The Authority Approval dated 21.12.2022 and numbered E-24931227-512.99-11304 has been published by the Turkey Ministry of Health, Turkish Medicines and Medical Devices Agency.
About the Relevant Authority Approval
The Biocidal Product Tracking System (UTS) Biocidal Module has come into service with the Ministry Approval numbered 2021/1.
In the announcement published on 30.11.2021; for the licenses of Product type-1 and 19 biocidal products which is licensed by the Authority and whose license validity period continues, It was informed that the basic data fields were transferred to the UTS Biocidal Module and that the missing data of the licensed products should be completed by the companies accordingly. With the announcement published on 24.10.2022, it was stated that the data regarding the licensed products should be transferred to UTS until 31.12.2022, otherwise, no action can be taken for the products that are not transferred to UTS after this date.
However; It has been determined that there are companies in the system that have not yet applied and have not completed their application processes.
In this direction; ,in the authority's approval dated 21.12.2022 and numbered E-24931227-512.99-11304, the following issues have been reported:
- For Product type-1 and Product type-19 biocidal products licensed by General Directorate of Public Health and whose validity period expires on 31/12/2022; those who do not apply for a license evaluation at UTS until 31/12/2022, their licenses will be canceled and they will not be available in the market as of 31/12/2022.
- For Product type-1 and Product type-19 biocidal products whose license validity expires on 31/12/2022; products that have applied for a license evaluation at UTS until 31/12/2022 but whose licensing process continues, can be in the market provided that their applications are completed within 6 months as of 31/12/2022, otherwise their license process will be canceled and they will not be available on the market.
- For Product type-1 and 19 biocidal products that have applied for a license evaluation before the UTS Biocidal Module was used but have not completed their deficiencies yet and were transferred to UTS as "deficiency data transfer"; the applications should be submitted until 31/12/2022, after this date, applications for incomplete transfer will not be accepted.
- For Product type-1 and 19 biocidal products that are licensed by the Medical Device Agency and whose license validity period is still valid, the applications for the products that are in the UTS as "license data transfer" and whose data transfers are not completed should be completed within 6 months as of 31/12/2022, otherwise their license will be cancelled.
You can reach the related Authority Approval from here.