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法規名稱(Title) Veterinary Drugs Control Act Ch
公發布日(Date) 2016.11.09
法規沿革(Legislative) 1.Promulgated on August 16, 1971
2.Article 2, 15, 19, 22, 25, 26, 29, 30 and 46 were amended and
promulgated on June 19, 2002.
3.Article 3-1, 3-2, 7, 12, 12-1 to 12-4, 16, 16-1, 18, 18-1, 23,
24, 32, 32-1 to 32-3, 40 and 41 were amended and promulgated on
December 18, 2002.
4.Article 34, 37, 38 and 45 were deleted; article 26, 32-3, 33,
35, 36, 39, 40 and 41 were amended and promulgated on
December 3, 2008.
5.Article 12-3 was deleted; Articles 12, 14, 26, 33, 35, 36, 40
and 43 were amended and promulgated on January 23, 2013; Articles
14-1 and 14-2 were added and promulgated on January 23, 2013.
6.Articles 1, 3, ,3-1, 5, 12-2, 14, 16, 16-1, 19, 20, 21, 24, 32-1
to 33, 39, 40 to 43 were amended and promulgated on November 9,
2016; Articles 14-3, 19-1, 40-1, and 40-2 were added and
promulgated on November 9, 2016.
法規內文(Content)

Article 1
This Act is enacted to improve the quality of veterinary drugs,
to enhance animal health, and to foster a robust livestock industry.


Article 2
The term “competent authority ” in this Act refers to one of
the following: the Council of Agriculture of the central government;
or the municipal government of a special municipality, or a
city/county at the local level; hereinafter “municipal competent
authority” for the two preceding items.


Article 3
The term “veterinary drug” refers to one of the following substance
in the form of bulk chemical compound, formulated preparation,
or over the counter drug:
3.1 Biologics specifically made for preventing and treating animal
diseases based on microbiology, immunology or molecular biology. 
3.2 Antibiotics specifically made for preventing and treating
animal diseases. 
3.3 Diagnostics announced and designated by the central competent
authority for the diagnosis of animal diseases.
3.4 Drugs other than those in Sections 3.1 to 3.3 to enhance or
regulate animal physical functions specifically for preventing
and treating animal diseases.


Article 3-1
3-1.1 The term “formulated preparation” in this Act refers to
a veterinary drug formulated from bulk chemical compounds and
prepared into a specific form and dosage.   
3-1.2 Categories of formulated preparations are to be declared
by the central competent authority.
3-1.3 Some formulated preparations require a prescription by a
veterinarian (or a veterinarian assistant); the others do not.
3-1.4 Regarding prescription drugs mentioned in Section 3-1.3,
the category names, sales terms, usage, entries in the prescription,
mandatory bookkeeping for storage and sales, and other guidelines
are to be prescribed by the central competent authority.


Article 3-2
The term “new drug” in this Act refers to a veterinary drug that
has been reviewed and recognized by the central competent authority
as associated with new ingredients, new combinations, new indications,
new routes of drug delivery, new dosage forms, or formulated
preparations of new usage and dosage.


Article 4
The term “counterfeit veterinary drug” in this Act refers to a
drug – after testing – found to:
4.1 have been manufactured without government approval,
4.2 relpacing or mixing ingredient of an existing product,
4.3 show a defaced or altered expiration date,
4.4 contain ingredients whose name is not consistent with what
have been approved, and
4.5 have failed to affix the seal of approval required by Article
18.


Article 5
5.1 The term “banned veterinary drug” in this Act refers to the
one in either of the following situations:
5.1.1 Declared by the central competent authority that its
manufacturing, dispensing, importation, exportation, sales, or
display is prohibited,
or
5.1.2 Imported without a permit. However, a drug can be exempt if
it is other than a biologic described in Section 3.1, brought in
by a tourist or member of transport service staff for use in one’s
own pet, and compliant with guidelines about specific drug categories,
dosage forms and quantities.
5.2 The guidelines about specific categories, dosage forms and
quantities in Section 5.1.2 are to be declared by the central
competent authority in collaboration with the Ministry of Finance.


