NutriVigSafe®
the solution to implement nutrivigilance.
A nutrivigilance system is quality system used by the marketing responsible company to fulfil the tasks and responsibilities as required by the Competent Authorities and designed to monitor the safety of authorised food supplements and detect any change to their risk-benefit balance.
A nutrivigilance system is characterised by its structures, processes and outcomes.
The quality system is part of the nutrivigilance system and consists of its own structures and processes. It covers organisational structure, responsibilities, procedures, processes and resources of the nutrivigilance system as well as appropriate resource management, compliance management and record management.
The overall quality objectives of the nutrivigilance system are:
- complying with the expected legal requirements for nutrivigilance tasks and responsibilities.
- preventing harm from adverse reactions in humans arising from the use of authorised food supplements and analogous products within or outside the terms of marketing authorisation or from occupational exposure.
- monitoring the safe and effective use of food supplements, in particular through providing timely information about the safety of food supplements to companies responsible for the market.
- contributing to the protection of patients’ and public health.
Nutrivigilance is an indispensable precaution for the future of product safety.
NutriVigSafe®
is a Quality Management System that ensures the nutrivigilance of food supplements during the product life cycle.
NutriVigSafe®
ensures total treatment of complaints (Adverse Events Complaints, Serious Adverse Events Complaints) from the receipt to assessment and the reporting to the Company.
NutriVigSafe®
also ensures a scientific literature screening at regular and fixed time points of all the ingredients (active ingredients and excipients) of food supplements.
NutriVigSafe®
archives all nutrivigilance reports and, at the request of the company concerned, communicates with the competent authorities.
NutriVigSafe®
offers a company, a telephone number and an e-mail address that consumers and healthcare professionals can use to report complaints. This telephone number and e-mail address can be mentioned for this purpose on the website, on packaging and package leaflets of the products and in the B2C and B2B documents of the company.