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Resolution
- RE nš 528, 17 april 2001
(DO dated 08/06/01)
As the Chairman
of the Collegiate Directorate of the Brazilian Sanitary Surveillance
Agency in the use of the attribution vested in it by Administrative
Order nº 724 of the Chairman-Chairman, dated 10 October 2000
and in compliance with 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 in item XV of article 7
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 medication based on mercurial derivatives have an unfavorable
risk-benefit when compared to other topic antiseptics;
WHEREAS the international guidelines that recommend a reduction
in the exposition to mercurial derivatives, decides to:
Art.1 Forbid the use of mercury compounds in medication.
Art.2 Give a period of 60 (sixty) days starting from the publication
date of this Resolution for the companies that have a license
for the medications concerned in Article 1 to withdrawn the medications
from the national territory.
Art. 3 Inform the companies that detain a license for mercury-based
medicines that they can maintain their trademarks as long as they
present a formula alteration petition to ANVISA substituting the
mercury compounds of the original formula and as long as the words
“NEW FORMULA” are highlighted in the instructions
for use and label.
Art. 4 The manipulation of magistral formulas containing mercury
compounds is forbidden.
Art. 5 The use of mercury derivatives as vaccine preservatives
in the established concentrations is maintained.
Sole Paragraph. The Local Sanitation Authorities shall 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. 7º This Resolution shall enter into force on the date
of its publication.
GONZALO
VECINA NETO
(*) Republished for having been originally published incorrectly
in the Official Gazette of the Union nº 75-E, section 1,
page 147, dated 18 April 2001.
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