Resolution - RE nº 530, 17 April 2001*
(DO dated 06/08/01)

As the Chairman of the Collegiate Directorate of the Brazilian Sanitary Surveillance Agency, in the use of the attributions vested in it by Administrative Order nº 724 of the Chairman-Chairman, dated 10 October 2000, and considering that disposed in § 3 of article 111 of the Internal Regulation approved by Administrative Order nº 593, dated 25 August 2000,

WHEREAS that disposed in article 8 and article 41 of Law nº 9.782, dated 26 January 1999;

WHEREAS that disposed in articles 6 and 7 of Law nº 6.360 dated 23 September 1976;

WHEREAS medicines based on the substance CISAPRIDE are associated to the development of serious adverse reactions;

WHEREAS the need to monitor adverse reactions during treatment with these medicines;

WHEREAS some companies that possess a license for CISAPRIDE-based medicines do not develop actions of pharmacovigilance that allow for the monitoring of prescriptions and adverse reactions of these medicines, I hereby resolve to:

Art.1 Cancel the licenses of CISAPRIDE-based medicines according to the annexed list.

Art. 2 Grant a period of 30 (thirty) days counting from the publication date of this Resolution for the companies that possess a license of the medicines dealt with in Article 1 to withdraw their medicines from the national territory.

Art. 3 Inform the companies that possess a license of the cancelled medicines that:

a) they can maintain their trademarks as long as they present a formula alteration petition to ANVISA substituting the CISAPRIDE of the original formula and that the words “NEW FORMULA” are highlighted in the instructions for use and label.
b) If they can prove the existence of pharmacovigilance actions they can request a new license of the product.

Art. 4 The manipulation of magistral formulas containing CISAPRIDE is forbidden.
Sole Paragraph. The Local Sanitation Authority must adopt the appropriate measures regarding the existent stocks in the establishments under their jurisdiction.

Art. 6 Failure to comply with the provisions contained in this Resolution shall constitute sanitary infraction, subjecting the offenders to the penalties provided for in the legislation in force.

Art. 7 This Resolution shall enter into force on the date of its publication.

GONZALO VECINA NETO