1 Concept

2 Services

3 Registration – Requirements

4 Health License / Sanitary Registration NOT Requirement Certificate

5 Product classification Certificate

6 Health License Validity

1. Concept

Any substance or formulation intended to be put in contact with the superficial parts of the human body (epidermis, hair and capillary system, nails, lips and external genital organs) or with the teeth and oral mucous membranes, with the sole or main purpose of cleaning them. , perfume them, modify or improve their appearance, protect them, keep them in good condition or correct body odors.

Those substances or formulations intended for the prevention, treatment or diagnosis of diseases, or intended to be ingested, inhaled, injected or implanted in the human body are not considered cosmetic products. Cosmetic products may not declare therapeutic indications or other indications that contravene its definition.

2. Services

  • Obtaining the Sanitary Registry / Health Record for Foreign Cosmetics.
  • Modification of the Sanitary Registry / Health Record for Foreign Cosmetics.
  • Re-registration the Sanitary Registry / Health Record for Foreign Cosmetics.
  • Health License / Sanitary Registration NOT Requirement Certificate

3. Registration

  1. Quali-quantitative formula with the generic name and IUPAC nomenclature.
  2. Stability studies when the appropriate period of consumption is recommended on the container, label or leaflet.
  3. Organoleptic and physicochemical specifications of the finished product.
  4. Microbiological specifications, where applicable
  5. Justification of the benefits and claims attributable to the product.
  6. Art project for the label, which must be written in Spanish.
  7. Instructions for use of the product, when applicable.
  8. Material of the primary and secondary packaging.
  9. Lot number or production coding system.
  10. Legalized authorization from the foreign manufacturer or from the owner of the product to the legal holding in Ecuador, to submit the registration process. This document must be translated into Spanish.

4. Health License

Service that verifies if the product requires or not requires the sanitary registration / health license for the distribution, commercialization, and import.

5. Product Classification

Process directed to informing the user about the category to which the product belongs, which requires obtaining health registration for subsequent marketing.

6. Health License Validity

The License will be valid for 5 years, counted from the date of its issue and may be renewed for equal periods. (Re-registration).

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