Pursuant to the Law, the Board has the authority to impose administrative sanctions. It has been regulated that the Board may impose administrative fines for non-compliance with the obligation of disclosure, obligations related to data security, failure to comply with the decisions issued by the Board, violations of the obligation to register and notify the Data Controllers’ Registry, or non-compliance with the notification obligation regarding standard contracts. In addition…
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The primary regulation on the protection of personal data in Turkiye is the Personal Data Protection Law No. 6698 (“Law”), which came into force in 2016. Based on the European Council Data Protection Directive 95/46/EC, the Law has been influenced by the provisions of the European Union General Data Protection Regulation (“GDPR”) and its implementation is shaped by both the GDPR and the decisions of European data protection authorities. The Law adopts similar objectives and…
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AI technologies and their relationship with Intellectual Property (IP) rights have remained a prominent topic on the global agenda this year, as they were last year. With the increasing presence of generative AI models such as ChatGPT, BERT, LaMDA, and DALL-E2, which are capable of creating original content by processing data like text, images and sound, debates continue over whether the outputs generated by these models qualify as copyrighted works, who owns the rights to…
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According to the Competition Authority's (“Authority”) activity report for 2023, it is seen that 68 of the 117 investigation files were concluded with settlements and 28 files were concluded with commitments. Although the activity report for 2024 has not yet been published by the Authority, announcements of final decisions on its website indicate that the majority of investigations in 2024 have also been concluded through settlement.
Investigation of competition law…
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The pharmaceutical sector saw a 2.7% increase in production in 2023. However, between January and July of 2024, there was a 5.2% decrease compared to the same period in the previous year. By 2023, pharmaceutical imports increased by 8.8% reaching a value of 5.4 billion USD, while pharmaceutical exports grew by 15.8% to the size of 2.2 billion USD. In the first half of 2024, exports rose by 1.9%, while imports increased by 4.9% [1].
In 2023, the Turkish pharmaceutical market…
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The export of products that are produced for and imported to the Turkish market after being introduced to the market may restrict patients’ access to treatment. Additionally, pharmaceutical products that are purchased at prices significantly lower than those in many other countries and then exported can influence the market prices in other countries. In this context, the Circular No. 2014/11 on the Availability of Pharmaceutical Products in the Market prepared by the Agency…
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The 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…
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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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