On 26 May 2023, significant changes were made to the Medical Device Promotion Regulation. These changes introduced several new procedures to the medical device sector. Rather than being regulated under separate legislation, these procedures were incorporated into the existing Medical Device Promotion Regulation.
According to the updated regulation, additional obligations have been introduced for authorised sales centres for medical devices. These include providing technical…
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Hemp cultivation in Türkiye came to the forefront with the “Symposium on Local Governments in the Presidential Government System” held on 9 January 2019, followed by the preparation of the “Report and Action Plan on Industrial Hemp Cultivation in Türkiye”. The hemp cultivation reached a significant stage with the publication of the Law on Amendments to the Forestry Law and Certain Laws on 5 April 2025. This law encourages the production of fibre, seeds, and stems, with the…
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On 20 April 2023, significant changes were made to the regulations regarding the use of health claims on food and dietary supplements. As a result, the previous regulation, the Turkish Food Codex Nutrition and Health Claims Regulation, has been repealed.
With the new regulation, the process of obtaining prior administrative approval for the use of health claims has been eliminated. As long as the claims comply with the regulation and guidelines, health claims can be used…
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Promotion activities for pharmaceutical products for human use are regulated under the Regulation on the Promotion of Medicinal Products for Human Use dated 3 July 2015 (“Promotion Regulation”).
The Promotion Regulation stipulates that the promotion of pharmaceutical products can only be conducted with healthcare professionals such as doctors, dentists, and pharmacists. As a result, the interaction of pharmaceutical companies with patients are limited, and direct…
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aaaaIn the presence of alternative reimbursement models developed globally for pharmaceutical reimbursement systems, such as payback, value-based, indication-based reimbursements, and performance-based models, the Turkish pharmaceutical industry has also required alternative reimbursement models that fall outside the usual pricing and reimbursement rules for innovative products, and that can be negotiated with the Social Security Institution (SSI) to determine reimbursement…
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The prices of pharmaceuticals to be launched on the market are determined in accordance with the Decision on the Pricing of Medicinal Products for Human Use (”Decision”) and the Communiqué on the Pricing of Medicinal Products for Human Use (“Communiqué”) dated 29 September 2017, published by the Ministry of Health, which has been authorised to regulate this area.
The Decision foresees a reference pricing system in which the lowest wholesaler price for the relevant product in…
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