Nutrivigilance, is a portmanteau between vigilance, or the act of observing for potential dangers, and nutrient, and is nutraceutical analog to pharmacovigilance in pharmaceuticals. As a definition, the practice of nutrivigilance involves assessing the risk-to-benefit ratio of a product to ensure it is safe and effective.
There are always risks of adverse effects occurring a food supplement product is cleared to enter any market. While the EFSA does not have a provision to establish a dedicated vigilance system for food supplements, many Member States have defined their own national systems.
In addition to dicentra’s Adverse Event / Adverse Reaction Reporting services, we can help you prepare a plan to meet any nutrivigilance schemes applicable in the European market(s) you wish to list your product.
Contact us to learn how our Food Supplement Regulatory Services can help get your products to market in the European Union