Journal of Ethnopharmacology 158 (2014) 503–506

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Journal of Ethnopharmacology
journal homepage: www.elsevier.com/locate/jep

Research Paper

Regulation of herbal medicines in Brazil

Ana Cecília Bezerra Carvalho n, Lívia Santos Ramalho, Robelma France de Oliveira Marques,
João Paulo Silvério Perfeito
Agência Nacional de Vigilância Sanitária, Coordenação de Medicamentos Fitoterápicos e Dinamizados, SIA, Trecho 5, Área especial 57, Bloco A/B, 71.200-980
Brasília-DF, Brazil

art ic l e i nf o a b s t r a c t

Article history: Ethnopharmacological relevance: Rich Brazilian biodiversity is accompanied by a long acceptance of
Received 15 March 2014 medicinal plants and traditional knowledge by the Brazilian population. To improve the regulatory
Received in revised form framework for herbal medicines in Brazil, ANVISA recently revised its legislations. The aim of this study is
29 July 2014
to discuss the new Brazilian standards for herbal medicines regulation.
Accepted 13 August 2014
Available online 26 August 2014
Materials and methods: The national and international legislation on herbal medicines was revised to
prepare new Brazilian standards. This new legislation is discussed.
Keywords: Results: This new proposed regulation separates herbal into two categories: herbal medicines (HM) and
Regulation traditional herbal product (THP). The safety and efficacy of HM must be proven by clinical data. ANVISA
Brazil recognizes some plants as safe and effective; therefore, the registration of these species can be simplified.
Herbal medicines
ANVISA also recognizes the monographs of the European community as simplified registrations. THP can
Traditional herbal products
prove their safety and effectiveness by tradition of use or following a simplified registration.
Conclusion: Brazil has been altering their legal standards for herbal medicines, based on harmonization
with internationally practiced requirements and the characteristics of the Brazilian market, facilitating
the safe access and rational use of medicinal plants and herbal products to Brazilian population.
& 2014 Elsevier Ireland Ltd. All rights reserved.

1. Introduction
Brazil has a great biodiversity, with numbers exceeding 55,000
of described species corresponding to 22% of total species in the
world (Gonçalves et al., 2010). This rich biodiversity is accompa-
nied by a long acceptance of medicinal plants and traditional
knowledge (Veiga Junior and Mello, 2008). Moreover, since 2006,
Brazil has two current public policies favoring the widespread
use of Herbal Medicines (HM), namely, the National Policy on
Integrative and Complementary Practices in the Public Health
Abbreviations: ANVISA, National Agency of Heath Surveillance; CNS, National
Health Council; COFID, Office of Herbal and Homeopathic Medicines Licensing;
GMP, Good Manufacturing Practices; HM, Herbal medicines; IN, Normative
Instruction; MAPA, Ministry of Agriculture, Livestock and Supply; PNPIC, National
Policy on Integrative and Complementary Practices in the Public Health System;
PNPMF, National Policy on Medicinal Plants and Herbal Medicines; RE, Specific
Resolution; RDC, Resolution of Executive Board; SA, Special Announcement; THP,
Traditional Herbal Products; WHO, World Health Organization
n
Corresponding author. Tel.: þ 55 6134625526; fax: þ 55 6134625540.
E-mail addresses: cofid@anvisa.gov.br,
anacecijp@yahoo.com.br (A.C. Bezerra Carvalho), livia.ramalho@anvisa.gov.br,
liviaramalho@gmail.com (L.S. Ramalho),
robelma.marques@anvisa.gov.br (R.F. de Oliveira Marques),
joao.perfeito@anvisa.gov.br, jpperfeito@gmail.com (J.P. Silvério Perfeito).
System (PNPIC) and the National Policy on Medicinal Plants and
Herbal Medicines (PNPMF), through the Ordinance 971/2006 and
the Decree 5813/2006, respectively (Brazil, 2006; MS, 2006;
Anvisa, 2013a).
There are many forms of production and regulation of HM in
Brazil, including compounded and manufactured HM, which may
be destined for human or veterinary use. HM for human and
veterinary use are regulated by the National Health Surveillance
Agency (ANVISA) and the Ministry of Agriculture, Livestock and
Supply (MAPA), respectively (Anvisa, 2013a).
