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Food Supplement Registration in Colombia

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Food Supplement Registration in Colombia

Regulatory Authority

National Food and Drug Surveillance Institute (INVIMA)

Timeline

Within 15days

License Validity

10 years

Fees

USD 1,150. The prices are slightly different whether they are presented in solid, semisolid or liquid form.

  • Dietary supplements (suplementosdietarios) are regulated by “Decree (Decreto) No. 3249/2006” and “Decreto (Decreto) No. 3863/2008”.
  • They can be distributed in pharmaceutical forms (liquid, semisolid and solid) for oral use. Other forms are also permitted.

Nutraceutical Registration Process of INVIMA

Registration Of National Products

I Legal Documentation

  1.   Duly signed application by legal representative.
  2.  Company details: name, address, manufacturer’s name, and product brand.
  3.  Proof of petitioner entity’s constitution and legal representation.
  4.  Manufacturer’s existence and legal representation certificate.
  5.  GMP (Good Manufacturing Practices) certificate.
  6.  Power of attorney for process management if applicable.
  7.  Payment receipt for sanitary registry issuance.

II Technical Documentation

  1. Product technical sheet.
  2. Container, packaging details.
  3. Ingredient composition with scientific names for plants.
  4. Label artwork with mandatory statements, ingredients, and nutrition.
  5. Shelf life up to 2 years, extendable to 3 with stability studies.
  6. Proof of BSE-free ingredients if applicable.

Registration Of Imported Products

  1.   For imported products, additional documentation must be filed along with the documentation needed for national registrations.
  2.  A health certificate, no older than 1 year, issued by the exporting country of health department.
  3.  Express authorization from the owner to the importer to request the health registration in his name, use the brand and market the product.
  4. Documents with an official translation and an Apostille stamp, or documents certified by the Ministry of Foreign Affairs and the Colombian consul.

Authorization of Advertising

  • Before dietary supplements are publicized, authorization must be obtained.
  • This is not the same as registering a product.
  • The process takes 15 days and costs 85 USD for 100 pages.
  • The Ministry of Social Protection’s regulations must be followed while obtaining authorization from INVIMA.

Nutraceutical Labelling Requirements

    1.  Product Name.
    2. List of Ingredients used, along with their respective quantities.
    3. Nutrition Information: Nutritional content per serving, including macronutrients and micronutrients.
    4. Recommended dosage and instructions for use.
    5. Warnings and Precautions: Any potential side effects, contraindications, or special instructions
    6. Manufacturer Information (Name, address, and contact details of the manufacturer or distributor.)
    7. Batch Number and Expiry Date: For traceability and consumer safety.

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