Biocidal License

ÜTS Registration and Biocidal Products Registration Detailed Explanation

Product Tracking System (ÜTS) is a system used in Turkey to track medical devices, biocidal products and cosmetic products. Registration of biocidal products to ÜTS requires certain processes and documents due to legal obligations. In this article, we will provide detailed information on how to register biocidal products to ÜTS, the necessary documents and relevant legislation.

1. What is a Biocidal Product?

Biocidal products are products containing chemical or biological active substances used against harmful organisms. They are divided into various groups such as disinfectants, antiseptics, insecticides, and preservatives. The marketing of biocidal products in Turkey is regulated within the scope of the Biocidal Products Regulation.

📌 Biocidal products cannot be placed on the market without being licensed by the Ministry of Health.

📌 Biocidal products whose ÜTS registration has not been completed cannot be legally offered for sale.

📌 The production, import and distribution of biocidal products can only be done by authorized companies.

2. UTS Registration of Biocidal Products

The ÜTS registration of biocidal products is carried out by the Ministry of Health, Turkish Medicines and Medical Devices Agency (TİTCK).

2.1 Documents Required for Biocidal Product Registration

The following documents are required for the registration of biocidal products in ÜTS:

📌 Application Petition

📌 Product Safety Data Sheet (SDS)

📌 Active substance and formulation information

📌 Analysis certificates and efficacy test reports

📌 Manufacturer and importer company documents

📌 Biocidal license issued by TİTCK

📌 Instructions for use and product label information

📌 Toxicity and ecotoxicity reports (when necessary)

📌 Additional legislation compliance documents according to the area of ​​use of the product

2.2 Biocidal Product Registration Steps

Log in to ÜTS Portal

ÜTS System address is visited.

Company authorized person logs in with E-Government password.

Complete Company Registration

A company registration is created in ÜTS system and authorized persons are identified.

Apply for Biocidal Product Registration

Product name, active substance ratios and formulation information are entered into ÜTS system.

The license document issued by TİTCK is uploaded.

It is determined which biocidal category the product falls into (for example, disinfectant, pesticide etc.).

Document Upload and Approval Process

Necessary documents are uploaded to ÜTS system.

Product analyses, efficacy tests and toxicity reports must be added.

In case of missing or incorrect documents, correction is requested.

The product is added to ÜTS system as a result of the examination conducted by TİTCK.

Product Tracking and Updates

After the product is registered to ÜTS, it can be launched on the market.

In case of any changes in product information, an update should be made via ÜTS.

Updated test reports and new license documents related to the product should be uploaded to ÜTS.

3. Legislation and Legal Processes in Biocidal Products

Registration, licensing and market inspections of biocidal products are carried out within the framework of the following legislation:

📌 Biocidal Products Regulation (Issued by the Ministry of Health.)

📌 Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (KKDİK)

📌 TİTCK Licensing Guide

📌 Product Tracking System (ÜTS) User Guide

📌 EU Biocidal Products Regulation (528/2012/EU) (Valid for relevant products.)

Products that do not comply with these regulations are considered illegal and cannot be placed on the market.

4. Problems and Solutions Encountered in the Biocidal Product Registration Process

Companies may encounter various difficulties during the biocidal product registration process. Here are some common problems and solutions:

✅ Incomplete or incorrect document upload → Make sure that the documents are uploaded completely and in the correct format.

✅ Insufficient product efficacy tests → Current test reports from authorized laboratories should be attached.

✅ Long duration of the licensing process → Expert consultancy can be obtained to ensure that applications are made correctly.

✅ Technical errors in the ÜTS system → ÜTS support line or relevant ministry units should be contacted.

5. Conclusion and Summary

✔ Biocidal products cannot be placed on the market without ÜTS registration.

✔ Documents in accordance with the Biocidal Products Regulation must be submitted completely.

✔ ÜTS registration cannot be completed without a license issued by TİTCK.

✔ ÜTS registration must be up-to-date in order for products to be sold on the market. ✔ It is a great advantage to receive expert consultancy in the ÜTS registration process to prevent errors.