THE
NATIONAL ASSEMBLY
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|
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
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|
No:
34/2005/QH11
|
Hanoi,
June 14, 2005
|
LAW
ON PHARMACY
Pursuant to the 1992 Constitution
of the Socialist Republic of Vietnam, which was amended and supplemented under
Resolution No. 51/2001/QH10 of December 25, 2001, of the X th
National Assembly, the 10 th session;
This Law provides for activities in the domain of pharmacy.
Chapter I
GENERAL PROVISIONS
Article 1.- Governing scope and subjects of application
1. This Law
provides for drug trading; drug registration and circulation; drug use; drug
supply; drug information and advertisement; clinical trial of drugs; management
of habit-forming drugs, psychotrops, pre-substances used as drugs and
radioactive drugs; drug quality standards and drug assay.
2. This Law
applies to domestic and foreign agencies, organizations and individuals in
Vietnam.
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Article 2.- Interpretation of terms
In this Law,
the following terms shall be construed as follows:
1. Pharmacy
means drugs and drug-related activities.
2. Drugs mean
substances or mixtures of substances for human use for purposes of prophylaxis,
therapy or diagnosis of disease or modification of physiological functions of
human bodies, and consist of finished drugs, raw materials for drug
manufacture, vaccines and medical biological products other than functional
foods.
3. Vaccines
mean preparations containing antigens that provoke immune responses of human
bodies, and used for the purpose of prophylaxis.
4. Medical
biological products mean products of biological origin used for the purposes of
prophylaxis, therapy and diagnosis of human diseases.
5. Raw
materials for drug manufacture means substances constituting products in the
process of drug manufacture.
6.
Pharmaceutical ingredients (also called active ingredients) mean substances or
mixture of substances with therapeutic activity, which are used in drug
manufacture.
7. Finished
drugs mean medicinal product forms that have undergone all stages of
manufacture, including packaging in their final containers and labeling.
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Drugs
containing pure active ingredients extracted from materia medica, drugs being a
combination of materia medica and synthetic chemical active ingredients are not
called drugs from materia medica.
9.
Traditional medicaments mean drugs prepared from materia medica under theories
and by methods of traditional medicine of oriental countries.
10.
Prescription drugs mean those which may cause hazards to human life or health
if they are used not in accordance with indications of prescribers; require
specific prescriptions when being dispensed, retailed or used; and are included
in the list of prescription drug groups.
11.
Non-prescription drugs mean those which, when being dispensed, sold or used,
require no specific prescription.
12.
Habit-forming drugs means those which, when being used for a prolonged period,
may form bad habits, and are included in the list of habit-forming drugs
promulgated by the Health Minister and compliant with treaties to which the
Socialist Republic of Vietnam is a contracting party.
13.
Psychotrops mean drugs which have effects on the central nervous system, may
lead to users’ dependence if not used properly, and are included in the list of
psychotrops promulgated by the Health Minister and compliant with treaties to
which the Socialist Republic of Vietnam is a contracting party.
14. Pre-substances
used as drugs mean chemicals which are indispensable to the process of
preparation and manufacture of habit-forming drugs or psychotrops, are used as
formula components of habit-forming drugs or psychotrops, and included in the
list of pre-substances promulgated by the Health Minister and compliant with
treaties to which the Socialist Republic of Vietnam is a contracting party.
15.
Radioactive drugs mean those containing one or more radioactive substances, and
used for diagnosis or treatment of disease.
16. Essential
drugs mean those satisfying healthcare demands of a vast majority of people,
and included in the list of essential drugs promulgated by the Health Minister.
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18. New drugs
means those containing new pharmaceutical ingredients or those with a new
combination of pharmaceutical ingredients already in circulation.
19. Specifics
mean drugs having trade names given by manufacturing establishments and
different from original names or international generic names.
20. Adverse
reactions of drugs mean undesirable effects of drugs harmful to health, which
may appear at normal doses.
21. Expiry
date of drugs means use duration fixed for a specific lot of drug, after which
such drug is no longer permitted for use.
22. Drug
quality standards include regulations on criteria, technical requirements,
assay methods, packaging, labeling, transportation, preservation and other
requirements related to quality of drugs.
