ANVISA approves import of products through Single Declaration

On August 08, 2023, the Brazilian Health Regulatory Agency (“ANVISA”) published Collegiate Board Resolution (“RDC”) No. 807/2023, which establishes the criteria and procedures for the import of goods and products subject to sanitary oversight through the Single Import Declaration (“Duimp”).

We highlight below the main aspects of the new RDC:

• What is Duimp and when can it be used?

The import of goods and products subject to Anvisa’s consent through non-automatic licensing in the Integrated Foreign Trade System (“Siscomex”) can be carried out through Duimp, registered with the Single Foreign Trade Portal. Therefore, the use of Duimp is an alternative for the import of products subject to health surveillance in non-automatic licensing in Siscomex. The new RDC will enable the gradual inclusion of import consent, through Duimp, of the categories of products subject to sanitary intervention. The list of products and the implementation schedule will be published over the upcoming days on the official websites of Anvisa and Siscomex.

• Licenses, Permits, Certificates and Other Documents (“LPCO”)

Imports of goods, when carried out through Duimp, can be subject to Anvisa’s prior consent for licenses, permits or other documents to be registered with the LPCO module of the Single Foreign Trade Portal. The importer is required to identify the need to present LPCO and submit it to Anvisa’s consent, prior to the registration of Duimp.

• Transition phase

According to Anvisa, until the migration of import processes to the Single Foreign Trade Portal is completed, the importer may choose to use Duimp or maintain the import through the usual procedure, from the Siscomex Import License.

• Benefits to the regulated sector

The change is positive for the sector, given that:

(i) the simplification will enable a more efficient sanitary control of imports, considering that the information relating to import processes will be centralized in a single system, the Single Foreign Trade Portal; and

(ii) the change will also reduce the need to submit the required information and documents to all foreign trade consenting bodies, in order to implement the risk management as the main focus of practice.

Therefore, a significant cost reduction is expected for the sector, especially with regard to administrative activities relating to the import procedure and the storage time of the products until the import is completed.

Demarest’s Life Sciences and International Trade and Customs teams are monitoring the updates of the industry and are available to provide any further clarifications that may be necessary.