In Peru, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) is the National Authority that regulates the food suplements market.

A food supplement is any product that contains vitamins, minerals, amino acids, vegetal extracts, enzymes, chemical substances such as glucosamine, methylsulfonylmethane, hyaluronic acid, flavonoids, probiotics, and other nutritional substances intended to supplement our normal daily diet or reduce the risk of developing diseases. Dietary supplements must be marketed in a defined pharmaceutical dose form as tablets, capsules, powders, pearls, gel capsules, and syrups, among others.

Food supplements are not medicinal products. Therefore, their use is not intended to treat or prevent diseases in humans or to modify physiolofical functions. Manufacturers of dietary supplements must not claim diagnostic, therapeutic, or preventive properties. For example, “reduces high LDL”, “prevents heart disease”, “boosts the immune system”, and the like.

Food supplement are classified as pharmaceutical products, that is the same group as drugs, and medicinal gases.

To import and sell food supplements, first you must register as a pharmaceutical establishment with our national regulatory agency or appoint a legal representative based in the country or Peruvian Registration Holder (PRH) as Pharma Consulting. This way, your registrations in Peru are under your control. If you decide to end the relationship with your commercial distributor at any point, you would not be required to re-register your products.

When registering an imported, your designated registration holder must submit a registration application to Digemid. This application includes technical and regulatory documentation. Digemid evaluates the application to ensure the product meets their quality, safety, and efficacy standards. Please, consider that approvals from the European Union or the United States do not automatically guarantee registration in Peru.

Our regulatory framework is rigorous, aiming to gurantee the quality, safety, and effectiveness of food supplements available in the peruvian market. It is essential to have a thorough understanding of the guidelines established by Digemid to avoid any potential compliance issues, and facilitate the registration process for your products.

As your PRH, we are committed to acting honestly, fairly, professionally, and in the best interests of your business.

The U.S. Food and Drug Administration (FDA) has found that many bodybuilding (workout) products may contain anabolic steroids or steroid-like substances in their composition. Such ingredients included illegally or not declared by manufacturers may pose serious health risks to consumers, for example, severe liver (hepatic) injury, kidney damage, heart attack, stroke, pulmonary embolism, deep vein thrombosis, severe acne, hair loss, irritability, aggressiveness, depression, among others.

These types of products are promoted as concentrates with hormones or substitutes for anabolic steroids to increase muscle mass in a short time; however, they may contain steroids in their composition.

The FDA does not evaluate the efficacy or safety of these products before they reach the consumer market. In addition, they are usually sold online, in gyms, or by catalog, which makes control difficult. In Peru, all dietary products or supplements are rigorously evaluated by the General Directorate of Medicines, Supplies, and Drugs (Digemid) before and after entering the country, through a process called registration, in which the complete composition of the product is declared, and the nutritional or physiological effect of each active ingredient is assessed.

Source: FDA

Contact us on WhatsApp by clicking here or drop us a line at info@pharmaconsulting.pe to get more information about our Dietary Supplement registration service in Peru.

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.

• 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.

The FDA warned 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent chronic diseases, like diabetes mellitus. The Administration urges consumers not to consume products that have not been evaluated by the FDA to be safe or effective for their intended use.

In Perú, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) oversees the dietary supplement market. The agency registers nutritional supplements, inspects manufacturing facilities and warehouses, monitors product testing, and drafts policies and laws regarding supplements imported to and sold in Perú.