Why is the PIF (ÜBD) Important for Market Access?
Legal background
Entering the Turkish cosmetics market without a compliant Product Information File (PIF/ÜBD) is not only risky, it is illegal. Authorities can request your ÜBD at any time to verify that your product is safe, properly documented, and manufactured in line with applicable requirements.
A robust and compliant ÜBD:
- Ensures readiness for the mandatory Product Safety Assessment Report (PSAR).
- Demonstrates that your product complies with Good Manufacturing Practices (GMP) and Turkish legislation.
- Protects your brand from costly regulatory sanctions.
- Keeps you prepared for inspections and regulatory updates.
Our services
Expert Support for Product Information File (PIF/ ÜBD) Preparation
Obelis Group offers a comprehensive solution to create, review, and maintain your Product Information File (PIF/ÜBD) in line with Turkish requirements.
Our services include:
● Content-based verification for compliance with Turkish restrictions and prohibitions.
● Detailed formulation checks, including INCI names, CAS numbers, concentrations, and functions.
● Support in compiling the full formulation breakdown and all required documentation.
● Review of labels and claims to ensure they align with legal requirements.
● Coordination of laboratory testing where needed.
● Preparation of the Product Safety Assessment Report (PSAR).
● Collection and review of raw material documentation.
● Confidentiality guarantee, backed by a Non-Disclosure Agreement (NDA) when required.
By choosing Obelis, you gain a reliable partner for managing your cosmetic Product Information File (PIF/ÜBD) and securing a smooth, compliant, and timely entry into the Turkish cosmetics market.
FAQ
Frequently Asked Questions
It is a mandatory dossier that documents all product information, formulation, safety assessments, and manufacturing processes for cosmetics sold in Türkiye.
A compliant ÜBD/PIF demonstrates adherence to Turkish legislation and GMP, protecting your brand and ensuring smooth regulatory inspections in Türkiye.
The ÜBD/PIF must be updated whenever formulations, raw materials, or regulations change to remain compliant in Türkiye.
Yes, Obelis provides full support for preparing, reviewing, and maintaining ÜBD/PIFs for both domestic and foreign manufacturers entering the Turkish market.
Products without a compliant ÜBD/PIF risk regulatory sanctions, fines, market withdrawal, and delayed market entry in Türkiye.
