19
Nov

A Sanitary Registration is the document that authorizes individuals and a legal persons to import, manufacture or package products intended for human consumption.

In the Dominican Republic, the office responsible for granting and supervising Sanitary Permits and Registrations is the Ministry of Public Health. All the requirements needed to submit applications with the General Directorate of Medicines, Food and Health Products (known in Spanish as DIGEMAPS) are listed in Decree 528-01.

Below we will be listing the requirements to register in the Sanitary Registry of Human Consumption products. Some examples of these products are:

• Medications
• Cosmetics
• Personal hygiene
• Household Hygiene
• Food

The process can be initiated before the regulatory institution in two different ways:

• Traditional One-Stop Shop process: 90 days.
• Simplified process: 30 days.

These are the time frames established for the main products. However, these may vary depending on the type of said product.

The difference between these two methods is the following:

A) Duration

B) The Simplified process is conducted online (all other requirements remain the same).

You may see the requirements for each product in the following list:

List of requirements for the granting of Sanitary Registration of Medications

List of requirements for the granting of sanitary registration of cosmetics and hygiene products

List of requirements for the granting of Sanitary registration of Household Hygiene

List of requirements for the granting of sanitary registration of food and beverages

One of the most common sanitary permits in the Dominican Republic is the registration for food and beverages. The requirements to obtain these permits are:

1. For the simplified process, a Sanitary Registration Request form (obtained from the online registration platform) needs to be printed and signed .

2. Active power of attorney, signed by the titular company in favor of the representative in the Dominican Republic (domiciled in Dominican territory), notarized and certified in the Attorney General’s Office (for local products) and legalized or apostilled by the Ministry of Foreign Affairs (for imported products). You would need to include the authorization for the application of Sanitary Registry in the country.

3. Copy of the active trademark certificate issued by the National Industrial Property Office (known in Spanish as ONAPI), corresponding to the requested class, if applicable. It must be under the name of the holder, manufacturer or representative of the sanitary registry.

4. Original free sale certificate of the current product (if it does not have an effective date, two (2) years after its issuance will be used as valid). The certificate must have been issued by the sanitary authority of the country of manufacture or origin, legalized or apostilled by the Ministry of Foreign Affairs (imports).

5. In the case of maquila (as applicable):

5.1 Manufacture of imported products for foreign holders. This must comply with:

• Original free sale certificate of the current product (If it does not have an effective date, it will be two years after its issuance). The certificate must have been issued by the sanitary authority of the country of manufacture or origin, legalized or apostilled by the Ministry of Foreign Affairs (imports). You must explicitly state that the product whose registration is requested, is sold legally and consumed with the same name and formula in the country of origin or production. You must state the name and address of the manufacturer (plant where the product is manufactured). If the name of the product declared in the Certificate of Free Sale is different from how it will be marketed in the country, the owner would need to issue a legalized affidavit, indicating that it corresponds to the same product and composition.

– Manufacturing contract 1; You would need to include the name of the product(s) to be manufactured. Current. It must be signed by the owner or manufacturer.

5.2 Manufacture of imported products for establishments or national representatives. Must comply with:

A) Original export certificate 1. Must include the name of the product to be manufactured and be active (If it does not have an effective date, it will be two years after its issuance). You would also need to provide the name and address of the manufacturer (factory where the product is made). The export certificate must specify that the person responsible for manufacturing the product guarantees compliance with sanitary regulations. If applicable, an equivalent document issued by the competent authority of the country of origin can be used instead. If the name of the product in the Certificate of Free Sale is different from how it will be marketed in the country, the owner would need to issue a legalized affidavit, stating that it corresponds to the same composition and product affected by the change of name.

B) Manufacturing contract 1; You must include the name of the product that will be manufactured. Current. It must be signed by the owner or manufacturer. If the holder-manufacturer relationship is established in the export certificate, it will not be necessary to comply with this requirement.

5.3 Manufacture of local products for establishment or national representative. For this purpose, you would need to comply with:

A) Copy of the Health License or Permit of the establishment or premise where the product issued by the Ministry of Public Health (local products) is made. Must be active. You would also need to state the name and address of the manufacturer.

B) Manufacturing contract 1; You must include the name of the product that will be manufactured. Current. It must be signed by the owner or manufacturer.

6. Description of the product’s manufacture process (flow line).

• A flowchart of the manufacture process must be attached (outlining all the steps to follow).
• A description must be attached, including the process and all the steps that need to take place from the manufacture of the item until the final product.

7. A) Copy of the Health License or Permit of the establishment or premise where the product issued by the Ministry of Public Health (local products) is manufactured.

• Active
• You also need to state the name and address of the manufacturer.
• This information should be shown in the application form for the sanitary registration of the product.

8. Update of label art and packaging material in accordance with the requested update, complying with NORDOM 53 guidelines.

• Food Name.
• Registered trademark of the item. (If applicable)
• List of product ingredients, in decreasing order of weight and volume
• Product’s net content and drained weight.
• Name and address of the manufacturer, packer, distributor, importer, exporter or seller of the food.
• Health Registry number.