Vitamin drug products contain only vitamins or minerals, alone or in combination , that are meant to prevent or treat conditions caused by deficiencies or insufficiencies of them. Because they are drug products, they must have a Registration (Marketing Authorisation) granted by Cofepris so that they can be marketed. The Holder must also have a Certificate of Good Manufacturing Practices either in Mexico or in the country of origin abroad, like any other pharmaceutical product.

The Regulation for Health Supplies (RIS) establishes the daily doses of vitamins and minerals that determine the classification of the drug product, that is, so that they can be marketed without a medical prescription, and then they are classified as fraction V or VI (OTC) or those that exceed the doses established in the RIS, as well as those administered parenterally, will be classified as fraction IV and will require a medical prescription to be dispensed.

Since these are pharmaceutical products, safety, effectiveness and quality of the product must be verified in order for it to be authorised for marketing (registered). Therefore, all technical, quality and legal information related to the product must be submitted with a registration application for pharmaceutical products.

It is important to mention that a vitamin pharmaceutical product is not the same as a food supplement, the latter is classified as a product, within the classification of Products and Services, and a vitamin/minerals product is a pharmaceutical product. Food supplements do not require letter registration for their marketing and their function is only to complement the daily intake of vitamins and/or minerals in the diet, they do not have any therapeutic function, they are regulated in the Regulation of Health Control of Products and Services. (RCSPS) and cannot contain only vitamins and minerals, but must contain a combination  with other substances such as carbohydrates, proteins, amino acids, fatty acids, metabolites, plants, herbs, algae, dehydrated or other foods. The RCSPS is also i charge of establishing the daily intake limits of vitamins and minerals allowed for Food Supplements.

If you have any questions about your product, we are experts in the classification, labelling and compliance of requirements of both Vitamin pharmaceutical Products and Food Supplements, so please contact us.