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TITCK Updated the Guidelines for Preparing the Documents Regarding Pharmaceutical Products

European Union, Turkey - January 12 2023 Turkish Pharmaceuticals and Medical Devices Agency (“TITCK”) published the Guideline for Issuance of “Pharmaceutical Product Certificate”, “Free Sale…

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Certain Amendments are Introduced to the Regulation on the Safety of Medicines

Turkey - September 30 2022 Regulation Amending the Regulation on the Safety of Medicines (“Amendment Regulation”) was published in the Official Gazette dated 21 July 2022 and…

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İlaçların Güvenliliği Hakkında Yönetmelik’te Değişiklik Yapıldı

Turkey - September 30 2022 Ilaçların Güvenliliği Hakkında Yönetmelikte Değişiklik Yapılmasına Dair Yönetmelik (“Değişiklik Yönetmeliği”), 21 Temmuz 2022 tarihli ve 31899 sayılı…

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The Bolar Exemption and Data Exclusivity: How They Apply In Turkey

Turkey - August 17 2022 In Turkey, pharmaceutical products for human use cannot be marketed unless they are authorized by the Ministry of Health (“MoH”). In order to grant…

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TITCK Published Guidelines for the Classification of Diversification Applications and Variation Applications of Licensed Medicinal Products for Human Use

Turkey - June 6 2022 Turkish Pharmaceuticals and Medical Devices Agency (“TITCK”) published the Guidelines for the Classification of Diversification Applications and…

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