Drug quality
standards are expressed in the form of technical documents.
23. Drugs of
inferior quality mean those which are not up to quality standards already
registered with competent agencies.
24.
Counterfeit drugs mean products manufactured in any form of drug with a
deceitful intention, and falling into one of the following cases:
a/ They have
no pharmaceutical ingredients;
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c/ They have
pharmaceutical ingredients different from those listed in their labels;
d/ They
imitate names and industrial designs of drugs which have been registered for
industrial property protection of other manufacturing establishments.
25. Drug
trading means the performance of one, a number or all of the stages of the
investment process, from manufacture to sale of drugs or provision of
drug-related services in the market for profit-making purposes.
26. Pharmacy
practice means the use of pharmaceutical qualifications of individuals for drug
trading.
27. Good
practice means sets of principles and standards promulgated by the Health
Ministry for manufacture, preservation, assay and circulation of drugs, and
culture, cultivation, harvest and processing of materia medica.
28. Pre-clinical
drug trial means scientific activities of studying the effects of drugs in
order to evaluate and prove the effectiveness and safety of drugs on animals,
as a procedural step for clinical trial.
29. Clinical
drug trial means scientific activities of systematically studying the effects
of drugs on human beings for the purpose of determining clinical effectiveness,
recognizing and detecting adverse reactions of studied products; the
absorption, distribution, metabolism and excretion of such products for the
purpose of ascertaining the safety and effectiveness of drugs.
30. Drug
information means activities of gathering and supplying information related to
drugs to organizations or individuals directly engaged in medical or
pharmaceutical activities or drug users.
31. Drug
assay means the sampling and examination of technical standards, performance of
corresponding and necessary tests for the purpose of determining whether or not
raw materials, semi-finished products or finished products meet the technical
standards before deciding to accept or reject such drugs.
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Article 3.- State policies on pharmacy
The State
shall materialize the following policies on pharmacy:
1. To develop
pharmacy into a spearhead techno-economic branch, and prioritize the
development of the pharmaceutical industry.
Projects on
application of advanced technologies to manufacture of drugs, raw materials for
drug manufacture, main drugs, drugs as substitutes for imported drugs, drugs
for prevention and treatment of social diseases, vaccines, medical biological
products, drugs from materia medica and traditional medicaments shall enjoy the
investment preferences provided for by law;
2. To
encourage organizations and individuals at home and broad as well as overseas
Vietnamese to conduct scientific research into preparation technologies and
biotechnologies for manufacturing new drugs; to invest in production of raw
materials for drug manufacture and finished drugs suitable to the disease
structure and drug use demands of people;
3. To
encourage research into and inheritance of traditional medicine recipes and
experiences, and harmoniously combine traditional medicine and modern medicine
as well as pharmacy; to explore, exploit and use new materia medica and export
materia medica; to materialize policies on preferences and supports for culture
and planting of materia medica, rational exploitation of natural materia
medica, thus ensuring the preservation and development of genetic sources of
materia medica; to modernize the manufacture of drugs from materia medica;
4. To provide
drug-related supports in appropriate forms to social policy beneficiaries,
areas inhabited by ethnic minority people, areas being under particularly
difficult socio-economic conditions and areas under difficult socio-economic
conditions;
5. To develop
a network of circulation, distribution and supply of drugs, thus ensuring
sufficient quality drugs to meet the people's drug use demands;
6. To protect
lawful rights and interests of organizations and individuals in drug research,
trading and use in Vietnam.
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1. The State
sets up a national reserve of drugs for use for the following purposes:
a/ Preventing
and combating diseases and epidemics, and overcoming consequences of natural
calamities or catastrophes;
b/
Maintaining defense and security;
c/
Contributing to stabilizing the drug market.
2. The
setting up, organization, management, administration and use of the national
drug reserve shall comply with the provisions of law.
Article 5.- State management over drug prices
1. The State
manages drug prices on the principle that drug-manufacturing, exporting,
importing or trading establishments shall fix prices by themselves, compete
with one another in price and bear responsibility therefor before law; and
takes measures to stabilize market prices of drugs in service of public
healthcare.