Compounded HM are prepared in pharmacies authorized by the
Health Surveillance secretariats, which can be either state or muni-
cipal. The rule that governs the preparation of compounded medi-
cines is the Resolution of executive board, Resolução de Diretoria
Colegiada (RDC) 67/2007, updated by RDC 87/2008, which defines
the Good Manufacturing Practices (GMP) for compounded HM for
human use in pharmacies. Recently, public pharmacies to prepare
compounded HM, according to the established in the PNPMF, have
been created in Brazil. These are called Live Pharmacies—Farmácias
Vivas, and have their rules of GMP described in RDC 18/2013
(Carvalho, 2011; Anvisa, 2013b).
The industrial production of HM is performed by companies
authorized by ANVISA which must be certificated in GMP. Brazil
has rules for the registration of HM since 1967, the Ordinance

http://dx.doi.org/10.1016/j.jep.2014.08.019
0378-8741/& 2014 Elsevier Ireland Ltd. All rights reserved.
504 A.C. Bezerra Carvalho et al. / Journal of Ethnopharmacology 158 (2014) 503–506
22, which was followed by Ordinance 06, published in 1995, RDC
17, published in 2000, the RDC 48, published in 2004, RDC 14
published in 2010 and the applicable standard RDC 26, published
in 2014 (Anvisa, 2014a).
Currently, there are 382 HM registered in Brazil, 357 of them
are single medicines and the other 25 are composed of more than
one medicinal plant, obtained from a group of 98 medicinal plants;
only 25% of these are species originally from South America. There
are 78 companies authorized to manufacture herbal medicines in
Brazil (Carvalho, 2011; Perfeito, 2012).
2. ANVISA and the Brazilian regulatory system
In Brazil, the term health surveillance was used to demarcate
the field of public health that has as main purpose the protection
of health through the elimination or reduction of the risk involved
in the use and consumption of technologies—products and
services—and environmental conditions (Lucchese, 2001).
Health surveillance in Brazil ceased to have an essentially
bureaucratic and normative paper since the publication of Law
8.080/1990, when started using the concept of risk and, since then,
significant changes have occurred (Brazil, 1990; Lucchese, 2001).
ANVISA was created through Law 9.782/1999, as coordinator of
the National Sanitary Surveillance System, responsible for the
regulation of any products that interfere with health, such as food,
medicines, cosmetics, disinfectants and health products, as well as
sanitary control of ports, airports and borders (Brazil, 1999).
ANVISA also carries health surveillance relating to the marketing,
dispensing, and distribution of materials of plant origin, as well as
the registration and inspection of HM production (Lucchese, 2001;
Perfeito, 2012).
To improve the regulatory framework for HM, and as a
determination of PNPMF, ANVISA recently revised health legisla-
tion for the registration of HM. To accomplish this task, an
extensive survey was performed reviewing documents from the
World Health Organization (WHO) and the requirements for the
registration of HM in international legislations such as those from
the European Community, Australia, Mexico, and Canada. The
rules and guidelines of these countries were studied, bringing to
the Brazilian regulations the most important points of each one.
This new proposed normative separates herbal into two cate-
gories: herbal medicines (HM) and traditional herbal product
(THP). Herbal medicines have their safety and efficacy based on
clinical trials while THP have to present proofs of long-term safe
and effective use in humans (Anvisa, 2014a).
For HM and THP, the same requirements of quality control,
covering all stages of production from raw materials to final
product are enforced. The new rule will also apply to products
derived from multicellular fungi and algae (Anvisa, 2014a).
3. Registration and renewals of herbal medicines and
traditional herbal products
In Brazil, no product, including the imported ones, can be
manufactured, exposed for sale or delivered to the consumer before
being registered. The registration of medicines is valid for five years
and may be renewed for equal successive periods (Brazil, 2013).
The currently applicable standard for the registration of HM is
the RDC 26/2014, which brings all the requirements for applying a
registration. At the time of requesting registration, the company
must submit a dossier to ANVISA registration, comprising: doc-
umentary report, technical production report, drug quality control,
safety and efficacy report, results of the stability studies, as well as
package inserts models and labeling. In granting the registration,
ANVISA recognizes that the drug is safe, effective, and has a
quality in concordance with the intended purpose ( Perfeito,
2012; Brazil, 2013).
Determinations for renewal of HM registration are also
expressed to the RDC 26/2014, which essentially requires demon-
strating that the product retains the characteristics of safety,
efficacy, and quality. The manufacturer must additionally submit
the Periodic Reports in Pharmacovigilance, standardized according
to the Periodic Safety Update Report (PSUR), as required by current
legislation, the RDC 4/2009 (Brazil, 2013; 2014a).
