New Update in the Biocidal Product Authorisation Renewal Process
The Ministry of Health of the Republic of Turkey, Turkish Medicines and Medical Devices Agency (TITCK) has published a new announcement regarding applications for biocidal product authorisation renewals.
According to this announcement; biocidal products that directly contact the human body and that have been licensed by TITCK, whose long-term stability analyses have been completed, and whose license period has expired or will expire were made under the “Biocidal Product Authorisation Renewal (General Amendment - EBS)” application type through Electronic Application System (EBS) in the past period. The authorisation renewal applications for these products are now made through the Product Tracking System (UTS) in the “License Period Extension Application” field within the scope of “Paid Evaluation Application”.
After the module on authorisation renewal applications for products with expired or expiring license periods in UTS is completed, the relevant applications have started to be received from this field. According to the announcement, first of all, before this module was configured, "License Period Extension Application" was triggered in the Product Tracking System for products with a issued license among the applications for which a license period extension was made, after an application was created in EBS. Later, applications for products whose license extension application process was ongoing were triggered.
The payments for these applications are made through the same field, and approved label and license originals must be physically sent to TITCK by mail. Applications must be created after all required documents have been submitted and the document renewal application transfer has been completed. Additionally, it should be noted that no further update applications can be made until the license extension applications triggered in the system are completed. In this context, it is recommended to transfer relevant data and create applications without delay.
Individuals wishing to renew documents for biocidal products that come into contact with the human body, licensed by TITCK, and for which long-term stability analyses have been completed, and whose license period has expired or is about to expire, are advised to proceed with their applications in accordance with the mentioned announcement.