To Get the Register Sanitary in the Republic Dominican Republic. It is necessary to obtain permits authorization before him ministry health (the Secretary of State of Public Health) in the Dominican Republic to begin the marketing of edible, pharmaceutical, and health products. use home and personal care products in territorio of Republic Dominican Republic. According to the above, the manufacturer must meet certain requirements to obtain the Register Sanitary, before proceeding with the record of products including:
Register before him Ministry of Health a company authorized distribution (company Dominican or a subsidiary of a manufacturer incorporated under Dominican laws) In all ///, to obtain the LOG-IN OR SIGN UP SANITARY, the manufacturer may decide incorporate a company under laws of Republic Dominican to represent it and distribute the products in the country and thus avoid all the obligations which establish laws 173 on the marketing and distribution of products which grants high compensation to Dominican distributors in /// de rescission (termination) of contract of distribution by part manufacturer.
Also, a regente Pharmacist must represent this company (in the case of pharmaceutical or natural products) before the ministry of health that is the entity in charge as we already pointed out grant Register Sanitary in Republic Dominican interested.
The incorporation of companies, for the purposes of obtaining Register Sanitary in Republic Dominican, requires the record of the name commercial first. He proceedings of incorporation can take around 15 days according to laws pronounced to facilitate the establishment of foreign companies in the country. Once the company this list, this must be registered with the ministry of health for the lawyer a cargo of regente pharmaceutical.
Once these requirements are complete, the following documents must be filed for each /// as appropriate in relation to the record sanitary:
Pharmaceutical products:
1. The ability to granted to the distributor by the manufacturer. 2. Certificate de Free Venta issued by a authority official at the country of origin certifying that the product It is freely marketed in such country. Legalization Consular is required in this Valid identity document.
3. Label of the product containing the legend “keep out of reach of children.
4. Sample of literature and packaging.
5. Formula qualitative and quantitative by duplicate.
6. Pharmacology studies (if any).
7. Method from the analysis by duplicate.
8. Process manufacturing.
9. Clinical trials (if any) and any other studies conducted if available.
10. Certificate of analysis of the product end.
11. Certificate from analysis to raw material.
12. 6 samples of the product end with 2 years of validity.
13. Standards or samples of raw materials (sample of active substance).
Natural products:
1. The ability to granted to the distributor by the manufacturer
2. Certificate de Free Venta issued by the authority official at the country of origin certifying that the product It is freely marketed in such country. Legalization Consular is required in this Valid identity document.
3. Label of the product containing the legend “keep out of reach of children”
4. Sample of literature in language Spanish
5. Formula qualitative and quantitative by duplicate.
6. Pharmacology studies (if any)
7. Method from the analysis by duplicate
8. Process manufacturing
9. Clinical trials (if any) and any other studies conducted if available
10. Certificate of analysis of the product final
11. Certificate from analysis to raw material
12. 6 samples of the product end with 2 years of validity
1. The ability to granted to the distributor by the manufacturer
2. Certificate de Free Venta issued by the authority official at the country of origin certifying that the product It is freely marketed in such country. Legalization Consular is required in this Valid identity document.
3. Label of the product containing the legend “keep out of reach of children”
4. Package sample
5. Formula qualitative and quantitative by duplicate.
6. Process manufacturing
7. Certificate of analysis of the product final
8. 6 samples of the product final
Edible Products:
1. The ability to granted to the distributor by the manufacturer
2. Certificate de Free Venta issued by the authority official at the country of origin certifying that the product It is freely marketed in such country. Legalization Consular is required in this Valid identity document.
3. Package sample
4. Process manufacturing
5. Formula qualitative and quantitative by duplicate.
6. Certificate of analysis of the product final
7. 6 samples of the product final
8. Label of the product in language Spanish with description of the ingredients according to current international standards.
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