Regulation on Products Derived from Cannabis Published

Introduction

Following the legislative amendments adopted by the Grand National Assembly of Turkey (TBMM) in 2025, which established the primary legal framework for medicinal products, health products, personal care products with no narcotic effect, and support products derived from the cannabis plant, the secondary legislation in this field has now entered into force.

In this context, the Regulation on Products Derived from Cannabis (“Regulation”), published in the Official Gazette dated 31 January 2026 and numbered 33154 and entering into force on the date of its publication, constitutes a comprehensive regulatory instrument guiding implementation by setting out in detail the procedures and principles regarding the production, licensing, tracking, export, and sale of such products.

(You may access our legal alert on the legislative amendment here.)

Developments

The Regulation covers the processing, preparation, export, licensing, registration in electronic tracking systems, and sale of medicinal products, health products, personal care products with no narcotic effect, and support products derived from cannabis. It has been prepared on the basis of, in particular, Law No. 2313 on the Supervision of Narcotic Substances, as well as Law No. 1262 on Pharmaceutical and Medicinal Preparations, Law No. 5324 on Cosmetics, and Law No. 7223 on Product Safety and Technical Regulations.

With the new Regulation, the authorities and responsibilities relating to placing cannabis-derived products on the market have been clearly delineated. Accordingly, while the agricultural production and cultivation of the cannabis plant continue to be governed by the legislation of the Ministry of Agriculture and Forestry, the processing of cannabis-derived products, their conversion into finished products, licensing, tracking through electronic systems, export, and sales authorisations fall entirely within the competence of the Ministry of Health and its affiliated institution, the Turkish Medicines and Medical Devices Agency (“Agency”). In this respect, the Regulation clearly defines the institutional boundary between agricultural activities and the health products market.

Licensing

The Regulation subjects cannabis-derived products to different regulatory regimes depending on their nature. The licensing, variation procedures, and tracking of medicinal products derived from cannabis are carried out within the framework of the legislation on medicinal products for human use, and no medicinal product that has not been licensed by the Agency may be placed on the market.

Health products and support products derived from cannabis may not be placed on the market without being licensed by the Agency pursuant to the Regulation. For these products, licence applications must be submitted together with the technical, scientific, and administrative information and documents stipulated in the Regulation and the relevant guidelines.

Personal care products derived from cannabis are subject to cosmetics legislation. In order for such products to be placed on the market, a cosmetic product notification must be submitted to, and recorded by, the Agency. It is not possible to place personal care products containing cannabis-derived ingredients on the market without completing the cosmetic product notification.

THC Content

The Regulation sets an explicit upper limit for the tetrahydrocannabinol (“THC”) content of cannabis-derived support products and personal care products. Accordingly, these products must contain a maximum THC level of 0.3% and must include cannabinoids[1] or combination mixtures at a level that has no narcotic effect. Compliance with this upper limit for support products must be evidenced by analysis reports obtained from accredited laboratories holding TSE ISO/IEC 17025 certification.

Electronic Tracking System

For cannabis-derived health products and support products, the Regulation introduces a QR code–based electronic tracking system covering the entire process from production to the final point of sale. Within the scope of this system, all stakeholders—including licence holders, pharmaceutical warehouses, and community pharmacies—are obliged to electronically report all movements of the products, including production, sale, return, export, export cancellation, expiry, theft, deterioration, and destruction.

Through the electronic tracking system, all movements of cannabis-derived health products from production to the end user, and of support products from production to the pharmacy, are monitored on a unique package basis. Based on these records, the Agency carries out market surveillance and inspection activities and is authorised to take the necessary administrative measures under the Regulation and relevant legislation, including suspension or revocation of licences, withdrawal of products from the market, and destruction.

In addition, the Regulation requires that cannabis products harvested following cultivation be recorded in the electronic tracking system during transportation, delivery, and until they are incorporated into the production process, and that these records be kept accessible to the relevant public authorities.

International Reporting

The Regulation also includes provisions on international reporting obligations. Accordingly, data relating to the export, stock levels, and domestic consumption of products covered by the Regulation are reported by the Agency, together with data obtained from the General Directorate of the Turkish Grain Board (TMO), to the International Narcotics Control Board of the United Nations.

Sale of Products

One of the most notable provisions of the Regulation is the clear and definitive restriction of sales channels for all cannabis-derived products. Under this framework, medicinal products, health products, personal care products, and support products derived from cannabis may be sold exclusively through pharmacies. Medicinal products and health products may only be supplied against a prescription generated via a specific system (Reçetem Bilgi Sistemi) and over-the-counter sales are strictly prohibited. The sale of these products through non-pharmacy retail channels or online platforms is not permitted; in the event of non-compliant sales, the relevant provisions of the applicable legislation—including seizure and destruction of the products—shall be applied.

Conclusion

With this Regulation, a detailed and systematic secondary legislative framework has been established in Turkey with respect to the production, licensing, tracking, and distribution of cannabis-based products. While aiming to protect public health and ensure product safety, the Regulation significantly enhances legal certainty and predictability for natural and legal persons operating in the sector.

On the other hand, the Agency’s authority under the Regulation to issue guidelines, implement fee structures, and require that applications be conducted, as a rule, through electronic platforms indicates that practical details will be clarified through secondary regulations and that compliance processes will exhibit a dynamic structure.

You may access the full text of the Regulation, which is only in Turkish, here.