Law

Provides for research involving humans and establishes the Brazilian System of Ethics in Research involving Humans.

Alters Law no. 6,360 of 23 September 1976, which provides for the health surveillance actions medicinal products, drugs, pharmaceutical inputs and related products, cosmetics, sanitizers, and other products are subject to, and makes other provisions, and Law no. 9,782 of 26 January 1999, which defines the Brazilian Health Surveillance System, creates the Brazilian Health Regulatory Agency, and makes other provisions, in order to promote transparency and predictability to the process of grant and renewal of marketing authorization for medicinal products and post-marketing authorization alterations.

LAW No. 9,787 OF 10 FEBRUARY 1999

1999

Alters Law No. 6,360 of 23 September 1976, which provides for health surveillance, establishes the generic medicinal product, provides for the use of generic names in pharmaceutical products, and gives other provisions.

1976

Provides for the Health Surveillance which medicinal products, drugs, pharmaceutical inputs and related products, cosmetics, sanitizing products, and other products are henceforth subject to, and gives other provisions.