MINISTRY
OF AGRICULTURE AND RURAL DEVELOPMENT
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|
SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom - Happiness
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|
No.:
13/2016/TT-BNNPTNT
|
Hanoi, June 02,
2016
|
CIRCULAR
ON VETERINARY DRUG MANAGEMENT
Pursuant to the Law on veterinary
medicine 2015;
Pursuant to the Law on Product and
goods quality 2007;
Pursuant to the Decree No. 89/2006/ND-CP
dated 30/8/2006 by the Government providing for labels of goods;
Pursuant to the Decree No.
132/2008/ND-CP dated December 31, 2008 by the Government detailing the
implementation of a number of articles of the Law on Product and goods quality;
Pursuant to the Decree No. 181/2013/ND-CP dated 14/11/2013 by the
Government detailing the implementation of a number of articles of the Law on
Advertising;
Pursuant to Decree No.
199/2013/ND-CP dated 26/11/2013 by the Government defining the functions, tasks,
entitlements and organizational structure of the Ministry of Agriculture and
Rural development;
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At the request of the Director of
the Department of Animal Health,
The Minister of Agriculture and
Rural development hereby promulgates the Circular on veterinary drug
management.
Chapter I
GENERAL
PROVISIONS
Article 1. Scope
of regulation and regulated entities
1. Scope of regulation
This Circular provides for the
registration, testing/inspection, manufacture, trade, export, import, quality
inspection, recalling, destruction and advertising of veterinary drug.
2. Regulated entities
This Circular applies to Vietnamese and
foreign organizations and individuals related to the registration, testing,
manufacture, trade, export, import, quality inspection, recalling, destruction
or advertising of veterinary drugs in Vietnam.
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In this Circular, these terms can be
construed as follows:
1. “Manufacture of veterinary drugs”
includes the forms of manufacture, processing, portioning and packaging of
veterinary drugs.
2. “New drug” means a drug with a dosage
formula containing new active ingredients, drugs with a new combination of
active ingredients, drugs with a new dosage form, drugs with new indications or
drugs with a new route of administration.
3. “New active ingredient” means an
active ingredient with is registered for sale in Vietnam for the first time.
4. “Innovator drug” means drug which
has a patent and a stable manufacturing process which has been issued with a
License for free sale.
5. “Generic drug” means a drug that
has the same formulation, dosage form, uses, indications, dosage and the
withdrawal time as those of the innovator drug when the patent or the exclusive
license is expired.
6. “Proprietary name” means a
commercial brand named by a drug manufacturer, which is different from the original
or international nonproprietary name.
7. “Drug label” means written,
printed or drawn words, drawings, images or signs which are directly printed
on, or stuck, pinned or securely attached to, the commercial packaging of a
drug.
8. “Labeling” of a drug means the
presentation of basic and necessary information on a drug on its label for user
to identify, select and consume, serving as the basis for inspection and
control by functional agencies.
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10. “Supplementary label” means a
label displaying compulsory information translated from a foreign language into
Vietnamese and supplementing compulsory information in Vietnamese as required
by law, which the original label does not contain.
11. “Commercial packaging” of a drug
means the packaging which contains the drug and is sold together with the drug,
comprising two types:
a) Primary packaging, which means the
packaging in direct contact with and directly containing the drug;
b) Secondary packaging, which means
the packaging used for packing one or a number of drug units contained in
primary packagings.
12. Name and address of the organization
or individual responsible for a drug means the name and address of the
manufacturer, exporter, importer, entrusted exporter or entrusted importer of
the drug.
13. “Packing specifications” of a
drug means the drug quantity in net weight, actual volume or cardinal number in
a packaging unit.
14. “Batch number” means the code in
numbers or letters or a combination of numbers and letters to enable
recognition, and tracing back of the history of, a drug batch, covering all
stages of manufacture, quality inspection and distribution of such batch.
15. “Date of manufacture” means the
point of time when the manufacture, processing, bottling, packing or another
form of finishing the final manufacture stage of a drug batch is completed.
16. “Expiry date” means the point of
time past which a drug must not be used.
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18. “Indications” means information
relating to the use, and necessary conditions for use and preservation, of a
drug; warnings; and remedies for hazardous incidents, guiding users how to
safely and properly use such drug.
“Package insert” means a document
attached to a drug's commercial packaging, which presents use instructions and
other information under regulations.
19. “State inspection of veterinary
drug quality” means when a regulatory agency considers assessing the quality of
a veterinary drug which is manufactured/imported or sold after applying quality
control measures by an organization/individual producing/trading such
veterinary drug.
20. “Conformable drug” means a drug
satisfying quality standards which have been registered according to the
pharmacopoeia, National Technical Regulation regarding veterinary drugs,
National standards regarding veterinary drugs or intramural standards issued by
the manufacturer and approved by a regulatory body.
21. “Unconformable drug” means a drug
that does not fully satisfy the quality standards that have been registered
with a regulatory body.
22. “Batch” means a certain amount of
veterinary drugs which are consistent in quality, manufactured under a single
procedure or a chain of procedures and whose label displayed the same batch
codes.
23. “Import shipment” means a certain
amount of veterinary drugs or materials thereof in one or a number of batches
of the same type of products which are manufactured by the same manufacturer
and imported by the same organization on the same consignment and are covered
by the same import dossier.
Chapter II
REGISTRATION,
TESTING, MANUFACTURE, TRADE AND IMPORT OF VETERINARY DRUG
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Section 3. Application
for registration of veterinary drug
1. Regarding new veterinary drug
being pharmaceutical products, chemicals or bioproducts, an application for
registration shall include:
a) An application form for
registration using the form specified in Annex I enclosed with this Circular;
b) A brief description of
characteristics of the product using the form specified in Annex VIII enclosed
with this Circular;
c) Models of the label of the product
and the package insert;
d) The Certificate of GMP or the certificate
of the ISO Quality Control System, applicable to a number of common chemicals,
the certificate of sale isssued by a competent agency of the producing country,
applicable to imported drugs;
dd) Manufacture process;
e) Quality standards and testing
methods;
g) A report on data proving the the
safety, including researches on the toxicity (acute toxicity, semichronic
toxicity, chronic toxicity, cytotoxicity and the carcinogenicity);
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i) Researches on residues in animals
taken the drug to determine the withdrawal time;
k) Documents on the stability and the
expiry of the drug;
l) Researches on dosage regimen and
treatment course for specific species of animals;
m) The Certificate of analysis for
the product issued by the manufacturer and the Certificate of analysis of the
product issued by a designated veterinary drug testing authority;
n) The result of the inspection;
o) A written undertaking not to
violate the provisions of the Law on Intellectual property using the form
provided in Annex VII enclosed with this Circular;
p) Other technical information (if
any).
2. Regarding pharmaceutical products,
chemicals and bioproducts which are excempt from inspection specified in
Article 11 of this Circular, an application for registration shall include:
a) Documents specified in points a,
b, c, d, dd, e, k, m, o and p clause 1 of this Article;
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3. Regarding vaccines and antibodies,
the application shall include:
a) An application form for
registration using the form specified in Annex II enclosed with this Circular;
b) A brief description of
characteristics of the product using the form specified in Annex VIII enclosed
with this Circular;
c) Models of the label of the product
and the indication;
d) The GMP Certificate and/or the
License for free sale issued by the competent agencies of the country of manufacture,
applicable to imported products;
dd) Manufacture process;
e) Quality standards and testing
methods for vaccines and antibodies;
g) Reports on data proving the
safety, medical uses of the product, including researches on the antibody content
and the immunity duration of vaccine/antibody;
h) Researches on residues in animals
to determine the time for terminating the application of the vaccine/antibody;
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k) Methods for determining the dosage
regimen and the treatment course for specific types of animals;
l) The Certificate of analysis for
the product issued by the manufacturer and/or the Certificate of analysis of
the product issued by a designated veterinary drug testing authority;
m) A report on the test on the effect
and the safety of the product;
n) Relevant documents, including: the
origin, the history and the stability of the original microorganism spieces
used for producing vaccines/antibodies; documents relevant to the copyright and
the application of the certificate of manufacture of vaccines/antibodies (if
any);
o) Other technical information
including the results of the test within the laboratody, data proving that the
product has been sold in other countries in the world (if any);
p) epidemiological data proving the
existence of pathogens in Vietnam (applicable to new vaccines/antibodies).
