CAMEVET
PROCEEDINGS III
REVIEW DATA in BRAZIL:
HOMEOPATHIC COMMISSION - SINDAN
August 04, 2014
GUIDE TO REGISTER PRODUCTS
HOMEOPATHIC FOR VETERINARY USE
SÃO PAULO, BRAZIL
August 2014
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GUIDE TO REGISTER PRODUCTS
HOMEOPATHIC FOR VETERINARY MEDICINE
1. INTRODUCTION
Currently, in the practice of Veterinary Medicine, there is an increasing
demand for homeopathic products.
The worldwide trend is to treat the animals with substances of natural origin,
seeking to reduce the indiscriminate use of active ingredients with
undesirable secondary effects.
For this reason, among the functions of regulatory bodies in each country,
there are the legislating and harmonizing the use of homeopathic products in
Veterinary Medicine, in order to verify the compliance with strict
requirements on Manufacturing, Inspection and Quality Control.
2. PURPOSE AND SCOPE:
Establish requirements for registering homeopathic products for veterinary
use.
This document includes all persons, natural or juridical, engaged in the
production, production by agreement and import of veterinary homeopathic
products, wishing to register homeopathic veterinary products with the
purpose to market them.
3. DEFINITIONS. For purposes of this document, the following were adopted:
3.1 GOOD MANUFACTURING PRACTICES. Set of procedures and standards of
technical character, intended to ensure the quality of homeopathic products
in Veterinary Medicine.
3.2 HOMEOPATHIC STRAIN OR PARENT DYE. It is the whole primary
preparation from raw materials of animal, vegetable, mineral or synthetic
origin, used as a starting point for homeopathic preparations.
3.3 TAG OR LABEL. Is the printed information, under any system, that should
be in the primary packaging, whatever is its type of material.
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3.4 EXCIPIENT OR INERT INGREDIENT. It's that compound or mixture of
compounds that, at concentrations present in a pharmaceutical form, does
not have any activity or drug-drug reaction (pharmacological).
3.5 OFFICIAL HOMEOPATHIC PHARMACOPOEIAS. For purposes of this
document, are accepted as Official Homeopathic Pharmacopoeia, in their
latest editions in force, the European Union, United States of North America,
Germany, France, England, India, Mexico, Brazil and others that the official
organ deems appropriate to welcome, provided they are recognized
worldwide.
3.6 PHARMACEUTICAL FORM. Physical form of a pharmaceutical preparation,
sterile or not, whose purpose is to facilitate the administration and dosage of
a drug.
3.7 PACKAGE INSERT. It is the complementary information to that expressed
on the label or product packaging.
3.8 BATCH. Amount of a veterinary input produced in a single manufacturing
cycle. The essential feature of the batch is its homogeneity and identification
by numbers, letters or a combination of both.
3.9 HOMEOPATHIC PRODUCT FOR VETERINARY USE. It is the pharmaceutical
preparation obtained from Strains or homeopathic Parent Dyes, according to
the preparation rules described in the official homeopathic pharmacopoeia,
with the purpose to:
 prevent the disease, alleviate, cure, treat and/or rehabilitate an animal
individually or;
 prevent the disease, alleviate, cure, treat and/or rehabilitate the
animals and promote the zoo-technical performance of livestock,
individually or the entire herd or batch.
3.10 BIOTHERAPEUTICS - are pharmaceutical preparations obtained from
biological products, chemically undefined, such as; secretions, tissues,
bodies, products of microbial origin, helminthes, arthropods, hemoparasites,
larval stages, cysts, eggs and embryonic stages of animals.
These preparations may be of pathological origin (nosodes) or not
pathological origin (Sarcodes), and must be prepared according to the official
Homeopathic Pharmacopoeia of election.
3.11 REFERENCE COUNTRIES. For purposes of this document, the reference
countries are Member States of OIE - International Organization of Epizootics
and the others that the official body deems appropriate to nominate,
whenever it counts on the experience of the subject.
