Vitamins and Minerals

The Icelandic Medicines Agency (IMA) does not define maximum daily doses for vitamins and minerals in food supplements. Food supplements are regulated in accordance with Regulation No. 624/2004 which is set pursuant to the Food Act No. 93/1995 as amended, and fall under the authority of the Food Agency. All queries concerning maximum daily doses for vitamins and minerals should therefore be addressed to that agency.

It should be noted however that the dosage forms of vitamins and minerals may place them in the category of medicinal products (Medicinal Act No. 93/1994 as amended). If the product is intended to be consumed in a way different from the oral/topical route it needs to be classified with regard to the dosage form. Furthermore claims that imply medical indications may also place the product in the category of a medicinal product. Example: “For vitamin deficiency”.

A list of claims that have been evaluated by the Agency can be accessed on IMA´s website (Claims). Should a product containing vitamins and minerals need a classification due to the above-mentioned factors, a formal application should be submitted along with a sample of the finished product (labels suffice). Fee for classification of a product is in accordance with IMA´s tariff. The Agency requires up to 90 days to complete the task and will not commence the work until the fee has been paid.