Colombia Cannabis License Guidelines

Colombia Ministries of Agriculture, Health, and Justice

Licensing and Enforcement Criteria

There are several agencies involved in the authorization of medical cannabis in Colombia. The ICA (the Colombian Agency for Agricultural and Animal Husbandry Products) will confirm that any kind of industrial crop farming has obtained certain phytosanitary and food safety approvals. The Ministry of Justice authorizes the cultivation. The Ministry of Health issues the authorization to process the raw materials into processed ingredients, such as resins and oils that are not to be sold to the public. INVIMA is the agency that conducts market approval procedures for finished products. 

The regulations intent is for patients to have access to pharmaceutical products. If a patient prefers to use raw cannabis, the regulations provide for the possibility of growth for personal consumption. No processing or commercialization is allowed for this personal consumption option.

As established in Resolution 579, 2017, issued by the Ministries of Health, Justice and Agriculture, growers that cultivate on a half a hectare area (5,000 square meters) or less are considered small and medium growers and, therefore, may access technical advice, priority allocation of quotas and purchase of their production by the processor. The regulation, in effect, establishes that 10 percent of the total production of the processor must come from a small and medium producer.

Colombia Cannabis Law & Compliance

Several laws and ordinances regulate Colombia’s medical cannabis industry, as well as the many different steps in the supply chain. These laws range over dispositions for cultivators, manufacturers, distributors and retail dispensaries. The most recent news can be found on these websites:

FAQs

The INVIMA grants licenses for what aspect of the medical cannabis field?

The Ministry of Health and Protections oversee the manufacture of cannabis derivatives, extracts from the cannabis plant, commonly found in the form of an oil.

Which Ministry is in charge of the licensing for cultivating psychoactive cannabis?

The Ministry of Justice and Law is responsible for the regulations and licensing for the cultivation of psychoactive cannabis.  The Ministry of Justice and Law checks the modality of psychoactive cannabis seeds from production of seeds for planting to final disposal.

 

What are the regulatory challenges in allowing the medical and recreational use of cannabis and cannabinoids in Colombia?

  1. Colombia has been one of the epicenters of the “war on drugs” and, paradoxically, one of their major producers. This has created a complicated scenario that requires a shift in the approach towards cannabis and other cannabinoids, conceiving them as a medicinal product and a raw material with a high potential for the manufacturing of various products (such as paper, bricks and fuel, among others) and as an alternative to pharmaceuticals, rather than as an illicit and harmful drug.
  2. The “Green-Gold” boom has led to an avalanche of requests and applications for licenses, which has led to the authorization processes taking longer than expected.
  3. Many companies are facing challenges in obtaining the quality certification required for the industry. Manufacturers of products for human use or consumption must comply with the Good Manufacturing Practices (GMP) to guarantee the high-quality standards that will prevent harm to consumers. The GMP are an essential condition for meeting the standards recommended by the agencies controlling authorization and licensing for the manufacture and sale of products such as food, drinks, dietary supplements, medicinal products, active pharmaceutical ingredients and medical devices.
  4. The industry has encountered significant difficulties with the financial sector: opening bank accounts, accessing credit and monetizing funds, etc. There are significant federal restrictions on the transfer of funds associated with the cannabis business, and the fact that some Colombian banks hold securities in the United States (where the trade and distribution of cannabis is still prohibited) has cultivated fear that the US Government could take reprisals. This fear has ultimately brought several corporate investment initiatives to a halt.

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