Registering and marketing biocidal products in Türkiye requires compliance with the Turkish Biocidal Product Regulation dated 31 December 2009 and numbered 27449(4), enforced by the Ministry of Health (MoH). Whether you are a domestic manufacturer or a foreign company, obtaining a biocidal product license is a mandatory step before placing your products on the Turkish market.
Our Biocidal Product Licensing Services
- Regulatory Compliance & Strategy
✅ Regulatory Assessment
✅ Active Substance Compliance – Ensuring active substances are approved or under evaluation in Türkiye
✅ Strategic Guidance – Advising on licensing pathways (simplified, mutual recognition, or standard registration)
- Dossier Preparation & Submission
✅ Technical File Preparation – Compiling necessary documents (Preparation of Annex-IIA for active substances, Annex-IIB for biocidal products, Risk Assessment Report under Annex-VI, etc.)
✅ Label & SDS Compliance – Ensuring labels and Safety Data Sheets (SDS) align with Turkish regulations
✅ Application Submission – Preparing and submitting the Biocidal Product License application to the MoH
- Analysis & Risk Assessment Support
✅ Analysis Requirements – Communication with accredited Turkish laboratories and assisting in conducting efficacy, physicochemical and stability tests.
✅ Risk Assessment & Exposure Scenarios – Ensuring product safety for human health and the environment and preparation of RAR accordingly.
- Ministry of Health Communication & Follow-up
✅ Regulatory Authority Liaison – Managing interactions with the Turkish Ministry of Health
✅ Deficiency Reports & Revisions – Addressing additional data requests from authorities
- Post-Licensing Support & Renewals
✅ License Renewals & Amendments – Managing regulatory updates, license modifications, and renewals
✅ Product Compliance Monitoring – Ensuring ongoing compliance with regulatory changes
✅ Biocidal Product Market Surveillance – Supporting post-market surveillance requirements
Who Needs Biocidal Product Licensing in Türkiye?
✔ Local Manufacturers – Seeking to sell biocidal products in Türkiye
✔ Foreign Manufacturers – Requiring an Only Representative (OR) to register their products
✔ Importers & Distributors – Ensuring compliance before product placement on the Turkish market
Why Choose Us?
🔹 Expertise in Turkish Biocidal Regulations – Proven experience in regulatory compliance for biocidal products
🔹 Full Licensing Support – End-to-end management of the licensing process
🔹 Direct Communication with Turkish Authorities – Efficient and smooth application handling
Ensure your biocidal products meet Turkish regulatory requirements with our expert licensing services.
