On 23 July 2023, the Presidential Decree numbered 6932 on the Amendment of the Decision on Pricing of Medicinal Products for Human Use ("Decision") was published in the Official Gazette numbered 32257.
With the provisional articles added to the Decision:
It has been arranged that the euro value in Turkish Lira to be used in the pricing of medicinal products for human use was increased by 30.5% to 14.0387 TRY in July 2023. While applying this increase, it is stated that the…
»
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…
»
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…
»
»
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…
»
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…
»
