29 Nov 2022
Turkish Pharmaceuticals and Medical Devices Agency (“Agency”) published the Trust Practices Guide for Licensing of Medicinal Products for Human Use (the “Guide”) on 24 September 2022. The Guide sets out the procedures and principles for considering the evaluations of […]
28 Oct 2022
The Regulation Amending the Regulation on Medical Devices prepared by the Turkish Medicines and Medical Devices Agency (“Agency”) and the Regulation on Amending the Regulation on Medical Devices for In Vitro Diagnostic Purposes were published in Official Gazette dated […]
30 Sep 2022
The Trust Guide for Good Manufacturing Practices Assessments (“Guide”), prepared by the Turkish Medicines and Medical Devices Agency (“Agency”) within the framework of the World Health Organization (WHO) and Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines, was published on 9 […]
24 Aug 2022
The Regulation on Pharmaceutical Establishments and Products in Pharmaceutical Establishments (“Regulation”), drafted by the Turkish Pharmaceuticals and Medical Devices Agency (“Agency”), was published in Official Gazette dated 15 June 2022 and numbered 31867 and entered into force on the […]
22 Aug 2022
In Turkey, and in other countries around the world, there is a fairly common misconception that if a trademark is not registered then it’s not enforceable. The truth is that even an unregistered trademark is enforceable in Turkey, although […]
27 Jul 2022
Turkey initiated arbitration procedure against the World Trade Organization’s (“WTO”) report concerning the dispute between Turkey and the European Union (“EU”) regarding Turkey’s localization of pharmaceuticals practice. The dispute between the EU and Turkey was initiated by the complaint […]
6 Jun 2022
As a result of its market surveillance and inspection activities, the Department of Cosmetic Inspection (Vice Presidency of Inspectorate) published the data regarding the first three months of 2022 on products that were found to be unsafe and non-compliant, […]
6 Jun 2022
Turkish Pharmaceuticals and Medical Devices Agency (“TITCK”) published the Guidelines for the Classification of Diversification Applications and Variation Applications (“Guidelines”) on 14 April 2022. The Guidelines aims to help the classification by comparing variation applications with diversification applications. The […]
29 Apr 2022
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 […]
29 Apr 2022
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 […]
