Foreign investment, Foreign trade, Pharmaceutical

The key aspect to commercialise cannabis derived products

02/11/2018

As commercializing is one of the key stages in every productive project, being well aware of Colombia’s government imperatives is crucial in order to achieve the projected economic returns, and cannabis projects are no exception. Hence, one of the fundamental steps to follow is obtaining the sanitary register for the cannabis derived products to be marketed, which is granted by Colombia’s National Institute for Medicine and Food Surveillance (INVIMA).

 

In order to regulate this procedure, Decree 1156 of 2018 was issued by Ministry of Health and Social Welfare; according to it, the sanitary registers must be obtained in order to prepare, manufacture, sell, or export cannabis derived products (either for animal or human consumption), and they have already been granted by INVIMA for products containing tetrahydrocannabinol (THC), cannabidiol (CBD) and cannabinol  (CBN), among others.  Every product must have a sanitary register and once it is granted  it will be valid for 10 years, existing the chance to renew them.

 

In order to grant the sanitary register, INVIMA must perform a toxicological evaluation regarding the efficiency and safety of the product, as it is for medicinal purposes; they will also study the brand of the product, which must be previously granted by the Industry and Commerce Superintendency, and require for the manufacturer to exhibit its Certificate of compliance with Good Manufacturing Practices.

 

As for other pharmaceutical requirements, the pharmaceutical phormula must be presented, indicating the components and the kind of plant species it was based of, as well as the certificates of quality control.

 

Now, ven when Colombia’s sanitary authority has authorized the commercializing of oils, resins, tinctures, extracts and drug preparations that are based on psychoactive and non psychoactive cannabis, the rules for commercializing them are not the same. For instance, psychoactive cannabis derived products can be sold exclusively under medical prescription, while non-psychoactive cannabis derived products do have unregulated sale. Moreover, psychoactive cannabis products must be also registered before the National Narcotic Funds for their surveillance.

 

It's also important to precise that cosmetic products containing cannabis products do not require a sanitary register, but a merely sanitary notification, informing they will be marketed; this means their safety and performance will be presumed at a first stage, understanding they must comply with international parameters for cosmetics[1]. Nevertheless, cosmetic products that are based on psychoactive cannabis plants are not allowed to be commercialized.

 

All of the dispositions that have been mentioned before, pursuit the intention of making the market for cannabis derived products as reliable and profitable as investors expect it to be, which seems to be working as cannabis derived products have already been authorized and are currently in the market.

 

[1] Decisión Andina 516 de 2002

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