To your attention,

The Turkish Medicines and Medical Devices Agency, Deputy Directorate General of Medical Devices and Cosmetics, has published a Presidential Decree dated 21.11.2021, numbered E-24931227-512-6419. With this Presidential Decree, starting from 09.12.2021, license applications for Biocidal Products of Product Type-1 and Product Type-19 will be accepted through the ÜTS Biocidal Module. Additionally, regarding the license durations of biocidal products under Product Type 1 and Product Type 19:

• For Product Type-1 and Product Type-19 biocidal products licensed by the General Directorate of Public Health (HSGM) and whose license validity expires on 31/12/2021, the license validity has been extended until 31/12/2022, and these products can remain on the market until 31/12/2022. License holders must submit a license evaluation application with all necessary documents for the product through the ÜTS Biocidal Module within this period and complete the licensing process by the deadline. Otherwise, the licenses of companies that do not complete the licensing process by the specified deadline will be canceled.
• For Product Type-1 and Product Type-19 biocidal products licensed by the General Directorate of Public Health (HSGM) and whose license validity expires on 31/12/2021, the physicochemical, accelerated stability, long-term stability, and open packaging stability tests, as well as irritation test reports in the existing license file, will be accepted provided they meet the provisions specified in the "Instruction on the Analysis of Product Type-1 and Product Type-19 Biocidal Products" published by the Turkish Medicines and Medical Devices Agency. Otherwise, these tests must be renewed in accordance with the instruction.
• Regarding biological efficacy tests; for Product Type-1 biocidal products, all microbial efficacy analyses related to the product claim must be renewed as specified in the updated instruction in line with changing standards to prove the continuation of efficacy. For Product Type-19 biocidal products, biological efficacy tests must be renewed for products whose analysis period has reached ten years, as per the fifth paragraph of Article 9 of the instruction.
• Companies with ongoing deficiency processes must complete the necessary information and documents through the system, and the deficiency application process for the product must continue through the ÜTS biocidal module.
• The licensing process for framework formulations will begin after the main licensing process is completed in the ÜTS Biocidal Module.
• For effective tracking of the licensing process both institutionally and sectorally, after the license evaluation application is made in ÜTS, a maximum of 3 deficiency updates will be allowed by ÜTS for obtaining the license, otherwise, the application process will be terminated. In this case, a new license evaluation application must be created through ÜTS.
• Provided that the right of the agency to request physical documents when deemed necessary is reserved; no physical documents will be requested during the license application, and the process will be carried out electronically through ÜTS. The documents uploaded to the system electronically must be e-signed.