Regulatory aspects of dietary products and sweeteners
The General Directorate of Medicines, Supplies, and Drugs (DIGEMID), during the first “Virtual technical meeting on the registration process of nutritional supplements and sweeteners”, established some criteria to be taken into account by users interested in registering these products.
Requirements for the health registration of dietary supplements (nutritional)
• The registration is granted by product name, pharmaceutical form, amount of active ingredient, manufacturer, and country of origin.
• Technical specifications of the finished product. The technical specifications of the product must include the tests carried out on the finished product
• Certificate of Free Sale (FSC) issued by the competent authority in the country of origin
• Product formula indicating its basic and secondary ingredients
• Stability studies
• Labeling projects and package label
• Good Manufacturing Practices (GMP) Certificate
From now on, the registration or re-registration of dietary supplements in the General Directorate of Environmental Health (DIGESA) will not be allowed.
Authorization is requested virtually to the Ministry of Health.
Source: DIGEMID
Contact us at 997556699 or by mail info@pharmaconsulting.pe and learn more about dietary supplement and sweeteners registration in Peru.