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 […]
15 Apr 2022
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 […]
15 Apr 2022
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 […]
11 Mar 2022
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 […]
11 Mar 2022
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 […]
11 Mar 2022
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 […]
11 Mar 2022
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 […]