Article 6
6.1The term “substandard veterinary drug” in this Act refers to
a veterinary drug that had been approved for registration but –
upon subsequent testing – found to:
6.1.1 contain ingredients of a quality, quantity or strength not
conforming to stipulated standards,
6.1.2 contain some or all ingredients that are contaminated or
have degraded,    
6.1.3 exceed the expiration date, or
6.1.4 make assertions that are inconsistent with approved indications.
6.2 The standards mentioned in Section 6.1.1 are to be prescribed
by the central competent authority.


Article 7
7.1 The term “veterinary drug manufacturer” in this Act refers
to an entity engaged in manufacturing and processing of veterinary
drugs, wholesale and exportation of such products, and importation
of materials for its own use.
7.2 The criteria, procedure, guidelines, and other items to comply
with – for veterinary drug manufacturers to apply for importation
of self-use materials – are to be prescribed by the central competent
authority.
7.3 Unless approved by the central competent authority, such
imported-for-self-use materials must not be assigned or resold to
a third party.


Article 8
The term “veterinary drug dealer” in this Act refers to an entity
engaged in the wholesale, retail sale, importation and exportation
of veterinary drugs.


Article 9
The term “label” in this Act refers to an identification article
with text, picture or symbol affixed on the container or package
of a veterinary drug.


Article 10
The term “package insert” in this Act refers to the instruction
sheet that comes with the veterinary drug.


Article 11
The term “seal of approval” in this Act refers to a seal (such
as a sticker) to seal off a veterinary biologics to indicate the
drug has passed testing and inspection, therefore approved by the
central competent authority.


Article 12
12.1 To apply for product registration and license to manufacture
or import veterinary drugs, one shall submit documents (about
ingredients, functionality, essential manufacturing process, assay,
and relevant information or certificates) along with samples (of
the label, package insert and drug) and fees (for the license and
testing) to the central competent authority. One must not begin
to manufacture or import the drug until the license is obtained. 
12.2 Guidelines for product registration in Section 12.1– its
review process, license-related matters (the change, renewal,
reissuance, replacement, annulation, and other items to comply
with thereof) and rules to follow– are to be prescribed by the
central competent authority.
12.3 The central competent authority may cite Good Manufacturing
Practice (GMP) for veterinary drugs as a criterion for the issuance
or renewal of manufacture/import licenses. The Good Manufacturing
Practice (GMP) for veterinary drugs is to be prescribed by the
central competent authority.   
12.4 The review criteria and procedure for a made-for-export-only
manufacture license may be simplified made less onerous; however,
the veterinary drug thus produced must not be sold domestically or
used for other purposes.
12.5 Before a new drug is approved for product registration, it
shall be subject to safety and efficacy tests conducted by the
central competent authority itself or an accredited agency delegated
by the said authority; the applicant for product registration shall
bear the cost of such tests; the testing methodology is to be
prescribed by the central competent authority.


Article 12-1  
A veterinary drug license shall contain the following information:    
12-1.1 License number,
12-1.2 Name of the veterinary drug,
12-1.3 Names and addresses of the manufacturer and/or importer,
12-1.4 Name and address of the person in charge,
12-1.5 Name and address of the manufacturing factory,
12-1.6 Dosage form and packaging,
12-1.7 Name and the amount of each active ingredient,
12-1.8 Indications,
12-1.9 Other information required by the central competent authority.

 
Article 12-2
12-2.1 The label and package insert of a veterinary drug shall
contain the following information as approved:
12-2.1.1 It is for animal use,
12-2.1.2 Name and address of the manufacturer/importer,
12-2.1.3 Drug name and license number,
12-2.1.4 Name and level of each active ingredient, route of drug
delivery, and dosage,
12-2.1.5 Indications,
12-2.1.6 Side effects, contradiction and other signs to watch for,
12-2.1.7 Withdrawal period (the time between the last drug use
and human consumption),
12-2.1.8 Manufacture date and lot number,
12-2.1.9 Shelf life or expiration date, and
12-2.1.10 Other information required.
12-2.2 Some of the entries listed in Section 12-2.1 may be omitted
if so declared and approved by the central competent authority. 


Article 12-3
(Deleted)


Article 12-4
Regarding fees charged by competent authorities – for license
document, testing, inspection and so on – according to this Act,
the fee scales are to be prescribed by the central competent
authority.


Article 13
Once approved for registration, a manufactured or imported
veterinary drug must not change the entries on its registration
unless so approved by the central competent authority.


