On February 2, 2022, the National Health Regulatory Agency (Anvisa) published Rule No. 597 (“RDC 597/2022”), which allows and regulates remote inspection of imported goods that are subject to health inspection in ports and airports. The new Rule will enter into force on March 2, 2022.
The purpose of this measure is to improve the efficiency and speed of the procedure, respecting the social distancing protocols instituted as a result of the COVID-19 pandemic.
Below is a summary of the main aspects of RDC 597/2022:
• Scope: goods classified according to Mercosur Common Nomenclature (NCM) codes subject to Anvisa’s consent, even if the purpose declared by the importer is not subject to health intervention procedures.
• Technology: Remote health inspection will be carried out using videoconferencing technology, or any other specific system as contracted by Anvisa. The video technology to be used in inspections must allow for: (i) scheduling of inspections; (ii) access via internet; (iii) real-time image transmission; (iv) Image Capture; (v) downloading files arising from the inspection; and (vi) recording and subsequent access to the collected material.
• Anvisa’s decision: It is up to Anvisa to decide whether to replace face-to-face inspection with remote inspection. The latter is a procedure complementary to the import documentary analysis.
• Conditions for remote inspection: Remote inspection must take place under conditions that (i) do not compromise the products’ condition and conservation; (ii) provide an adequate and clear visualization of the inspected products and their labeling; (iii) it is possible to hear those involved in the inspection; and (iv) allow verification of the environmental conditions of the location in which the inspection is being carried out.
• Instructions: instructions for organizing and carrying out the remote inspections will be made available on the integrated foreign trade system (Siscomex) or an equivalent system that may replace it. It is the responsibility of the Depositary of international express and postal shipments to comply with Anvisa’s instructions for organizing and carrying out remote inspections.
• Rescheduling: In exceptional cases – including absence of the importer’s representative or the cargo’s non-availability, the remote inspection can be rescheduled. However, the respective party must justify the rescheduling.
Demarest’s Life Sciences Team continues to monitor activities in the sector and is available should you need any further clarification on this matter.