Colombia Moves to Regulate Medical Cannabis for Pharmacy Sale

The national government in Colombia is preparing new regulations to allow the sale of cannabis-derived medications in the country’s drugstores.

According to the proposal, pharmaceutical establishments in Colombia will be able to offer cannabis medications as long as they are in dosage form. This includes presentations such as tablets, capsules, or liquid or semi-solid formulations, in which the quantity is controlled per gram or milliliter, as is the case with oral solutions, creams, or ointments.

New decree in Colombia to authorize controlled cannabis-based medications, enhance patient access, and ensure strict health oversight and traceability

The draft decree in Colombia establishes that products authorized for sale under special control may come from a variety of sources, including synthetic formulas, herbal remedies classified as phytotherapeutics, homeopathic medicines, and magistral preparations. The latter correspond to personalized formulations developed based on medical prescriptions for specific patients.

Regarding cannabis-based master preparations, the document specifies that they may only be prepared by pharmacies and pharmaceutical services that have express authorization to do so. Additionally, they must operate under the guidelines established by the Ministry of Health and possess certification of compliance with good manufacturing practices, issued by the National Institute for Drug and Food Surveillance (INVIMA).

For its part, cannabis cultivation control will be in the hands of several entities in Colombia. The Colombian Agricultural Institute (ICA), INVIMA, the Ministries of Agriculture and Commerce, and the Anti-Narcotics Directorate of the National Police will be responsible for issuing licenses for the cultivation of both psychoactive and non-psychoactive plants.

Regarding non-psychoactive cannabis, the draft text indicates that those holding the respective license may transfer or deliver the product to third parties for use as a medicinal product, as long as the recipient has the relevant health authorizations. “In the case of licenses for the cultivation of non-psychoactive cannabis plants for domestic use and export, the transfer or delivery of non-psychoactive cannabis to be used as a finished product for medical purposes may be carried out under any title to persons who hold the appropriate health authorizations,” the document states.

One of the most anticipated developments among various sectors is the possible authorization of cannabis flower as a finished product for therapeutic purposes. The corresponding regulations will be issued nine months after the decree comes into effect. These regulations will be developed by the competent entities, according to their scope of action, and must define the parameters under which cannabis flower may be marketed within the medical context in Colombia.

The project’s approach seeks to consolidate a regulated system that allows access to medical cannabis derivatives under medical prescription, in an environment controlled by health authorities in Colombia. Marketing will only be valid if all the quality, safety, and control requirements established in the regulations issued by the national government are met.

Furthermore, medications must comply with the current regime for special control products, which entails specific requirements for their handling, storage, distribution, and delivery. Traceability mechanisms will also be included to monitor the use and final destination of the products, in order to guarantee the legality of the process.

The draft decree is currently under review by the various entities involved and will be subject to comments before its final publication. The initiative seeks to strengthen access to alternative therapies for patients with diagnoses that may benefit from the use of medical cannabis, always under medical supervision and in compliance with the highest technical standards.

This regulation is part of a set of strategies promoted by the Government of Colombia to harness the medicinal potential of cannabis within a regulatory framework that guarantees institutional control and secure access. It also aims to strengthen domestic production of this type of medication and facilitate its circulation in the healthcare system through certified prescription mechanisms.

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