The application for a HM registration or for the renewal of a
HM is denied when the conditions, requirements, and procedures
laid down by law or by any regulation or statement of ANVISA, are
not met. Moreover, if the drug is proven harmful or the require-
ments established by law were not completed, the drug may also
be immediately withdrawn from trade (Brazil, 2013).
As mentioned above, there was a revision of Brazilian stan-
dards. These new standards will allow an appropriate regulation
for HM following scientific and technological developments and
enabling the expansion and the access to these medicines.
4. Safety and efficacy of herbal medicines and traditional
herbal products
The safety and efficacy of HM must be proven by clinical data.
ANVISA recognizes some plants as safe and effective; therefore,
the registration of these species can be simplified. Medicinal
plants already evaluated are constantly published at ANVISA HM
simplified list. ANVISA also recognizes the monographs of the
European community as simplified registrations (Anvisa, 2014a).
ANVISA has a guide for conducting non-clinical studies that
applies to any medicine and that should be followed by HM,
namely, the “Guide for the conduction of non-clinical toxicology
studies and safety pharmacology required for the development of
medicines.” (Anvisa, 2013a).
For conducting clinical trials with HM it is necessary to follow
the rules for clinical research published by ANVISA, the RDC 39/
2008, the guide “Operating Instructions Required for driving
clinical trials with herbal medicines,” published by WHO/Brazilian
Health Ministry, in 2008, and the provisions of the National Health
Council (CNS), established through Resolution 466/2012 and
Resolution 251/1997 (Anvisa, 2014a).
According to these rules, it is necessary to obtain permission from
the local research ethics committee before starting the research in
each of the phases I, II, and III to protect the population undergoing
the study. It is also necessary to obtain the consent of ANVISA that
evaluate the technical content of the protocol assay through the
issuance of a special announcement (SA) (Anvisa, 2013a).
RDC 39/2008 applies to all drug clinical researches in phases I,
II, and III, including HM, which could subsidize the registration of
drugs or any post-registration change. Clinical studies performed
in Brazil will only be accepted for registration if they have the SA
(Anvisa, 2013a).
In the case of simplified registrations, the holder does not need to
submit additional data on safety and efficacy, because the regulator
has done it previously. A list of Brazilian simplified registrations exists
since 2000 and has been updated and expanded over the years;
currently there are 27 plant species holding simplified registrations in
HM. In a simplified registration, the holder must follow the specifica-
tions defined for each species, such as type of derivative, daily dose/
dosage, indications, usage restrictions, markers, etc. (Anvisa, 2014a).
For registrations of HM containing more than one herb, all data
related to safety and efficacy should be presented to the association
to be registered. To complement the data on safety and efficacy,
 A.C. Bezerra Carvalho et al. / Journal of Ethnopharmacology 158 (2014) 503–506
technical and scientific documentation for each separate plant
species must be submitted (Anvisa, 2014a).
THP also has two options to prove their safety and effective-
ness, either prove their tradition of use, or follow a simplified
registration. It is necessary to demonstrate the safe use for the
claim intended to the product for a minimum of 30 years, it is not
necessary that such use occurs in the Brazilian territory.
THP should be designated for the symptomatic relief of
diseases and conditions of low gravity and cannot refer to clinical
parameters and broad actions. These products can only be used
orally and topically and may not be suitable for injectable and
ophthalmic administration. The holder must submit data demon-
strating the consistency of the information related to the use of the
product in traditional medicine and data that showing the absence
of raw materials exceeding the concentration limits proven safe for
use. The new regulation brings as attachments a list of known
toxic plant species that cannot be used in traditional products, but
also an annex with plants that can be used with restrictions
depending on their concentrations (Anvisa, 2014a).
Just as for herbal medicines, the registry can be simplified
according to the Brazilian species list of simplified registrations,
which contains 16 species of traditional simplified registration or
as the Community herbal monographs with traditional use devel-
oped by the HMPC/EMA (Anvisa, 2014a).
In cases where technical documentation for a traditional herbal
product in combination is not available, data from the separate
species and a justification for the rationality of their association
must be submitted (Anvisa, 2014a).