Article 14
14.1 A license to manufacture or import veterinary drugs is valid
for a maximum of five years; entities intending to continue to
manufacture or import shall apply with the central competent
authority for renewal two to six months before expiration date;
such renewal may not exceed five years each; licenses are rendered
invalid if no renewal is sought on expiration date or the renewal
is denied; such invalidated licenses are to be declared by the
central competent authority in a government gazette.
14.2 During the valid period of a license described in Section
14.1, the central competent authority may – for protection of
animal and human health or other major concerns – re-evaluate
the specific licensed veterinary drug and restrict its usage and
scope; when necessary a license described in Section 14.1 may be
annulled.
14.3 For the review of importation license application, renewal,
re-evaluation cited in Section 14.2, or for actual needs, the
central competent authority may send personnel to the specific
veterinary drug’s overseas manufacturing factory for verification;
expenses incurred shall be governed by relevant regulations, and
be borne by the entity importing the said drug.


Article 14-1
14-1.1 The central competent authority shall reject the application
for product registration, license renewal or change to registration
if false information or document has been submitted by the applicant
(the veterinary drug manufacturer or importer); in case an approval
has been granted, the specific veterinary drug license shall be
revoked.     
14-1.2 The central competent authority shall ignore any follow-up
application by the entity (involved in conducts described in Section
14-1.1) for a period of two yeas starting from the date of application
rejection or license revocation.


Article 14-2
When there is a concern for animal or human health over a veterinary
drug whose license has been annulled or revoked, the central
competent authority may order the veterinary drug manufacturer or
dealer to recall or destroy the said veterinary drug by a set
deadline.


Article 14-3
14-3.1 Sample veterinary drugs from trial production by academic
research institutes or veterinary drug manufacturers – with
central competent authority’s prior approval –– may be exempt
from seeking product registration and/or license; an exclusive
label issued by the central competent authority shall be affixed
to the container of sample drug indicating that it has been
approved for trial production and it must not be used for other
purposes.
14-3.2 Field study of a sample veterinary drug described in Section
14-3.1 shall not start until an approval of the central competent
authority is obtained.
14-3.3 Guidelines for the sample veterinary drug in Section
14-3.1(its application procedure, required documents, criteria
for approval, the trial production facility and how to affix the
label) and guidelines for the field study in Section 14-3.2
(application procedure, required documents, criteria for approval)
and rules to follow are to be prescribed by the central competent
authority.


Article 15
When there is an outbreak, or an imminent outbreak, of a notifiable
animal infectious disease, the central competent authority may take
emergent measures to order or approve (without lengthy reviews)
the manufacture or importation of veterinary biologics.


Article 16
16.1 Veterinary drugs shall be produced in a facility exclusively
for making drugs for animal use. However, a facility approved by
the central competent authority for trial-production described in
Section 14-3.1 may be exempt from this requirement.  
16.2 A veterinary drug factory shall be set up in compliance with
establishment standards for veterinary drug factories, and conduct
factory registration in compliance with relevant regulations.
16.3Standards for establishing veterinary drug factories in Section
16.2 are to be prescribed by the central competent authority in
collaboration with the central industry regulatory authority.


Article 16-1
16-1.1 A veterinary drug manufacturer shall obtain central competent
authority’s approval before giving or taking consignment to make
veterinary drugs.
16-1.2 Qualification and criteria to give or take the said
drug-making consignment in Section 16-1.1, the approval procedure,
and relevant guidelines are to be prescribed by the central
competent authority.


Article 17
A facility making veterinary biologics shall have veterinarians
on staff, whereas a facility making antibiotics or regular
veterinary drugs shall have pharmacists on staff to supervise
drug production.


Article 18
18.1 After veterinary biologics are produced or have cleared the
customs with all tariffs paid, the manufacturer or importer shall
apply to the municipal competent authority for batch-by-batch
sample testing; such a drug may not be sold until it has passed
sample testing and inspection and is secured with the seal of
approval by personnel dispatched from the relevant competent
authority.    
18.2 Regulations governing the inspection in Section 18.1 are to
be prescribed by the central competent authority.


