Checklist for Pharmaceutical Product Registration

 

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Requirements for Pharmaceutical Product Registration In Dominican Republic

1. 1. Power granted to the distributor by manufacturer.

7. 2. Free sale certificated issued by Official authorities in the country of origin certifying the product is freely commercialized in such country. Consular legalization of this document is required.

8. 3. Label of the product containing the legend Keep away from the reach of children

   4. Package sample and literature

   5. Qualitative and quantitative formula by duplicate

   6. Pharmacology Studies (if any)

   7. Analysis Method by duplicate

   8. Manufacturing process

   9. Clinic Essays (if any) and any other studies made if available

   10. Analysis Certificate for the finished product

   11.Analysis Certificate for the raw material

   12. 6 samples of the finished product with 3 years of validity

9. 13. Standards or raw materials samples (active substance sample)

Natural Product Registration

1. 1. Power granted to the distributor by the manufacturer.
5. 2. Free sale certificate issued by Official authorities in the country of origin certifying the product is freely commercialized in such country Consular legalization of this document is required.
7. 3. Label of the product containing the legend Keep away from the reach of children
8. 4. Package sample and literature in Spanish language
9. 5. Qualitative and quantitative formula by duplicate
10. 6. Pharmacology Studies (if any)
11. 7. Analysis Method by duplicate
12. 8. Manufacturing process
13. 9. Clinic Essays (if any) and any other studies made if available
14. 10. Analysis Certificate for the finished product
15. 11. Analysis Certificate for the raw material
16. 12. 6 samples of the finished product with 3 years of validity

Household Product Registration

1. 1. Power granted to the distributor by the manufacturer
2. 2. Free sale certificate issued by Official authorities in the country of origin certifying the product is freely commercialized in such country Consular legalization of this document is required.
3. 3. Label of the product containing the legend Keep away from the reach of children
4. 4. Package sample
5. 5. Qualitative and quantitative formula by duplicate
6. 6. Manufacturing process
7. 7. Analysis Certificate for the finished product
8. 8. 6 samples of finished product.

Eatable Product Registration

• 1. Power granted to the distributor by the manufacturer
• Free sale certificate issued by Official authorities in the country of origin certifying the product is freely commercialized in such country Consular legalization of this document is required.
• 2. Package sample
• 3. Manufacturing process
• 4. Qualitative and quantitative formula by duplicate
• 5. Analysis Certificate for the finished product
• 6. 6 samples of the finished product with 3 years of validity
• 7. Labels in Spanish language with a description of ingredients in accordance with current international standards.