5. Quality control
The quality control in HM and THP is performed in all produc-
tion stages: herbal drugs, herbal derivatives, and herbal medicines
or products. Herbal drug is the medicinal plant, or plant parts,
which contain the substances responsible for the therapeutic
action after collection processes, stabilization, where applicable,
and drying. The herbal drug may be whole, fragmented, cut or
pulverized. The herbal derivative is the product of the extraction of
fresh herbs or herbal drugs, containing the substances responsible
for the therapeutic action. Herbal derivatives may be in the form of
extracts, fixed and volatile oils, waxes, exudates and others. The
tests performed should be able to identify the plant species and
the absence or presence of contaminants within acceptable limits,
demonstrating the product's quality (Anvisa, 2014a, 2014b).
Identifying plant species involves sensorial or organoleptic
analysis, botanical identification (macroscopic and microscopic
analysis), and fingerprint (chromatographic profile of constituents)
(Anvisa, 2014a).
The introduction of undesirable impurities of chemical or micro-
biological origin, or of foreign matter, in raw materials or in herbal
medicine can occur during production, sampling, packaging, trans-
portation or storage. Contamination by mycotoxins in plant material
can cause acute and chronic health risks. Mycotoxins are compounds
usually derived from the secondary metabolism of fungi, the most
commonly reported Aspergillus, Fusarium and Penicillium (WHO,
2007), comprising four main groups: aflatoxins, ochratoxin, fumoni-
sins, and trichothecenes, all with toxic effects (Silveira et al., 2010).
Mycotoxin contamination can occur during both growing and in
storage. These mycotoxins can be present in plant material even if
the microorganism that produced them is not detected (Commission
SFSTP et al., 2007). In Brazil, as there is not a set limit, the limits of
the European Pharmacopoeia are adopted by default. Thus, the
determination of mycotoxins should be performed when the need
for such review or reports of contamination has been quoted in
technical and scientific documentation.
505
Contamination of medicinal plants with heavy metals can also
occur. Such contamination can be traced to many causes, including
environmental pollution and traces of pesticides (WHO, 2007). The
content of heavy metals is generally measured by atomic absorp-
tion or atomic emission spectrophotometry.
Medicinal plants may also contain pesticide residues that
accumulate as a result of agricultural practices, such as spraying,
treatment of soils during cultivation and management of fumi-
gants during storage (WHO, 2007). The determination of pesticide
residues in herbal drugs, herbal derivatives, and herbal medicines
or products should be included in the registration or notification of
herbal medicines or products.
A degree of exposure of plant material to ionizing radiation is
inevitable due to the existence of various sources, including radio-
nuclides that occur naturally in soil and atmosphere. The health risks
caused by HM and THP accidentally contaminated by radionuclides
depend on the specific radionuclide, the level of contamination, the
dose and duration of use of the contaminated product. The determi-
nation of radioactivity should be performed when the plant material
has been originated from a local source with probable radioactive
contamination. Specific radioactivity test should include the type of
radioactive contamination and the active concentration of radio-
isotopes (Anvisa, 2014b).
Other contaminants that must be monitored are inorganic waste
material through ash tests, bacteria, fungi, other plant species or
even parts of the plant species other than the one indicated as a
place of greater concentration of actives. The plant species gather-
ing or cropping site and whether methods of eliminating contami-
nants were used must be informed followed by the search for
possible residues (Anvisa, 2014b).
For herbal derivatives, extraction methods and the detection of
solvent residues should be reported. Physico-chemical tests are
requested including a) for fluid extracts: characterization, solid
residues, pH, alcoholic content, density; b) for dry extracts: water
determination, apparent solubility, and density; c) for essential
oils: density, refractive index, optical rotation; and d) for fixed oils
—ester, iodine and acidity indexes (Anvisa, 2014a).
The qualitative and quantitative analyses of markers via chro-
matographic and spectrometric techniques must be presented.
There are specific requisites based on quality assurance, requiring
reproducibility of herbal medicines. The permissible variation of
marker content in the finished product cannot be greater than 15%,
when it is the active marker, or 20%, in the case of the analytical
marker. To achieve the specification of variations for each type of
marker bands, can be used mixtures of batches of raw materials
and/or make addition of excipients. Alternatively, marker quanti-
tative control can be replaced by the therapeutic activity's biolo-
gical control (Anvisa, 2014b).
For quality control of herbal materials, excipients, HM and THP,
the methodologies described in pharmacopeias recognized by
ANVISA (RDC 37/2009) (Anvisa, 2013a) should be used preferably.