Article 18-1
18-1.1 The municipal competent authority shall notify the applicant
if the drug has failed the test in Article 18; the applicant may
pay a re-test fee to apply for a re-testing – allowed only once
– within fourteen days of the notice.
18-1.2 Regarding the disqualified veterinary drugs, the municipal
competent authority may (1) supervise destruction of the goods
should the original applicant fails to seek re-inspection within
the time limit in Section 18-1.1, or (2) require the original
importer to return the goods by a specific deadline.  


Article 19
19.1 A veterinary drug dealer shall initiate business registration
only after a veterinary drug dealer license is obtained from the
local municipal competent authority.
19.2 The license in Section 19.1 is valid for a maximum of five
years; an entity intending to continue to deal shall apply with
the local municipal competent authority for renewal within two
to six months before expiration date; such renewal may not exceed
five years each time; a license becomes invalid if no renewal is
sought on expiration date or the renewal is denied;
19.3 Regarding veterinary drug dealer license in Sections 19.1-19.2,
regulations governing the license (qualification and criteria for
application; issuance, replacement, reissuance, renewal, annulation,
mandatory entries of the license), changes to business registration,
facilities required at the business venue, and other rules to
follow are to be prescribed by the central competent authority.
19.4 A veterinary drugs shall display or sell only veterinary
drug from a dealer or manufacturer of a veterinary drug that can
verify the sources.      


Article 19-1    
19-1.1 Presentation, promotion and advertisement of a veterinary
drug is to be performed by veterinary drug manufacturers or dealers
only.
19-1.2 The presentation, promotion and advertisement of a veterinary
drug in Section 19-1.1 must not claim, suggest or insinuate
ingredients or efficacy that are false or exaggerated beyond the
scope of the drug’s product registration.
19-1.3 Non-veterinary drugs must not be presented, promoted or
advertised as capable of preventing or treating animal diseases,
or enhancing or regulating animal physiological functions.
19-1.4 Interviews, news reports or promotions – that suggests or
insinuates the efficacy of preventing or treating animal diseases,
or enhancing or regulating animal physiological functions – are
deemed as advertisements defined in Sections 19-1.1 to 19-1.3.


Article 20
A veterinary drug shall have the label affixed onto it and be
accompanied with the package insert. However, specific drugs –
for which the central competent authority’s approval is sought
and obtained to use other options for labeling and package insert
– may be exempt from this requirement.      


Article 21
21.1 A veterinary drug dealer must not repack drugs into smaller
sizes. However drugs imported in large packs is exempt if (1)
central competent authority’s prior approval is sought and
obtained – and (2) meeting the following conditions:
21.1.1 to be repackaged by a registered veterinary drug factory,
21.1.2 to be sold under the original brand name,
21.1.3 indicating the name and address of the re-packer besides
the labeling and package insert required in Article 22-2, and
21.1.4 to be sealed with a label specifically for repacked goods. 
21.2 The municipal competent authority shall send personnel to
supervise the repackaging in Section 21.1.


Article 22
22.1 When hiring a sales person, the employer (a veterinary drug
manufacturer or dealer) shall register the employee with the
municipal competent authority and revise the registered information
whenever there is a change.
22.2 A veterinary drug sales person must not promote products not
manufactured or distributed by his employer; he must not peddle
products out of a street stand, break the seal of veterinary drugs,
repack the goods or make false claims for promotion purposes.


Article 23
23.1 Veterinary drugs used for samples or complimentary gifts –
though imported with an approval – must not be sold for a price.
23.2 Veterinary drugs with existing import license or under import
control must not be named on an import application under the
pretense of samples or gifts. 
23.3 Rules governing samples and gifts in Section 23.1 are to be
prescribed by the central competent authority.


Article 24
Veterinary drugs approved for manufacturing shall require export
licenses if to be shipped abroad; the veterinary drug manufacturer
shall file the application for an export license with the central
competent authority in advance.


Article 25
25.1 The municipal competent authority shall dispatch personnel
to inspect the premises and equipment of a veterinary drug
manufacturer – regarding its manufacturing process, apparatus,
quality control and record-keeping – on a regular basis.   
25.2 When necessary, the central competent authority may send
personnel to conduct spot-checking within the scope set in Section
25.1.
25.3 When the competent authority arrives to conduct an inspection
or a spot-checking, the veterinary drug manufacturer must not
refuse without due cause.
25.4 If the municipal competent authority decides there are still
rooms for improvement after the inspection described in Section
25.1, it shall inform the entity to rectify the issues before a
set deadline; failure to rectify may result in a report to central
competent authority seeking an order to suspend the entity’s
production of part or all veterinary drugs at the factory. Continued
production – despite a suspension order – may result in a report
to central competent authority seeking to annul the entity’s
veterinary drug manufacture license. 

