Guidelines For Withdrawal and Recall of Medical Devices Published
On 19 July 2023, the Medicines and Medical Devices Agency published Guidelines for withdrawal and recall of medical devices and in vitro diagnostic devices (Turkish language) on its official website. The Guidelines regulate the procedures to be implemented to prevent unsafe and non-conforming medical devices from being placed on the market and the responsibilities of the relevant parties pursuant to Law No 7223 on Product Safety and Technical Regulations. In this regard, the… »
Highly Logical: Turkish IP Office's Vulcan Salute Ruling Sets Final Frontier For Copyright Ownership Argument
According to Article 6/6 of the Turkish Industrial Property Code, “An application for registration of a trademark shall be refused upon the opposition of the right holder if it consists of a person’s name, trade name, photography, copyright or any other intellectual property right of another.” Based on this provision, it is possible to oppose an application relying upon the opponent’s other intellectual property rights ownership. On December 20 2022, the Re-Examination and… »
Sanal Moda
Regulation on Licensing of Medicines Amended
On 27 May 2023, the Regulation Amending the Regulation on Licensing of Human Medicinal Products (Turkish language) (Regulation) was published in the Official Gazette numbered 32203. With the amended provisions, a new reason for the suspension of the licence has been introduced in connection with licence transfer applications. To avoid suspension, licence holders must submit documentation showing that the production site complies with the Good Manufacturing Practice Guidelines… »
Regulation on Technical Services For Medical Devices Published
On 26 May 2023, the Turkish Medicines and Medical Devices Agency (Agency) published the Regulation on Technical Services for Medical Devices Used for Provision of Healthcare Services (Turkish language) (Regulation) in the Official Gazette numbered 32202. The Regulation has been prepared by the Agency to regulate the qualifications, authorisation, supervision and training of technical services that will support activities such as installation, updates, upgrades, modification… »
The Exception Criteria for Registration Obligation with the Data Controllers' Registry has been Changed by the Decision of the Personal Data Protection Board
The Personal Data Protection Board ("Board"), through its decision dated 06.07.2023 and numbered 2023/1154 published in the Official Gazette dated 25.07.2023 and numbered 32259, has decided to increase the monetary threshold regarding the total annual financial balance sheet from TRY 25 million to TRY 100 million as one of the criteria for exemption from Obligation to Register with the Data Controllers' Registry (“VERBIS”). According to the Board's decision dated 19.07.2018… »