Pharmaceutical Products Registration in Dominican Republic

It is necessary to obtain authorization permits before Ministry of Health in Dominican Republic in order to start trading any eatable, pharmaceutical, household, and personal care products in Dominican Republic territory.

According to this, manufacturer must accomplish certain requirements before proceeding with such registration of products, including among others:
To register an authorized distributor company (either Dominican company or a manufacturer’s subsidiary incorporated under Dominican laws)  before the Ministry of Health.  In the event the manufacturer decides to incorporate a company under Dominican Republic laws in order to represent it here and thus avoid all obligations provided by law 173 on Merchandising and Products Distribution Law, a Pharmaceutical regent must represent this company at its time before the Ministry of Health.

Incorporation of companies requires of registration of commercial name first.   Incorporation process might take around 3 months and thus is suggested to start soon with this procedure.   Once company is ready, this should be registered with the Ministry of Health by the attorney in charge through a Pharmaceutical Regent.

Once these requirements are completed, following documents shall be filed:

  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 2 years of validity
  13. Standards or raw materials samples (active substance sample)

Natural Products

  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 2 years of validity

Household Products

  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

  • 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 2 years of validity
  • Labels in Spanish language with a description of ingredients in accordance with current international standards.