 
Article 26
26.1 The competent authority may send personnel to the premises
of an entity – a veterinary drug manufacturer or dealer,
veterinarian care facility, or a user of veterinary drugs – and
may obtain samples at the original price for quality inspection.
26.2 The competent authority may send personnel to animal farms
(of livestock, poultry and aquaculture) and feed factories to
audit the use of veterinary drugs, and may conduct biopsies on
some animals.
26.3 Regarding the sampling, audit and biopsy in Sections 26.1
and 26.2, the entities (veterinary drug manufacturers and dealers,
veterinary care facilities, farms of livestock, poultry and
aquaculture) must not evade, obstruct or refuse such reqests.
26.4 After the competent authority’s inspection and/or testing,
if an entity (a veterinary drug manufacturer or dealer, veterinary
care facility, farm of livestock, poultry or aquaculture, or feed
manufacturer) is found to have used veterinary drugs not compliant
with this Act, the entity may be ordered to provide relevant
information.
The entity must not evade, obstruct, refuse the order or provide
false information.


Article 27
Veterinary drug inspector shall identify oneself with an
identification badge/paper when performing tasks describe in
Sections 25.1, 25.2 and 26.1.


Article 28
28.1 Regarding suspicious counterfeit, banned or substandard
veterinary drugs pending sampling verification, the competent
authority shall seal them off for the related entity to sign an
affidavit to take them into custody.
28.2 The samples taken in Section 28.1 shall be subject to
verification and disposal as soon as possible – no later than
two months after the date suspicious drug is uncovered.


Article 29
Regarding substandard veterinary drug uncovered under this Act,
(1) if it is made domestically and – upon inspection – can be
modified and made usable, the municipal competent authority shall
send personnel to supervise the original manufacturer to modify
the drug before a set deadline; (2) if it is imported with approval,
the authority shall have it sealed and put in custody while the
central competent authority orders the importer to initiate a
goods-for-return process with the original overseas manufacturer.


Article 30
Besides disposing of dubious veterinary drugs – deemed counterfeit,
banned or substandard after audit or testing – as stipulated in
this Act, the party involved shall be dealt with as follows: 
30.1 Regarding the entity that manufactures, imports or repackages
counterfeit/banned veterinary drugs, or the one provides licenses
for others to do so, the original license-issuing agency may annul
all the entity’s veterinary drug licenses or dealership license.
30.2 Regarding the entity that displays or stockpiles
counterfeit/banned veterinary drugs to sell or having intent to
sell, the municipal competent authority is to publicize the (1)
name and address of the entity, (2) name and address of the person
in charge, (3) names of the drugs and (4) specifics of the offense.
For a repeat offender, the original license-issuing agency may
annul all the entity’s veterinary drug licenses or dealership
license.
30.3 Regarding the entity that deals with (manufactures, imports
or repackages; displays or stockpiles to sell or intent to sell
substandard drugs, the municipal competent authority is to publicize
the (1) name and address of the entity, (2) name and address of the
person in charge, (3) names of the drugs and (4) specifics of the
offense. Regarding a major or repeat offender, the original
license-issuing agency may annul each specific veterinary drug
license or dealership license. 


Article 31
Whistle blowers shall be rewarded for offering information to uncover
counterfeit, banned and substandard veterinary drugs. Rules governing
the reward are to be prescribed by the central competent authority.


Article 32
Regarding the usage of veterinary drugs (target animal, purpose,
route of drug delivery, dosage, withdrawal period and precautions
to take), users shall abide by usage guidelines prescribed by the
central competent authority.


Article 32-1
Bulk chemical compound material shall only be supplied or sold to
veterinary drug manufacturers making drugs containing such a
material.
However, bulk chemical compound material imported with central
competent authority’s approval may be sold to a veterinary drug
dealer to be resold to a veterinary drug manufacturer making drugs
containing such a material; each batch of material can be resold
only once.