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3.12 ACTIVE INPUT. It is the starting point for the preparation of homeopathic
product, which constitutes a drug, medicine, parent dye and derived
pharmaceutical form.
3.13 THERAPEUTIC INDICATION. are several properties that an homeopathic
product can have to prevent diseases and balance the animal or herd,
improving its individual animal performance or collectively or restore the
health of an animal or herd before a specific pathological picture, which
justifies its use as a therapeutic.
3.14 ISOTHERAPY. Therapeutic technique that is based on the Law of Equals
(Aequalia Aequalibus Curantur), whose use does not require a pathogenetic
experimentation.
3.15 DILUTION. It is the reduction of the active input concentration by the
addition of a suitable inert input.
3.16 STREAMLINING. The process of dilutions followed by succussion and/or
successive crunches of the active ingredient in a suitable inert ingredient.
3.17 STRENGTH. It is a quantitative indication of the number of streamlining
that a matrix or homeopathic drug received.
4. GENERAL PROVISIONS OF REGISTRATION.
Registration will not be granted to the homeopathic product for veterinary
use manufactured in the country in which the production and marketing of
these products are not regulated and controlled.
Will not be accepted homeopathic products whose composition contains
parents dyes and dilutions before the fourth decimal or second hundreds,
except those set in the homeopathic pharmacopoeia officially accepted and/or
in the official monographs prepared by expert committees of reference
countries or scientific papers, reports and references attesting the atoxicity at
lower dilutions than the aforementioned, or when they are used for the
preparation of pharmaceutical forms for external use only.
The degree of dilution of homeopathic drug must ensure its innocuousness.
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Changes in the composition of the homeopathic product, relating to the
parent dye or homeopathic strain, dilution, streamlining scale or
pharmaceutical form, will require a review of the record, adapting to the
Label, Package Insert, etc...
Homeopathic products for veterinary use have a time of shortage of zero (0)
days, provided that its concentration meets the requirements listed above. If
a product shows previous dilutions of the fourth decimal, the time of shortage
specified in the labeled shall not be less than seven (7) days for the eggs, for
the milk and for meat. Nevertheless, times of shortage mentioned may be
modified if present scientific studies that advocate different times.
Any change in the processes and materials of the container determines the
execution of a new stability study and submission of the respective report.
5. REGISTRATION
VETERINARY USE.
REQUIREMENTS
OF
HOMEOPATHIC
PRODUCTS
FOR
 Every duly qualified legal Establishment may produce, market and
register homeopathic products for veterinary use, provided that they
keep the items described below.
 Every person, natural or juridical, interested in marketing and register
homeopathic products for veterinary use which are produced in another
country, should appear before the official organ, registration application
for each product separately, with the following information and
attachments:
5.1 GENERAL REQUIREMENTS
5.1.1 Count on the registry to perform activities of: Manufacturer,
Producer by Agreement or Importer of homeopathic products for
veterinary use, granted by the National Competent Authority
(ANC).
5.1.2 Presenting a registration application signed by the applicant. The
technical documents must be signed by the relevant responsible
professional (Veterinary Doctor and/or Pharmacist).
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EXPLICATIVE / COMPLEMENTARY NOTES
When dealing about the IMPORTER, the technical documents must be
accompanied by an official public or sworn translation (Apostille or Consular
Survey) and official certifications.
The texts must be in the language of the country where the product
will be registered.
5.1.3 Documents that include the following information:
A) Name or corporate name of the registrant, the home address of the
factory, warehouse or storage facility.
B) Scientific name of the strain or homeopathic parent dye.
C) Trade name of the homeopathic product
D) Route of administration.
E) The pharmaceutical form, streamlining, power and production
method. Possible pharmaceutical forms are all usually allowed in
Veterinary Medicine, as well as those described in the official
Pharmacopoeia.
F) Animal species for which they are indicated.
G) Commercial presentations, specifying the type and material of the
container and packaging.
H) Information on precautions, contraindications and timing of
proposed lack.
