ANVISA – National Health Surveillance Agency, is responsible for releasing all medicines imported into Brazil. These drugs are allowed to enter the country after undergoing rigorous inspection.
But, ANVISA guarantees access to imported medicines for urgent and rare cases. For rare and incurable diseases, and for which the drug only exists in other countries, ANVISA authorizes its importation upon presentation of a series of documentation.
Find out more details about ANVISA's procedures, below.
ANVISA authorizes access to important medicines
Today there are more than 13 million people who have some kind of rare disease, just here in Brazil. For this reason, ANVISA has mechanisms that guarantee the importation of these already approved drugs.
Drugs with substances approved by the Federal Government and other regulatory agencies can easily be purchased and imported by users. These will need to present only the personal documents and also the doctor's request, containing these medicines.
Now, drugs that are considered prohibited, need a prior authorization.
To be able to import these medicines, you will need to make a request directly to the ANVISA email: [email protected]
Or at ANVISA's address:
National Health Surveillance Agency (ANVISA) / Controlled Products Coordination (CPCON) / Industry and Supply Sector (SAI) Section 5, Special Area 57, Block A, Ground Floor – Brasília, Federal District – CEP: 71.205-050
ANVISA looks for ways to facilitate the importation of medicines to Brazil
Recently, ANVISA proposed to the Government ways to simplify the procedures for importing these medicines, only for exceptional cases. The proposal is to facilitate the importation of unregistered medicines in cases of public health emergencies.
This change would be very important, so that the Unified Health System (SUS) does not run out of medication.
But this proposal causes divisions of opinion. For example, Nelson Mussolini, a member of the Pharmaceutical Products Industry Union, believes and says that ANVISA cannot give up its responsibility for oversight of medicines.
As for the executive president of the Union of Pharmaceutical Industries in the State of Goiás, Marçal Soares, Brazil will become a great field for drug testing. Their biggest concern, if this resolution is passed, is that drugs from some unreliable countries will be able to enter the country freely.
Despite this discussion, Roberto Dias, director of the Department of Logistics at the Ministry of Health, guarantees that this much easier import would only happen on an exceptional basis. That is, this medicine will only be adopted in cases of emergency.
Why does ANVISA want to facilitate the importation of medicines to Brazil?
ANVISA is looking for this change, due to what happened in 2019. Many medicines arrived late due to difficulties in importing.
For example, immunoglobulin was a case for concern because of delays in delivery. According to Roberto Dias, there was no shortage of medication, but it worried everyone.
A confirmação dessa nova medida para facilitar a importação dos medicamentos, ainda não foi aprovada, vamos aguardar os próximos dias.
