How to Export to Brazil - Sprint Lazio

Brazil – Ministry of External Relations
surveillance of settings, processes, supplies and technologies related to them. It also
exercises control of sanitary conditions and procedures in ports, airports, borders
and customs facilities in the primary and secondary zones, and acts in international
issues related to sanitary surveillance.
Among its activities, ANVISA is responsible for regulation, control and inspection of
products that impact human health – medication, reagents for diagnosis, cosmetics,
sanitizers, foods, tobacco products, medical products, blood and blood-related
products –, as well as health services; for monitoring the price of medication; for prior
concession in the process of granting patents to pharmaceutical products and
pharmaceutical processes; and for the control of advertisement of products subject
to the sanitary surveillance regime.
The Brazilian sanitary law requires that companies interested in importing goods
under sanitary surveillance comply with rules set by the National Sanitary Surveillance
System prior to performing imports. Such requirement comprises the attainment of a
Work License (Sanitary Permit), to be issued by the state or municipal sanitary agency
where the company is located, as well as the Authorization for the Operation of
Companies (AFE), issued by ANVISA.
Information on how to proceed to obtain the aforementioned Authorization and License,
as well as the required documentation – which may vary according to the type of
product the company wishes to import – can be found in the website https://
www.anvisa.gov.br/peticionamento/sat/global/sistemas.asp.
Once it is done, the importer has to make sure that the products to be imported
satisfy the pre-requisites set by the National Sanitary Surveillance System. Procedures
regarding this regularization comprise registration (mandatory for medication, medical
products, foods, products for in vitro diagnosis, sanitizers and grade II risk cosmetics);
notification (for cosmetics, perfumes and risk I hygiene products, as well as risk I
sanitizing products); and compliance to the Identity and Quality Standards – PIQ,
applicable to foods that are listed in the categories with “registration exempt” status.
It should also be noted that medication comprised in the Brazilian pharmacopoeia,
as well as homeopathic drugs, are exempt from registration but are subject to sanitary
control and to meeting the specific requirements. Several categories of foods that
are exempt from registration with ANVISA must comply with the conditions required
in the Identity and Quality Standard of their categories.
More information on the requirements for different regularization procedures pertaining
to different categories of products can be found in ANVISA’s website: http://
www.anvisa.gov.br.
It is essential that imports for industrial and commercial purposes be planned in advance,
since the existing sanitary requirements are specific to each class of goods, as determined
by Attachment XLIV of the Resolution RDC ANVISA no. 350/05. This Resolution, which
rules on the technical regulations for the sanitary surveillance of imported goods, also
brings the description of products subject to inspection by ANVISA in its Attachment
XLIV, with their respective NCM codes, and also shows the technical and administrative
documentation needed to process regularization with that agency. RDC 350/05 can be
seen at http://e-legis.anvisa.gov.br/leisref/public/showAct.php?id=20313&word.
So as to avoid the denial of the import of goods, it is advisable to provide information
(regarding bills of lading and commercial invoices) to the contractors and tax authorities
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