I) Composition of homeopathic product, indicating separately the strain
or homeopathic parent dye (identified with the scientific name in Latin
with a graphical font in italic and respective botanical, zoological,
chemical or biological names), followed by the dilution and streamlining
scale as the official homeopathic pharmacopoeia current used,
excipients and the amounts employed.
5.1.4 Attach the Report or Technical Report that describes:

 the obtainment and certification of the quality control of the
parent dye or homeopathic strain, indicating edition and full
name of the official homeopathic pharmacopoeia used, quality
and quantity of active ingredients with the method of
preparation of strains or homeopathic parent dyes, observing
the pattern or degree of quality described in the monographs
of the official homeopathic pharmacopoeia accepted in each
country, for each active ingredient;
 for the case of an active ingredient that is not an official
homeopathic pharmacopoeia, it should be demonstrated a
pattern or degree of quality similar to other strains or
homeopathic
parent
dyes
described
in
the
official
Pharmacopoeia.
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In the case of inert excipients or inputs, it must demonstrate their
quality and ensure the origin.
For
homeopathic
products
for
veterinary
use
containing
Biotherapeutics, the Report must include a description of measures taken to
ensure the elimination of any pathogenic agent.
5.1.5 Description of the manufacturing process according to the
pharmaceutical form, indicating the dilution method, streamlining
scale and pharmacopoeia used.
If the route of administration of homeopathic product for veterinary use
is parenteral, they should include evidence of sterility and apyrogenicity.
5.1.6 Description of the specifications and results of the quality
control: microbiological, physical-chemical and others, described
by the monographs of the official homeopathic pharmacopoeia
employed for the finished product.
5.1.7 Stability Study Report of the pharmaceutical form of the drug
which allows for the establishment of the expiration date and
storage conditions. The report must include the following:
A) Full Description of the product object of registry.
B) Specifications: physical, chemical and microbiological of the
product.
C) Parameters to Evaluate: physical, chemical or microbiological,
according to the pharmaceutical form.
D) Duration of the Study: as a minimum, the expiration date of
which is intended for the product, or the duration described in
the Accelerated Stability studies of each country.
E) Packing: studies should be developed in the same primary
packaging in which the product will be marketed. Indicate the
specifications of the primary packaging. When a product has
packaging with various specifications, the Stability Study will be
made for each one of them. For products whose commercial
presentation is greater than one (01) kilo or one (01) liter, the
Stability Studies can be made in smaller presentations, in
packages that have the same features and specifications of those
in which the product will be marketed.
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F) Number of Batches: the Stability study should include at least
one (01) industrial batch identified. The size (kilograms /
milliliter) of each product batch must be indicated.
G) Samples for each Batch: those necessary according to the
pharmaceutical form, the commercial presentation and type of
packaging, for analyses to be performed, in at least three
independent samples at the times indicated.
H) Sampling Times: at time zero (0) and a time for every year of
the product's life. The final analysis should be done on the edge
of the product's life that if you want to ask, except as described
in item D, on the Accelerated Stability studies.
I) Temperature and Relative Humidity (RH - when applicable):
Identify and justify the temperature and relative humidity,
chosen for the study. The company should take a permanent
record of these parameters. The conditions of the stability study
should match the climate zone of the country you intend to
market the product.
J) Analysis: description of the parameters analyzed according to
the official homeopathic pharmacopoeia employed.
K) Summary of data obtained in different times of sampling until
the end of the expiration period proposed, including the
assessments and conclusions of the study.
EXPLANATORY NOTE: for the homeopathic products, the lifetime is at
most five (5) years.
5.1.8 Three color copies of the final arts on the product label (tag, box
and package insert, if included).
5.1.9 If the homeopathic product to be registered is not produced by
the applicant, but is manufactured in the country, attach a copy
of the Manufacturing Agreement and Quality Control entered into
with a manufacturer of homeopathic products registered with the
official body.
Also present existing certificate before the official body in Good
Manufacturing Practices or an equivalent document, and if the product in
question is remanufactured, attach a copy of the Agreement entered with a
Quality Control Laboratory registered before the official body, if it does not
have its own laboratory or if all quality tests required for homeopathic
products are not made in it.