2. The
Government stipulates in detail the management of drug prices suitable to the
socio-economic situation in each period on the following principles:
a/ Drugs,
before being circulated in the market, must have their prices declared or
re-declared in case of any change thereof by manufacturing or importing
establishments with competent state agencies, ensuring that drug prices at home
are not higher than drug prices in regional countries which have healthcare and
commercial conditions similar to Vietnam's;
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c/ Drug
wholesale or retail prices must be posted up;
d/ Competent
state agencies shall publicly announce declared drug prices; and periodically
announce ceiling prices of drugs paid with the state budget and medical
insurance;
e/ The Health
Ministry shall assume the prime responsibility for, and coordinate with the
Finance Ministry, the Industry Ministry, the Trade Ministry, the Planning and
Investment Ministry and other concerned state agencies in, performing the state
management over drug prices as assigned by the Government.
Article 6.- Agencies in charge of state management over pharmacy
1. The
Government performs the unified state management over pharmacy.
2. The Health
Ministry is answerable to the Government for performing the state management
over pharmacy.
3. Ministries
and ministerial-level agencies shall have to coordinate with the Health
Ministry in performing the state management over pharmacy under the
Government's assignment.
4. People's
Committees at all levels perform the state management over pharmacy within
their respective localities, as decentralized by Government.
Article 7.- Pharmacy inspectorate
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The
organization, functions, tasks and powers of the pharmacy inspectorate shall
comply with the provisions of law on inspection.
Article 8.- Pharmaceutical societies and associations
1.
Pharmaceutical societies and associations are socio-professional organizations
of pharmacists and persons engaged in pharmacy.
2.
Pharmacists and persons engaged in pharmacy have the right to join and found
pharmaceutical societies and associations.
3. The
organization and operation of pharmaceutical societies and associations shall
comply with the provisions of law.
Article 9.- Prohibited acts
1. Trading in
drugs without certificates of satisfaction of drug trading conditions.
2. Practicing
pharmacy without pharmacy practice certificates.
3. Trading in
drugs of unidentified origins, counterfeit drugs, drugs of inferior quality,
expired drugs, drugs on the list of drugs banned from import, drugs subject to
clinical trials, drugs not yet permitted for circulation, sample drugs used for
registration or introduction to medical doctors.
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5. Supplying
untruthful information on or making untruthful advertisements for drugs,
causing consumers' confusion; advertising drugs in contravention of historical
and cultural traditions, ethics, fine traditions and customs of the Vietnamese
nation.
6. Selling
drugs at places which are not lawful drug-selling establishments.
7. Taking
advantage of monopoly in drug trading to earn illicit profits, dumping drugs,
raising drug prices in contravention of law.
8. Conducting
drug sale promotion in contravention of law.
9. Selling
drugs belonging to national target programs and aid drugs which are not for
sale according to regulations; drugs supplied as humanitarian aid and
non-commercially imported drugs.
10. Retailing
prescription drugs without prescription.
11. Taking
advantage of drug prescription to seek personal benefits.
12.
Destroying precious materia medica sources.
13. Other
acts which are strictly prohibited in pharmaceutical activities according to
the provisions of law.
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DRUG TRADING
Section I. DRUG TRADING CONDITIONS
Article 10.- Forms of drug trading
Drug trading
covers drug manufacture, export, import, wholesale, retail, preservation
service and assay service.
Article 11.- Conditions and competence for granting
certificates of satisfaction of drug trading conditions
1. Drug
trading is a conditional business line. Drug-trading agencies, organizations
and individuals (hereinafter referred collectively to as drug-trading
establishments) must have certificates of satisfaction of drug-trading
conditions.
2. To be
granted certificates of satisfaction of drug-trading conditions, drug-trading
establishments must fully satisfy the following conditions:
a/ Having
material and technical foundations and personnel with professional
qualifications necessary for each form of drug trading;
b/ Having
pharmaceutically professional managers who have been granted pharmacy practice
certificates suitable to their trading forms.
