FREQUENTLY ASKED QUESTION*

1) WHAT ARE THE ADMINISTRATIVE FEES FOR PRODUCT REGISTRATION?

The Administrative fees charged upon a medicine product are R$ 80.000,00 (for a new drug/large company), R$ 8.000,00 (new drug/small company); R$ 21.000,00 (similar medicine/large company) and R$ 2.100,00 (similar/small company); R$ 6.000,00 (generic/large company) R$ 600,00 (generic /small company).

The Administrative fees charged upon a health product ranges between R$ 2.000,00 (small company) and R$ 20.000,00 (large company).

Note:

The size of the company is stipulated according with its annual revenue.

2) DOES BRAZIL ACCEPT BIO-EQUIVALENCE TEST DONE ABROAD?

Brazil accepts bio-equivalence tests done abroad. If the product is made in Brazil, the clinical tests should be done by a Brazilian Laboratory accredited by ANVISA.

3) IS THERE COMMON REGISTRATION PROCESS FOR THE MERCOSUR COUNTRIES?

It is not possible to use the registration issued in Brazil for other countries of Mercosur (Argentina, Uruguay and Paraguay). There is no common registra-tion procedure for the Mercosur countries. The company must apply for reg-istration in each country individually.

4) IS THERE A PRE-MARKET NOTIFICATION PROCESS?

No. Brazil does not have any policy for pre-market notification process. The company must get the registration approval before launching its product in the market.

5) HOW MANY DISTRIBUTORS CAN MARKET A COMPANY PRODUCT AND REGISTER IT IN BRAZIL?

There is no limit. However, we recommend that the company elect just one main distributor to register its product at ANVISA and gives the authorization for new distributors to sell the products under his registration number. 

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* IMPORTANT NOTE

Information of a guidance, without claiming to cover all existing legislation or to ensure your upgrade. Always consult the relevant regulatory bodies for such security. The PLATINUM Consulting is happy to answer questions relating to Regulatory Affairs is making available if you need more detail.