4. Regarding bioproducts used for
diagnosis (Test KIT), the application shall include:
a) An application form for
registration using the form specified in Annex III enclosed with this Circular;
b) A brief description of
characteristics of the product using the form specified in Annex VIII enclosed
with this Circular;
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d) The Certificate of GMP or the
certificate of the ISO Quality Control System or other equivalent certificates,
the certificate of sale issued by a competent agency of the producing country,
applicable to imported drugs;
dd) The Certificate of analysis for
bioproducts issued by the manufacturer and the Certificate of analysis of
bioproducts issued by a designated veterinary drug testing authority of
Vietnam;
e) A report on data proving the
sensitivity analysis;
g) A report on data proving the
specificity of the product;
h) Manufacture process;
i) Quality standards and testing
methods for bioproducts;
k) Researches on the stability, a
brief description of the manufacturing process of 3 consecutive batches and a
suggestion on the expiration;
l) A report on the test results,
including results of test of the sensitivity and specificity of the product;
m) Relevant documents, including: the
origin, the history of the original microorganism spieces used for producing
bioproducts; documents relevant to the copyright and the application of the
certificate of manufacture of bioproducts (if any);
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5. For veterinary drugs made from
herbal ingredients, the application shall consist of:a) An application form for
registration using the form specified in Annex I enclosed with this Circular;
b) A brief description of
characteristics of the product using the form specified in Annex VIII enclosed
with this Circular;
c) Models of the label of the product
and the indication;
d) The GMP Certificate and/or the
certificate of free sale issued by the competent agencies of the country of
manufacture, applicable to imported drugs;
dd) Manufacture process;
e) Quality standards and testing
methods;
g) A report on data proving the
safety and the effectiveness of the product;
h) Researches on residues in animals
taken the drug the determine the time for terminating the use of the drug;
i) Documents on the stability and the
expiration of the drug;
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l) The Certificate of analysis for
the product issued by the manufacturer and the Certificate of analysis of the
product issued by an designated veterinary drug testing authority;
m) A written undertaking not to
violate the provisions of the Law on Intellectual property using the form
provided in Annex VII enclosed with this Circular;
n) Other technical information (if
any).
6. Regarding veterinary drugs with
the certificate of free sale in Vietnam which are processed or portioned out,
the application shall consist of:
a) An application form for
processing/portioning drugs using the form specified in Annex I enclosed with
this Circular;
b) A summary of information about the
product (name, composition, dosage form, form of packaging, effect, use,
expiration);
c) Models of the label of the product
and the indication (the label of registration, processing and portioning);
d) The GMP Certificate or the certificate
of eligibility for manufacture of the establishment carrying out the
processing/portioning;
dd) The Certificate of free sale of
the processing/portioning requester issued by the Department of Animal Health;
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g) Manufacturing process of the
processing/portioning requester;
h) Quality standards and methods for
testing the original materials, semi-finished products and finished products of
the processing/portioning requester;
i) The Certificate of analysis of
products of the establishment carrying out the processing/portioning;
7. Regarding veterinary drugs without
the certificate of free sale in Vietnam to be exported, the application shall
consist of:
a) An application form using the form
specified in Annex XI enclosed with this Circular;
b) A brief description of
characteristics of the product using the form specified in Annex VIII enclosed
with this Circular;
c) Models of the label of the product
and the indication;
d) The GMP Certificate of the
manufacturer;
dd) Manufacture process;
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g) The Certificate of analysis for
the product issued by the manufacturer and the Certificate of analysis of the
product issued by an designated veterinary drug testing authority;
h) An undertaking that the drugs
manufacturing for export are not sold in Vietnam;
i) A written undertaking not to
violate the provisions of the Law on Intellectual property using the form
provided in Annex XII enclosed with this Circular.
Article 4.
Requirements for processing/portioning of veterinary drugs
1. Only drugs which have an
effective certificate of free sale in Vietnam or drugs for
export are allowed to be processed/portioned out.
2. The establishment processing/portioning
drugs shall be an establishment that has obtained the GMP certificate or the
certificate of eligibility to manufacture the drug to be processed/portioned
out.
Article 5.
Contract for processing/portioning of veterinary drugs
The contract for processing/portioning drugs shall
be made in writing and shall be conformable to relevant legal regulations which
are applicable and shall include:
1. The agreement on the supply
of materials, auxiliary materials, the provision of manufacturing
process, technical standards and testing methods
for the original materials/auxiliary materials, semi-finished
products, finished products and other documents
relevant to the processing/portioning.
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3. Entitlements
and responsibilities of each party pertaining to the retention of
records of the manufacture, quality inspection, distribution and sale of drugs,
retention of drug samples, handling of issues related to quality, complaint or
recalling of products.
Article 6. Languages and format
of the application
1. Languages in the
application
a) The application for registration of domestically
manufactured veterinary medicine must be written in Vietnamese;
b) The application for veterinary
medicine manufactured overseas must be written in Vietnamese or English. If the
application is written in English, the information in the package insert
and the summary of product characteristics must be written in
Vietnamese.
2. Format of the application
a) The application for veterinary drug registration
must be written on A4 papers and must be firmly bound. The
application must have a cover and table of contents and the parts must
be separate. The separation must be numbered; registration
for each type of drug shall be separate;
b) Documents enclosed with the application,
including the GMP certificate, the ISO certificate, the certificate of
eligibility to manufacture veterinary drugs, the certificate of eligibility to
import veterinary drugs, the Certificate of analysis, the certificate
of free sale (CFS, CPP, MA) and/or the contract for
processing/portioning veterinary drugs shall be the original or copies
certified by the applicant.
Article 7. Drug’s name
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2. If the drug is not so
named, the applicant may choose a trade name for it. The commercial name of the
drug must satisfy the following principles:
a) Do not exaggerate drug effects;
b) Do not provide incorrect information about
treatment effects and pharmacological effects of the drug;
c) Do not infringe Vietnam's native cultural
tradition;
d) Do not cause conflict with protected
intellectual property of other organizations and individuals;
dd) The drug names must not be identical or similar
to those that are issued with registration numbers of other facilities;
e) Drugs with different active
ingredients must not have the same name;
g) Drugs with the same formulation, the same manufacturing process of the same manufacturer
must not have different names.
Article 8.
Appraisal of application, issuance of Certificate of free sale for veterinary
drugs and time limit for response
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a) The Department of Animal Health
shall receive the application, conduct appraisal of it, hold a consultation
with the Veterinary drug council, issue Certificate of free sale for veterinary
drugs using the form specified in Annex IX enclosed with this Circular, request
the Ministry of Agriculture and Rural development to recognize and add the drug
to the List of veterinary drugs allowable in Vietnam.The Veterinary drug
council shall be established under the establishment decision issued by the
Director of Department of Animal Health. The Veterinary drug council shall meet
at least every 3 months to assess the results of the appraisal of the
application, the test results then request the Director of Department of Animal
Health to issue the Certificate of free sale for veterinary drugs;
b) Regarding application for processing/portioning
veterinary drugs with the certificate of free sale in Vietnam, the Department of Animal Health shall conduct appraisal of the
application, issue the certificate using the form in Annex
XIII enclosed with this Circular and request the Minister of
Agriculture and Rural development to grant recognition and add such drug
to the List of veterinary drugs allowed to be sold in Vietnam. Regarding
application for export of veterinary drugs without the certificate of free sale
in Vietnam, the Department of Animal Health shall conduct
appraisal of the application, issue the certificate using the form in Annex XIV
enclosed with this Circular or according to the request of the importing
country.
2. Validity of the Certificate of
free sale for veterinary drugs
a) The Certificate of free sale for
veterinary drugs shall be valid for 05 years from the date of issue;
b) The validity of the Certificate of
free sale for veterinary drugs which are processed/portioned shall be
equivalent to sum of the valid period of the Contract for processing/portioning
veterinary drugs and the useful period of the product which must not exceed 05
years from the date of issue.
3. Time limit for response
a) Within 10 days from the day on which the
application is received, if the application is unsatisfactory, the Department of Animal Health shall notify the applicant for
completion;
b) The Department of Animal Health
shall conduct appraisal of the application and make response within 20 days
from the day on which the satisfactory application is received, applicable to
application for manufacture for export, processing/portioning, or 40 days from
the day on which the satisfactory application is received, applicable to
application for registration of drugs exempt from testing or bioproducts
used for diagnosis, or 06 months from the day on which the satisfactory
application is received, applicable to application for registration of new
drugs, vaccines, antibodies or herbal medicines.
Section 9.
Application for reissuance of the Certificate of free sale for veterinary drugs
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2. For cases of loss, omission,
damage; modification, addition to drug name, name/address of applicant,
name/address of manufacturer; change in packaging specifications
of the product, form of the label; modification of expiration and withdrawal
time, contraindications, treatment courses; changes which
do not affect the quality, effect and the safety of the veterinary drugs: The
application shall comprise: An application for reissuance of the Certificate
of free sale for veterinary drugs using the form specified in Annex IV
enclosed with this Circular; documents proving the modified contents; the
former and the new label; the issued Certificate of free sale for
veterinary drugs (the original or copies which are certified by the
applicant) unless such documents are lost.
Section 10.
Application for extension of the Certificate of free sale for veterinary drugs
An application for extension of the Certificate of
free sale for veterinary drugs shall consist of:
1. An application form for
registration using the form specified in Annex V enclosed
with this Circular.
2. A copy of the effective
Certificate of free sale for veterinary drugs.
3. The GMP certificate or the ISO certificate or
the certificate of eligibility to manufacture veterinary drugs or the
certificate of eligibility to import veterinary drugs; the certificate of free
sale issued by a regulatory body of the producing country for the importing
country.