Article 32-2
32-2.1 By the end of each January and July, veterinary drug
manufacturers and importers shall compile and submit data (drug
type, quantity produced or imported, quantity sold, and customer
names) to the municipal competent authority for the record, and
also retain the data for three years.
32-2.2 By the end of each February and August, municipal competent
authorities shall summarize and submit the data in Section 32-2.1
to the central competent authority.


Article 32-3
32-3.1 Animal farmers (of livestock, poultry and aquaculture) and
feed manufacturers must not use any of the following formulated
preparations or drugs on animals or in animal feed:
32-3.1.1 Counterfeit veterinary drugs described in Sections 4.1,
4.2 or 4.4,
32-3.1.2 Banned veterinary drug,
32-3.1.3 Formulated preparations for animal use but of dubious
origin (besides those cited in Sections 32-3.1.1 and 32-3.1.2),
32-3.1.4 Formulated preparations for human use, or
32-3.1.5 Bulk chemical compound materials for veterinary or human
drugs.
32-3.2 In either of the following situations, the animal or product
must not be moved, assigned to a third party, or supplied for
slaughtering, food processing or human food.
32-3.2.1 An animal (livestock, poultry or aquaculture) found to
contain specific banned veterinary drugs in a pre-market test, or
32-3.2.2 Other than the situation above, an animal (livestock,
poultry or aquaculture) or animal product (milk, egg or edible
parts thereof) that fails to meet the standards for veterinary
drug residues in a pre-market test. 
32-3.3 An animal described in Section 32-3.2 may be re-tested by
the municipal competent authority if such an application is filed.
For animals in Section 32-3.3.1, one shall apply for re-testing
within a certain time limit. Regarding animals for which no
re-testing is sought within the time limit, or those fail the
re-test, the municipal competent authority shall order the
(livestock, poultry or aquaculture) farmer to dispose of – by
rendering, composting, destruction or necessary measure – the
animal within seven days.
32-3.4 The owner of animals/products described in either situation
in Section 32-3.2 shall clearly mark the animal/product for easy
differentiation.
32-3.5 Details about the “specific banned veterinary drugs”
(Section 32-3.2.1), time limit” (Section 32-3.3) and “marking
method” (Section 32-3.4) are to be declared by the central
competent authority.
32-3.6 The fee for re-testing in Section 32-3.3 shall be compliant
with relevant regulations, and to be borne by the specific
(livestock, poultry or aquaculture) farmer.


Article 33
33.1 The person making or importing counterfeit/banned veterinary
drugs – except for the one described in Section 5.1.2 – shall
be subject to a prison term of one to seven years, and a fine of
under NT$4.5 million.
33.2 The person causing human death due to the offense in Section
33.1 shall be subject to life sentence or a prison term of over
seven years; or a prison term of three to ten years if the offense
leads to severe injury.
33.3 The person committing the offense in Section 33.1 out of
negligence is subject to a prison term of under three years, penal
servitude or a fine of under NT$ 500,000.
33.4 The person/entity having attempted the act in Section 33.1
is subject to penalty.   


Article 34
(Deleted)


Article 35
35.1 The person handling counterfeit or banned veterinary drugs
– repacking, selling, transporting, holding for oneself or others,
brokering, assigning to a third party, or displaying/caching with
intent to sell – is subject a prison term of six months to five
years, and may also be fined up to NT$5 million.
35.2 The person committing the offense in Section 35.1 causing
human death is subject to a prison term of over seven years; or a
prison term of one to seven years if the offense leads to severe
injury.
35.3 The person committing the offense in Section 35.1 due to
negligence is subject to a prison term of under two years, penal
servitude or a fine of under NT$300,000.
35.4 The person/entity having attempted the act in Section 35.1
is subject to penalty.


Article 36
36.1 The person manufacturing or importing substandard veterinary
drugs is subject to a fine of NT$60,000 to NT$300,000.
36.2 The person handling substandard veterinary drugs – repacking,
selling, transporting, holding for oneself or others, brokering,
assigning to a third party, or displaying/caching with intent to
sell – is subject to a fine of NT$30,000 to NT$150,000.


