Biocidal Products Licensing Process

Biocidal Products are allowed to be sold in Turkey after fulfilling the requirements of "Biocidal Products Regulation dated 31 December 2009 and numbered 27449 (4. Duplicate)" published by the Ministry of Health. Products within the scope of Biocides need to be accepted to the Inventory List or licensed by the Ministry of Health. To learn in which cases a product is considered as a Biocidal Product, you can read our article. Biocidal Products can only be on the market within the borders of Turkey after these permits.

The deadline of Inventory Notification for Biocidal Products Types 7,8,9,10,11,12,21,22,23 was 31/12/2017. As of 01/01/2018, Biocidal Products can be on the market in Turkey after getting the Biocidal Product License. In accordance with the "Biocidal Products Regulation", the condition of being on the market in Turkey for Biocidal Products starts with the provisional application and continues with the “Biocidal Product Registration Process” for getting the product’s license.

Registration Process to Get Biocidal Product License

1. STEP: Provisional Application Process

- Preparing Provisional Application Form of the Biocidal Product
- Preparing the label of the Biocidal Product
- Preparing the Safety Data Sheet (SDS/MSDS) of the Biocidal Product
- Preparing the Formulation and Specification documents of the Biocidal Product
- Preparing other required documents of the Biocidal Product during the provisional application process in accordance with the requirements of the "Biocidal Products Regulation"
- Submission of the documents and necessary information of the Biocidal Product to the "Biocidal Product Following up System (BUTs)"
- The authority evaluation and approval of the Provisional Application

2. STEP: Sampling Stage

- To search laboratory to perform the analysis requested by the Ministry
- Technical evaluation and suitability assessment for the analysis methods of the Biocidal Product for avoiding any problems that may occur further steps
- To follow up the samples of the Biocidal Product
- Performing the required applications during the sampling process
- Sealing stage of the samples
- To follow up each stages of the analysis and take action if it is necessary

3. STEP: License Process 
- Finalization of chemical analysis, physical testing, short-term stability tests and efficacy tests
- Monitoring and evaluating the results of the analysis required for submission of Temporary License
- Preparing Biocidal Product License File
- Submission of the documents and necessary information of the product to the "Biocidal Product Following System (BUTs)" for License File
- To deliver the hard copies of the Biocidal Product License File to the Ministry of Health Follow-up the application regularly
- To provide the additional information or documents requested by the Ministry timely and correctly
- Evaluation of the authority and licensing of Biocidal Product

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