News and Publications

Protective letters, which are available in some European countries and before the Unified Patent Court (UPC), serve as a “first line of defense” for accused infringers against potential ex-parte provisional measures. There is no doubt that, this protective letter […]

The Communiqué on Amendments to the Social Security Institution’s Health Implementation Communiqué (“Amendment Communiqué”) was published in the Official Gazette dated February 23, 2025, and numbered 32822. It entered into force on its publication date, with retroactive effect from […]

On 28 January 2025, Unified Patent Court (“UPC”) Düsseldorf Local Division delivered a decision[1] in a patent infringement action brought by Fujifilm Corporation (“Fujifilm”) against Kodak GmBH, Kodak Graphic Communications GmBH and Kodak Holding GmBH (together referred  as “Kodak”), […]

The Regulation Amending the Regulation on the Licensing of Homeopathic Medicinal Products (“Amendment Regulation”) was published in the Official Gazette dated December 3, 2024, and numbered 32741, and entered into force on its publication date. The Amendment Regulation includes […]

The Regulation Amending the Regulation on the Licensing of Human Medicinal Products (“Amendment Regulation”) was published in the Official Gazette dated December 3, 2024, and numbered 32741, and entered into force as of its publication date. The Amendment Regulation […]

The Regulation on the Withdrawal of Medicinal Products for Human Use and Foods for Special Medical Purposes was published in the Official Gazette dated October 23, 2024 and numbered 32701 and entered into force as of the date of […]

In accordance with the Regulation on the Use of Health Declarations in Food and Food Supplements (“Regulation”) and the Guideline on the Use of Health Declarations in Food and Food Supplements (“Guideline”), health declarations may be used in food […]

One of the most significant updates in the Guideline on the Scheduling Processes for Marketing Authorization Applications of Medicinal Products for Human Use (“Scheduling Guideline”) is the new regulations regarding hybrid applications. Firstly, the Scheduling Guideline has been updated […]

“The Regulation Amending the Medical Devices Regulation” (“Regulation“) has introduced detailed amendments to Article 10 titled “General Obligations of the Manufacturer.” The Regulation on notified bodies has been amended to provide for an assessment 5 years after notification and […]

The “Guide for Import Applications and Market Placement Permits” (“Guide“) was updated on May 27, 2024, by the Turkish Medicines and Medical Devices Agency (“TİTCK”) and published on the TİTCK website. These updates include various regulations concerning import applications […]