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5.1.10 For products not produced in the country, should be enclosed
with the application:
A) Original of the certificate of free sale in the country of origin,
issued by the competent authority or official certification that
explains the reason for which it is not registered, with the
issuance date not exceeding twelve (12) months of the
application for registration. This certificate must express the
following:
 Product composition, identifying each of the parent dyes or
homeopathic strains with their respective classifications,
botanical, zoological, chemical or biological, in Latin, followed
by dilution and scale of dynamics, according to the official
homeopathic pharmacopoeia used, excipients and inert
ingredients and quantities used.
 Pharmaceutical form.
 The registrant.
 Name of manufacturer.
 Number and expiration date of the registration.
B) Official certificate of the country of origin, certifying that the
manufacturer observes the Good Manufacturing Practices or
equivalent document.
C) Expressed authorization from the owner of the product in the
country of origin, to process the record and market the product.
5.1.11 Certificate of the brand or freedom to use it, issued by the
competent authority, where it applies, or Agreement between the
parties allowing its use.
5.1.12 Scientific documentation justifying the therapeutic usefulness of
homeopathic veterinary product (homeopathic medical subjects,
official monographs of the components developed by expert
committees of reference countries, recognized scientificcharacter publications and scientific studies available).
5.1.13 Proof of payment according to the current rate established by the
official body.
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6. SPECIFIC REQUIREMENTS
6.1 EVALUATION OF THERAPEUTIC UTILITY OF VETERINARY HOMEOPATHIC
PRODUCTS FROM NON-BIOLOGICAL STRAINS AND NOT INCLUDED IN
PHARMACOPEIA:
To make the evaluation of the therapeutic utility of homeopathic
veterinary products from strains or homeopathic parent dyes, that used raw
materials of non-biological origin, not included in any of the official
homeopathic pharmacopoeia, it is considered as a minimum the following
criterion:
6.1.1 Justification and defense of the strains or combination of them in
their
respective
dilutions,
supported
by
a
scientific
documentation:
A) Monograph of the strain(s) not included in the pharmacopoeia, the
strain must be authorized in the composition of a homeopathic product in, at
least, one reference country. For the assessment effects of homeopathic
strain, it must attach the information regarding the description of the raw
material, the method of preparation and their specifications, as well as the
certificate of quality control.
B) Report of the homeopathic use of strain, based on studies of
pathogenetic trials, studies of natural or experimental toxicological effects or
document corresponding to any of the health authorities or organizations
accredited by the same, the reference countries to certify the use or potential
homeopathic use of said strain (similarity or equality).
6.1.2 EVALUATION OF THERAPEUTIC UTILITY OF HOMEOPATHIC VETERINARY
PRODUCTS FROM BIOLOGICAL STRAINS:
To obtain the registration, the homeopathic products of biological origin
must comply with the requirements established in number five point one
(5.1) of this document and those listed below:
A) That the strains or homeopathic parent dyes are expressed in any
official homeopathic pharmacopoeia in force in the Reference Countries.
B) Certificate issued by the health authority of at least one reference
country, stating that the product is approved and marketed in that country.
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C) That fulfills the requirements of quality required to ensure the
elimination of pathogenic agents.
D) Certificate of fulfillment of Good Manufacturing Practices from the
laboratory manufacturer, issued by the competent health authority or similar
document stating the authorization for its production.
EXPLANATORY NOTE: The national manufacturers laboratories may
manufacture strains or homeopathic parent dyes and homeopathic veterinary
products obtained from raw materials of biological origin, as long as the
strain is authorized in the composition of a homeopathic product, at least one
reference country, and count on the ANC written authorization, except in
cases of Technological Innovation (see 6.1.3.C).
6.1.3 EVALUATION OF THERAPEUTIC UTILITY OF NON-PHARMACOPOEICAL
BIOTHERAPICS HOMEOPATHIC VETERINARY PRODUCTS:
In the case of homeopathic veterinary products of biological origin
(biotherapics) containing strains not included in any of the official
homeopathic pharmacopoeia, it must observe the provisions in number six
point one point two (6.1.2), except the statement in the letter A.
