Resolution - RDC nº 138 of 29 May 2003
Republished in the D.O.U of 01/06/2004

The Collegiate Board of Directors of the National Sanitary Surveillance Agency, in the use of the attributions vested in it under Article 11, item IV of the ANVISA Regulation approved by Decree Nº 3.029 dated 16 April 1999, c/c item 1 of Article 95 of the Internal Regimen approved by resolution nº 1, dated 26 April 1999, in meeting held on 6 March 2003,

Whereas the need to implement actions that contribute to improve the quality of healthcare;

Whereas it is up to the National Sanitary Surveillance Agency to set guidelines for the productive sector, in compliance with Law nº 6.360, dated 23 September 1976, and with this Regulation;

Whereas the specific legislations that regulate the registration of drug products at ANVISA;

Whereas the use of the following criteria: therapeutic index, toxicity, international legislations and the list of essential drug products (RENAME)
Adopts the following resolution and I, the Chairman, determine its publication.

Article 1 All drug products that have their therapeutic groups and indications described in the Annex: List of Specified Therapeutic Groups and Indications (GITE), respecting textual restrictions and other pertinent legal norms and regulations, shall be sold over the counter, except for those administered parenterally, that shall be sold with prescription only.

Article 2 All drug products and therapeutic groups and indications that are not described in the GITE shall be sold with prescription only.

Article 3 Medicine associations or two or more presentations in one same packaging for concomitant or sequential use that do not have the therapeutic group and indications of at least one of their active ingredients described in the GITE shall be sold with prescription only.

Article 4 Classification in the category of homeopathic drug products is regulated by specific registration and trade regulations.

Article 5 Companies that hold the registration of products that need to alter their sales classification in order to adapt to this resolution shall do so upon the first registration renewal by submitting the necessary documentation for the alteration of the labeling and package insert, in compliance with the legislation in force.

Article 6 All New Drugs shall be sold with prescription only, their sales classification being subject to reevaluation upon the registration renewal, according to pharmacovigilance data.

Sole Paragraph. New Drugs with a minimum of five years on the American or European market (as long as approved by the FDA or the EMEA) with therapeutic groups and indications described in the GITE, with the presentation of pharmacovigilance data (PSUR) and proof of sales classification in the over the counter category in the country where the product is marketed may request classification as Over the Counter Drugs at any moment during the registration process.

Article 7 This resolution revokes Presidential Decree nº 2 dated 24 January 1995 of the Sanitary Surveillance Secretariat of the Ministry of Health.

Article 8 This resolution enters into force on the date of its publication.

CLAUDIO MAIEROVITCH PESSANHA HENRIQUES

Annex

List of Specified Therapeutic Groups and Indications (GITE)