From the Health Control of Products
The sanitary registration is the document that authorizes a natural or legal person to manufacture, package, and import a product intended for human consumption. Sanitary registrations in the Dominican Republic are regulated by the Ministry of Public Health, as expressed in the General Health Law.
This law in its Art. 109 indicates that it is the responsibility of the Ministry of Health, through the corresponding regulations and through the institutions and organisms created for this purpose:
1.- The sanitary control of the process, importation, and exportation, evaluation and registration, control of the promotion and advertising of food, alcoholic and non-alcoholic beverages, beers, medicines, cosmetics, personal and household hygiene products, tobacco, pesticides, toxic substances that pose a risk to health and all matters involved in their elaboration.
2.- The sanitary control of the process, use, maintenance, importation, exportation, and final disposal of medical equipment, prostheses, orthotics, functional aids, diagnostic agents, dental supplies, surgical and healing materials, and hygiene products.
By decree of the year 2015, the Executive Branch creates the General Directorate of Medicines and Food and Sanitary Products (DIGEMAPS), a dependency of the Ministry of Public Health, which will regulate all aspects concerning the issuance and renewal of sanitary registrations.
Decree No. 284-21, issued on April 30, 2021, by the Executive Power of the Dominican Republic, establishes a comprehensive reform of the health sector with a priority focus on the modernization of the General Directorate of Medicines, Food, and Health Products (DIGEMAPS).
The objective of this decree is to regulate the processes of health registration, as well as the control and supervision procedures related to its commercialization .
Simplification of Procedures
Within the framework of zero bureaucracy program, the decree provides for the simplification of the following administrative processes:
Granting of health registrations.
-Importation of controlled products .
-Health surveillance.
-Enabling establishments.
General Requirements:
To qualify for obtaining sanitary registrations, the manufacturer must meet the following general requirements, namely:
* Being incorporated as a commercial company in the Dominican Republic or registering the country as a branch of a foreign commercial company.
* Obtain a especial license for distribution of its products in the Dominican Republic or have agreement with a local company with a license of distribution.
Specific Requirements:
Depending on the type of product for which the sanitary registration is requested, certain requirements must be met, namely:
Pharmaceutical Products:
* Power granted to the distributor by the manufacturer.
* Certificate of free sale issued by an official authority in the country of origin, certifying that the product is freely marketed in such country. (Consular legalization required on this document).
* Copy of the current good manufacturing practices certificate of the manufacturer/conditioner laboratory corresponding to the classification of the requested product. (Consular legalization required for this document)
* Product label containing the legend "keep out of reach of children".
* Sample of the literature and package.
* Quantitative and qualitative formula in duplicate.
* Pharmacology studies, if any.
* Duplicate analysis method.
* Manufacturing process.
* Clinical trials (if any) and any other studies conducted if available.
* Certificate of analysis of the final product.
* Certificate of analysis of the raw material.
* 6 samples of the final product with 2 years of validity.
* Standards or samples of raw materials (sample of active substance).
* Packaging material .
*Official technical sheet.
*Professional information sheet .
*Summary of safety and efficacy studies
Natural Products:
- Power granted to the distributor by the manufacturer.
- Certificate of free sale issued by the official authority in the country of origin, certifying that the product is freely marketed in such country. (Consular legalization is required on this document).
- Copy of the current good manufacturing practices certificate of the manufacturer/conditioner laboratory corresponding to the classification of the requested product. (Consular legalization required for this document)
-Product label containing the legend "keep out of reach of children".
- Sample of the literature in Spanish.
- Qualitative and quantitative formula in duplicate.
- Pharmacology studies (if any).
- Duplicate analysis method.
- Manufacturing process.
- Clinical trials (if any) and any other studies conducted if available.
- Certificate of analysis of the final product.
- Certificate of analysis of the raw material.
- 6 samples of the final product with 2 years of validity
.
Household Use Products:
* Power granted to the distributor by the manufacturer.
* Certificate of free sale issued by the official authority in the country of origin, certifying that the product is freely marketed in such country. (Consular legalization is required on this document).
* Product label containing the legend "keep out of reach of children".
* Copy of the trademark certificate issued by the National Office of Industrial Property (ONAPI)
* Sample of the package.
* Qualitative and quantitative formula in duplicate.
* Manufacturing process.
* Certificate of analysis of the final product.
* 6 samples of the final product.
Food Products:
- Power granted to the distributor by the manufacturer.
- Certificate of free sale issued by the official authority in the country of origin, certifying that the product is freely marketed in such country. (Consular legalization is required on this document).
- Sample of the package.
- Manufacturing process.
- Qualitative and quantitative formula in duplicate.
- Certificate of analysis of the final product.
-6 samples of the final product.
-Product label in Spanish with description of the ingredients according to current international standards.
Duration:
At present, DIGEMAP is immersed in a process of technification and reform of the sanitary registration processes. However, the accumulation of requests exceeds the capacity of the regulator, so there is a delay in the issuance of registrations. New requests take between 6 and 7 months.
Simplified Procedure:
Since 2015, DIGEMAP has implemented the simplified sanitary registration procedure, which is available for a determined list of pharmaceutical, cosmetic, and food products. This procedure aims to reduce the number of requirements and the time for issuing sanitary registration. Currently, the simplified process takes approximately 4 months, and DIGEMAP seeks to reduce it to 2 months.
Mesa | Abogados has extensive experience in obtaining sanitary registrations. Among its clients are important companies in the pharmaceutical sector, as well as cosmetic and medicine manufacturers and distributors. For more information, write to us at the email address.