Medical Cannabis in Panama

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All relevant GMP/GDP/GACP aspects for Medical Cannabis

Medical use of cannabis has been legalized in Panama since October 2021. The new regulatory framework allows the use and controlled access to medical cannabis for therapeutic, medical, veterinary, scientific and research purposes. The law regulates the evaluation, monitoring and control relating to importation, exportation, cultivation, manufacturing, storage, transport, and distribution.

Manufacturing License

The license for the manufacture of medical cannabis will be authorized by the Ministry of Health. It includes the acquisition and the importation of medical cannabis for the purpose of product manufacturing, as well as the storage, transportation, commercialization, marketing and exportation. The license will be granted for a period of ten years as of its issuance, renewable for the same period. The renewal of the license must be requested within six months prior to the date of its expiration.

In order to obtain the manufacturing license for medical cannabis the applicant must meet the following specific requirements: 

• Submit the cadastral plan duly approved by the competent authority that shows the areas where the activities requested in the license will be carried out, including measures and dimensions, as well as the corresponding photos of the property destined to the manufacture.
• In the event that the applicant is not the owner of the property or properties, attach, together with the application, the document through which he / she acquired the right to make use of the property for this activity.
• Present the protocols approved by the Ministry of Public Security that contain measures to guarantee that the areas and properties are permanently provided with the appropriate levels of protection that guarantee security.
• Present the production plan, which must be projected for an initial period of three years. This plan must contain a work schedule and an organizational chart showing responsibilities and tasks of each of the employees and / or contractors who are directly involved in the operation.
• Present the export plan, in the case of manufacturing for this purpose, projected for a period of three years, which must include, at least, the potential markets and purchasers, in order to guarantee that the finished product will be used exclusively for medical, scientific and research purposes only.
• Submit the defective product disposal plan, including the name and address of any waste disposal service.

In addition, the applicant for medical cannabis products shall comply with the following:

• Approved security protocol to be used for the storage of medical cannabis.
• Authenticated copy of the certificate of origin of the product for medical and therapeutic use, proving the legality of the product.
• Annual projections to commercialize in the use of medical cannabis.
• Technical data sheet of extract derived from medical cannabis, with its physicochemical characteristics.

The Ministry of Health shall verify the validity of the information presented during inspection of the place where the activities will be developed. The visits will be prior to the granting of licenses. 

Import / Export of Medical Cannabis Products

Medical cannabis products may only be supplied by duly certified companies that are licensed or authorized to manufacture medical cannabis products in the country of origin from where they are imported and that can be exported to the Republic of Panama. The importation of cannabis products will be authorized to licensees holding the "License for the Manufacture of Medical Cannabis". This authorization will be valid for two years as of the date of approval of each license, and may only be granted for a period of two years. Licensees authorized to import medical cannabis products must comply with Law 14 of 2016, which regulates the use of controlled substances for medical and / or scientific purposes.

In order to export medical cannabis products, the application shall be submitted to the Ministry of Health and the authorization shall consist of an export certificate that the holder of the "Manufacturing License" shall obtain for each shipment, in accordance with the provisions of the present law and, in a supplementary manner, by Law 14 of 2016.

For more information please see Law N° 242 (13 October 2021) LEY QUE REGULA EL USO MEDICINAL Y TERAPÉUTICO DEL CANNABIS Y SUS DERIVADOS Y DICTA OTRAS DISPOSICIONES in Gaceta oficial 29398 - B of 15 October 2021.