In Peru, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) is the National Authority that regulates the food suplements market.
What a food supplement is (and what it is not) in Peru
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.
Product Classification
Food supplement are classified as pharmaceutical products, that is the same group as drugs, and medicinal gases.
Food Supplements Registration Process
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.
Required Documents
Product Information
• Name.
• Strenght.
• Dose form.
• Trademark.
• Quantitative and qualitative composition.
• Shelf life.
• Retail packaging.
• Description of the batch numbering system.
• Storage conditions.
Manufacturer Information
• Company name.
• Address (number, street, city, state, country).
Technical Information
• Raw materials (active ingredients, solvent, excipients).
• References to standards.
Technical Documents and Certificates
• Finished product specifications.
• Stability studies.
• Proposed labeling.
• IFU.
• Free Sale Certificate.
• Good Manufacturing Practice (GMP) certificate.
Final Thoughts
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.
