The Guideline on Co-Marketing of Medicinal Products for Human Use ("Guideline") contains regulations on the evaluation of marketing authorization applications for co-marketed products and the evaluation of authorized co-marketed products. The Guideline published on February 17, 2023, was updated by the Turkish Medicines and Medical Devices Agency and re-published on June 07, 2024.
The Guideline used to stipulate that if variations are made in the main product that also affect…
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Amendments to the Regulation on the Procedures and Principles of Media Services ("Regulation") introduced new rules regarding the content rating for television programs. New rules immediately entered into force upon publication in the Official Gazette dated 13.06.2024 and numbered 32575. The new amendments are particularly relevant for news programs and, in some cases, live broadcast programs.
Highlights of the Amendments:
It is regulated that the Content Rating System will…
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Similar as in other countries, trademark squatting is also a common problem which foreign brands face in Türkiye. Trademark squatting creates challenges for market entry and registration of trademarks for foreign companies, as well as leading to dilution of the original trademark. Although there are steps to be taken to better prevent squatters, the current intellectual property (IP) legislation still has effective tools to protect the rights of foreign trademark owners and…
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Amendments to the Law on the Protection of Personal Data (“Law”) entered into force as of June 1, 2024. Please review our detailed article here about the amendments to the Law.
The main actions to be taken by data controllers within the framework of the amendments are briefly as follows:
1. Providing Appropriate Safeguards for Transfers Abroad
Except for cross-border transfers that are irregular, occur on one or a few occasions, are not continuous and are not in the ordinary…
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On May 28, 2024, the Turkish Medicines and Medical Devices Agency (“Agency”) published a Draft Regulation on the Promotional Activities of Human Medicinal Products and Food for Special Medical Purposes (“Draft”) on its official website and announced that opinions regarding the Draft can be delivered to the Agency. Significant amendment proposals that differ from the current regulation are as follows:
In General
In addition to physicians, dentists, and pharmacists, promotion…
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Pharmaceuticals that are not authorized in Türkiye or authorized but not available on the market shall be procured from abroad as per a special authorization and on a case by case basis (Named Patient Program-NPP). This supply can be conducted by public institutions approved by the Ministry ofHealth that are defined as Foreign Pharmaceutical Suppliers (Suppliers) and currently constitute theSocial Security Institution and the Turkish Pharmacists Association. The Suppliers can…
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