CHECKLIST FOR MARKETING AUTHORIZATION OF HERBAL DRUG

TECHNICAL AND SCIENTIFIC INFORMATION

1. Qualitative-Quantitative Formula. The formula that expresses the botanical name (s) by
genus and species, and excipient or vehicle, as the case may be
2. Monograph of the medicinal plant(s)
Scientific name
Popular name
Part(s) used of the plant
Chemical composition.
Region to which it corresponds
Medical uses
Bibliographic references
3. Certificate of taxonomic identification, original or certified copy, of each of the botanical
ingredients used in the formulation issued by an institution that has an herbarium
4. Certificate of analysis of the active ingredients issued by the manufacturer and/or supplier
5. Certificate of analysis of each excipient issued by manufacturer and/or supplier
6. Analytical method of identification of the active ingredients and excipients.
7. Validation of analytical methods when they are not from pharmacopeial
8. Determination absence of toxic residues, pesticides, heavy metals, dated and signed
approved, reviewed and prepared by the Quality Responsible
9. Description of the manufacturing process and In-process controls
10. Protocol, Report and data of Stability studies (at least from 3 batches)
11. Certificate of analysis of the finished product from the Stability studies.
12. Conditions of conservation and handling during the transport of the product
13. Description and capacity of the primary and secondary packaging
14. Certificate of the packaging, issued by the manufacturer or supplier.
15. Tightness test of the primary container indicating the method of analysis and bibliographic
reference.
16. Therapeutic indication: Studies published in national or international scientific journals that
guarantee safety and efficacy. Studies demonstrating the efficacy of the medication
according to the indication requested.
- Maintenance of good bladder function and urinary flow
- Helps maintain a healthy bladder in adults 40 years of age and older.
- Vitamin E contributes to the protection of cells against oxidative stress
17. Bibliographic references of the active ingredients.
18. Box and label legends and leaflet.
19. The SmPC

LEGAL DOCUMENTATION
1. Free sale certificate issued by the health authority, original product or export certificate
2. Letter of representation from the manufacturer, authenticated by the legal procedure that
exists in the country of origin
3. The GMP certificate or Certified copy of the document issued by a recognized international
entity that certifies the Manufacturer's Quality Management System for Active ingredient.
4. The GMP certificate or the certificate of pharmaceutical product (CPP) for the finished
product.
5. License, certificate or document that certifies that the company has the permission to
manufacture drugs, issued by the competent authority of the country of origin.