BIOCIDE REGISTRATION
- Biocidal License Procedure
Registration process apply to The Ministry of Health, Public Health Agency of Turkey, Turkey Department of Environmental Health. The two-stage application.
Pre-Application Procedure
- Letter of application
- Pre Registration Form
- Label (According to Biocidal Reglation)
- Safety Data Sheet (SDS) (A certificated specialist need to author SDS in Turkey according to Turkish regulations)
- Product Specification
- Active Substance Specification
- Receipt Fee (75,00 TL)
After the pre-registration (If import samples take in costum). Provincial Health teams seal the samples Sent to an authorized laboratory for analysis.
After the analysis proceeds, the second stage passed. (Process Duration: 1-1,5 Month)
In the second step according to analysis results the Common Data Set Annex-2B called is prepared:
- Letter of application
- Pre Registration Form
- Safety Data Sheet (SDS) (A certificated specialist need to author SDS in Turkey according to Turkish regulations)
- If production is outsourced Contract Manufacturing Agreement (If there is production in Turkey)
- Non-Sanitary Institution Licence (2. Class Non-Sanitary Institution Licence)
- %100 formulation
- Responsible Manager Contract (If there is production in Turkey)
- Responsible Manager Diploma (If there is production in Turkey)
- Responsible Manager Certificate (If there is production in Turkey)
- Signature Circular
- Annex -2B Dossier
- Literature information
- Product and Active Substance Specification
- Analysis Results
- Workflow Diagram
Total Procedure can take up to 3-12 month. Analysis can take up to approximately 1-1.5 months. After assessing of the file and the process has arranged delivery of the license.
We have services about SDS/MSDS authoring (Turkish, English and other languages), Chemical labelling, Biocide registration (Turkish and EU), Cosmetic safety assessment (Turkish and EU), Product information file, Deterjant Notification, Local&Global Chemical Regulation Consultancy.
You can reach us at info@ayansan.com or +90 (212) 485 50 59 for free consulting, price offers and technical information.