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Resolutions
Resolution - RDC no. 96
de 2008
This regulation is applied
to the propaganda, publicity,
information and other
practices whose objective is
the popularization or
commercial promotion of
medicines
In
Portuguese
Resolution - RDC no. 103,
of May 8, 2003
Certification of good
practices in bioequivalence
of medicines.
Technical regulation of the
Good Practices for the
Production of Medicines.
In
Portuguese
Resolution - RDC nº 135
of
29 May, 2003
Approve the
attached Technical
Regulation for Generic Drugs.
Resolution - RDC nº 136
of 29 May, 2003
Approve the
attached Technical
Regulation for New Drugs
with Synthetic or
Semi-Synthetic Active
Ingredients
Resolução 196/96, ,
de 10 de outubro de 1996
This present Resolution is based on the major international instruments providing statements and guidelines related to
researches involving human.
Resolution no. 251,
of August 07, 1997
Research norms involving
human beings for the
thematic area of research
with new medicines, vaccines
and tests diagnoses.
In
Portuguese
Resolution no. 391,
of August 09, 1999
That the implantation of the
generic medicine in the
Country is priority of the
politics of medicines of
Ministry of Health; The need
to assure the quality,
safety and effectiveness of
the generic medicine.
In
Portuguese
Resolution - RE no. 893,
of May 29, 2003
Guides for accomplishment of
alterations, inclusions and
notifications
powder-registration of
medicines.
In
Portuguese
Resolution - RE no. 894,
of May 29, 2003
Guides for elaboration of
protocol of study of
bioequivalence.
In
Portuguese
Resolution - RE no. 895,
of May 29, 2003
Guides for elaboration of
technical report of study of
bioequivalence.
In
Portuguese
Resolution - RE nº 896 of 29 May,
2003
To determine
the publication for the
attached “Guide for Relative
Bioavailability/
Bioequivalence testes".
Resolution - RE no. 897,
of May 29, 2003
Guides for exemption and
substitution of
bioequivalence studies.
In
Portuguese
Resolution - RE no. 898,
of May 29, 2003
Guides for planning and
accomplishment of the
statistical stage of studies
of bioequivalence.
In
Portuguese
Resolution - RE no. 899,
of May 29, 2003
Guides for validation of
analytical methods.
In
Portuguese
Resolution - RE no. 900,
of May 29, 2003
Guides for accomplishment of
the study and elaboration of
the report of pharmaceutical
equivalence.
In
Portuguese
Resolution - RE no. 901,
of May 29, 2003
It guides for dissolution
rehearsals for forms solid
pharmaceutical orals of
immediate liberation.
In
Portuguese
Resolution - RE no. 902,
of May 29, 2003
Guides for fill-pilot's of
medicines notification.
In
Portuguese
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