New Regulations on Hemp Cultivation for Medicinal Active Ingredient Production and Its Control

The Regulation on Hemp Cultivation for Medicinal Active Ingredient Production and Its Control (“Regulation”), published in the Official Gazette No. 32661 on September 13, 2024, regulates the procedures and principles regarding the procedures to be applied within the scope of cannabis cultivation to obtain pharmaceutical active ingredients and the duties and responsibilities regarding the necessary controls.

In summary, the Regulation sets out the following procedures and principles regarding the application process:

– Anyone wishing to engage in hemp cultivation for the production of medicinal active ingredients, and who meets the requirements outlined in the Regulation, must complete the designated form and submit it along with the necessary documents to the Agricultural Products Office (“TMO”).

– All processes related to the application will be conducted by the TMO.

– Once the application process yields a positive outcome, a cultivation contract will be signed between the Agricultural Products Office (TMO) and the applicant, whether an individual or a legal entity.

– The Ministry will issue a hemp cultivation certificate to those who have been granted a competence certificate by the TMO, in accordance with the timelines specified in the Regulation.

– For scientific purposes, institutions with research permits, such as universities, are not required to obtain a competence certificate for their research and R&D activities under this framework. These institutions must obtain a scientific research permit from the Ministry for each scientific study, as specified in the Regulation, and conduct their research within the established limits.

Within the scope of the Regulation, detailed regulations are included regarding the characteristics of the facilities where hemp cultivation will be carried out and the responsibilities of real or legal persons who will cultivate hemp as well. In this context, the following issues are regulated in summary:

– Hemp cultivation must be conducted in secure, enclosed, and climate-controlled facilities that are equipped with perimeter surveillance camera systems and alarm systems.

– The facilities are equipped with all-round camera systems and alarm systems.

– These conditions also apply to hemp cultivation for scientific research purposes.

– Cultivators are required to implement security measures and retain records for a period of two years.

– They must also take necessary precautions for the safe transportation of harvested hemp and inform the control committee.

– Only authorized personnel may enter these facilities, without prejudice to supervisory controls.

The control committee comprises representatives from relevant institutions and is tasked with inspecting facilities in accordance with the provisions set forth in the Regulation.

Individuals and institutions holding a permit who wish to discontinue production must apply to the TMO, which will then issue a cancellation decision on behalf of the Ministry. In the event of cancellation, the control committee will oversee the destruction of the plant materials and residues present at the facility.

TMO, regulates the domestic and international sale of hemp. TMO, collects and verifies the necessary permits and documents for export operations and reports them to the relevant authorities.

You can access the text of the Regulation on Hemp Cultivation for Medicinal Active Ingredient Production and Its Control, which came into effect on September 13, 2024, here.