Health Supplement Registration: Health Supplement product is defined by NPRA as a product that is used to supplement a diet and to maintain, enhance and improve the health function of human body. It may contain one or more of the following combination:
- Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances;
- Substances derived from natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates, metabolite
- Synthetic sources of ingredients mentioned in (i) and (ii) may only be used where the safety of these has been proven.
Requirements of a health supplement registration is comparatively less stringent (lesser document requirements) compared to Generic registration.
For the product to be classified under Health Supplement registration, there are several factors that NPRA considers such as the proposed indication, active ingredients, content of Vitamins/Minerals and dosage form used. If the product does not meet the requirement under a Health Supplement, the product would then need to be registered under Generic Non-Scheduled Poison registration.
NVS’s consultant has the necessary experience to guide the company on routes to register the product under Health Supplement (if it abides by the factors stated above).