What should be done for Biocidal Products Marketted in Turkey?
As is known, the companies should fulfill the relevant requirements of "Turkish Biocidal Products Regulation" before exporting the Biocidal Products, which will be on Turkish market, to Turkey.
The applications of the process were carried out in 2 ways until 01 January 2018. Prior to January 1, 2018, the requirements could be summarized such as for some Biocidal Product Types should have been licenced and some BP types should have submitted to the Inventory notification and approved by the Ministry.
Before January 01, 2018, Biocidal Product Types 7, 8, 9, 10, 11, 12, 21, 22 and 23 could submitted to the Inventory Notification though the other Biocidal Product Types should have been licenced. However, according to the Consolidated Biocidal Product Regulation No. 28939 dated 12 March 2014, the Inventory Notification period for the Biocidal Product Types 7, 8, 9, 10, 11, 12, 21, 22 and 23 expired on 31 December 2017.
As of 01 January 2018, what should companies do for Biocidal Products;
All Biocidal Product Types, which will be on the Turkish market for the first time, should be licenced before exporting to Turkey as of January 01, 2018.
For Biocidal Product Types 7, 8, 9, 10, 11, 12, 21, 22 and 23: There are some transition periods for these types of Biocidal Products which are on the Inventory List or submitted to the Inventory Notification before 01 January 2018 to be on the Turkish market. These Biocidal Product Types can be found on the market by January 1, 2020 on condition that to carry out Provisional Application, the first step of the licensing process, between the dates January 01, 2018 and January 01, 2019.
As of January 1, 2018, the requirements which should be done for licensing Biocidal Products before being on Turkish market summarized as following steps;
- Appointing an Only Representative (for the companies not located in Turkey),
- Compilation of the Provisional Application File,
- Uploading the Provisional Application File and relevant information to the Ministry’s online Biocidal Product Following System,
- Evaluation of the Provisional Application File by the Competent Authority,
- Approval of the Provisional Application,
- Researching of the analysis and test methods' compliance with the obligatory methods,
- Researching an accredited laboratory which will perform the chemical analysis, physical and efficacy tests that are requested by the MoH,
- To be sent the samples of the Biocidal Product,
- To be sealed of the samples at the customs,
- Sending the sealed samples to the laboratory,
- Performing chemical analyses, physical tests and efficiency tests, requested by the Ministry, in the authorized laboratory,
- Follow up the analysis, make correct interventions when necessary,
- Compilation of the Biocidal Product Licence File after completion of the analysis and efficacy tests that must be on the Biocidal Product Licence File,
- Uploading the Biocidal Product Licence File to the Biocidal Product Following System,
- Evaluation of the Licensing application by the Competent Authority,
- Approval of the License File application,
- Getting the temporary License of the Biocidal Product.
Upon completion of the above processes, Biocidal Product getting the temporary license can be exported to Turkey to be on the market. The Biocidal Product, which got the temporary license, may obtain a permanent license after the completion of the Long-Term Stability tests reports and the implementation of the relevant application to the Ministry.
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