Otherwise it is necessary to validate the used methodologies. To
do so, the method must present the parameters stated by Specific
Resolution RE 899/2003, demonstrating that the analytical method
is specific, robust, sensitive, precise, and accurate; these require-
ments are crucial for the quality control of HM (Anvisa, 2013a).
Thus, beyond the requirements made to the standards, equipment,
and materials used in the validation must be properly calibrated
and the analyst must be qualified.
RE 01/05 provides the information that must be present in all
stability study reports for each pharmaceutical form, and also
covers the stability study monitoring and photostability. The
stability of pharmaceuticals depends on environmental factors
such as temperature, humidity and light. In addition, the stability
also depends on parameters related to the product itself such as
the physical and chemical properties of the active substances and
506 A.C. Bezerra Carvalho et al. / Journal of Ethnopharmacology 158 (2014) 503–506
pharmaceutical excipients, the pharmaceutical form and composi-
tion, process manufacturing, type and properties of packaging
materials. Thus, stability testing of drugs is important to predict,
determine, and monitor the expiration date of pharmaceuticals.
The stability study of medicines should be carried out in both
accelerated mode as well as long lasting mode. The accelerated
study is designed to accelerate the chemical degradation and/or
physical changes of a pharmaceutical product in forced storage
conditions. The long-term study is designed for the verification of
physical, chemical, biological, and microbiological characteristics
of a pharmaceutical product during (and optionally after) the
expected expiry date. The results are used for the establishment or
confirmation of the product's expiry date and recommendations
for the products's appropriate storage conditions at the marketing
point and by the user (Anvisa, 2013a).
During stability studies it is crucial to demonstrate through
quantitative analysis, the amount of marker remained stable
throughout the study and the validity of the product through the
presentation of chromatograms in the final period of the stability
study. The fingerprint performed in the study at zero time should
not be significantly changed. For the stability study of HM and THP
is accepted a variation in the content of markers r 10% of the
value of analysis of batch release testing and product degradation
and dissolution are not required. However, the results of the test
for disintegration should be displayed. Such exemptions are due to
the fact that the execution of these tests are complex for the
application to herbal medicines, when considering that the raw
material for these medicines contains hundreds of substances,
some of which are present in very low concentrations, and many
are not identified (Klein et al., 2010). In addition, there would be
no way of knowing whether the degradation products would be
the marker itself, i.e., the hundreds of substances that form the
phytocomplex, to degrade, could be responsible for the formation
of the marker itself (ANVISA, 2013a).
6. Other applicable norms
Some Brazilian normatives are common to any medicine to be
registered with ANVISA such as the package insert and labeling.
The normative for pharmaceutical package inserts is RDC 47/
2009 (Anvisa, 2013a). ANVISA began to standardize inserts of HM
and THP. Currently there is standardized package insert informa-
tion for 18 plant species selected among the most registered. These
inserts are available in ANVISA's webpage. The regulation of the
labeling for HM follows the RDC 71/2009, which is the general
regulation for labeling of medicines, but also contains unique
features for herbal items (ANVISA, 2013a).
Trade names of HM are regulated under the RDC 333/2003. The
name chosen for the HM and THP should not lead consumers to an
error, or be similar to another name on the market. Sale's restriction
of HM is defined in two resolutions: RDC 138/2003 and Normative
Instruction IN 02/2014. For HM and THP registered by the simplified
procedure, the description of sales restriction is established in IN 02/
2014. On the other hand, HM and not registered by the simplified
procedure should follow the provisions of RDC 138/2003, which
establishes the categories of sale's restriction. The HM containing
therapeutic classes described in the RDC 138/2003 (for example,
antispasmodic and healing), are classified as over-the-counter (OTC).
All classes not provided for in that RDC are under prescription
(Anvisa, 2013a).
Any modification in an already registered product should be
submitted to ANVISA following the previsions specified in the
guide to making changes and additions after registration of HM,
published by RDC 38/2014, or their updates (Anvisa, 2013a).
7. Conclusion
Brazil has regulations for HM regulation and public policies
that support research programs, but only since in 2006 policies for
developing the production of HM were published: the PNPMF and
PNPIC. These policies favored, among other things, the develop-
ment/adaptation of the regulatory framework of HM as well as the
incentive to research in medicinal plants, prioritizing the country's
biodiversity.
Thus, since 2006, ANVISA has been altering their legal frame-
works for herbal medicines, based on harmonization with inter-
nationally practiced requirements and the characteristics of the
Brazilian market, facilitating the safe access and rational use of
medicinal plants and herbal medicines to Brazilian population.
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