''LICENSING PROCEDURES OF BIOCIDAL PRODUCTS''

What are the licensing procedures for biocidal products?

Biocidal Products within the scope of Biocides need to be licensed by the Ministry of Health. Biocidal Products can only be on the market within the borders of Turkey after these permits.

Registration Process to Get Biocidal Product License

The Regulation on the Amendment of the Biocidal Products Regulation has been published in the Official Gazette dated 30 December 2021 and numbered 31705.

The provisional application and sealed sampling process, which caused difficulties in the registration process in BPR, has been abolished. These amendments will ensure that the Biocidal Products Regulation and implementation are closer to the EU legislation and practice. In addition to abolishing the provisional application process, it is stated that the analysis of the biocidal products performed abroad (physicochemical tests, long and short-term stability tests, and efficacy tests) can be accepted by MoH for imported product registration applications (If these tests meet some conditions under the Regulation)

For the Registration Application

  1.In Turkey you should have a Turkish Legal Entity when you want to submit any products evaluated under Biocidal claim. Only the Turkish Legal Entity can apply for biocidal products on your behalf. One of Chemleg's services is to act as a representative for our client.     

  2.All required documents must be prepared to apply for a license application. These documents are listed as follows:

-  Preparing Biocidal Product License File in accordance with the ANNEX IIB format.

-  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 of the Active Substance Dossier in accordance with ANNEX IIA format

-  Preparation of the Risk Assessment Reports of the Biocidal Product

-  Submission of the documents and necessary information on the Biocidal Product to the "Biocidal Product Following up System (Cevsis)."

-  Reviewing test reports and checking compliance (These test results should be submitted to the Ministry within the license dossier. If the tests of the biocidal product are not available, these tests need to be carried out in Turkey or abroad.)

-  Literature review and translations of the test reports and other required documents

  3.After the submission of the documents to the CA

- To provide the additional information or documents requested by the Ministry timely and correctly

- Evaluation of the authority and getting the license of Biocidal Product

        You can get support from our team and ask for help with the service details.