4. The Certificate of analysis for
the product issued by the manufacturer or by the veterinary drug testing
authority appointed in Vietnam within 12 months, applicable to medicinal
products, chemicals or bioproducts; or the Certificate of analysis for the product issued by the
manufacturer and the veterinary drug testing authority appoint in Vietnam
within 12 months, applicable to vaccines and antibodies.
5. e) The contract on processing/portion out of the
veterinary drugs, applicable to drugs which are processed/portioned out.
6. A report on the stability of the product in
storage condition.
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Article 2.
Applicant for permission to conduct veterinary drug test
Article 11.
Veterinary drugs exempt from testing
1. Veterinary drugs manufactured
following the innovator drug, generic drug of pharmaceutical products,
chemicals, bioproducts; imported veterinary drugs excluding vaccines and
antibodies which are allowable in USA, Japan, Australia, Canada and Europe.
2. Pursuant to the eligibility to
manufacture veterinary drugs of countries other than those specified in clause
1 of this Article, the Department of Animal Health shall consider requesting
the Minister of Agriculture and Rural development to supplement countries whose
veterinary drugs are exempt from testing.
Article 12.
Requirements for animals to be tested
1. Its spieces, features, age and
weight are conformable to the indications of the drug.
2. It is clinically strong to the
vaccine/antibody.
3. It does not have an antibody
corresponding the vaccine/antibody to be tested.
Article 13.
Criteria for testing veterinary drugs being medicinal products, chemicals, bioproducts
(excluding vaccines/antibodies)
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a) For animals assigned to use the
drug: whether or not the animal keep alive and growing normally;
b) For aquaculture environment: DO,
pH, the purity;
c) Residues, applicable to animal
products: the withdrawal time.
2. Effect, applicable to animals
assigned to use the drug
a) Health conditions of animals after
testing: whether or not the animal has the clinic symptoms of the disease;
b) Rate of animal recovering from the
disease after the test.
3. Other technical criteria (which
must be specified in the application for registration).
Article 14.
Scale and time of test of veterinary drugs being medicinal products, chemicals,
bioproducts (excluding vaccines/antibodies)
1. Scale of test
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b) For aquatic animals: the test
shall be conducted in laboratorial environment for the scale of at least 3
raising ponds/cages.
2. Time of test shall be determined
on the basis of the treatment courses of the drug.
Article 15.
Criteria for testing vaccines/antibodies
1. Safety, applicable to animals
assigned to use the drug according to the technical record.
2. Effect, applicable to animals
assigned to use the drug.
a) The rate of animals with the
content of antibodies at the protected benchmark after being injected;
b) The rate of protection.
3. Other technical criteria (which
must be specified in the application for registration).
Article 16.
Scale and time of test of vaccines/antibodies
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a) Domestic fowls: at leats 300;
swines: at least 40; bovines, goats, sheeps, horses, dogs, cats: at least 20;
fish: 1000;
b) In special cases, the
determination of quantity of animals to be tested is specified in the testing
license;
c) The determination of quantity of
serums taken for testing antibodies must provide a reliable result about
biological statistics.
2. Time of test shall be determined
for specific type of vaccines/antibodies.
Article 17.
Criteria and scale of test of bioproducts for diagnosis (Test KIT)
1. The criteria shall be based on the
standards declared by the manufacturer, comprising:
a) The sensitivity analysis;
b) The specificity.
2. Scale of test: The test shall be
conducted in a laboratory, at least 30 experiments shall be performed for each
type of product.
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An application for
issuance/reissuance of the License to conduct veterinary drug tests shall
consist of:
1. An application form for
issuance/reissuance of the license to conduct veterinary drug tests using the
form provided in Annex XV or XVII enclosed with this Circular.
2. A report on the assessment of the
establishment proving the eligibility to conduct the test as prescribed in
clause 2 Article 45 of this Circular.
3. Technical documents for specific
types of drug, including:
a) A report on specifications of the
product using the form in Annex VIII enclosed with this Circular;
b) Technical information about the
quality of the product;
c) Technical information about the
safety and the effect of the product;
d) A certificate of analysis of the
product issued by the manufacturer (the original or a copy certified by the
establishment applying for registration);
dd) A certificate of analysis of the
product issued by veterinary drug testing agency of Vietnam (the original or a
copy certified by the establishment applying for registration);
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g) The testing contract between the
applicant establishment and the testing establishment (the original or a copy
certifiied by the establishment applying for registration).
Article 19.
License to conduct a test and reporting about veterinary drug test results
1. The form of the license to conduct
a veterinary drug test is provided in Annex XVI enclosed with this Circular.
2. The establishment applying for
conducting a test shall send a report on the test to Department of Animal
Health not later than 15 days counted from the day on which the test finishes.
The report shall be in accordance with the testing outline, including contents
specified in Annex XVIII enclosed with this Circular and shall be certified by
the test supervising body.
Section 3.
MANUFACTURE, TRADE AND IMPORT OF VETERINARY DRUGS
Article 20.
Application for issuance, extension or reissuance of the certificate of eligibility
to manufacture veterinary drugs
An application for issuance,
extension or reissuance of the certificate of eligibility to manufacture
veterinary drugs shall consist of:
1. An application form for issuance,
extension or reissuance of the certificate of eligibility
to manufacture veterinary drug using the form provided in Annex XIX or XXXI enclosed with this Circular.
2. A detailed description of
facilities and technology for the manufacture of veterinary drug using the form
specified in Annex XXI enclosed with this Circular.
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4. An application form for issuance,
extension or reissuance of the GMP certificate for veterinary drugs using the
form specified in Annexes XXVIII and XXXI enclosed with this Circular; an GMP
inspection record for veterinary drugs and a GMP certificate using the form specified
in Annexes XXIX and XXX enclosed with this Circular.
Article 21.
Application for issuance, extension or reissuance of the certificate of
eligibility to trade/import veterinary drugs
An application for issuance,
extension or reissuance of the certificate of eligibility to trade/import
veterinary drugs shall consist of:
1. An application form for issuance,
extension or reissuance of the certificate of eligibility to trade/import
veterinary drug using the form provided in Annex XX or XXXI enclosed with this
Circular.
2. A detailed description of
facilities and technology for the manufacture of veterinary drug using the form
specified in Annex XXII enclosed with this Circular.
3. A inspection record of the
conditions of trade/import of veterinary drugs using the form in Annex XXIV
enclosed with this Circular and a certificate of eligibility to trade/import
veterinary drugs using the form in Annex XXVI or XXVII enclosed with this
Circular.
Section 4. IMPORT
OF VETERINARY DRUGS AND MATERIALS FOR THE MANUFACTURE THEREOF
Section 22.
Application for permission to import veterinary drugs and materials for the
manufacture thereof
1. An application for permission to
import veterinary drugs without the certificate of free sale which serving the
prevention and fighting against emergency animal epidemic and/or serving
disaster recovery shall consist of:
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b) A copy of the Certificate of
Business registration or the Certificate of Enterprise registration or the
investment license appropriate to the profession of the applicant;
c) A GMP certificate or an ISO certificate
or other equivalent certificates, for common chemicals;
d) A certificate of free sale (CFS, CPP or MA) issued by a competent body of the country of manufacture;
dd) A Certificate of analysis (CoA)
by the manufacturer;
e) The model of the product label.
2. An application for permission to
import veterinary drugs for test or registration shall consist of:
a) An application form for permission to import
veterinary drugs using the form in Annex XXXII enclosed with this Circular. A copy in electronic file shall be sent by mail as well;
b) A copy of the Certificate of Business
registration or the Certificate of Enterprise registration or the investment
license of the applicant, applicable to organizations/individuals
applying for issuance of the license to import veterinary drugs for the first
time;
c) A GMP certificate or an ISO certificate or other
equivalent certificates, for common chemicals;
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dd) A Certificate of analysis (CoA)
by the manufacturer;
e) A summary of product
characteristics (SmPC).
3. An application for permission to
import veterinary drugs to be displayed at a fair, an exhibition or for
scientific research shall consist of:
a) An application form for permission to import
veterinary drugs using the form in Annex XXXII enclosed with this Circular. A copy in electronic file shall be sent by mail as well;
b) A copy of the Certificate of Business
registration or the Certificate of Enterprise registration or the investment
license of the applicant, applicable to organizations/individuals applying for
issuance of the license to import veterinary drugs for the first time;
c) Copies of documents proving the
purposes of importing veterinary drugs;
d) A Certificate of analysis (CoA)
by the manufacturer;
dd) A summary of product
characteristics (SmPC);
e) The model of the product label.
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a) An application form for permission to import
veterinary drugs using the form in Annex XXXII enclosed with this Circular. A copy in electronic file shall be sent by mail as well;
b) A Certificate of analysis (CoA) by the manufacturer;
c) Copies of documents proving the purposes of
importing veterinary drugs;
d) The model of the product
label.
