Legislation
Decree

Decree nº 3.181, of September 23, 1999

The PRESIDENT OF THE REPUBLIC, in the use of the attribution vested in him under article 84, item IV of the Constitution, and, in view of provisions in article 57, of Law No. 6.360, of September 23 ,1976 and in article 4, of Law No. 9.787, of February 10,1999,
DECREES:

Article 1 - The terminology of the Brazilian Common Denomination - DCB or, in its absence, the International Nonproprietary Name - INN, must be used in all packaging, labels, leaflets, handouts, texts, or in any other type of marketing and medical information material referring to medicines.

Article 2 - The generic denomination of the medicines must be placed in the same printing field and below the trade mark.

Article 3 - The lettering used must maintain due proportion in terms of distance between letters, with a view to easy reading and highlighting, especially with respect to generic denomination for the base substance, which should correspond to half the size of the letters and characters of the trade mark.

Article 4 - The cartoon used in the packaging of medicines, dietetic products and related products which can only be sold under medical prescription, should have a red strip in all of its extension, in its bottom middle third part, its placement at the bottom of the packaging being forbidden, its width not inferior to one fifth of the largest total face, containing the statement: "Sold under medical prescription."

Article 5 - Whenever the medicine contains an association or combination of active principles in a fixed dose, the National Sanitary Surveillance Agency, by means of an administrative deed, shall determine the correspondences with the generic denomination.

Article 6 - The use of the generic denomination in the forms or registration requests and authorizations related to the production, trade and importation of medicines is mandatory.

Article 7 - The laboratories currently producing and trading medicines with or without trade mark shall be granted a four-month period to carry out alterations and adaptations need to comply with provisions stated in Law No. 9.787, of February 10, 1999 and in this Decree.
Only Paragraph. The so-called "similar" medicine shall only be traded and identified by its trade mark.

Article 8 - The Sanitary Surveillance Agency shall regulate the labeling criteria regarding the Brazilian Common Denomination - DCB in all medicines, following the provisions of articles 3 and 5 of this Decree.

Article 9 - This Decree enters into force on the date of its publication.

Article 10 - Decree No. 793, of April 5, 1993 is hereby revoked.

Brasília, September 23rd 1999; 178th day of the Independence and 111th of the Republic.

Fernando Henrique Cardoso

José Serra