From Plant to Pill: Introducing Cannabis to the Pharma Industry

The Regulation on the Cultivation and Control of Cannabis for the Production of Active Pharmaceutical Ingredients ("Regulation") prepared by the Ministry of Agriculture and Forestry (“Ministry”) was published and came into force upon being published in the Official Gazette numbered 32661 dated 13 September, 2024. The Regulation includes provisions on the control, harvesting, evaluation, processing, disposal, display, export and/or purchase/sale of cannabis cultivation for the purpose of obtaining active pharmaceutical ingredients, as well as taking all kinds of measures to prevent the institutions/organizations permitted to conduct scientific research from using the flowers and leaves obtained from cannabis for purposes other than their intended use, and outlines the duties and responsibilities regarding the necessary principles for control and inspection.

To cultivate cannabis for the production of active pharmaceutical ingredients within the scope of the Regulation, it is necessary to firstly apply to the General Directorate of the Turkish Grain Board (“TMO”). If the necessary conditions are met, a cultivation agreement is signed, and a production site permit is obtained from the Turkish Medicines and Medical Devices Agency. Once this process is completed, a new application is made to the TMO to obtain a certificate of competence. Lastly, the Ministry shall issue a cannabis cultivation permit to real and legal persons who obtain a certificate of competence from the TMO.

In addition, according to the Regulation, universities, research institutes of Ministry and organizations with research permits will be able to conduct scientific research and R&D studies within the scope of cannabis cultivation to produce active pharmaceutical ingredients without obtaining a certificate of competence. However, for these organizations to be able to conduct research within the limits of the number of individual plants and cultivation area determined by TMO, their scientific research projects will need to be approved by the TMO and then a permit for scientific research will need to be issued by the Ministry.

Pursuant to the Regulation, it is also envisaged to establish a control committee in charge of determining the suitability of the location for cultivation, checking whether the facility meets the conditions for obtaining a certificate of competence, following the cultivational activities between planting and harvesting, inspecting the facility/scientific research organization authorized for cannabis cultivation for the production of active pharmaceutical ingredients at least once a month, keeping records of the data regarding the flowers and leaves harvested and disposing of the surplus products, and cancelling permissions. The aforementioned control committee will consist of representatives of the Provincial Directorate of Agriculture and Forestry, Provincial Directorate of Health, the TMO, and representatives of the narcotics units of the Provincial Directorate of Security or Provincial Gendarmerie Command who are trained and/or experienced in cannabis cultivation and whose field of duty is relevant.

The Regulation provides that the Ministry of Agriculture and Forestry, the Ministry of Internal Affairs and the Ministry of Health will be authorized to respond to any questions that may arise in practice, according to their relevant areas of expertise. With the potential to establish Turkey as a center for pharmaceutical research, this Regulation represents a major milestone for Turkey in the international cannabis industry. It is known that cannabis could improve therapies for a range of illnesses by permitting its supervised cultivation. Compared to other countries that have similar oversight and control procedures, Turkey’s approach to cannabis is still cautious and focuses on scientific research and therapeutic applications.

First published by Legalink European Monthly Newsletters in Sep 20, 2024.