issued Resolution 315, which not only opens up the Colombian market for medicinal cannabis but also allows the transformation of dry cannabis flower into derivative products for companies that set up industries at free trade zones.
“The resolution benefits the sector because it provides clarity on narcotic drugs, psychotropic substances and precursors that are subjected to be controlled, and differentiates them from those that do not require oversight,” Rodrigo Arcilla, director of the Colombian cannabis association Asocolcanna told Cannabis Business Times.
Master cannabis preparations with 0.2% of THC or higher, including oils, non-psychoactive and psychoactive cannabis, must be registered to the country’s National Narcotics Fund, according to the resolution.
For the magistral formulations derived from cannabis with less than 0.2% of THC, the derivative products will not be audited by the National Narcotics Fund.
The resolution states that all magistral formulations based on cannabis must be sold only with a medical prescription at pharmacies in this South American nation with a population of 50 million residents.
In addition, all magistral formulations must all be certified by the National Food and Drug Surveillance Institute, INVIMA, for meeting Good Elaborating Practices (GEP) standards. Analysts, companies and law firms believe INVIMA could take between four to 12 months to issue the certificates on GEP practices.
Carlos Ernesto Lucio, expert in cannabis regulation, said