For the purpose of making the assessment of therapeutic utility, it
must take into account, as a minimum, justification and defense of the
strains or combination of them in their respective dilutions, supported by
scientific documentation:
A) Monograph of strain(s) not included in pharmacopoeia(s). The strain
must be authorized in the composition of a homeopathic drug for at
least one referenced country. For the assessment effects of
homeopathic strain, it must attach the information regarding the
description of the raw material, the method of preparation of the
parent dye and their specifications, as well as the certificate of quality
control, or,
B) Report of the homeopathic use of strain, based on studies of
pathogenetic trials or document of any health authority or
organizations accredited by the same, the reference countries to certify
the use or potential homeopathic use of said strain, or,
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C) Document that justifies that such strain is the result of a
TECHNOLOGICAL INNOVATION, the use of which is based on the
therapeutic isotherapy and not of pathogenetic trials or other type of
indication applicable.
7. MEDICAL MATTERS.
For purposes of this document, the following Medical Matters are
accepted: Medical Matter of Hahnemann, William Boericke, James Tyler Kent,
B. Nash, H. Allen, Lathoud, Leon Vannier, Bardoulat, Bernardo Vjjnovsky,
Pharmacology and Medical Matter of Jacques Jouanni, Dennis DemarqueCrapanne, Farrington, Hans Reckeweg, Phatak, George Vithoulkas, J. Clark,
Quinquandon, H, Pigot, Tyler, M and others, as well as Text Books, that the
official body deems appropriate to host.
8. RESEARCH ACTIVITIES. Homeopathic laboratories can start the researches,
for the purpose of obtaining dyes or strains with the object of carrying out
the preparation of homeopathic products, if and when, presenting the official
body of research protocols and data sheets of products, so that is authorized
the favorable prior research concept.
9. LABELING. The final arts of the label, box and package insert of
homeopathic veterinary products must:
9.1 Include the following information:
A) Name of the owner of record.
B) Product name or scientific name of the strain or strains, followed by
the dilution degree, using the symbols of official homeopathic
pharmacopoeia employed.
C) Composition of the drug, identifying each of the homeopathic strains
used with respective name, botanical, zoological, chemical or biological
in Latin, dilution and scale of streamlining, as the official homeopathic
pharmacopoeia in force employed, quantity of each dilution and
reference of the inputs inert used.
D) Pharmaceutical Form.
E) Route of administration.
F) Animal species for which the medicine or product is intended for.
G) Therapeutic indications and dosage should be included in the
labeling, as well as the sentence "Indications and dosage at the
discretion of the veterinarian."
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H) Liquid content expressed in units of the decimal or International
metric system.
I) Manufacturing date and batch.
J) Expiration date.
K) Registration number of official authority.
L) When it is about a product manufactured by third parties, shall bear
the manufacturer's name. For imported products, must show the
country of origin and the name of the importer. The imported products,
with fractionation or filling process in the importing country, must show
the legal name of the person who performs it.
M) Instructions on conservation and storage conditions of the product.
N) Precautions and contraindications.
O) The expressions: stay out of the reach of children, keep away from
electrical appliances or that emit electromagnetic waves, sale under
prescription by a veterinary doctor, lack of time or equivalent terms,
should be written so that they are easy to read.
9.2 The label should carry, as a minimum, the following information: Product
name and holder of the record, the term "homeopathic product for
veterinary use", batch, expiration date and registration of the official
authority.
9.3 The label must be in the language of the country which will be marketed
and may be in another language required by the holder, with the
exception of information concerning the name of the strain or
homeopathic parent dye that should appear in Latin.
9.4 When the commercial presentation of the product is not accompanied by a
box or a package insert, all the information required on the label must
appear on the label.
9.5 The characters used on the label should be presented in dimensions that
allow its easy reading.
