In Brazil ANVISA Greenlights Imports Using Single Declaration Approach

The Brazilian Health Regulatory Agency (Anvisa) has approved a regulation that allows the use of the Single Import Declaration (Duimp) as an alternative for the importation of goods and products subject to Anvisa's non-automatic licensing approval within the Siscomex system. The decision was made unanimously during the public meeting of the directors on August 2nd.

The use of Duimp and other modules available on the Single Foreign Trade Portal will contribute to a more efficient health control of imports, in addition to avoiding the need to submit required documents to all relevant foreign trade agencies. As a result, a significant reduction in costs for the regulated sector in administrative activities and storage time is expected. For instance, the latter directly affects the efficiency of national and international logistics chains.

Outlined below are the primary components of the new RDC:

Understanding Duimp and Its Applicability The Duimp serves as a gateway for importing goods and products that require ANVISA's approval through the non-automatic licensing process within the Integrated Foreign Trade System (Siscomex). This mechanism offers an alternative route for the importation of items that are subject to health scrutiny under non-automatic licensing within Siscomex. With the introduction of the new RDC, the incorporation of import approval via Duimp for various product categories requiring health oversight will be introduced gradually. The specific list of products and the rollout timeline will be announced on the official websites of both ANVISA and Siscomex in the days to come.

Licenses, Permits, Certificates, and Other Essential Documents (LPCO) Utilizing Duimp for imports necessitates adhering to ANVISA's prerequisite for obtaining licenses, permits, or other essential documents, which must be registered using the LPCO module on the Single Foreign Trade Portal. Importers are obligated to ascertain the necessity for presenting LPCO and securing ANVISA's approval before initiating the Duimp registration process.

Transition Phase and Flexibility ANVISA has stipulated a transitional phase during which importers can opt to use Duimp or maintain the traditional import procedure via the Siscomex Import License. This transitional period will remain in effect until the full migration of import processes to the Single Foreign Trade Portal is finalized.

Gains for the Regulated Sector This pivotal shift carries significant advantages for the sector as it entails:

(i) Streamlining import-related health checks, as all pertinent import process data will be consolidated within the Single Foreign Trade Portal.

(ii) Diminishing the requirement to furnish mandatory information and documents to various foreign trade regulatory bodies, thereby enhancing risk management as a primary operational focal point.

As a result, substantial cost reductions are anticipated within the sector, particularly in terms of administrative functions associated with the import process and the duration for which products are stored prior to completion of the importation procedure.