How to Obtain a Biocidal Product License in Türkiye?

Obtaining a biocidal product license involves a structured process and preparation of specific documentation. In Türkiye, this procedure is overseen by the Ministry of Health, and the responsible authority depends on the product type.

Please find the headings regarding the licensing process below.

1. Determine the Product Type

• Type 1 and Type 19 (e.g., hand disinfectants, body-applied insect repellents):

Applications are submitted to the Turkish Medicines and Medical Devices Agency (TİTCK).

• Other product types (e.g., surface disinfectants, insecticides, antibacterial paints):

Applications go to the General Directorate of Public Health.

2. Conduct Required Tests
The application file must include the following analyses:

• Physicochemical tests
• Stability tests (short- and long-term)
• Efficacy tests
• Unpackaged product stability test (Performed only for the disinfectant group.)

Tests must be conducted in authorized laboratories in Türkiye. For imported products, foreign test results may be accepted under certain conditions. (GLP, Accreditation and Validation Certificates are requested from the laboratories that will perform the tests, proving that they are competent.)

3. Prepare the Application File
Required documents include:

• Biocidal Product Analysis Reports
• Administrative Documents related to the company making the application (For foreign companies, the application must be submitted through a branch or representative located in Turkey)
• Safety Data Sheet (SDS)
• Label design (in compliance with Annex-XII)
• Formulation and specification documents
• Active substance dossier (Annex-IIA)
• Product dossier (Annex-IIB)
• Toxicological and ecotoxicological risk assessment report (Annex-VI)
   

4. Submit the Application

• Applications can be made electronically through the Product Tracking System (UTS) or physically by preparing files.
• If there are deficiencies, they are reported through the system, and applicants are given three chances to correct them.
• Once complete, the license fee is paid, and the process continues.
   

5. License Issuance
If the application is approved:

• The approved label and license certificate are issued to the applicant.
• The product can now be legally marketed in Türkiye.