5. An application for permission to
import veterinary drugs and materials thereof or microorganisms serving the
reseach and manufacture of veterinary drugs, diagnosis or test of veterinary
drug shall consist of:
a) An application form for permission to import
veterinary drugs using the form in Annex XXXII enclosed with this Circular. A copy in electronic file shall be sent by mail as well;
b) A copy of the Certificate of Business
registration or the Certificate of Enterprise registration or the investment
license of the applicant, applicable to organizations/individuals applying for
issuance of the license to import veterinary drugs for the first time;
c) A Certificate of analysis (CoA) by the manufacturer;
d) A summary of product characteristics
(SmPC);
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6. An application for permission to
import veterinary drugs as aid from an international organization and other
non-commercial forms of import shall consist of:
a) An application form for permission to import
veterinary drugs using the form in Annex XXXII enclosed with this Circular. A copy in electronic file shall be sent by mail as well;
b) A copy of the Certificate of Business
registration or the Certificate of Enterprise registration or the investment
license appropriate to the profession of the applicant;
c) A GMP certificate or an ISO certificate or other
equivalent certificates, for common chemicals;
d) A certificate of free sale (CFS,
CPP or MA) issued by a competent body of the country of manufacture;
dd) A Certificate of analysis (CoA)
of the manufacturer;
e) The model of the product label.
7. An application for permission to
import veterinary drug materials shall consist of:
a) An application form for permission to import
veterinary drugs using the form in Annex XXXII enclosed with this Circular. A copy in electronic file shall be sent by mail as well;
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c) A certificate of free sale (CFS, CPP or MA) issued by a competent body of the country of
manufacture;
d) A Certificate of analysis (CoA)
by the manufacturer;
dd) A copy of the certificate of
eligibility to import veterinary drugs issued by the Department of Animal
Health, applicable to establishment applying for permission to import
veterinary drug materials for the first time;
e) A report on the quantity and
purpose of antibiotic materials, the address of the establishment purchasing
the antibiotic materials from the previous batch of antibiotic materials using
the form in Annex XXXIV enclosed with this Circular, applicable to the
application for permission to import antibiotic materials for the second time
or later.
8. An application for permission to
import vaccines and/or microorganisms in the List of veterinary drugs allowable
in Vietnam or obtained the certificate of free sale in Vietnam shall consist
of:
a) An application form for permission to import
vaccines/microorganisms using the form in Annex XXXIII enclosed with this
Circular. A copy in electronic file shall be sent by mail as
well;
b) A copy of the certificate
of eligibility to import veterinary drugs issued by the Department of Animal
Health, applicable to establishment applying for permission to import vaccines/microorganisms for the first time.
9. The certificates (GMP, ISO, CFS,
CPP, MA or CoA) included in the application may be the original or copies
certified by the applicant.
10. The License to import veterinary
drugs/veterinary drug materials shall be valid not exceeding 01 year as from
the date of issue.
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LABEL OF
VETERINARY DRUGS
Article 23.
Types of veterinary drugs subject to labeling
1. Durgs which are domestically sold,
exported or imported shall be labeled according to regulations in this
Circular, except for cases specified in clause 2 of this Article.
2. If the foreign
organization/individual importing drugs from Vietnam and request such drugs to
be labeled according to a business contract and take responsibility for such request,
then the organization/individual exporting drugs may follow such request,
provided that such request does not falsify the substances of the drugs and is
not contrary to laws of Vietnam and the importing country.
Article 24.
Responsibilities for labeling of veterinary drugs
1. For veterinary drugs which are
domestically manufactured for domestic sale, manufacturers shall be responsible
for labeling thereof.
2. For veterinary drugs which are
domestically manufactured for domestic sale, manufacturers shall be responsible
for labeling thereof.
3. If the veterinary drugs having the
certificate of free sale in Vietnam which are not exported and returned to be
sale in Vietnam, the organization/individual selling such drugs shall carry out
the labelling as prescribed in Article 26 of this Circular.
4. If the organization/individual
responsible for the labelling of the drugs as prescribed in Article 10 of
Decree No. 89/2006/ND-CP dated 30/8/2006 by the Government requests another organization/individual
to carry out the labelling, the former organization/individual shall be still
responsible for such labels.
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6. Any organization/individual
trading drugs shall comply which law provisions on intellectual property and
shall take legal responsibility for the intellectual property towards
information written on the label.
Article 25.
Location, size, color of letters, symbols and images on the label
1. Location of labels of veterinary
drug
Labels of veterinary drugs must be
displayed (printed, stuck or attached) on their packages at a noticeable
location, where the provided information can be seen easily and sufficiently
with no need to disassemble the products, as prescribed in clause 1 Article 6
of Decree No. 89/2006/ND-CP.
2. Size of labels of veterinary drug
Any organization/individual
responsible for labelling drugs shall itself determine the size of the label
which must contain .sufficiently the information specified in Article 27 of
this Cicular
3. Color of letters, symbols and
images on the label
Color of letters, numberals,
paintings, pictures, signs and symbols displayed on labels of drugs must be
readable. For mandatory contents, letters and numerals must contrast with the
background of the label as prescribed in Article 8 of Decree No. 89/2006/ND-CP.
Article 26.
Languague used on labels of drugs
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2. For veterinary drugs domestically
manufactured and sold, their labels, apart from complying with the provisions
of Clause 1 of this Article, may contain information in another language.
Contents in another language must correspond those in Vietnamese. The size of
letters in another language must not be bigger than that of contents in
Vietnamese.
3. If labels of veterinary drugs
imported into Vietnam do not contain or do not fully contain compulsory
contents in Vietnamese, they shall be kept together with with supplementary
labels showing compulsory information in Vietnamese. The original labels shall
be kept unchanged.
4. The following contents may be
presented in other languages of Latin origin:
a) Proprietary name, generic name or
international nonproprietary names of drugs;
b) International names or scientific
names of ingredients or ingredient quantities of goods, in case they cannot be
translated into Vietnamese or their Vietnamese translations are meaningless;
c) Names and addresses of foreign
manufacturing or franchising enterprises.
5. Contents displayed on veterinary
drugs’ labels, including supplementary labels and package inserts, must be
truthful, clear, precise and correctly reflect the substance of the goods.
Article 27.
Contents of labels of veterinary drugs
1. A veterinary drug’s label must
display fully the following contents:
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b) Composition and quantity of active
ingredients (content or concentration);
c) Packing specifications;
d) Indications, route of
administration and contraindications of drugs; withdrawa time (if any) to use
eggs, meat or milk for each animal species to be treated;
dd) Dosage form, registration number,
number of batch, date of manufacture, expiry date and the phrase “Chỉ dùng
trong thú y” (for use in animal healthcare only);
e) Remarkable signs: For schedule-A toxic
veterinary drugs, to add the phrase (in black): “không dùng quá liều quy dịnh”
(Do not overdose); for schedule-B toxic veterinary drugs, to add the phrase (in
red) “không dùng quá liều quy dịnh” (Do not overdose);
g) Name and address of
organization/individual responsible for the drug;
h) Origin of the drug, except for
veterinary drugs domestically manufactured and sold whose labels already
display the place of manufacture;
i) Use and storage instructions
When it is impossible to present all
the above information on a label, the information specified in points a, b, c, dd,
e, g and h of this Clause shall be presented. Other compulsory information
shall be presented in a supplementary label or the package insert. In this
case, the label must indicate where such information is presented.
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Apart from compulsory contents
specified in clause 1 Article 27 of thia Circular, a label may contain other
information, for example, the quality standard code. Such information must be
truthful and accurate and must not misrepresent the nature and effect of a drug
as well as other information presented on the label.
3. The label of a veterinary drug
material must contain the following information:
a) Name of the material;
b) Content or concentration (if any);
c) Standards of the material;
d) Net weight or volume;
dd) Number of batch, date of
manufacture;
e) Expiry date, storage conditions;
g) Registration number (if any);
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i) Origin of the material
(except materials which are domestically manufactured and sold whose labels already contain addresses of manufacturers);
k) Name and address of importer
(applicable to imported materials);
l) Remarkable signs.
4. The label of a veterinary drug
pack must at least contain the following information:
a) Name of the drug;
b) Active ingredients, contents. For
a veterinary drug containing 3 or fewer active ingredients, its label must
fully indicate these active ingredients and their contents;
c) Number of batch, expiry date,
registration number;
d) Name of manufacturer, which may be
abbreviated, but must ensure the identity of the manufacturer.
A drug pack shall be put in a
secondary packaging which has a label fully displaying the information
specified in clause 1 Article 27 of this Circular.
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a) The label of a veterinary drugs on
a small-sized primary packaging with a special shape that cannot fully display
compulsory information specified in clause 1 Article 27 of this Circular, must
at least contain the following information: name if the drug; active
ingredients, contents, for a drug containing 3 or fewer active ingredients, its
label must fully indicate these active ingredients and their contents; volume
or weight; number of batch, expiry date, registration number; name of
manufacturer, which may be abbreviated, but must ensure the identity of the
manufacturer;
b) Primary packagings of these
veterinary drugs shall be put inside secondary packagings which have labels
fully displaying the information specified in clause 1 Article 27 of this
Circular.
Article 28.
