Regulatory Framework
Turkey regulates cosmetics through its national cosmetics framework under TITCK, with the market structure closely aligned to the EU model. The route depends on a Turkey-established Responsible Person, product notification through the local system, a complete technical file, and compliant Turkish market labelling.
Cosmetic Definition
Any substance or mixture intended to be placed in contact with the external parts of the human body, or with the teeth and oral mucosa, mainly to clean, perfume, change appearance, protect, keep in good condition, or correct body odours.
Responsible Person Requirements
A Turkey-based legal entity must act as the Responsible Person. In practice, the local setup should also include the qualified technical support required to manage GMP-linked obligations, artwork release, technical file control, and market surveillance response.
Compliance Process
- Local RP and System Setup
- Appoint the Turkey-based Responsible Person and set up the local filing access used for cosmetics work.
- Align the local technical and operational responsibilities before dossier preparation begins.
- Formula and Label Review
- Review the formula against Turkey restrictions and the intended product classification.
- Prepare Turkish artwork and confirm the local Responsible Person details appear correctly on-pack.
- Notification and Technical File
- Prepare the notification inputs, product identity, formula summary, and packaging materials for the local submission route.
- Compile the PIF-equivalent file with safety report, GMP support, specifications, and claims evidence.
- Launch and Post-market Follow-up
- Confirm market-ready labels, document retention, and traceability arrangements before supply.
- Support future inspections, technical questions, or vigilance follow-up as needed.
Turkey expects a locally controlled technical file comparable in depth to the EU model, so notification should not be treated as the only compliance milestone.
Deliverables
- Turkey formula and category review
- Turkish artwork and mandatory label review
- Local notification package preparation
- PIF and safety-report gap analysis
- Claim-support and technical-file structuring
- Turkey Responsible Person coordination service
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