Industry

In this section, industry professionals can obtain information about Brazil's Generic Drugs Policy.

If your company wishes to apply for registration of a generic drug, whose reference drug has not yet been informed by ANVISA, please make a formal request to the Office of Generic Drugs through fax number (61) 3448-1386 or get in touch by e-mail at gemeg@anvisa.gov.br.

Pharmaceutical equivalence and bioequivalence tests needed for registering generic drugs can only be carried out by reference centers duly authorized by ANVISA. Parties interested in these tests must supply proof of their registration with this Agency - General Office of Public Health Laboratories - GGLAS: telephone (61) 3448-6300 and 3448-6361 or by e-mail: reblas@anvisa.gov.br

Bioequivalence Centers (in portuguese)

Legislation (in english, but page is from hotsite of generics in portuguese)

List of priority drugs for the registration of generic drugs classified by therapeutics class 2002 (format pdf)