The Regulation on the Products Obtained from Hemp (the “Regulation”) was published in the Official Gazette dated 31 January 2026 and numbered 33154 and entered into force on the date of its publication.
Through the Regulation, the procedures and principles regarding the processing, preparation, licensing, export, registration with electronic tracking systems, sale, inspection, and destruction of medical products, health products, personal care products with no narcotic effect, and dietary supplements obtained from hemp are regulated. The Regulation aims to ensure uniformity in practice in licensing, tracking, inspection, and authorization processes.
Purpose, Scope, and Legal Basis
The purpose of the Regulation is to determine the procedures and principles to be applied in transactions and operations related to the production, licensing, notification, tracking, sale, and export of products obtained from hemp.
The Regulation concerns products obtained from hemp produced through industrial processes, as well as natural persons and companies that apply for a license, hold a license, or submit cosmetic product notifications for such products.
Licensing Requirement, Right to Apply, and Application Conditions for Health and Dietary Supplements
Pursuant to the provisions of the Regulation, health supplements and dietary supplements derived from hemp cannot be marketed unless they are licensed by the Turkish Medicines and Medical Devices Agency (the “Agency”).
License applications are submitted to the Agency by natural persons or companies established in Türkiye. Under the Regulation, clear conditions are stipulated for applicants regarding their level of education, professional competence, criminal record, and absence of convictions for certain crimes.
As part of the license application, documents such as the name, content, and formulation of the product, along with control and test results, must be submitted to the Agency, together with the applicant’s authorization and qualification documents.
Under the Regulation, a THC threshold of 0.3% is adopted as a distinguishing criterion for product categories. Accordingly, it is mandatory to verify that the THC ratio in dietary supplements does not exceed 0.3% with an analysis report obtained from a laboratory certified to the TS EN ISO/IEC 17025 standard. Products exceeding this ratio are not evaluated as dietary supplements but are subject to the health product regime and, in this context, are subject to licensing and scientific data requirements specific to the relevant product category.
Examination, Evaluation, and Grounds for Rejection of License Applications
Applications are subject to preliminary evaluation, completion of any deficiencies, and licensing review. During preliminary evaluation, the application file is examined for completeness in terms of form and content; if deficiencies are not remedied within the specified time, the application is rejected on procedural grounds. Applications found to be complete are then reviewed for quality, safety, and scientific adequacy within the framework of licensing criteria. The timeframes, evaluation procedure, and the Agency’s authority to request additional information and documentation are detailed in the Regulation.
If the analyses and scientific reviews reveal that the product does not meet the criteria for quality, safety, efficacy, or compliance with the declared formula and specifications, the application is rejected on its merits. The applicant is granted the right to appeal the decision to reject on its merits within a specified period, and the decision on the appeal is final.
Strict rules have been established regarding the trade names of health or dietary supplements derived from hemp in terms of licensed products. Accordingly, a second license cannot be granted to the same natural person or company for another product that has the same qualitative and quantitative composition in terms of active ingredients per unit dose, the same intended use or health effect, and the same pharmaceutical form as a product licensed by the Agency, even under a different trade name. However, this restriction does not apply if the only difference between primary packaging forms such as lozenges, oral sprays, chewable tablets, syrups, and sachets is the aroma or the distinction between single-dose and multi-dose use. Furthermore, the same natural person or company cannot use different trade names for products with the same active ingredients and the same intended use but with different dosages, routes of administration, or pharmaceutical forms. It is also stipulated that health or dietary supplements derived from hemp cannot be licensed under the same name as a human medicinal product, food for special medical purposes, cosmetic product, or medical device.
Granting, Suspension, Cancellation, and Amendments of Licenses
Where the required conditions are met, a license shall be issued. The suspension, revocation, lifting of suspension, and market release obligations of the license are detailed in the Regulation.
The Regulation also allows for the transfer of the license and the license application. All changes to be made after licensing are subject to variation provisions. It is stipulated that lists of suspended or cancelled licenses shall be published on the Agency’s website.
Expected Procedures and Applicable Legislation by Product Type
For export and domestic allocation transactions, a distinction has been made based on a THC threshold of 0.3%; for products containing more than 0.3% THC and subject to international control, both the issuance of permits by the Institution and the obtaining of relevant authorizations for export, as well as the application of special authorization and allocation procedures under the supervision of the Institution for domestic allocation, are envisaged.
Medical products derived from hemp are subject to human medical product regulations and cannot be marketed without being licensed by the Agency; personal care products are subject to cosmetic regulations and cannot be marketed without their notifications being registered.
Export, Allocation, and Electronic Tracking System
Export permits, export permit procedures, integration with the Single-window System, and domestic allocation processes are regulated by making distinctions based on THC ratios. It is stipulated that exports shall be carried out using specified transportation methods.
Health and dietary supplements are registered in the electronic tracking system via QR codes, ensuring traceability from production to the end user. The delivery and tracking of post-harvest hemp products are also carried out through the electronic system.
Inspection, Other Provisions, Entry into Force, and Execution
The institution carries out market surveillance, inspection, sampling, recall, and destruction procedures. International reporting, fee collection, sales channels, confidentiality, guideline publication, and electronic application principles are regulated within the scope of the Regulation.
The Regulation entered into force on the date of its publication and its provisions are executed by the Minister of Health.
The full text of the Regulation can be reached through this link. (only Available in Turkish)
