The General Directorate of Medicines, Food, and Medical Devices (DIGEMAPS) took a decisive step toward harmonizing the regulatory standards applicable to medicines marketed in the Dominican Republic. Through Resolution DG-0003-2026, signed on June 2, the health authority establishes a uniform mechanism for verifying compliance with Good Manufacturing Practices (GMP) for medicines manufactured abroad and, most importantly, sets the dates from which such compliance will be mandatory.
Although the resolution represents a significant change for the sector, it should be clarified that the requirement to hold a GMP certification is not new. Since Decree 246-06—which approves the Medicines Regulations—took effect, both the health registration and the importation of products manufactured outside the country have required proof that the manufacturing laboratory complies with Good Manufacturing Practices.
What is changing now, however, is the way in which that compliance will be assessed.
To date, there has been no standardized mechanism for verifying GMP compliance among foreign manufacturers. With this resolution, DIGEMAPS formally adopts as a reference the Good Manufacturing Practices Inspection Guide based on Technical Reports 32 and 37 of the World Health Organization (WHO) and on the guidance developed by the Pan American Network for the Harmonization of Pharmaceutical Regulations (RED PARF).
These standards began to be gradually incorporated into the Dominican regulatory system starting in 2016, although their practical application had been limited to domestic laboratories, especially following the issuance of Resolution 05/2025, which officially approved the guidelines for that sector.
With Resolution DG-0003-2026, that distinction disappears. From now on, the same verification mechanism that already applies to domestic manufacturers will also be required for medicines produced outside the country, establishing a uniform standard for all holders and applicants of marketing authorizations.
What does this mean for the pharmaceutical industry?
The impact will be immediate for importers, representatives, and holders of health registrations for drugs manufactured abroad.
In practice, manufacturers must demonstrate compliance with Good Manufacturing Practices in accordance with the RED PARF Inspection Guide or through a system that DIGEMAPS recognizes as equivalent or superior. This requirement will be decisive for registering new products, renewing existing registrations, and maintaining marketing authorization in the Dominican market.
This means that companies can no longer assume that any GMP certificate will suffice. It will be essential to verify with their manufacturers whether the available certification meets the specific verification mechanism required by the Dominican health authority.
A Timeline That Leaves No Room for Improvisation
The resolution establishes a clear timeline that leaves little room to postpone preparations:
September 1, 2026: Compliance with the new mechanism will be mandatory for all applications for health registration and renewals of drugs manufactured abroad.
January 1, 2027: No company may import drugs manufactured outside the country without demonstrating compliance with this requirement.
Rather than a new requirement, the resolution consolidates a process of regulatory harmonization that the country has been pursuing for several years. The difference is that there are now clear rules, a defined mechanism, and mandatory compliance deadlines.
For companies involved in the importation and distribution of medications, now is the time to review their documentation and verify the regulatory status of their manufacturers. Waiting until the deadlines are approaching could result in delays in health registrations, difficulties in renewing authorizations, and even obstacles to continuing to import products into the Dominican market.
