Imported Products Registration

Imported Products Registration

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The import and distribution of packaged foods and beverages in the Dominican Republic requires  a Health Permit Registration prior to their supply to the general public

The Ministry of Health in the Dominican Republic is the entity that controls the sanitary process of foods, alcoholic and non alcoholic beverages, beer, medicines, cosmetic products, personal hygiene and household cleaning products; including the importation, exportation, evaluation, registration, publicity and promotion of such products; pursuant to the provisions of General Health Law 42-01, dated March 8 of 2001.

Through the General Regulation 528-01, for the Control of Risks in Foods and Beverages in the Dominican Republic, the General Directorate of Drugs, Food and Sanitary Products (“DIGEMAPS”) is able to establish the health provisions for the production and trade process of foods and beverages for human consumption, exercise compliance control, and set forth the process for obtaining the Health Permit Registration (“registro sanitario” in Spanish).

For pre-packaged foods and beverages, the general requirements to apply for a Health Permit Registration consist on the following:

  1. Formal application letter addressed to the Health Minister specifying: (i) trade name of applicant, name of applicant’s legal representative (if applicable, including copy of Business Register); address, phone number, tax payer registration number and general contact information; (ii) name of the manufacturer and country of origin, (iii) name and type of product including packaging characteristics (specifying volume or weight), quantitative and qualitative formula of the product and description of product flow.

Said application letter shall be accompanied by the following documents:

  1. Copy of Trademark Registration Certificate.
  2. Copy of Trade Name Certificate.
  3. Three samples of the product as it will be sold in the market (if case of solids each sample must contain at least 200gr and in case of liquids, 250ml), or acceptance of such samples by their authorized private lab.
  4. Labeling must comply with the NORDOM 53 directives in Spanish language or including Spanish translation.

For pre-packaged foods and beverages manufactured in the Dominican Republic, a copy of the health permit of the manufacturing establishment is also required.

For pre-packaged foods and beverages imported into the Dominican Republic, a Certificate of Free Sale or Certificate of Export and a Power of Attorney, granted to the legal representative or distributor in the Dominican Republic, should also be submitted with the application letter. Such documents must be duly legalized (by Apostille or by the Ministry of Foreign Affairs, as applicable) in the country of issuance, and translated by a certified legal interpreter in the Dominican Republic to the Spanish language, if applicable.

There are Government fees payable for each product sanitary health permit registration.

In practice, the time frame for obtaining each product health permit registration is approximately three months after the application letter is filed before the Dominican Ministry of Health.

 

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