News and Publications

The Guideline on Triggers for Routine and/or for “Specific Reason” Inspections and the Guideline on Triggers for Inspections of Bioavailability / Bioequivalence (“BY / BE”) Studies have been published by the Turkish Medicines and Medical Devices Agency (“Agency”). The […]

Inspection reports on cosmetics and biocidal products belonging to the fourth quarter of 2021 have been published by the Vice Presidency of Inspection Services of the Turkish Medicines and Medical Devices Agency. Notable matters stated in the report are […]

Turkish Pharmaceuticals and Medical Devices Agency (“TITCK”) published the guideline for Issuance of “Pharmaceutical Product Certificate”, “Free Sale Certificate” and “Pharmaceutical Product License Status Statement” (“Guideline”) to be applied for applications filed as of 1 February 2022, on its […]

The Regulation on Variations to Licensed Medicinal Products for Human Use (“Regulation”), drafted by the Turkish Pharmaceuticals and Medical Devices Agency (“Agency”), was published in Official Gazette dated 18 December 2021 and numbered 31693 and entered into force on […]

On 5 January 2022, the Turkish Medicines and Medical Devices Agency (“Agency”) has published the Guideline on Counterfeit, İllicit or Out-of-the Legal Supply Chain Medicines (“Guideline”). The Guideline aims to provide the guidance on the actions that can be […]

On 6 January 2022, the Turkish Medicines and Medical Devices Agency (“Agency”) published the new Guideline (“Guideline”) on the Implementation of the Regulation on Test, Control, and Calibration of Medical Devices (“Regulation”). With the Guideline, the previous guideline on […]

Within the scope of the Product Safety and Technical Regulations Law No. 7223, the products must be safe and comply with the technical regulations prepared by the authorized institution. In this context, the products that the Turkish Pharmaceuticals and […]

The Regulation Amending the Regulation on Biocidal Products (the “Amendment Regulation”), effective as of 30 December 2021, were published in Official Gazette numbered 31705 of even date. The Amendment Regulation aims to align the Regulation on Biocidal Products closer […]

 1. General Information  1.1 Governing Copyright Statute Copyright protection in Turkey is governed by the Law on Intellectual and Artistic Works numbered 5846 (the “Law”), which came into force on 13 January 1951 and was amended in 1983, 1995, […]

   1. Intellectual Property Rights and Granting Procedure  1.1 Types of Intellectual Property Rights The Turkish legal system provides for “patents” and “utility models” for the protection of inventions. Both of these forms of protection are based on statutory […]