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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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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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…
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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…
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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…
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