Article 37
(Deleted)


Article 38
(Deleted)


Article 39
39.1 A person in any of the following situations is subject to a
fine of NT$200,00 to NT$1 million:
39.1.1 Violation of Section 14-3.1, namely using trial-produced
sample veterinary drugs for other purposes.
39.1.2 Violation of Section 14-3.2, namely proceeding to field
study without the central competent authority’s approval.
39.1.3 Violation of Section 19-1.1 or 19-1.2, namely conducting
drug presentation, promotion or advertisement without approval.
39.1.4 Violation of Section 19-1.3, namely branding, promoting
or advertising non-veterinary drugs for animal use. 
39.1.5 Violation of Section 32-3.1 by a feed manufacturer, namely
using the drugs or formulated preparations listed there on animals
or in animal feed.
39.2 A second violation within one year of Section 32-3.1 by a
feed manufacturer – namely using drugs or prepared formulation
listed in Section 32-3.1.1 to 32-3.1.4 on animals or in animal
feed – is subject to a fine of NT$1.5 million to NT$7.5 million.
39.3 A person whose act described in Section 39.1.1, 39.1.2,
39.1.5 or 39.2 causing harm to human health is subject to a prison
term of under seven years, and may also be fined from NT$2.5
million to NT$10 million.
39.4 Regarding the offender of Sections 39.1.5 or 39.2, the
competent authority shall publicize the name and address of the
entity, name of the person in charge and specifics of the offense.


Article 40
40.1 A fine of NT$90,00 to NT$450,000 is to be imposed for any of
the following offenses:
40.1.1 Violation of Section 3-1.4 by someone other than a livestock,
poultry or aquaculture farmer, namely failure to follow rules about
prescription drug in Section 3-1.4 – sales terms, usage, entries
and retention of prescription records, and/or mandatory sales data.
40.1.2 Violation of Section 7.3, namely assigning or reselling
for-self-use material to a third party without approval.
40.1.3 Violation of Section 12.4, namely selling for-export-only
veterinary drug on the domestic market, or using it for other
purposes.
40.1.4 Violation of Article 13, namely making statements different
from those in original drug registrations.
40.1.5 Violation of Articles 14-2, 20, 24, and Section 25.3, or
a non-farmer violating Section 26.3.
40.1.6 Violation of Section 14-3.1, namely failure to affix the
exclusive label issued by the central competent authority on the
container of trial-produced sample veterinary drug.
40.1.7 Violation of guidelines – about the exclusive sample drug
label and field study venue – prescribed according to Section
14-3.3.
40.1.8 Violation of standards – for the structure, environment,
equipment, utility and measures of a facility (factory or venue
for operation, inspection or storage) – prescribed according to
Section 16.3.
40.1.9 Violation of Section 16-1.1, namely giving drug-making
assignment to, or taking such assignment from, another veterinary
drugs manufacturer without approval of the central competent
authority.
40.1.10 Violation of Article 17, namely failure to hire in-house
veterinarians or pharmacists as required.
40.1.11 Violation of Section 19.1, namely engaging in the business
without a license.
40.1.12 Violation of regulations prescribed according to Section
19.3 to govern the license (seeking change to and placement
thereof), sales people (issuance of ID badges and wearing/presenting
guideline), major event notification (business termination,
resumption or suspension), drug management technician (qualifications
and training), business venue (environment and equipment), drug
handling (storage, transport, manipulation, record-keeping, duty
of disclosure, notification of adverse events), and sales data
submission.
40.1.13 Violation of Section 19.4, namely displaying or selling
veterinary drugs of dubious origin – not from legitimate
veterinary drug dealer or manufacturer – or without any proof
of origin.  
40.1.14 Violation of Section 21.1, namely repacking veterinary
drugs into smaller portions.
40.1.15 Violation of Section 23.1, or regulations prescribed
Section 23.3 to govern samples and complimentary gifts such as
marking, access to a logbook, record keeping and retention.
40.1.16 Non-farmers’ violation of guideline prescribed according
to Article 32 to govern drug usage (target animal, purpose, route
of drug delivery, dosage, withdrawal period and precautions to
take), user qualifications, access to a logbook, record keeping
and retention.
40.1.17 Violation of Article 32-1 or Section 32-2.1
40.2 The person committing the offense in Section 40.1.5 –
specifically Section 14-2: causing harm to human health – is
subject to a prison term of under seven years, and may also be
fined NT$2.5 million to NT$10 million.
40.3 The person violating Section 26.4, namely evading, obstructing
or refusing to provide information, or providing false information,
about the source of veterinary drugs that contravene this Act,
is subject to a fine of NT$30,00 to NT$150,000.   


