ANVISA approves rule that includes Singlie Import Declaration (DUIMP) in imports subject to Health Surveillance

Duimp integrates updating and harmonization of customs procedures subject to sanitary inspection.

The Collegiate Board (DICOL) of the Brazilian Health Regulatory Agency (Anvisa), approved during the 11th Ordinary Public Meeting (ROP 11), held on August 2, 2023, a Resolution proposal that aims to regulate the importation through Duimp of goods and products subject to health surveillance. The new standard comes from a set of initiatives by public authorities to update customs procedures, to adapt Brazilian legislation to the most modern international standards.

Although its draft is already available, the Resolution must be published in the next couple of days and will come into force on the day of its publication.

Brief Regulatory Context

During DICOL’s meeting, adaptations of health surveillance along with new customs processes were repeatedly discussed. With the publication of Decree nº 8.229/2014, the Single Portal of Foreign Trade (Siscomex) was created, whose main objective was to centralize the interaction between public authorities and private operators.

Recently, Law No. 14,195/2021 also brought provisions on facilitating foreign trade, but it was Decree No. 11,577/2023 that amended Decree No. 660/1992 and forced public bodies to use the Single Portal exclusively in communications with the sector regulated. This exclusive use must be fulfilled for exports by September 1, 2023, and for imports by March 1, 2024.

New aspects of the Rule

As main points of attention of the new Resolution, the following is highlighted:

• Goods and products subject to Anvisa’s consent for non-automatic licensing on Siscomex may be imported through Duimp;
   
• The list of goods authorized for submission to Anvisa’s import consent through Duimp will be published on the health authority’s website in due course;
   
• When carried out through Duimp, imports may be subject to prior approval by Anvisa of licenses, authorizations, or other documents to be registered in the Licenses, Permissions, Certificates and Other Documents (LPCO) module — which replaces the “Import License” – LI”;
   
• It will be up to the importer to identify the need for an LPCO and submit it to Anvisa for approval prior to Duimp registration;
   
• The companies must present Anvisa’s RDC No. 81/2008 documents required by the authority at Duimp or at the LPCO. A petition for inspection and sanitary release must also be presented by the importer under sanitary surveillance, as well as payment of the fee;
   
• Anvisa will have access, at any time, to Duimp information under the Agency’s control.

It is worth mentioning that non-compliance with the provisions contained in the new Resolution constitutes a breach of sanitary legislation, under the terms of Law No. 6,427/1977.

For further information on this new Resolution, please do not hesitate to contact our Life Sciences & Healthcare, International Trade and Tax teams via email: lifesciences@soutocorrea.com.br.