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a/ The Health
Ministry shall grant certificates of satisfaction of drug-trading conditions to
establishments manufacturing drugs, providing drug preservation services or
drug assay services;
b/
Provincial/municipal Health Services shall grant certificates of satisfaction
of drug-trading conditions to establishments conducting drug trading in other
business forms, except for the cases specified at Point a of this Clause.
4. Competent
state agencies defined in Clause 3 of this Article shall have to grant
certificates of satisfaction of drug-trading conditions within thirty days
after receiving complete and valid dossiers. In case of refusal to grant
certificates, they must issue written replies clearly stating the reasons
therefor.
5. The
Government shall specify conditions for each form of drug trading; time limit,
dossiers, procedures for granting, supplementing, renewing, extending or withdrawing
certificates of satisfaction of drug-trading conditions.
Article 12.- Certificates of satisfaction of drug-trading
conditions
1. A
certificate of satisfaction of drug-trading conditions must clearly state the
name, address, professional manager, trading form and scope of the trading
establishment, and its valid term.
2. Drug
trading establishments may operate only at the already registered places and
within the trading scope already stated in their certificates of satisfaction
of drug-trading conditions. Where their trading scope is broadened or their
trading place is changed, they shall have to carry out procedures for
supplementing or renewing their certificates of satisfaction of trading
conditions.
Article 13.- Pharmacy practice certificates
1. To be
granted a pharmacy practice certificate, applicants must fully satisfy the
following conditions:
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b/ Having
practiced for at least between two and five years at a lawful pharmaceutical
establishment for each trading form;
c/ Possessing
professional ethics;
d/ Being
physically fit for practicing pharmacy.
2. The
following persons shall not be granted a pharmacy practice certificate:
a/ Those who are
banned from practicing pharmacy under court judgments or rulings;
b/ Those who
are being examined for penal liability;
c/ Those who
are serving criminal sentences or rulings of courts, or executing decisions on
application of administrative handling measures such as consignment into a
reformatory or medical treatment establishment, or administrative probation;
d/ Those who
are in the period of being disciplined in the form of caution or serving a
severer disciplining form for their violations related to the medical or
pharmaceutical profession;
e/ Those who
have lost civil act capacity or restricted civil act capacity.
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a/ The Health
Minister shall grant pharmacy practice certificates to individuals who register
to practice pharmacy with foreign investment capital;
b/ Directors
of provincial/municipal Health Services shall grant pharmacy practice
certificates to individuals who register to practice pharmacy, except for the
cases specified at Point a of this Clause;
4. The
Government shall specify professional diplomas and certificates and duration of
practice at pharmaceutical establishments for each form of drug trading;
dossiers and procedures for granting, renewing, extending and withdrawing
pharmacy practice certificates.
Article 14.- Fees for grant of certificates of satisfaction
of drug trading conditions and pharmacy practice certificates
Drug-trading
establishments applying for certificates of satisfaction of drug trading
conditions, and individuals applying for pharmacy practice certificates must
pay fees therefor according to the provisions of law.
Section II. CTURE
Article 15.- Rights of drug-manufacturing establishments
1. To enjoy
capital, land and tax preferences and other preferences for manufacture of
drugs in the domains specified in Article 3 of this Law and other relevant
provisions of law.
2. To supply
information on and/or make advertisements for drugs according to the provisions
of law on advertising for the purpose of introducing and promoting sale of
their products.
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Article 16.- Obligations of drug-manufacturing establishments
1. To comply
with regulations on good practice in drug manufacture, distribution, preservation
and assay, and relevant professional regulations.
2. To
manufacture drugs in strict accordance with the registered manufacture process
and quality standards; to report to competent state agencies on changes in the
manufacture process.
3. To bear
responsibility for the quality of drugs they manufacture and deliver from their
factories only drugs up to the registered quality standards.
4. To have
technical facilities and professional personnel satisfying requirements of
inspection of quality and management of drugs they manufacture.
5. To keep
samples of drugs in each manufacture lot for at least one year after the expiry
date of such drugs; documents on manufacture and other documents necessary for
the inspection and evaluation of all drug-manufacturing activities according to
the provisions of law.
6. To monitor
the quality of drugs they have manufactured and circulated in the market, and
to recover drugs according to the provisions of this Law.
