Natural Products

HEALTH LICENSE/REGISTRATION

Natural 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 the finished and labeled medicinal product whose active ingredients are formed for any part of the natural resources for medicinal use or their combinations, such as raw drug, standardized extract or in a recognized pharmaceutical form, which is used for therapeutic purposes. It is not considered a processed natural product for medicinal use, if the natural resource for medicinal use is combined with active substances defined from the point chemically, including constituents of natural resources, isolated and chemically defined.

2. Services

  • Obtaining the Health Registry / Health License certification for Foreign Natural Products.
  • Legal and Technical Holding
  • Modification of the Health Registry/ Health License certification for Foreign Natural Products.
  • Re-registration of the Health Registry/ Health License for Foreign Natural Products.
  • Health License / Sanitary Registration NOT Requirement Certificate

3. Registration

  1. Certificate of Good Manufacturing Practices (GMP).
  2. 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.
  3. Authorization of the product owner for the use of technical documentation.
  4. Certificate of identification or verification of the natural resource for medicinal use.
  5. Interpretation of the batch code.
  6. Raw material quality specifications with tolerance limits.
  7. Product stability sheets.
  8. Finished Product Specifications.
  9. Description of the nature of the primary and secondary packaging and technical specifications.
  10. Procedures for physical, physicochemical, chemical, microbiological and biological analysis of the finished product.
  11. External and internal label formats and projects.
  12. Technical justification of the composition formula.
  13. Document from the provider of the natural resource for medicinal use containing the conditions of cultivation and management of the natural resource, and quality specifications of the raw material.
  14. Description of the procedure for making the product.
  15. Pharmacological and toxicological documentation.
  16. Pharmacological Documentation
  17. Legalized Free sale certificate (FSC) or Export Certificate of the origin country.

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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