10. OBLIGATIONS.
10.1 The areas used for the production and packaging of homeopathic
veterinary products should be used exclusively for these activities and
must comply with the Good Manufacturing Practices.
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10.2 The parent dyes or homeopathic strains and the base dilutions
industrially developed can only be manufactured by homeopathic
pharmaceutical laboratories legally allowed to comply with the Good
Manufacturing Practices as determined herein.
10.3 When the product is presented in a collective package for retail or
counter sale, it is mandatory to include a package insert for each unit of
sale contained.
10.4 The holders of record of the products must meet the pharmacovigilance
requirements established by the ANC.
11. SAFETY OF THE HOMEOPATHIC PRODUCT FOR VETERINARY USE:
For security purposes with the use of homeopathic products on animals
and livestock populations, comply with the following assumptions are
mandatory:
11.1 INNOCUOUSNESS: the homeopathic product for veterinary use should
be innocuous (absence of pathogens), while its packaging is inviolate and
within the expiration date. Quality controls should be validated and
monitored.
11.2 DISPOSAL OF PRODUCTS: intermediate homeopathic preparations,
active ingredients and finished products for disposal must have the
appropriate destination, according to their category and environmental
risk, always considering the peculiarities and lack of toxicity from the
homeopathic manufacturing process and environmental legislation in the
country. This procedure should be described and the records maintained
by the manufacturing laboratory.
12. REFERENCES
 Council Regulation (EEC) Nᵒ 2377/90. Laying down a Community
procedure for the establishment of maximum residue limits of veterinary
medicinal products in foodstuffs of animal origin.
 CPMP Committee for proprietary medicinal products. European Medicines
Agency. 2003. Guideline on stability testing: stability testing of existing
active substances and related finished products.
 Guideline 2009/9/CE of the Commission (February 10, 2009). Amending
the Guideline 2001/82/CE of the European Parliament and of the Council
by which a Community code on veterinary medicines is established.
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 Directive 2001/82/EC of the European Parliament and of the Council of 6
November 2001 on the Community code relating to veterinary products.
 Directive 2004/28/EC of the European Parliament and of the Council of
31 March 2004 amending Directive 2001/82/EC on the Community code
relating to veterinary medicinal products.
 Irish medicines board. 2008. Guide to the registration of homeopathic
veterinary medicinal products.
 MAPA Ministry of Agriculture, Livestock and Supply. Agriculture Defense
Secretariat. 2001. Service Instruction No. 001/CPV. Coordinating
supervision of veterinary products.
 ANVISA. Brazilian Homeopathic Pharmacopoeia 3rd edition.
 MAPA. Circular Letter 002 DFIP/DAS 03/28/2013
 MAPA. Circular Letter 003 DFIP/DAS 4/10/2013
 MAPA. Normative Instruction 46, as of 10/06/2011
 Regulation (UE) No. 37/2010 of the Commission. Concerning
pharmacologically active substances and their classification regarding the
maximum residue limits in foodstuffs of animal origin.
 Regulation (CE) No. 470/2009 of the European Parliament and of the
Council (May 06, 2009). By which to establish Community procedures for
the establishment of LMR for pharmacologically active substances in
foodstuffs of animal origin, the Regulation (CEE) No. 2377/90 of the
Council is derogated and modifies the Guideline 2001/82/CE of the
European Parliament and Council and the Regulation (CE) No. 726/2004
of the European Parliament and the Council.
Page 16 of 16
12. AUTHORS:
National Service of Animal Health of Costa Rica (SENASA).
Institute of Veterinary Medicine of Ministry of Agriculture of Cuba.
National Service of Sanitation, Innocuousness and Quality of Food Processing
(SENASICA).
National Association of Pharmaceutical Laboratories (ANALAC).
National Association of Industrial Products for Animal Health (SINDAN). Brazil.
National Chamber of Pharmaceutical Industry (INFARVET).
National Association of Veterinary Products Laboratories (APROVET).
National Federation of Traders (FENALCO)
Colombian Agricultural Institute (ICA).
São Paulo, August 04, 2014