This article is an introduction to the import of drugs and medicines in Brazil. You will get to know the legal procedures, the lists of substances allowed by the sanitary agencies and the licenses companies will need in order to import them.
The institution responsible for overseeing the importation of medicines and drugs in Brazil is Anvisa. Everything related to this activity, from legislation to authorizations is in charge of this public agency.
Generally, the process of importing products into Brazil follow the same basic rules, which you can consult here. In this article we will focus on the specific requirements of the imports of drugs and medicines in the country.
Individuals importing medicine in Brazil
According to the Brazilian legislation, the importation of medicines is allowed if the person who is importing has a doctor’s statement affirming that:
- The medicine in question is really needed
- The medicine is not available to be purchased in Brazil
- The medicine doesn’t cause physical or psychological dependence
These three prerequisites must be obeyed. In addition, the doctor must specify in the statement the amount of medicine the person need and for how long he needs to take it.
The medicines imported by individuals are destined for personal use only. Selling is strictly forbidden.
- Doctor’s statement
- Identity card (notarized copy)
- CPF (notarized copy)
There are several companies that provide advice and consultancy in the activity of importing medicines in Brazil and abroad. Their service is to take care of all the customs procedures and paperwork.
Anvisa lists of medicines and drugs
Anvisa has different lists of drugs that are allowed to be commercialized by authorized companies in Brazil. In order to know which permits a company will need to have to import those drugs, it is necessary to consult in which list the drug figures in.
Because the lists of drugs are very extensive we are not publishing them here. You can consult the name of the drugs in this file from Anvisa.
- A1 - Narcotics
- A2 – Narcotics allowed in special concentration
- A3 – Psychotropics
- B1 - Psychotropics
- B2 – Psychotropics Anorectics
- C1 - Drugs subject to special control
- C2 – Glycolic drugs
- C3 - Antiretroviral drugs
- C4 – Imunosupressive drugs
- D1 – Inputs for Narcotics and Psychotropics
- D2 – Chemical inputs
Companies importing medicines: Permits from sanitary institutions required to import medicines
In order to import medicines with purporses of selling in Brazil, it is necessary to have the following documents:
Autorização de Importação (Import Permit)
It is a document issued by the Health Surveillance Secretariat of the Ministry of Health, allowing the import of substances in the lists A1 and A2, A3, B1, B2, C3 and D1.
Certificado de Autorização Especial (Certificate of Special Permit)
A document issued by the Health Surveillance Secretariat of the Ministry of Health, which constitutes the granting of the Special Permit, which is a the license granted by Anvisa to companies, institutions and bodies, to exercise activities of extraction, production, processing, manufacture, fractionation, handling, packaging, distribution, transportation, repackaging, import and export of drugs.
Licença de Importação (Import License)
It is the previous registration required to SISCOMEX. The document is requested electronically (online), by the importer or his legal representative. It can be ordered before or after the goods are shipped abroad, according to legal requirements. The License is granted after approval of the Ministry of Health to import a product or raw material under sanitary surveillance by demonstrating compliance with legal requirements that person, prior to customs clearance.
Certificado de Não Objeção (Non Objection Certificate)
Document issued by the competent organ of the Ministry of Health of Brazil, ensuring that substances or drugs to be imported are not subject to special controls in Brazil.
Cota de Importação Annual (Annual Import Quota)
Document that specifies the amount of drugs from the lists A1, A2, A3, B1, B2, C3 and D1 that the company is allowed to import up to the first quarter of the year following the award.
Cota de Importação Suplementar (Supplementary Import Quota)
Document that specifies the amount of drugs from the lists A1, A2, A3, B1, B2, C3 and D1 the company is allowed to import, in a supplementary to the annual quota.
Cota Total Annual de Importação (Total Annual Import Quota)
Sum of Annual and Supplemental Quotas authorized for each company in the current year.
For a company to extract, produce, manufacture, process, distribute, transport, prepare, handle, crumble, import, export, process, pack, repack, for any purpose, substances on the lists of Anvisa, or even medications that contain them, it is required to obtain special permits (autorizações especiais) granted by the institution. Each economic activity regarding medicines and drugs will have different requirements by the Sanitary institutions.
The illegal importing of medicines is subject of penalties of warning, confiscation, destruction, prohibition, cancellation of the operating permit, cancellation of the registration of the product and fines.