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
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 […]
21 Feb 2022
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 […]
24 Dec 2021
Guideline on Procurement and Use of Medicines from Abroad (“Guideline”) was amended by the Turkish Medicines and Medical Devices Agency (“Agency”) and published on 23 October 2021. Accordingly, “foreign suppliers” authorized to supply drugs from abroad have been defined. […]
22 Nov 2021
Turkish Medicines and Medical Devices Agency (“Agency”) updated the Guideline on Biosimilar Medicinal Products (“Guideline”) on 14 September 2021. The previous Guideline prepared by the Agency did not include a broad range of details regarding the matter, yet it […]
22 Nov 2021
The Draft Regulation on Licensing Homeopathic Medicinal Products (“Draft Regulation”) was published by the Turkish Medicines and Medical Devices Agency (“Agency”) on 9 September 2021 and the Draft Regulation was opened for third parties’ opinion. The Draft Regulation was […]
