Legislation
Decree

Decree nº 4.204, of April 23, 2002

THE PRESIDENT OF THE REPUBLIC, in the use of the attributions vested in him under Article 84, item IV, of the Constitution, and under the provisions of Article 4 of Law n. 9.787, of February 10, 1999,

DECREES:

Article 1 - The provisions of Article 1 of Decree n.3.675, of November 28, 2000, shall henceforth be in force with the following changes:

"Article 1 - Prior to November 28, 2002, the National Sanitary Surveillance Agency shall grant special registration for unprecedented generic drug products concerning their active principle, pharmaceutical form and dose, as to increase the adoption and use of new generic products in the country.

§1º The special registration shall be valid for 1 (one) year, from the publishing date of the concession of the registration.

§2º For the purpose of this article, there shall be understood as unprecedented generic products those which have never obtained registration as generic in Brazil." (NR)

Article 2 - This Decree enters into force on the date of its publication.

Article 13 - Decree n. 3.960, of October 10, 2001, and Decree 4.173 of March, 21, 2002 are hereby revoked.

Brasilia, April 23rd, 2002; 181st of the Independence and 114th of the Republic.

FERNANDO HENRIQUE CARDOSO
Barjas Negri

The above text does not replace the one published in the DOU on April, 24th, 2002.