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Industry
Legislation
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Laws
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Law
nº 9.787, of February 10, 1999
Alters
Law nº 6.360, of September
23, 1976, concerning sanitary surveillance, establishes the generic
drug, decides upon the use of generic names in pharmaceutical products,
among other procedures.
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Law
nº 6.360, of September 23, 1976
Deals with sanitary surveillance, to which medicines, drugs, pharmaceutical
inputs and related products, and others are henceforth subject and
enacts other provisions.
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Provisional
Remdy
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Provisional
Remedy nº 2.039-20, of August 25, 2000
Alters provisions of Law nº 9.782, of January 26, 1999, which
Defines the National Sanitary Surveillance System, establishes the
National Sanitary Surveillance Agency and sets out other provisions.
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Decree
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Decree
nº 4.204, of April 23, 2002
The
provisions of Article 1 of Decree
n.3.675, of November 28, 2000, shall henceforth be in force with
the following changes:
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Decree
nº 3.841, of June 11, 2001
Alters
the dispositions stated on Decree
nº 3.675, of November 28, 2000, concerning special measures
in relation to the registration of generic medicine, under art. 4th
of Law nº 9.787, of February
10, 1999.
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Decree
nº 3.718, of January 3, 2001
Alters
the dispositions stated on Decree
nº 3.675, of November 28, 2000, concerning special measures
in relation to the registration of generic medicine, under art. 4th
of Law nº 9.787, of February
10, 1999.
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Decree
nº 3.675, of November 28, 2000
Which
establishes special measures to provide the filing of generic medicines,
regarding the item 4 of the Law
nº 9,787 of February 2, 1999.
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Decree
nº 3.181, of September 23, 1999
Regulates
Law nº 9.787, of February
10, 1999, concerning Sanitary Surveillance, establishes the generic
medicine, and decides upon the use of generic names in pharmaceutical
products, among other procedures.
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Administrative
Order
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Administrative
Order nº 185, of March 8, 1999
The
importation of pharmaceutical products subject to the Sanitary Surveillance
Regimen shall only be made by companies which are legally authorized
to function as importers by the Sanitary Surveillance Secretary /
Ministry of Health.
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Administrative
Order nº 911, of November 12, 1998
To
approve the list, annexed to this Administrative Order, of documents
needed for the instruction of authorization requests to carry out
Clinical Research with Pharmaceutical Substances, Medicaments, Vaccines
and New Diagnosis Tests.
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Administrative
Order nº 772, of October 2, 1998
To
approve the Procedures to be adopted in the importation of products
and raw materials subject to sanitary control as provisioned for in
Annex 1 of this Administrative Order.
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Administrative
Order nº 331, of May 6, 1998
To
authorize the clearance, by the Sanitary Surveillance Office of the
Ministry of Health, of products imported directly or by third party
means, for institutions or agencies interested in carrying out researches
or scientific investigations.
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Administrative
Order nº 110, of March 10, 1997
To
establish guidelines for the text of the "direction for use"
of medicines, whose items must be strictly followed, as to order and
content.
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Administrative
Order nº 19, of February 16, 1996
To
approve the list of documents needed to open processes requesting
registration of imported medicines.
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Resolution
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Resolution
- RE nº 902, of May 29, 2003
To determine the publication of the "Guide
for notification of pilot batches of drug products”, attached.
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Resolution
- RE nº 901, of May 29, 2003
To
determine the publication of the "Guide for dissolution assays
for immediate release oral solid pharmaceutical forms (FFSOLI)”,
attached.
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Resolution
- RE nº 900, of May 29, 2003
To
determine the publication of the "Guide for carrying out study
and preparing report on pharmaceutical equivalence”, attached.
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Resolution
- RE nº 899, of May 29, 2003 (PDF)
To
determine the publication of the "Guide for validation of analytical
and bioanalytical methods”, attached.
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Resolution
- RE nº 898, of May 29, 2003 (PDF)
To
determine the publication of the " Guide for planning and carrying
out the statistical stage of relative bioavailability/ bioequivalence
studies”, attached
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Resolution
- RE nº 897, of May 29, 2003
To
determine the publication of the " Guide for exemption and substitution
of bioequivalence studies”, attached.
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Resolution
- RE nº 896, of May 29, 2003
To
determine the publication of the "Guide for relative bioavailability/bioequivalence
tests”, attached.
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Resolution
- RE nº 895, of May 29, 2003
To
determine the publication of the "Guide for design of technical
report of relative bioavailability/bioequivalence study”, attached.
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Resolution
- RE nº 894, of May 29, 2003
To
determine the publication of the "Guide for protocol and technical
report of bioequivalence study”, attached.
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Resolution
- RE nº 893, of May 29, 2003
To
determine the publication of the “Guide for Making Post-Registration
Alterations, Inclusions and Notifications of Drug Products”,
attached
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Resolution
- RDC nº 140, of May 29, 2003
Definitions
contained in the GLOSSARY OF LEGAL DEFINITIONS
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Resolution
- RDC nº 135, of May 29, 2003
Approve
the attached Technical Regulation for Generic Drugs.
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Resolution
- RE nº 560, of April 2, 2002
To
determine the publication of the Guide for the Undertaking of Stability
Studies, attached.
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Resolution
- RDC nº 84, of March 19, 2002
Approve
the attached Technical Regulations for Generic Drugs.
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Resolution
- RE nº 484, of March 19, 2002
To
determine the publication of the "Guide for Designs Applicable to
Bioequivalence Studies", attached.
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Resolution
- RE nº 483, of March 19, 2002
To
determine the publication of the "Guide for Dissolution Testing
of Oral Solid Immediate Release Dosage Forms (FFSOLI)", attached.
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Resolution
- RE nº 482, of March 19, 2002
To determine the publication of the "Guide for Studies of In
Vitro-In Vivo Correlation (CIVIV)", attached.
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Resolution
- RE nº 481, of March 19, 2002
To
determine the publication of the "Guide for Exemption and Substitution
of Bioequivalence Studies", attached.
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Resolution
- RE nº 480, of March 19, 2002
To
determine the publication of the "Guide for Production of Pilot
Batches", attached.
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Resolution
- RE nº 479, of March 19, 2002
To
determine the publication of the "Guide for Protocol and Technical
Report of Bioequivalence Study", attached.
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Resolution
- RE nº 478, of March 19, 2002
To
determine the publication of the "Guide for Proof of Bioequivalence
of Generic Drugs", attached.
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Resolution
- RE nº 477, of March 19, 2002
To determine the publication of the "Guide for Making Post-Registration
Alterations and Inclusions of Drug Products",
attached<.
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Resolution
- RE nº 476, of March 19, 2002
To
determine the publication of the "Guide for the Undertaking of
Study and Preparation of Report of Pharmaceutical Equivalence",
attached.
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Resolution
- RE nº 475, of March 19, 2002
To
determine the publication of the "Guide for Validation of Analytical
Methods", attached.
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Resolution
- RDC nº 92, of October 23, 2000
Resolution
ANVS nº 510, of October 1, 1999, published in the Official Journal
of the Union, enters into force with the language given by this Resolution.
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Resolution
- RDC nº 78, of August 17, 2000
Regulates
the presentation of monthly information referring to the production
and trade of generic products.
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Resolution
nº 41, of April 28, 2000
The
entities or companies that intend to register vis-à-vis ANVS/MS
in order to qualify for carrying out the trials of pharmaceutical
equivalence, bioavailability and/or bioequivalence must proceed to
the completion of the specific form available on the Internet, at
the following electronic address: http://anvs.saude.gov.br, section
of the Rede Brasileira de Laboratórios, registration item.
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