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Anvisa - The 10 Commandments

Atualizado: 12 de dez. de 2019

Here are lists of the 10 commandments to do business in Brazil and get your product registration approval:

1. You need to register your product at Anvisa before you enter into the Brazilian market (even exempted products need  Anvisa's authorization before launched into the market);

2. For the Anvisa's approval process you need to set up your company in Brazil or apply for the product registration through a local company (Distributor);

3. It is strongly recommended to protect your intellectual rights before starting a business in the Brazil;

4. The Brazilian Constitution Principles states that no one shall be oblige or refrain from doing something excepted by the virtue of law. In other words, Anvisa just can refuse or impose obligations based on law;

5. Sign a solid contract with your distributor and partners to protect your interest/rights before starting your business in Brazil;

6. The Brazilian Regulatory System is base on "Benefits/Risk Assessment" and "Risk Minimization". This is a Brazilian Constitutional Principle;

7. The Brazilian Regulatory System promotes transparency. It means that Anvisa's decision must be published in the oficial jornal and electronic system.

8. All Anvisa's decision are subject to judicial review, if necessary.

9. The Brazilian official language is Portuguese which means that all legal documents need to be in translated to Portuguese.

10. Always consult a lawyer before enter in a new business market

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