The Biocidal Product Authorisation Process

The Biocidal Product authorisation process

The authorisation of biocidal products, whether produced domestically or imported, sits under the Ministry of Health through the Turkish Public Health Institution and its Environmental Health Department. Sistem Patent Kalite acts as the consultancy partner and prepares and manages the file across the two-stage process the department operates.

Before the main authorisation file is filed, a pre-application confirms that the product fits the declared product type. Once that fit is confirmed, the Ministry issues a sampling letter so that the product can be examined by authorised laboratories across biological, chemical, long- and short-term stability, skin-irritation, and related parameters. A sealed sample is taken from the manufacturing site and reviewed at one of the assigned laboratories. The laboratory results then feed the dossier for the main authorisation. Annex 2B is prepared using the test results and national and international literature, and the full file is submitted to the Turkish Public Health Institution. Close follow-up of the application, and rapid correction of any findings, shortens the approval timeline significantly. When the authority is satisfied that all requirements are in place, the product authorisation is issued.

Pre-application stage

• Preparation of the Safety Data Sheet (MSDS) by certified personnel.
• Preparation of labels and the wider pre-application documentation.
• Obtaining the sampling letter and routing the sample for the correct examinations.
• Identification of the authorised laboratories where sampling will take place.
• Follow-up where the laboratory review is carried out in Ankara.

Main authorisation filing

• Preparation of Annex 2B using laboratory findings and national and international literature.
• Compilation of the supporting documents and submission of the full file to the Turkish Public Health Institution.
• Active follow-up and reporting on file status.
• Rapid correction of any missing items so the stage does not stall.
• Issue of the biocidal product authorisation for production or import once all requirements are met.