Article 40-1
40-1.1 An animal farmer (of livestock, poultry or aquaculture) in
any of the following situations is subject to a fine of NT$60,00
to NT$300,000:
40-1.1.1 Violation of Section 32-3.1, namely using drugs or
formulated preparations in Section 32-3.1.1 to Section 32-3.1.4
on animals or in animal feed.
40-1.1.2 Violation of Section 32-3.2.1, namely moving, assigning
to a third party, or supplying (for slaughter, food processing,
or human food) the animal.
40-1.1.3 Violation of Section 32-3.3, namely failure to follow
municipal competent authority’s order to do disposal (rendering,
compost, destruction or other action) within seven days.
40-1.2 An animal farmer’s repeat offense of Section 32-3.1 within
one year – namely using the drug or formulated preparation in
Sections 32-3.1.1 to 32-3.1.4 on animal or in animal feed – is
punishable with a fine of NT$500,000 to NT$2.5 million.
40-1.3 The person committing the offense in Section 40-1.1.1,
40-1.1.2, or 40-1.2 causing harm to human health is subject to a
prison term of under seven years, and may also be fined NT$2.5
million to NT$10 million.
40-1.4 Regarding the offender of Section 40-1.1.1 or 40-1.2, the
competent authority shall publicize the name and address of the
entity, name of the person in charge, and specifics of the offense.


Article 40-2
40-2.1 An animal farmer (of livestock, poultry or aquaculture) in
any of the following situations is subject to a fine of NT$30,000
to NT$150,000:
40-2.1.1 Violation of regulations prescribed according to Section
3-1.4 to govern sales condition and usage of prescription drugs,
or retention of prescription records.
40-2.1.2 Violation of Section 26.3.
40-2.1.3 Violation of guidelines prescribed according to Article
32 to govern drug usage (target animal, purpose, route of drug
delivery, dosage, withdrawal period and precautions to take),
user qualifications, access to a logbook, record keeping and
retention. 
40-2.1.4 Violation of Section 32-3.1.5, namely using bulk chemical
compound materials (for veterinary or human drug) on animal or
in animal feed.
40-2.1.5 Violation of Section 32-3.2.2, namely moving, assigning
to a third party, or supplying (for slaughter, food processing
or human food) the animal or product.
40-2.1.6 Violation of Section 32-3.4, namely failure to mark the
dubious animal/product in the manner designated by the central
competent authority.
40-2.2 Regarding the offender in Sections 40-2.1.1 to 40-2.1.4,
the competent authority shall publicize the name and address of
the entity, name of the person in charge, and specifics of the
offense.


Article 41
The person in any of the following situations is subject to a
fine of NT$100,000 to NT$500,000:
41.1 Violation of Article 12-2, namely failure to list pre-approved
entries on the label or package insert.   
41.2 Failure to follow central competent authority’s order issued
according to Article 15 without due cause.
41.3 Violation of Section 22.1, namely performing sales/promotional
tasks without having registered with local competent authority,
or violation of Section 22.2.
41.4 Violation of Section 28.1, namely refusing to sign the affidavit
to take custody.


Article 42
If an individual commits any offense from Article 33 to Article
38 while performing job duty on behalf of another party – as the
representative of a legal entity, or as the agent, employee or
hired help of a legal entity or natural person – besides punishing
the responsible individual for the specific offense, the (underlying)
legal entity or natural person is also subject to the corresponding
fine. 


Article 43
Substandard veterinary drugs uncovered under this Act – if not
modified or returned by a deadline set according to Article 29
– may be confiscated for destruction.


Article 44
Insistent refusal to pay a fine imposed under this Act will be
referred to the court for compulsory execution.


Article 45
(Deleted)


Article 46
Monetary fines in this Act are to be imposed by the municipal
competent authority.


Article 47
Enforcement rules of this Act are to be prescribed by the central
competent authority.


Article 48
This Act takes effect on the date of promulgation.