Merve Altinay Öztekin
Moroğlu Arseven
Articles
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…
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…
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…
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…
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…
