The importing and commercialization of drugs into Brazil is subjected to norms and regulations established by the national health surveillance agency – Anvisa. Learn in this article how drugs can be imported and commercialized in Brazil.
Who can import drugs?
Drugs can be imported into Brazil by both legal entities and private people. In this last case, the import is limited to an amount destined to personal consumption and cannot be commercialized.
The imports of drugs into Brazil is regulated by Anvisa, which is the Brazilian organization coordinating and inspecting health and sanitary conditions of products and services commercialized in the country, so in order to import, an authorization from Anvisa is required.
This authorization regulates the imports of the following substances and drugs containing them:
An import license is a prior registration required from cargo that is subjected to non-automatic licensing on Siscomex. It is requested online by the importer or by his legal representative. It can be issued in two ways: before the shipment of the cargo - applied to the import of goods or raw material subjected to health surveillance before being shipped abroad -, or after the shipment - applied to goods subjected to sanitary inspection before customs clearance.
The import of these products is subjected to an annual quota that regulates the amount of drugs the company can import until the first quarter of the upcoming year. This amount can be extended if there is an internal demand for health products. For this, the importer must request an additional quota.
In order to register the imported drugs, the legal entity or private person importing them must collect all the required technical and sanitary documents and protocol them at UNIAP – Unidade de Atendimento e Protocolo, which integrates GGCON (Gerência Geral de Gestão do Conhecimento e Documentação).
The information and documents to be provided vary according to the category in which the drug fits in, being them:
- New drugs;
- Generic drugs;
- Similar drugs;
- Herbal drugs;
- Homeopathic drugs;
- Specific drugs.
New drugs that are imported to the country only for experimental purposes are exempted from the Anvisa registration. For this, it is necessary to issue a three-year authorization.
The commercialization of these drugs is limited to companies or commercial establishments that are duly legalized with Secretaria de Vigilância Sanitária do Ministério da Saúde, which is the ministry’s branch in charge of health surveillance.
In 2009, Anvisa prohibited the commercialization of drugs that can be acquired without medical prescription (such as pain killers and antipyretic drugs) on the shelves of drugstores, easily accessible to customers, who could buy them very easily, as if buying cosmetics).
The purpose of such measure was to decrease the number of intoxications caused by the use of these drugs, but as it was not achieved, the decision was reverted in 2012.
The stock of immunosuppressive drugs cannot exceed the amount necessary for 12 months of consumption. The stock for the other drugs cannot surpass the amount necessary for six months of consumption.
Companies importing drugs are required to keep the registration of its resellers constantly updated. They are also responsible for the accreditation of their partners with Anvisa.