Labelling of veterinary drugs
1. Veterinary drug names
a) A veterinary drug shall be
named by its manufacturer or trader. Such a name must not
misrepresent the substance and effect of the drug. The letters for a drug name
must be bold and prominent.
The label of a single-element
proprietary drug must indicate the generic name or the international
nonproprietary name of the drug right after the proprietary name;
b) A drug may be named after: the generic
name; the international nonproprietary name (INN); proprietary name.
2. Composition of active ingredients,
contents or concentrations
a) Composition of all active
ingredients and excipients contained in a finished drug product shall be
displayed according to regulations in clause 1 Article 18 of Decree No.
89/2006/ND-CP even when those materials change their forms in the manufacture
process;
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c) Units of measurement
Units of quantitative measurement shall
be presented on veterinary drug labels in their full or abbreviated forms.
Units of active power may be used according to international practive for some
special active ingredients.
3. Packing specifications
a) Packing specifications of a drug
means the quantity, net weight or actual volume of a drug contained in a
commercial packing;
b) Packing specifications shall be
presented in natural numbers;
c) Packing indications of spme
specific forms of veterinary drugs shall be presented as follows:
- For capsules: quantity of capsules,
contents of active ingredients/capsules;
- For powder: weight;
- For liquid: real volumetric
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d) For a drug whose commercial packaging
contains many packing units, the weight of each packing unit and the quantity
of packing units must be presented.
4. Indication, route of
administration, contraindication and withdrawa time
a) Indication for treatment of each
animal species indicated on a drug label must match the effect of such drug.
b) Use instructions must
conspicuously indicate the route of administration, dose and treatment duration;
c) Contraindication cases shall be
specified for drugs with contraindication. For drugs without contraindication,
the non-contraindication status shall be stated;
d) The indication, route of
administration-contraindication for a drug may be presented in either of the
following ways:
- Directly on the commercial
packaging;
- In the package insert enclosed in
the commercial packaging, for a drug whose label on the secondary packaging
fails to display the drug's indication, route of administration and contraindication.
In this case, the phrase “Chỉ dịnh, cách dùng, chống chỉ dịnh: xin dọc trong tờ
hướng dẫn sử dụng” (See the package insert for indication, route of
administration and contraindication) shall be printed on the label on the
commercial packaging;
dd) Withdrawa time shall be specified
for each animal species to be treated. In case the withdrawa time is not
available, this shall be stated.
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5. Dosage forms, registration
numbers, batch numbers, date of manufacture, expiry date, storage conditions
a) Dosage forms of a drug as capsule,
powder, injection solution, injection suspension, powder for injection, or oral
solution shall be presented;
b) The registration number, which is
the code of a veterinary drug granted by the Animal Health Department to
certify the registration for sale of such drug in Vietnam shall be presented;
c) The batch number shall be presented
as “Số lô sản xuất” or “Số lô SX”. The batch numbers structure shall be prescribed by the manufacturer;
d) The date of manufacture, expiry
date and storage duration shall be specified as follows: the date of
manufacture and expiry date shall be presented on the label fully or in
abbreviation in upper case letters as NSX, HSD in the format [dd/mm/yyyy] of
the calendar year. The numberals presenting a date must be displayed on the
same line according to regulations in Article 16 of Decree no. 89/2006/ND-CP.
When it is impossible to display “NSX”, “HSD” together with the numbers
indicating fully the date the label must so indicate. When a label displays the
date of manufacture NSX and expiry date HSD in a foreign language, the
supplementary label must display the date of manufacture and expiry date or the
phrase “NSX/HSD xem Mfg Date/Exp Date trên bao bì” (See Mfg Date/Exp Date for
NSX/HSD).
dd) Storage conditions means climate
factors to ensure the unchanging of quality of drugs. Necessary storage
conditions shall be presented on the drug label. For example: Store in a dry
and cool place at 30oC or below.
6. Remarkable signs
a) For injection drugs or powder for
injection, the administration shall be specified. Administrations of drugs may be
abbreviated to tb (tiêm bắp - intramuscular injection), tdd (tiêm dưới da - subcutaneous
injection), tm (tiêm tĩnh mạch - intravenous injection);
b) For eyedrops, the phrase “Thuốc tra
mắt” (ophthalmic drugs) shall be displayed;
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d) For drugs in ampoules for oral use,
the phrase “không dược tiêm” (Not for injection) shall be displayed;
dd) For some chemicals used in animal
healthcare, their typical qualitative indicators shall be displayed. For
inflammable, explosive, toxic or corrosive chemicals, respective warnings shall
be displayed. For chemicals in pressure containers, container numbers, capacity
and warnings shall be displayed;
e) Warnings (if any) shall be
displayed on drug labels to ensure the safety for drug administrator;
g) Presentation of remarkable signs
Remarkable letters and signs shall be
conspicuous and bold to be easily seen. If a drug has multiple remarkable
signs, such remarkable signs shall be fully presented.
7. Name and address of
organization/individual responsible for the drugs
a) Name and address of
organization/individual responsible for the drugs must not be
abbreviated;
b) Name and address of
organization/individual responsible for the drug shall be
presented according to regulations in Annex XXXV enclosed with this Circular;
c) A label containing the name and address
of the distributor must display such name and address in the same place with
the manufacturer's and of a size not bigger than the manufacturer's;
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dd) Addresses of manufacturer,
packaging establishments, franchise manufactures or subcontract manufacturers
including house number, street (village), commune (ward, township), district
(town, provincial city) and province (central-affiliated cities) shall be
displayed.
8. Origin of veterinary drugs
a) For imported drugs: The phrase
“sản xuất tại” (manufactured in) or “xuất xứ” (origin) followed by the name of
country or territory of manufacture shall be presented;
b) For domestically
manufactured and sold drugs whose
label already indicates the place of manufacture, the presentation of the
drug's origin is not required;
c) The origin of a drug shall be
presented on its secondary and primary packagings.
9. Use instructions
a) Veterinary drugs labeled
under this Circular must have a package insert in
Vietnamese. The contents of this insert may be printed on the primary
packaging or intermediary label instead of a separate insert.
The size and color of letters printed
on the package insert must be big and conspicuous to the naked eye.
b) Content of the package insert
shall be conformable to regulations in Annex XXXVI enclosed with this Circular.
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A supplementary label shall be
attached to the secondary packaging of a veterinary drug and must not hide from
view contents of the original label. Contents of a supplementary label must not
cause misunderstanding about those of the original label and the labeling
organization/individual shall take legal responsibility for the accuracy and
truthfulness of additional contents. A supplementary label shall be presented
as follows:
a) For labela with sufficient space,
all compulsory contents shall be specified according to regulations in clause 1
Article 27 of this Circular;
b) If the supplementary is small and
cannot fully display compulsory contents, at least the following information
shall be presented: name of the drug; active ingredients, content or
concentration; name of organization or individual responsible for the drug;
registration number; packaging specifications; date of manufacture, number of
batch; origin of the drug.
Other remaining compulsory information
shall be presented in the package insert. In such case the supplementary label
must contain the phrase: “Các thông tin khác dề nghị xem trong tờ hướng dẫn sử
dụng kèm theo” (See the package insert for other information) and the contents
on the package insert indicated on the supplementary label shall be regarded as
part of the supplementary label;
c) When the original label of a drug
is presented in a Latin-originated language and contains the information below,
the translation into Vietnamese and presentation on a supplementary label of
such information is not required: proprietary name, generic or international
non-proprietary name of the drug; international non-proprietary name or
scientific name of each ingredient of the drug when it is impossible to
translate into Vietnamese or such translation bear no meaning; name and address
of foreign manufacturer or manufacture franchising grantor.
Chapter IV
TESTING OF
VETERINARY DRUGS
Article 29.
Veterinary drug-testing system
1. Testing establishments affiliated
to Department of Animal Health: National center of vet medicine control I and
National center of vet medicine control II.
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Article 30.
Operation of veterinary drug-testing establishments
1. Testing establishments affiliated
to Department of Animal Health:
a) Conduct tests and assessments of
drug quality nationwide;
b) Conduct tests of drug quality
applying for registration;
c) Conduct appraisal of quality
standards of drugs and other products at the request of the Ministry of
Agriculture and Rural development;
d) Provide testing services;
dd) Other activities according to
relevant law provisions.
2. Drug testing service providers
Provide services of testing drug
materials and semi-finished products during the manufacture process and the
finished drugs for establishments producing and trading drugs, serving the
state management and control regarding drug quality.
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Article 31.
Application of methods for testing veterinary drugs
1. The testing of drugs shall be
conducted according to the assigned testing methods and conformable to the drug
testing methods registered by the establishment producting/trading such drugs.
Any application of methods other than
those specified in the registered standards must be conducted only under the
approval by Department of Animal Health.
2. In case of suspicion of
composition or quality of a drug, the testing agency affiliated to the
Department of Animal Health may take measures other than those specified in the
registered standards to conduct testing of the drug and produce the drug
quality testing result.
