Checklist for Pharmaceutical Product Registration
Trust the pharmaceutical registration products to us, our body of lawyers specialists on pharmaceutical product registration will advise and register your products in the Dominican Republic in the shortest time, contact us now.
Requirements for Pharmaceutical Product Registration In Dominican Republic
1. Power granted to the distributor by manufacturer.
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.
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. Firm 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.
13. Standards or raw materials samples (active substance sample).
Natural Product Registration
1. Power granted to the distributor by the manufacturer.
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. Label of the product containing the legend Keep away from the reach of children
4. Package sample and literature in Spanish language
5. Qualitative and quantitative formula by duplicate
6. Pharmacology Studies (if any)
7. Analysis Method by duplicate
8. Manufacturing process
9. Firm 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
Household Product Registration
1. Power granted to the distributor by the manufacturer
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. Label of the product containing the legend Keep away from the reach of children
4. Package sample
5. Qualitative and quantitative formula by duplicate
6. Manufacturing process
7. Analysis Certificate for the finished product
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. A 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 with a description of ingredients in accordance with current international standards.
