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Resolution
- RDC nš 67, 14 July 2000
(DO dated 07/17/00)
As the Chairman-Chairman
of the Brazilian Sanitary Surveillance Agency, ANVISA, in the
use of the attributions vested in it, in compliance with article
13, item IV, of the Regulation of this Agency, approved by Decree
n. 3.029, dated April 16, 1999, combined with article 7 of Law
nº 6.360 dated 23 September 1976, article 4 paragraph 1,
item I of Decree nº 3.029 dated 16 April 1999, article 7
item XV of Law nº 9.782 dated 26 January 1999 and article
8, caput, and its sole paragraph, of Decree nº 79.094 dated
05 January 1977.
WHEREAS the reports of the General Management of the Technical
Advisory Commission on Medication – CONATEM, and WHEREAS
the urgency of the subject, I, ad referendum, adopt the following
Resolution of the Collegiate Directorate and determine its publication:
Art. 1 To suspend as of this date, as a measure of sanitary interest,
the fabrication, distribution, trade/sale and dispensation of
products that contain the substance TERFENADINE and its salts
in their formula, be it in isolation or in association to other
substances.
Art. 2 To grant a period of 90 (ninety) days for companies that
have a license of the products containing the substance TERFENADINE
to withdraw their products from the national territory. Sole Paragraph.
Failure to comply with the provisions contained in this resolution
shall subject the offenders to the penalties provided for in Law
nº 6.437, dated 20 August 1977.
Art. 3 This Resolution of the Collegiate Directorate shall enter
into force on the date of its publication.
Gonzalo Vecina Neto
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