Countries › Dominican Republic › Guide › 12. Sectors › Medicines, food and health products

Medicines, food and health products

Last verified: 2026-10-30 · Status: Stable

DIGEMAPS, under the Ministry of Public Health, regulates medicines, food, drinks, cosmetics and health products. Its service sheet for renewing a product's sanitary registration shows RD$21,000 for a medicine and RD$9,000 for a natural product, with 90 working days to respond. Foreign owners act through a local representative.

USD figures use the Banco Central de la República Dominicana reference selling rate of RD$60.9007 per US dollar, as shown on its home page on 30 October 2026, rounded to the cent.

Key facts

Renewal of medicine registration	21000 DOPDIGEMAPS service sheet, as of 2026-10-30 · in force
Renewal of natural product registration	9000 DOPDIGEMAPS service sheet, as of 2026-10-30 · in force
Response time	90 working daysDIGEMAPS service sheet, as of 2026-10-30 · in force

The rule

1. DIGEMAPS was created under the Ministry of Public Health.Decreto 82-15, art. 1, 2015-04-30 official text · verified 2026-10-30

2. It is the competent body to regulate, control and monitor medicines, health products, food, drinks, cosmetics, hygiene products and related technologies, along with the establishments that handle them.Decreto 82-15, art. 2, 2015-04-30 official text · verified 2026-10-30

3. It took over the roles of the former drugs and pharmacies directorate and the food risk department under Decreto 246-06 and Decreto 528-01.Decreto 82-15, art. 3, 2015-04-30 official text · verified 2026-10-30

4. Certain changes to a registered medicine, including factory changes, data sheet updates, packaging and manufacturing process, use a simplified procedure.Decreto 246-06 art. 81 as replaced by Decreto 82-15, art. 5, 2015-04-30 official text · verified 2026-10-30

5. Renewal needs the form, the current sanitary registration of the local establishment, a product certificate with at least three months left, a manufacturing practice certificate where it applies, and a power from the foreign owner to the local representative.DIGEMAPS service sheet, Ley 42-01 and Decreto 246-06, requirements, 2026-10-30 official text · verified 2026-10-30

6. The fee is RD$21,000 for a medicine and RD$9,000 for a natural product, with a response time of 90 working days.
Cost to do it: RD$21,000 (about US$344.82) for a medicine, RD$9,000 (about US$147.78) for a natural product.
Example: RD$21,000 per medicine / US$344.82 per medicineDIGEMAPS service sheet, cost and response time, 2026-10-30 official text · verified 2026-10-30

Worked example

A laboratory renews 20 medicines. Fees are RD$420,000 (about US$6,896.47). It files at least three months before expiry and plans for 90 working days.

Step by step

Appoint a local representative with a registered establishment.
Keep manufacturing certificates current.
File before the certificate has less than three months left.
Pay the fee and track the answer.
Use the simplified route for listed changes.

Common traps

The law text of Ley 42-01 and the full Decreto 246-06 were not retrieved, so the term of a medicine registration and first registration fees are left out.
A separate five year term seen in official texts applies to cosmetics establishments and should not be assumed for medicines.
Free zone devices for export follow other tracks. See investing/free-zone-regime.

Sources

← Agriculture and farm import licencesRegulatory compliance essentials →

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