BIOCIDE REGISTRATION

biyosidal ruhsatlandirma

  1. 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

  1. Letter of application
  2. Pre Registration Form
  3. Label (According to Biocidal Reglation)
  4. Safety Data Sheet (SDS) (A certificated specialist need to author SDS in Turkey according to Turkish regulations)
  5. Product Specification
  6. Active Substance Specification
  7. 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:biyosidal ürün ruhsatı

  1. Letter of application
  2. Pre Registration Form
  3. Safety Data Sheet (SDS) (A certificated specialist need to author SDS in Turkey according to Turkish regulations)
  4. If production is outsourced Contract Manufacturing Agreement (If there is production in Turkey)
  5. Non-Sanitary Institution Licence (2. Class Non-Sanitary Institution Licence)
  6. %100 formulation
  7. Responsible Manager Contract (If there is production in Turkey)
  1. Responsible Manager Diploma (If there is production in Turkey)
  2. Responsible Manager Certificate (If there is production in Turkey)
  3. Signature Circular
  4. Annex -2B Dossier
  5.  Literature information
  6. Product and Active Substance Specification
  7.  Analysis Results
  8.  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.

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I Approve the Law on Protection of Personal Data.