There are very limited cookies on our website to protect your privacy during your visit experience. You can review our Cookie Policy to get detailed information about our cookies.
I don't accept I acceptThe Named Patient Programs (NPP) are import regimes that allow medicines not authorized in Türkiye or authorized but unavailable for various reasons to be imported from abroad upon request by a physician. Following publication of the Regulation on the Importation of Medicines from Abroad ("NPP Regulation") published on 3 February 2023, the roles of stakeholders in the relevant process have been clarified. According to this NPP Regulation, institutions and organisations… »
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… »
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… »
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 As a result, the previous regulation, the Turkish Food Codex Nutrition and Health Claims Regulation, has been repealed.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… »
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… »
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… »
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… »
Legislative Framework Applicable Legislation 1. What legislation applies to arbitration? The main arbitration legislation in Türkiye is: The International Arbitration Code (No. 4686), which applies to an international arbitration seated in Türkiye and to an arbitration where its application is agreed by the parties. The Civil Procedure Code (No. 6100), which applies to a domestic arbitration. The arbitration laws in the International Arbitration Code and the Civil… »
Existing Facilitations for Capital Loss and Over-Indebtedness Calculations are Extended until 2026 Article 376 of the Turkish Commercial Code numbered 6102 (the “TCC”) regulates the measures to be taken and the precautions to be implemented by the board of directors of the company, and the procedures to be followed in cases where the company suffers capital loss or becomes over-indebted, to ensure the protection of the financial structure of the company and to secure the… »
With the Communiqué on Maintenance of Commercial Books Not Related to the Accounting of the Business in Electronic Form (the “Communiqué”) published in the Official Gazette dated 14 February 2025, it has become mandatory for companies to keep their commercial books not related to the accounting of the business electronically as of July 1, 2025. Books and Enterprises within the Scope of the Communiqué The commercial books, which have been made mandatory to be kept… »
Protecting patent rights in a timely manner is crucial for original pharmaceutical product manufacturers, particularly in being informed of potential infringements before an infringing product enters the market. However, information requests submitted by legal representatives of original drug marketing authorisation (MA) holders regarding the authorisation files of generic companies—who seek approval through an abridged application referencing the original pharmaceuticals—are… »
Executive Summary: Data Residency in Turkey – Q&A Format Overview 1.1 General Personal Data Q: Can personal data be transferred abroad? A: Yes, but under specific conditions. Before June 1, 2024, personal data could be transferred abroad only if explicit consent was obtained or if a legal basis other than consent existed. These legal bases were outlined under Article 5 of the Data Protection Law (DPL). However, the applicability of these bases was limited due to the… »
