What is biocidal product licensing?
Biocidal product licensing in Türkiye is the process of assessing the potential adverse effects of biocidal products on human health and the environment before they are placed on the market or put into use and ensuring their compliance with the relevant regulations.
Registering and marketing biocidal products in Türkiye requires compliance with the Turkish Biocidal Product Regulation, published on 31 December 2009 and numbered 27449 (4th Repeated), and 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.
Chemleg is ready to assist you in the registration process of your biocidal products.
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 placing products on the Turkish market
Challenges in Placing Biocidal Products on the Turkish Market
- Complex licensing process: The licensing process for biocidal products is highly detailed as it also requires compliance with EU legislation. A complete dossier must be prepared, including comprehensive toxicological, ecotoxicological, and efficacy data at both the active substance and formulation levels. Missing or incorrect data may result in rejection of the application or delays in the process.
- Lengthy review and evaluation: The examination of the dossier, scientific evaluation, and the Ministry of Health’s approval steps may sometimes take considerable time. This can negatively affect product launch plans and return on investment.
- Technical and financial burdens: The licensing process involves financial obligations such as analyses, laboratory tests, and official fees. Field and laboratory tests proving product efficacy and safety must be conducted under specific conditions, and the results must clearly demonstrate the claimed function of the product.
- Additional import procedures: For imported biocidal products, extra customs and import procedures apply. The licensing status of the product in the country of origin must comply with Turkish requirements, and all required import documents must be submitted completely.
- Post-licensing monitoring: After licensing, products on the market are regularly inspected for compliance. Non-compliance detected during inspections may result in administrative penalties.
Advantages of Working with Chemleg for Biocidal Product Licensing
- 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
Our Biocidal Product Licensing Services
- Regulatory Compliance & Strategy
- Regulatory Assessment
- Active Substance Compliance: Ensuring active substances are approved or assessment in Türkiye
- Strategic Guidance: Advising on licensing pathways
- Dossier Preparation & Submission
- Technical File Preparation: Compiling required documents (Annex-IIA and Annex-IIIA for active substances, Annex-IIB and Annex-IIIB for biocidal products, Risk Assessment Report under Annex VI, etc.)
- Label & SDS Compliance: Ensuring labels and Safety Data Sheets (SDS) meet Turkish requirements
- Application Submission: Preparing and submitting the Biocidal Product License application to the MoH
- Analysis & Risk Assessment Support
- Analysis Requirements: Coordinating with accredited Turkish laboratories for efficacy, physicochemical, and stability tests
- Risk Assessment & Exposure Scenarios: Ensuring product safety for human health and the environment, with preparation of the Risk Assessment Report (RAR)
- Ministry of Health Communication & Follow-up
- Regulatory Authority Liaison: Managing interactions with the Turkish MoH
- Deficiency Reports & Revisions: Responding to additional data requests from authorities
- Post-Licensing Support & Renewals
- License Renewals & Amendments: Managing regulatory updates, modifications, and renewals
- Product Compliance Monitoring: Ensuring ongoing compliance with evolving regulations
- Biocidal Product Market Surveillance: Supporting post-market obligations
Fill out the form now to consult with our experts about your biocidal products.
Frequently Asked Questions
Where should I apply for a biocidal product license?
Biocidal product license applications are submitted to the Turkish Medicines and Medical Devices Agency under the Ministry of Health for the Product Types 1&19. License applications for other product types are made to the General Directorate of Public Health of the Ministry of Health.
Which documents are required for a biocidal product license?
According to the Turkish Biocidal Products Regulation, the following basic information and documents are required:
- Applicant’s and manufacturer’s name, title, and contact details
- Product name, composition, physical and chemical properties, physical state
- Information on product use, testing, and intended purpose
- Safety Data Sheet (SDS)
- Packaging information
- The receipts confirming the payment of completeness fee, dossier evaluation fee, label registration fee and license fee
- Signed active substance specification and Letter of Supply (LoS) from the active substance supplier
How long is a biocidal product license valid?
The validity period of biocidal product licenses varies between 4 and 10 years, depending on the status of the active substance of biocidal product.
When is an update required?
Notification to the Ministry is mandatory in case of changes that may affect the validity of the license or registration. The information changes in question are stated in the regulation as follows:
- New information on the effects of the active substance or biocidal product on humans, animals, or the environment
- Changes regarding the manufacturer of the active substance
- Changes in the composition of each active substance
- Changes in the composition of the biocidal product
- Development of resistance
- Significant company-related changes (e.g., change of name, title, or production manager)
- Information about packaging material modifications
What happens if a license application is rejected?
If deficiencies or non-compliance are identified during dossier evaluation, the license application will be rejected. The decision is communicated in writing to the applicant, who may correct the deficiencies and reapply.
Can the address be changed during the ongoing licensing process?
Yes. For address changes during an ongoing licensing process, the following documents must be attached to the application:
- Trade Registry Gazette showing the new address
- Original or notarized copy of the new workplace opening and operating license
- Updated application documents reflecting the address change (Annex-IIB, Annex-IIIB, SDS, label samples)
