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Update on the Medical Devices Regulations in Turkey

All kinds of manufacturing, marketing, and after-sales activities of medical devices are highly regulated in Turkey. The main framework for ensuring safety and compliance with the technical specifications is governed by the Law on Product Safety and Technical Specifications No. 7,223, which is an umbrella legislation covering all products intended to be placed on the market, supplied, or placed on the Turkish market. Further to above, general rules and principles of medical… »

The Turkish Court of Cassation Reminds of the Significance of “Vested Rights” in Two Recent Decisions: Frigo V Frico

Güldeniz Doğan Alkan and Dilan Sıla Kayalıca of Gün + Partners consider the Turkish Court of Cassation’s two recent decisions, underlining the significance of “vested rights” in the Turkish trademark law. The concept of “vested rights” is notable in the Turkish trademark law, as it serves as a strong defense against potential refusal of a later mark because of the likelihood of confusion it may create against an earlier one. In its two recent decisions related to the court… »

Guideline on Circumstances Requiring Reissue of a Marketing Authorization For a Licensed Pharmaceutical

Updates -

The transfer of pharmaceutical marketing authorizations (“MA”) entails intricate and interconnected procedures. Especially when it comes to imported pharmaceuticals, comprehensive contracts control the process when the foreign licensor company gives a license to a distributor in Türkiye and the products are offered for sale in the Turkish market. Before the MA transfer application is submitted to the Turkish Medicines and Medical Devices Agency (“Agency”), the license… »

Advertisement Board is Again Able to Block Access

Turkish Constitutional Court (“Court”) annulled the paragraph 12 of Article 77 of the Consumer Protection Law, which granted the Advertisement Board (“Board”) the power to partially or entirely block access to websites containing unlawful advertising content. The relevant rule was considered to be unconstitutional pursuant to the Court’s decision dated 13 September 2023 and numbered 2022/70 E. - 2023/152 K. which was published on the Official Gazette dated 27 October 2023 and… »

Food Supplements

With the regulations published in the Official Gazette numbered 32169 and dated April 20, 2023, comprehensive amendments were made to the legislation on the use of health claims for food and food supplements and the use of nutrition claims. Thus, the Turkish Food Codex Regulation on Nutrition Claims under the authority of the Ministry of Agriculture and Forestry and the Regulation on Health Claims for Food and Food Supplements under the authority of the Agency, has entered… »

Application Fee for Scientific Meetings of Pharmaceuticals and Medical Devices Has Been Introduced

The Agency first announced on its official website on 4 January 2024, that the Guidelines on Scientific Meetings and Educational Activities to be Conducted within the Scope of the Regulation on the Sales, Advertisement and Promotion of Medical Devices (“Guidelines”) was amended, and that the most significant change introduced by the amendment to the Guideline is the collection of fees by the Agency for scientific meetings and applications for educational activities. According… »

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