Regulation on Cannabis Cultivation for Active Pharmaceutical Ingredients Published

In accordance with the Law on the Amendment of the Forestry Law and Certain Other Laws, published in the Official Gazette on April 5, 2023, the “Regulation on Cannabis Cultivation and Control for the Production of Pharmaceutical Active Substances” (“Regulation”) entered into force following its publication in the Official Gazette on September 13, 2024. The Regulation establishes the procedures and principles governing the duties and responsibilities related to the cultivation and/or commissioning of cannabis for the production of flowers and leaves intended for active pharmaceutical substances, as well as the necessary controls. [1]

Certificate of Competence and Authorization

Aside from the exceptional cases stipulated in the Regulation; in order to cultivate cannabis for the production of pharmaceutical active ingredients, it is necessary to obtain a Certificate of Competence from the General Directorate of the Turkish Grain Board (‘TMO’) and subsequently a Cannabis Cultivation Permit from the Ministry of Agriculture and Forestry (‘Ministry’).

In this context, the documents listed in the Regulation must be submitted to the TMO between October 1 and 31. If a positive result is obtained based on the supply and demand quota determined by the President of the Republic, a production site permit must be obtained from the Turkish Medicines and Medical Devices Agency within 18 months after signing a cultivation contract with the TMO. Following the completion of the requirements in the production plan, applicants must apply to the TMO for the Certificate of Competence. This certificate, valid for a maximum of 5 years, is issued to those found eligible as a result of the inspection. Natural or legal persons who receive a Certificate of Competence will be granted a cannabis cultivation permit by the Ministry, with the validity period specified in the document.

Production Provisions

The Regulation sets forth the minimum production conditions for cannabis cultivation and the characteristics of production facilities. Additionally, the measures growers must take regarding production and their compliance with the Regulation will be audited. The suitability of cannabis cultivation areas and facilities will be assessed and products will be weighed. A control committee will be established by the authorities for the destruction of unused cannabis resulting from the revocation of the permit.

Trade Provisions

In accordance with the provisions governing the trade of manufactured active pharmaceutical ingredients, the TMO and other authorities may sell them only to entities authorized by the Ministry of Health. Exports are conducted with the authorization of both the importing country and the Ministry of Health and may only be carried out by air. Exporters must submit the necessary documentation to the TMO and provide shipment information.

Conclusion

As the medicinal properties of cannabis for treating certain neurological and psychiatric disorders have gained recognition, comprehensive legal frameworks have been established in the USA and Europe to regulate and promote the production and use of medical cannabis. While this Regulation aligns with European and US legal frameworks, it places particular emphasis on scientific research and treatment applications.

[1] You can access the Regulation here (Only in Turkish)