How to Open a Drug Store in Brazil
There's a large number of drug stores in Brazil, mainly because the process of opening one isn't difficult. Find out what is required to open this type of business in Brazil.
In Brazil, a drug store can be found on every corner. At least in this aspect, the country displays larger numbers when compared to developed countries. there are more than 54,000 establishments that sell drugs in Brazil, a ratio of one drug store to every 3,200 inhabitants.
Unlike, what happens in other countries, Brazilian law does not make much distinction between a drug store and any other business establishment. "Opening a drug store in Brazil is relatively easy," says the president of the Brazilian Association of Pharmacies and Drug Stores Chains (Abrafarma), Sergio Mena Barreto.
First Steps to Open a Drug Store
As it was said, the process of opening a drug store is similar to the necessary steps to open a company, such as:
- Board of Trade registry
- Secretary of Finance registry
- Federal Revenue Service registry
- City Hall registry
- Registry in the INSS.
Sale of Medicines and Drugs
The differences appears when talking about the sale of medicines and drugs. In Brazil, the commercialization of these products can be only performed by companies or commercial establishments that are authorized and legalized by the Secretaria de Vigilância Sanitária, which is a branch of the Ministry of Health in charge of health surveillance, and by ANVISA. For that, it is mandatory to present:
- Health Surveillance Functioning Authorization (AFE)
- Technical Responsible Certified
- Ministry of Health registry.
The new business people must check with the city hall where they want to establish the drug store in order to obtain information about the physical installations of the business (related to location) and also the operation permit granted by city hall. Besides that, the business people must check the Procon legislation to adapt its products to the Consumer Defense Code.
Necessary Documentation
In order to function as a drug store, the commercial establishment must be duly registered in Regional Pharmacy Council (CRF), and for that application it is necessary to present the following documents:
- certified copy of a prior inspection report
- certified copy of the articles of association
- If there’s any contract amendment,certified copy of each change
- certified copy of the CNPJ
- certified copy of the state registration
- copy of the Carteira de Trabalho (photo page and verse or the contract or service agreement page with notary public authenticated photocopy)
- certified copy of the previous inspection report
- declaration informing the operation hours of the drug store, made on letterhead, with the CGC stamp (General registry of taxpayers), with the business people signature and with the signature of two witnesses with firms notarized.
The taxes will be issued only after the presentation of the documentation mentioned above, through receipt issued by CRF. More information can be obtained at the Regional Pharmacy Council of each State.
ANVISA’s Functioning License
In 2012, ANVISA launched officially the Autorização de Funcionamento Eletrônica, most known as AFE, which is an Electronic Functioning Authorization. That allows the sale of drugs or medicines to all commercial establishments that acquire AFE.
The electronic petition is not required, but is recommended because it presents numerous advantages. Requests made online without sending the physical documents to ANVISA, are as safe as the conventional way of filing documents, and ensure that is can be traced during the process and reduce printing and unnecessary accumulation of paper documents.
Companies that opt for Online Petition, must access the link, available on the ANVISA web page. To the electronic transaction be completed satisfactorily, it is necessary that the company has instructional documents scanned in JPEG, PDF or JPG file extension, with a maximum size of 256 KB. This file should be attached virtually in specific page during the course of the Online petitioning.
Differences from Physical to Online Protocol
| Documents Necessary for AFE Acquisition | Physical Protocol | Online Protocol |
| Petition Form | Must be filled, printed, signed and delivered to ANVISA, together with other documents required. | The form is completed electronically and at the end of the transaction, the data reported by the company is already available in the computerized system of ANVISA. |
| Original Guide of Union Collection Guide (GRU) proving the payment of the Sanitary Surveillance Inspection Fee | Must be delivered to ANVISA, together with other documents required. | The system will validate the fees that were paid or not. |
| Copy of Sanitary License or of the Inspection Report, both issued by ANVISA | Must be delivered to ANVISA, together with other documents required. | Should be attached virtually during the electronic application. |
Entities Involved on the Opening Process
ABCFARMA - Brazilian Association of Drug Store Trade
Santa Isabel Street, 160 - 5º floor - Vila Buarque - São Paulo - (SP)
Postal Code: 01221-010
Telephone. +55 (11) 223 8677.
ANVISA - National Health Surveillance Agency
SEPN, 515 - Bl.b - Ed. Omega - Brasília - (BR)
Postal Code: 70770-502
Telephone. +55 (61) 448 1327.