STRUCTURE – PROCEDURES – RESULTS
We follow a defined organizational structure that establishes procedures for compliance with legal requirements related to Nutritional Vigilance. Our goal is to prevent harm from adverse effects of approved products, whether used within or outside their intended indications. We monitor safe and effective use and provide accurate information regarding product safety.
Complaint Management
- Receiving and recording complaints about adverse events (AEs), serious adverse events (SAEs), or quality concerns through complaint-handling services.
- Evaluating reports using standardized questionnaires for documentation and investigation.
- Classifying documented reports based on causality assessment.
- Causality evaluation and literature review on overdose, toxicity studies, safety studies, lack of efficacy, pregnancy, lactation, etc.
- Informing the company’s Quality Control Manager about validated reports.
- Preparing Individual Case Safety Reports (ICSRs).
- Drafting and submitting Periodic Safety Update Reports (PSURs).
- Archiving, securing, and storing documentation for each report.
- Taking necessary actions to address complaints.
- Reporting adverse events (AEs) or serious adverse events (SAEs) to authorities as required.
Preventive Actions
- Maintaining a clear and well-defined Traceability Process.
- Establishing written procedures with practical and functional guidelines for timely product withdrawal, replacement, or recall, either by regulatory request or by company decision due to a serious safety risk, mislabeling, or poor product quality.
Product Signal Detection
- Monitoring information regarding raw materials and ingredients used in nutritional products.
- Tracking scientific publications related to raw materials and ingredients in existing and new application fields.
- Monitoring studies on combinations of raw materials and ingredients.
- Following global developments in new nutritional components.
Information Dissemination / Consumer Support
- Encouraging consumers to consult healthcare professionals when experiencing adverse effects.
- Providing information to the public regarding product composition and potential adverse effects.
- Ensuring seamless communication by making contact details for the responsible department available to address public inquiries and to comply with regulatory reporting requirements.
- Implementing transparent methods to protect personal data.
With a strong Nutritional Vigilance framework, we ensure products on the market remain safe, compliant, and responsibly monitored. We work to prevent adverse effects, track real-world product use, and provide reliable safety information. Our proactive approach protects consumers and strengthens product trust.