Hygiene Products

HEALTH LICENSE/REGISTRATION

Hygiene Products

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

It is that formulation whose main function is to remove dirt, disinfect, aromatize the environment and promote the care of utensils, objects, clothes or areas that will later be in contact with humans regardless of their commercial presentation.

2. Services

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

3. Registration

  1. Quali-quantitative formula with the generic name and IUPAC nomenclature.
  2. Organoleptic and physicochemical specifications of the finished product.
  3. Justification of the benefits and claims attributable to the product.
  4. Art project for the label, which must be written in Spanish.
  5. Instructions for use of the product, when applicable.
  6. Material of the primary and secondary packaging.
  7. Warnings, precautions, and restrictions.
  8. Comercial presentation.
  9. Lot number or production coding system.
  10. Information on the disinfectant and / or bactericidal properties of the product according to the special properties conferred on it.
  11. Legalized Free sale certificate (FSC) or Export Certificate of the origin country.
  12. 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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