Chapter I
VETERINARY DRUG QUALITY
INSPECTION
Article 32. Bases for
formulation of veterinary drug quality standards and basis for veterinary drug
quality test
1. Bases for
formulation of veterinary drug quality standards
a) National technical regulation
regarding veterinary drugs;
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c) Standards in Vietnam’s pharmacopoeia
or international standards, including: European, British, American, Japanese.
The application must contain all provisions of quality, quality rate and
testing methods specified in such pharmacopoeia.
2. Bases for veterinary drug quality
test are specified in clause 1 of this Article and intramural
standards issued and applied by manufacturers.
Article 33. State inspection
regarding veterinary drug quality in manufacture
1. Inspection authority: Department
of Animal Health
2. Bases for inspection
a) There is information and/or warning that an
exported veterinary drug is unconformable to conditions specified in Article 32
of the Law on Product and goods quality;
b) A product being sold on market is unconformable
to applied standards or corresponding
technical regulations, discovered by the inspection or supervision of product quality or through motion of a
competent agency about the quality of the product.
3. Form of inspection: An inspection shall be
conducted by inspectorates.
4. Contents of inspection
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b) Inspection of the registration of drug, the
research of the stability of the product and the labeling of drug according to
regulations;
c) Collection of samples: During the inspection at
manufacture establishments, if any product is found unconformable to quality
standards or denoting the unconformity with quality standards when it is on
market, its samples shall be collected for testing of quality. Such samples
shall be sent to recognized or appointed testing establishments for analyzing.
Testing results shall be the legal basis for the inspection authority to handle
during the inspection period.
5. Order and procedures for the inspection shall
comply with regulations in clause 3 Article 29 of the Law on Product
and goods quality.
6. Processing of inspection results: in accordance
with regulations in Article 30 of the Law on Product and goods
quality.
Article 34.
Testing of quality of imported veterinary drugs
1. Inspecting authority: Department of Animal Health
2. Subject of inspection
a) Veterinary drugs imported into Vietnam, except
for those not subject to testing specified in point b of
this clause;
b) Imported veterinary drugs not subject to quality test: samples for testing, registration, samples to be
displayed at a fair, exhibition or a scientific research;
veterinary drugs to be used for animals temporarily imported or transited
through Vietnam; veterinary drugs temporarily imported for re-export or for outward processing under a contract with a foreigner; materials
used in diagnosis or testing pertaining to animal healthcare; drugs as aids
from international organizations and drugs imported in
other non-commercial forms.
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a) Testing of quatitative of
for veterinary drug materials, medicinal products,
chemicals, bioproducts;
b) Testing of condition of sterility or purity, safety and effect of vaccines/antibodies.
4. Contents
a) Examination of documents;
b) Inspection of the
conformity of the contents of the Certificate of analysis of
the imported products with the technical standards, the applied
standards and applicable regulations;
c) Testing of samples of
drug’s label: the compulsory information to be displayed
on the labels (including the supplementary labels) according to regulations in Chapter
III of this Circular regarding labels of finished veterinary drugs; the
conformity of the label’s samples with the import dossier of the batch.
5. Collection of samples for quality analysis
The collection of samples for quality
test shall comply with regulations in the Technical standard No. QCVN
01-03: 2009/BNNPTNT enclosed with the Circular No. 66/2009/TT-BNNPTNT
dated 13/10/2009 by the Ministry of
Agriculture and Rural development.
6. Frequency of sampling
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Collect samples of 02 batches of consecutive import
shipments for quality test.
If the batches are satisfactory, the frequency of sampling
shall be reduced to 1 imported batch for the 05 next imported batches.
If the batches are unsatisfactory, the next 03
consecutive imported batches shall be sampled for testing; if such 03 batches
are satisfactory, samples from 01 batch of the next 05 batches shall be
collected for quality test;
b) For vaccines/antibodies
used in animal healthcare.
Collect samples of every batches of imported
vaccines for quality test regarding the sterility or purity and safety; collect
samples from 01 batch of imported drug of 05 consecutive batches of imported
drugs manufactured by the same manufacturer and imported by the sample unit for
quality test regarding the effect of drugs.
If the effect of the batch/es is unsatisfactory,
the next 02 consecutive imported batches shall be sampled for testing; if such
02 batches are satisfactory, samples of 01 batch from the 05 consecutive batches manufactured by the same manufacturer and imported by
the same unit shall be collected for testing.
Particularly regarding vaccines
against Avian influenza, Foot-and-mouth disease, Porcine
reproductive and respiratory syndrome (PRRS), 100% of batches of imported drugs
shall be sampled for testing regarding the sterility, purity, safety and
effect;
c) If the results of supervision or quality testing
of imported veterinary drugs present the unsatisfaction, all the imported drug
batches shall be sampled for quality testing. When samples from any 02
consecutive batches are satisfactory, the frequency of sampling shall be
reduced that samples from 01 batch of the 05 next batches of imported drugs
shall be collected for quality testing;
d) Samples shall be collected at the request of the
Department of Animal Health.
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1. An application for inspection
regarding the quality of imported veterinary drugs shall consist of
a) An application form for inspection
of imported veterinary drugs using the form in
Annex XXXVII enclosed with this Circular (02
copies);
b) The contracts, the Packing list,
Invoices, Bills of lading;
c) A written approval for the import
of veterinary drug materials, vaccines, microorganisms and/or veterinary drugs
issued by the Department of Animal Health or a Certificate of free sale for veterinary
drugs excluding vaccines/microorganisms;
d) A Certificate of analysis (CoA) issued
by the manufacturer;
dd) Samples of the label of the
imported veterinary drug and the supplementary label (if any) according to
regulations.
Documents enclosed with the
application may be the original or copies certified by the imported
establishment.
2. Procedures for application
a) Any establishment wishing to
import veterinary drugs shall prepare and send an application for quality
inspection by post or directly to the inspecting authority;
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If the sampling is required, the
importing establishment may transport the products to the place stated in the
application for testing, keep the current conditions of the product unchanged
but must not carry out the manufacture, trade or use of such products and wait
for the testing results according to regulations;c) Regarding veterinary drugs
subject to sampling for quality testing as prescribed in clause 6 Article 34 if
this Circular, within 02 working days when the satisfactory application is
received, the testing authority shall conduct physical testing accoring to the
form specified in Annex XXXVIII enclosed with this Circular, check the
documents according to regulations in clause 4 Article 34 of this Circular and
collection samples for quality testing.
Within 05 working days, applicable to
veterinary drug materials, medicinal products, chemicals and bioproducts, or 14
days, applicable to vaccines and antibodies which are tested for the sterility
or purity and safety; 60 days, applicable to vaccines/antibodies which are
tested for the effect since samples are collected for quality testing, the
testing authority shall notify the testing results using the form specified in
Annex XXXIX enclosed with this Circular to the importing establishment and the
customs authority to serve as the basis for following customs clearance
procedures for the batch of product.
If the samples are unsatisfactory,
the testing authority shall notify the importing establishment of the testing
results. Within 05 working days from the date of notification, if the importing
establishment does not make any complaint about the testing results, the
testing authority shall propose functional agencies to handle according to
regulations.
3. Any violations committed during
the testing period shall be handled according to regulations in Article 36 of
the Law on Product and goods quality.
Article 36.
State inspection regarding quality of veterinary drugs being sold
1. Inspection authority
a) Department of Animal Health shall
conduct inspection of quality of veterinary drugs nationwide;
b) Provincial veterinary authorities
shall conduct quality inspection at veterinary drug stores under management.
2. Contents and proceduers for
inspection of quality of veterinary drugs being sold shall be in accordance
with regulations in Circular No. 26/2012/TT-BKHCN dated December 12, 2012 by
the Ministry of Science and Technology.
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1. Pursuant to an international
treaty or an agreement regarding veterinary drug with veterinary medicine
authorities of different countries, the Department of Animal Health shall decide
the formulation of the inspectorate, plan and contents of on-site inspection at
veterinary drug-producing establishments at exporting countries.
2. Funding for the inspection shall
be provided annually by the State budget according to current regulations and
other funds according to laws.
Article 38.
State inspection regarding quality of exported veterinary drugs
1. Inspection authority: Department
of Animal Health
2. Subject and contents of inspection
a) Veterinary drugs shall be tested
before exporting according to the application of the exporting establishment
and at the request of the registration authority;
b) Exported veterinary drugs which
are unsatisfactory and sent back shall be tested according to regulations in
clauses 4, 5 and 6 Article 33 of this Circular.
3. Bases for inspection: applied
standards; regulations of the importing country, the contract or the
international treaty or the mutual recognition arrangement on conformity
assessment results signed with another country/region.
4. Application for inspection of
quality of exported products on request shall consist of:
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b) Applied standards, criteria to be tested;
c) The certificate
of analysis of the product issued by an appointed veterinary
drug testing agency for the criteria to be tested (the
original or a copy certified by the enterprise).
5. Procedure for inspection of
quality of exported products
a) The applicant shall send an
application for exported product quality inspection directly or by post to the
Department of Animal Health;
b) Within 05 working days from the
day on which the satisfactory application is received, the Department of Animal
Health shall appraise the application and notify the results using the form on
Annex XLI enclosed with this Circular.
