The Turkish Medicine and Medical Devices Authority (TÄ°TCK) published a critical announcement covering the topic of new practices for the registration and evaluation process of medical devices post-Brexit.
The Turkish Medicine and Medical Devices Authority (TÄ°TCK) published two announcements covering critical topics on certain procedures concerning the Product Tracking System (ĆTS).
On 28 April 2021, the Turkish Medicine and Medical Devices Authority (TÄ°TCK) announced the suspension of product promotion representatives’ visits to pharmacies and health organizations during the full lockdown as part of the measures against the COVID-19 pandemic.
The Turkish Medicine and Medical Devices Agency (TÄ°TCK) published the Application Guidelines for Electronic Scientific Meetings and Electronic Product Promotion Meetings (Guidelines) based on the Regulation on Promotion of Pharmaceuticals (Regulation). The Guidelines provide detailed explanations on electronic applications made to the TÄ°TCK by relevant companies (e.g. marketing authorization holders) for scientific meetings and electronic product promotion meetings.
Further to the amendments to the Presidential Decree published in the Official Gazette No. 30887 on 13 September 2019, “biocidal products that directly come in contact with the human body (Product Type-1 and Product Type-19)” are now under the governance and supervision of the TÄ°TCK. The licensing of biocidal products will be handled by the Cosmetic Products Department under the TÄ°TCK. Accordingly, the TÄ°TCK added ‘biocidal’ under the “Activity Areas” on its official website. The TÄ°TCK’s announcement is available here (in Turkish).
On 3 April 2020, the Turkish Medicine and Medical Devices Agency (TÄ°TCK) announced that as part of COVID-19 measures, readability tests, which are necessary for the authorization of pharmaceuticals, may be submitted later, before the sales permit application.