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Pharmaceutical Products Registration

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

Natural Products 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. 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

Household Products 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 Products Registration

  • 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.
  • Package sample
  • Manufacturing process
  • Qualitative and quantitative formula by duplicate
  • Analysis Certificate for the finished product
  • 6 samples of the finished product with 3 years of validity
  • Labels in Spanish language with a description of ingredients in accordance with current international standards.

 

 

Costs and Fees for Sanitary Registrations

  Fees Costs

Advice and Assistance on
*Hiring a pharmaceutical regent
*Opening a Dominican pharmaceutical Distributor
before the Ministry of Public Health including incorporation of company                    

                          

1,500.00

700.00

Registration of pharmaceutical, natural and eatable products                                          

400.00

150.00

Registration of Cosmetic and household care products                                                      


400.00        

150.00

Renewal of pharmaceutical, natural or Eatable products sanitary registration

400.00      

                                                                           150.00

Obtaining, reviewing and sending Sanitary registration certificate                            

75.00

80.00

     

*Prices are in US Dollars



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