Chapter VI
PROCEDURES FOR
RECALLING AND RESTRUCTION OF VETERINARY DRUGS
Article 39.
Procedures for recalling of veterinary drugs
1. Any competent agency discovering a
veterinary drug subject to recalling according to regulations in clause 1
Article 105 and clause 1 Article 106 of the Law on veterinary medicine shall
immediately affix seal and request a competent authority to issue a decision to
recall such veterinary drug.
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a) Regarding veterinary drug samples
collected at the producing/exporting/importing establishment (hereinafter
referred to as establishment)
Within 10 days, applicable to
pharmaceutical products, chemicals or bioproducts, or 60 days, applicable to
vaccines/antibodies, from the date of sampling, the Department of Animal Health
shall notify the establishment of the results of testing of the veterinary drug
sample and request the establishment to immediately recall the unconformable
veterinary drug batch itselt. Within 05 working days form the day on which the
notification from the Department of Animal Health is received, the
establishment may make a complaint with the Department of Animal Health about
the results of the test of the veterinary drug sample. Past this time limit, if
the establishment does not make any complaint, the Department of Animal Health
shall issue a decision to nationwide recall the unconformable veterinary drug
batch/es.
In case of complaint, the Department
of Animal Health shall collect samples of veterinary drugs for re-test. If the
result of the re-test still shows the unconformity, the Department of Animal
Health shall issue a decision to nationwide recall the unconformable veterinary
drug batch/es. If the result of the re-test shows the conformity, veterinary
drugs from the tested batch/es shall continue to be sold;
b) Regarding samples of veterinary
drugs collected at trading establishments in provinces or central-affiliated
cities:
Within 10 days, applicable to
pharmaceutical products, chemicals or bioproducts, or 60 days, applicable to
vaccines/antibodies, from the date of sampling, the sampling authority shall
notify the establishment trading, producing or importing such veterinary drug
of the testing result and immediately seal the unconformable veterinary drug batch/es.
Within 05 working days from the date on which the notification is received, the
establishment may make a complaint with the sampling authority of the testing
result. Past this time limit, if the establishment does not make any complaint
or the result of the re-test shows the unconformity, the sampling authority
shall issue a decision to recall products in the province/city and notify the
Department of Animal Health and the establishment producing or importing such
batch/es of veterinary drugs.
When receiving the notification of
the unconformable veterinary drug batch/es from the sampling authority, the
Department of Animal Health shall collect samples at the producing/importing
establishment for re-test. If the re-test result shows the unconformity, the
veterinary drug batch/es at the producing/importing establishment shall be
sealed. Within 05 working days from the date on which the notification is
received, the establishment may make a complaint with the Department of Animal
Health of the testing result. Past this time limit, if there is no complaint
made, the Department of Animal Health shall issue a decision to nationwide
recall the drug batch/es.
3. The producing/importing/trading
establishment whose veterinary drug products are recalled shall conduct the
recalling itself according to the decision to recall issued by the competent
authority. After recalling drugs, the establishment shall report the recalling
result to the authority issuing the recalling decision.
4. Regaridng veterinary drugs subject
to nationwide recalling, the Department of Animal Health shall issue a decision
to recall and post a notification of the recalling on its web portal within 24
hours. Provincial veterinary authorities shall supervise the recalling
activities within their management.
5. Regaridng veterinary drugs subject
to provincial recalling, provincial veterinary authorities shall issue
decisions to recall and post notifications of the recalling on their web portal
within 24 hours and shall take responsibility for supervising the recalling
activities within their management.
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1. Veterinary drugs with the
certificate of free sale in Vietnam whose labels are unconformable to laws or
which are not conformable to the registered quality standards, the
establishments in charge of such drugs shall carry out the recalling and
treatment as follows:
a) The recalling or destruction shall
be imposed on veterinary drugs violating drug quality of level 1, including:
the active ingredient is unconformable to the registration; the drug is quality
is changed about form (such as being curdy, turbid, transformed color,
deposited sediments, bedded, transformed shape); the drug does not contain or
contain fully main active ingredients stated on the label; the vaccine fails to
fullfil any of the 3 conditions: sterility or purity, safety and effectiveness;
the drug is urgently recalled according to the decision of a foreign authority
for imported drugs;
b) The recalling, recycling and
re-release shall be imposed on veterinary drugs violating drug quality of level
2, including: the drug fails to fullfil any of the registered criteria for
quality standards (organoleptic conditions; physical or chemical conditions;
bacterial contamination level, the sterility level; the content of drug is ±10%
exceeding the acceptable amount written on the label or the content of
probiotics is 90% less than the amount written on the label, applicable to
drugs containing probiotics; the net weight or the real volumetric exceeds the
limit prescribed by the current pharmacopoeia);
c) Recall and remedy the incorrect
labels, applicable to veterinary drugs with labels unconformable to laws on
labels;
d) If a veterinary drug specified in
point b of this clause cannot be recycled and re-released, it shall be
destroyed.
3. The veterinary drug establishment
whose products are subject to destroyed must carry out the destruction
according to regulations regarding hazardous waste management in laws on
environmental protection and must pay all the cost for such destruction.
4. Competent agencies shall be
responsible for issuing decisions to destroy veterinary drugs and decisions to
establish the veterinary drug-destroying council. The council shall comprise a
presiding agency, representatives of veterinary authorities, representatives of
resources and environment agencies.
Chapter VII
ADVERTISING
VETERINARY DRUGS
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1. An advertisement of a veterinary
drug shall include the following information, except cases specified in clause
2 of this Article:
a) Commercial name, formulation of
drug;
b) Uses and indications of use and
storage of veterinary drugs;
c) Name, address of organization/individual
registering or distributing drugs.
2. Advertisements for veterinary
drugs which are displayed on boards, plates, panels, shelves, other objects,
objects which are overhead, underwater, mobile objects, electronic equipment,
terminal devices and other telecommunication devices, means of transport,
advertisement transmittors are not required to displayed fully the compulsory
information.
3. Veterinary drug advertisement
contents shall by certified by a competent authority specified in Article 42 of
this Circular.
Article 42.
Competence in issuing a certificate of veterinary drug advertisment contents
1. The Department of Animal Health
shall issue the Certificate of advertisement content verification for press,
web portals, electronic equipment, terminal devices and other telecommunication
devices, printed products, audio and video recordings and other technological
devices of the Central government which are nationwide published.
2. Provincial veterinary authorities
shall issue the Certificate of advertisement content verification for
advertisements displayed via:
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b) Advertising boards, banners,
signboards, light box, advertising screens;
c) Means of transport;
d) Fairs, seminars, conferences,
events, exhibitions, cultural and sport programs;
dd) Advertisement transmittors,
advertisement objects;
e) Other means of advertising as
prescribed in laws.
Article 43.
Procedures for issuance of the certificate of advertisment content verification
for veterinary drugs
1. Submission of application
a) An application shall be sent directly
or by post to a competent agency as prescribed in Article 42 of this Circular;
b) Quantity of application: 01.
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a) An application form for verification
of veterinary drug using the form in Annex XLII enclosed
with this Circular;
b) A copy of the certificate of
registration of veterinary drug;
c) The advertisements (content, form
of advertising presented with images, sound, voice, letters, symbols, colors,
light and the like);
d) A list of speakers containing
information about their qualifications or academic ranks, applicable to
advertisements showed at fairs, seminars, conferences, events, exhibitions,
cultural/sport programs (which bears a seal of the enterprise).
3. Appraisal of application and
issuance of the certificate of advertisment content verification for veterinary
drugs
a) Within 05 working days from the
day on which the application for certificate of veterinary drug advertisement
contents, if the application is unsatisfactory, a competent agency specified in
Article 42 of this Circular shall notify the applicant for completion;
b) Within 10 days from the day on
which the satisfactory application is received, a competent agency specified in
Article 42 of this Circular shall issue the Certificate of advertisement
content verification for veterinary drugs using the form provided in Annex
XLIII enclosed with this Circular. If the application is refused, the competent
agency shall make a written response containing the explanation.
Chapter VIII
RESPONSIBILITIES
OF RELEVANT PARTIES
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1. Direct and provide guidance
pertaining to profession on the management of veterinary drugs; conduct tests
of the quality of veterinary drugs at producing, exporting, importing or
trading establishments.
2. Conduct appraisal of the
application, conduct assessment and grant recognition for establishments
eligible to manufacture or import veterinary drugs.
3. Conduct appraisal of the application,
issue the license for testing veterinary drugs.
4. Conduct appraisal of application,
issue the Certificate of free sale for veterinary drugs.
5. Conduct inspection/test of
veterinary drugs, conduct inspection of the implementation of responsibilities
and powers of agencies affiliated to the Department of Animal Health and
provincial veterinary authorities in the management of veterinary drugs.
Formulate annual plan for quality inspection of veterinary drugs which are
being sold.
6. Every year, formulate and send a
plan on management and supervision of antibiotics materials which are imported
for producing veterinary drugs to the Ministry of Agriculture and Rural
development for approval.
