Clever Leaves, an international cannabis company with its main operations in Colombia, said Thursday it obtained EU-Good Manufacturing Practice certification “to produce Active Pharmaceutical Ingredients (API), semi-finished and finished cannabis products for medical purposes” in its Colombian facilities.
The certification is “expected to broaden Clever Leaves’ ability to serve international markets,” according to the news release.
EU-GMP is an essential requirement to exporting medical marijuana – particularly extracts – for commercial and medicinal purposes to markets in the European Union.
“Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP,” the European Medicines Agency website stipulates.
A Clever Leaves spokesperson told Marijuana Business Daily that the Croatian Agency for Medicinal Products and Medical Devices inspected the company’s facilities in Colombia in January, issuing the certificate – verified by MJBizDaily – this week.
Only a handful of cannabis facilities in the world have EU-GMP certification to manufacture extracts.
Marijuana Business Daily isn’t aware of any other cannabis producer that has publicly announced obtaining EU-GMP certification for a Latin American facility, and no cannabis facility on the continent can be found in the publicly available official EudraGMDP database of the European Union.
While exports of high-THC medical flower to the European Union without EU-GMP certification are possible under certain conditions, Colombia does not allow the exportation of flower for commercial purposes.
This leaves Colombian producers little room to maneuver other than obtaining the EU certification if they want to export medicinal extracts manufactured from Colombia to the EU.
Clever Leaves, meanwhile, is aiming to list on the Nasdaq stock market.