How to Get an Anvisa License
Anvisa is a large Brazilian Agency with many responsibilities and competencies. This article outlines how to get an Anvisa license in some specific cases.
Anvisa is the Brazilian Sanitary Authority responsible for monitoring various products that enter and are commercialized Brazil. The importation of medicines, cosmetics, perfumes, hygiene and cleaning products, food, medical products and medicines are subjected to the Anvisa approval as it is presented below.
Products For Personal Usage
Since 2013, January, there's no need to present an Anvisa License for the importation of medicines, cosmetics, perfumes, hygiene and cleaning products, food, medical products and medicines for personal usage. The importation of these products is recognized by Anvisa as Importação para Consumo Pessoal – importation for personal usage.
If these products were imported in large quantities the importer must request an import permit to GIPAF (Gerência de Inspeção de Produtos e Autorização de Empresas em Portos, Aeroportos, Fronteiras e Recintos Alfandegados) and if the permit was granted the importation can continue.
Products For Professional Usage
If the product will be imported for usage in professional situations by a registered and qualified individual, it must follow the same steps presented above for the importation of health products for personal usage. The only particularity of this process is that the qualified individual must be registered in a health competent body recognized by Anvisa.
Products For Commercialization
The rules for each type of product monitored by Anvisa are different, varying from product to product. But usually the documentation below is always requested for every product subjected to Anvisa Licensing, but remember that, depending on the product, other documentation can also be requested.
- Petition for Sanitary Supervision and Release (copy)
- Union Collection Guide – GRU – (original)
- Authorization for physical inspection
- Commercial Invoice
- Load Recognition of the Load embarked
- Declaration informing the batches and the date of departures
- Analytical Report of Quality Control of the finished product, by batch or departure, issued by the manufacturer
- Power of attorney of the legal entity holding the regularization of the product at Anvisa to the legal representative, responsible for customs clearance.
Products For Scientific Research
Products for scientific and technological research can only be imported, when performed by a scientist/ researcher and/or by a scientific and technological institution duly accredited by CNPq – National Counsel of Technological and Scientific Development. The products designated for scientific research and subjected to the Anvisa Licensing can be imported to Brazil in two different ways:
Through SISCOMEX
- Petition/ Responsibility Term manual or electronic
- Union Collection Guide (GRU)
- LI or LSI (copy)
- Load Recognition (copy)
After the accomplishment of the legal requirements, the approval of the product LI / LSI will occur within 24 hours.
Through Mail Remittance
- Petition/ Responsibility Term manual or electronic
- Union Collection Guide (GRU)
- LSI (copy)
- Load Recognition (copy).
After the accomplishment of the legal requirements, the approval of the product LSI will occur within 24 hours.
International Donation of Products
The importation of goods under surveillance monitoring, through international donations, designated to philanthropic institutions must be registered in SISCOMEX and subject to the approval of Anvisa before the customs clearance.
The philanthropic institution that will receive the international donation shall, before the shipment of goods abroad, request the import permission to embark by:
- SISCOMEX, as was mentioned above, through the filling of the import license.
- Management of Ports, Airports, Borders and Bonded Warehouses through a Petition for Sanitary Supervision and Release.
- Presentation of documents before and after the embarking.
Documentation Before the Embarking
- Petition for Sanitary Supervision and Release (copy)
- Import License (copy)
- Union Collection Guide – GRU – (original)
- Information about the Anvisa license of product (when necessary)
- Declaration conceded by the owner of the Anvisa license authorizing the outsourcing of the importation (when necessary)
- List of the goods to be imported, being mandatory to inform to each commercial name the class, the category, the presentation, the maturity date and the respective batch numbering
- Notarized declaration signed by the legal representative of the company that will receive the importation, informing the importation finality and the identification of the warehouses where the products will be stored or the places in which they will be distributed in Brazil.
Documentation After the Embarking
- Petition for Sanitary Supervision and Release (copy)
- Import License (copy)
- Authorization to physical inspection
- Load recognition (original and copy)
- Notarized responsibility Term signed by the legal representative of the company that will receive the importation, assuming the responsibility to any harm caused to the health of the product users
- List of the goods imported, being mandatory to inform to each commercial name the class, the category, the presentation, the maturity date and the respective batch numbering.