7. Receive and conduct appraisal of
veterinary drug advertisement contents within the management as prescribed in
clause 1 Article 42 of this Circular; issue the Certificate of advertisement
content verification.
Article 45.
Agencies affiliated to the Department of Animal Health
1. Conduct quality inspection of veterinary
drugs which are imported and are being sold.
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3. Supervise the test of veterinary
drugs according to the license for testing veterinary drugs; verify the reports
of results of veterinary drug testing.
Article 46.
Provincial veterinary authorities
1. Conduct quality inspection of
veterinary drugs within management according to regulations.
2. Provide training, disseminate law
provisions on manufacture, trade and use of veterinary drugs for relevant
organizations and individuals.
3. Supervise the testing of
veterinary drugs (excluding vaccines/antibodies) according to the license for
testing veterinary drugs; verify the reports of results of veterinary drug
testing.
4. Conduct appraisal of the
application for registratioon, conduct assessment and grant recognition for
establishments eligible to trade veterinary drugs.
5. Receive and conduct appraisal of
veterinary drug advertisement contents within the management as prescribed in
clause 2 Article 42 of this Circular; issue the Certificate of advertisement
content verification.
6. Every 6 months, report the
situation of trade, quality inspection and use, the results of inspection and
the handling of violations pertaining to veterinary drugs under the management
to the Department of Animal Health and report annually or irregularly at the
request of of the Department of Animal Health.
Article 47.
Applicant for permission to conduct veterinary drug testing
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2. Conclude a contract for veterinary
drug testing with a testing establishment and fully comply with such contract.
Article 48.
Applicant for registration of veterinary drug
1. Take responsibility to law and
consumers for the quality of veterinary drugs it manufactured, traded or
distributed.
2. Facilitate the inspection of
competent agencies.
3. Report the situation of
manufacture and trade of veterinary drugs to the authority on request.
4. Notify the authority in charge of
animal healthcare of the dissolution or non-manufacture of the registered
products, as the case may be.
5. Be the transferee of reseach
findings, testing results, product's propriety according to laws on
intellectual property and other relevant legal documents.
Article 49.
Establishments producing, trading, importing veterinary drugs
1. Any manufacture establishment
shall fulfill conditions specified in Article 90, clause 2 Article 91 of the
Law on veterinary medicine and Articles 12 and 13 of Decree No. 35/2016/ND-CP
dated May 15, 2016.
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3. Any importing establishment shall
a) Fulfill conditions
specified in Article 94, clause 2 Article 95
of the Law on veterinary medicine and Articles 18 of
Decree No. 35/2016/ND-CP dated May 15, 2016.
b) Only sell veterinary drug
materials to establishments eligible to trade veterinary drug materials,
establishments eligible to manufacture veterinary drugs; must not sell
veterinary drug materials to veterinary drug stores, common people or
farming/aquaculture establishments.
Chapter IX
ORGANIZATION OF
IMPLEMENTATION
Article 50.
Implementary clause
1. This Circular comes into effect
from July 19, 2016.
2. This Circular annuls the following
provisions:
a) Regulations about testing of
veterinary drugs provided for in Decision No. 18/2002/QD-BTS dated 03/6/2002;
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c) Article 1 of Circular No.
20/2011/TT-BNNPTNT dated 06/4/2011 by the Ministry of Agriculture and Rural
development;
d) Articles 19, 20 and 21 of Circular
No. 04/2015/TT-BNNPTNT dated 12/02/2015 by the Ministry of Agriculture and
Rural development;
dd) Article 2 of Circular No.
10/2016/TT-BNNPTNT dated 01/6/2016 by the Ministry of Agriculture and Rural
development.
3. This Circular replaces the
following documents:
a) Circular No. 02/2009/TT-BNN dated 14/01/2009
by the Ministry of Agriculture and Rural development;
b) Circular No. 03/2009/TT-BNN dated
14/01/2009 by the Ministry of Agriculture and Rural development;
c) Decision No. 71/2007/QD-BNN dated
06/8/2007 by the Ministry of Agriculture and Rural development;
d) Decision No. 98/2007/QD-BNN dated
03/12/2007 by the Ministry of Agriculture and Rural development;
dd) Decision No. 72/2007/QD-BNN dated
06/8/2007 by the Ministry of Agriculture and Rural development;
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g) Decision No. 10/2006/QD-BNN dated
10/02/2006 by the Ministry of Agriculture and Rural development;
h) Decision No. 99/2007/QD-BNN dated
03/12/2007 by the Ministry of Agriculture and Rural development;
i) Circular No. 51/2009/TT-BNNPTNT
dated 21/8/2009 by the Ministry of Agriculture and Rural development;
k) Circular No. 07/2012/TT-BNNPTNT
dated 13/02/2012 by the Ministry of Agriculture and Rural development;
l) Circular No. 08/2012/TT-BNNPTNT
dated 13/02/2012 by the Ministry of Agriculture and Rural development;
m) Circular No. 33/2011/TT-BNNPTNT
dated 06/5/2011 by the Ministry of Agriculture and Rural development.
Article 51.
Transitional provisions
1. Any application for testing,
processing or selling veterinary drugs which is submited before the effective
date of this Circular shall be processed according to regulations in Decision
No. 10/2006/QD-BNN dated 10/02/2006 by the Ministry of Agriculture and Rural
development, Decision No. 71/2007/QD-BNN dated 06/8/2007 by the Ministry of
Agriculture and Rural development, Circular No. 08/2012/TT-BNNPTNT dated
13/02/2012 by the Ministry of Agriculture and Rural development and amendments
thereof.
2. The management of bioproducts,
microorganisms, chemicals and/or minerals used in aquaculture as prescribed in
Circular No. 23/2015/TT-BNNPTNT dated 22/6/2015 by the Ministry of Agriculture
and Rural development shall be carried out as follows:
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b) Products which are permitted to be
sold shall continue to be sold until the expiry date on the license for sale or
continue to be sold for 05 years as from the date of license (applicable to
license without expiry date). The application for reissuance or extension shall
comply with regulations in points c or d clause 2 of this Article.
c) For antiseptics and products used for
pasteurizing or disinfecting which have active ingredients specified in Annex
XLIV enclosed with this Circular, comply with regulations in this Circular
since this Circular comes into effect;
d) For products other than those
specified in point c of this clause which are used for disintegrating organic
substance, producing natural food, stabilizing raising environment or adding
minerals, comply with regulations on management of animal feed since this
Circular takes effect.
3. For products specified in part C
Annex IC enclosed with Circular No. 10/2016/TT-BNNPTNT dated 01/6/2016 by the
Ministry of Agriculture and Rural development promulgating a List of veterinary
drugs permitted to be marketed and banned from use in Vietnam, and announcement
of HS codes of imported veterinary drugs permitted to be marketed in Vietnam:
a) For antiseptics and
products used for pasteurizing or disinfecting which have active ingredients
specified in Annex XLIV enclosed with this Circular, continue to comply
with regulations in the Law on veterinary medicine and this
Circular.
b) Products other than those
specified in point a of this clause may be sold until the expiry date written
on the certificate of permission for sale, then regulations in point d clause 2
of this Article shall be applicable.
4. If an establishment producing or
trading products containing active ingredients prescribed in Annex XLIV
enclosed with this Circular has not obtained the certificate of eligibility to
product or trade veterinary drugs or the GMP certificate, within 12 months from
the day on which this Circular comes into effect, such establishment shall
apply for the certificate of eligibility to manufacture/trade veterinary drugs
according to regulations in the Law on veterinary medicine and this Circular.
Article 52.
Organization of implementation
Difficulties that arise during the
implementation of this Circular should be reported to the Ministry of
Agriculture and Rural development for consideration and solution./.
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P.P.
THE MINISTER
THE DEPUTY MINISTER
Vu Van Tam
ANNEX VIII
SUMMARY
OF PRODUCT CHARACTERISTICS
(Enclosed with the Circular No. 13/2016/TT-BNNPTNT dated June 02, 2016 by the
Minister of Agriculture and Rural development)
SUMMARY
OF PRODUCT CHARACTERISTICS
1. Name of product
2. Dosage form of product
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4. Composition, contents of active
ingredients and excipients in the formula of the product
5. Pharmacodynamic and pharmacokinetic
characteristics of the product
6. Indications
7. Dosage, usage and administration
route
8. Warning
a) Notes;
b) Interaction with other drugs,
other types of interaction;
c) Side effects when using
according to the instructions and dosage regimen of the product;
d) Side effects upon overdose and
handling measures (if any);
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e) Contraindications
9. Warning provided for drug users
for prevention of and treatment for animal diseases
10. Time to stop using drugs
11. Information about drug usage
a) Expiry date (before and/or after
the first time of opening of the product);
b) Storage conditions;
c) Characteristics and capacity of
the product's package;
d) Guidance on the reduction of
unused parts of the product.
12. Name and address of the manufacturer.
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[REPRESENTATIVE
OF ORGANIZATION/INDIVIDUAL]
(Signature, full name and seal)