7. To
register drugs; to declare drug prices before circulating such drugs in the
market.
8. To pay
damages to drug users in cases where damage is caused by their faults.
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Article 17.- Drugs prepared at drugstores, medical
examination and treatment establishments
1. Drugs
prepared according to prescriptions at drugstores and drugs prepared at medical
examination and treatment establishments shall not be subject to drug
registration but shall only be dispensed or retailed at such establishments.
Files on drug preparation must be kept for one year after such drugs are
prepared.
2. Owners of
drugstores, pharmaceutically professional managers of medical examination and
treatment establishments shall bear responsibility for the quality of drugs
prepared at their establishments; pay damages to drug users in case of damage
caused by errors in drug preparation.
Section III. DRUG EXPORT AND IMPORT
Article 18.- Rights and obligations of drug-exporting or
importing enterprises
1. To export,
import, entrust the export or import and undertake entrusted export or import
of drugs of types specified by the Health Ministry.
2. To comply
with regulations on good practice in drug preservation and distribution, and
declaration of drug prices.
3. To export
or import only drugs satisfying the quality standards; to monitor and bear
responsibility for the quality of drugs they have exported or imported for
circulation in the market.
4. To pay
damages to drug users in case of damage caused by their faults.
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Article 19.- Entrusted export or import of drugs
1.
Drug-trading establishments have the right to entrust export or import of
drugs.
2. The
entrustment of export or import of drugs shall comply with the provisions of
the Commercial Law and other relevant provisions of law.
Article 20.- Scope of import of drugs
1. Drugs with
registration numbers in Vietnam may be imported without quantity limitations,
except for vaccines, medical biological products and drugs on the list of drugs
subject to special control, as provided for in Article 63 of this Law.
2. Drugs
without registration numbers may be imported in specified quantities in the
following cases:
a/ They
contain pharmaceutical ingredients with or without registration numbers, which
are, however, insufficient to fully meet treatment needs;
b/ They are
imported to meet urgent needs of disease or epidemic prevention and combat,
overcoming of consequences of natural calamities or catastrophes, and special
treatment needs;
c/ They are
imported in service of national health programs;
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e/ They are
imported for clinical trials, for use as registration samples or for
exhibitions or trade fairs;
f/ They are
carried along for personal treatment;
g/ They are
imported in other non-commercial forms.
3. The Prime
Minister shall specify the import of drugs of types defined in Clause 2 of this
Article.
Section IV. WHOLESALE OF DRUGS
Article 21.- Drug wholesale establishments
Drug
wholesale establishments include:
1.
Drug-trading enterprises;
2.
Cooperatives or individual business households manufacturing or trading in
materia medica, traditional medicaments and/or drugs from materia medica;
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Article 22.- Rights of drug wholesale establishments
1. To
purchase raw materials for drug manufacture, finished drugs, vaccines or
medical biological products from drug-manufacturing or drug wholesale
establishments.
2. To sell
raw materials for drug manufacture, finished drugs, vaccines or medical
biological products to establishments with drug-trading functions and to
medical examination and treatment establishments.
Article 23.- Obligations of drug wholesale establishments
1. To
preserve drugs under the conditions stated in drug labels.
2. To keep
intact drug packing, not to change drug packing and labels. In cases where they
change labels or packing of drugs already registered, written authorization of
drug-manufacturing establishments and written approval of the Health Ministry
are required.
3. To assure
that the delivery, receipt and preservation of drugs are conducted by
professionally qualified persons.
4. To keep
vouchers and documents relating to each drug lot for at least one year after
the expiry date of drugs.
5. To post up
drug wholesale prices and comply with other regulations on drug price
management.
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7. To comply
with regulations on good practice in preservation, distribution or withdrawal
of drugs and other relevant provisions of law.
Section V. RETAIL OF DRUGS
Article 24.- Drug-retailing establishments
1.
Drug-retailing establishments include:
a/
Drugstores;
b/
Dispensaries;
c/ Drug sale
agents of enterprises;
d/ Drug
cabinets of health stations.
2. Medical
examination and treatment establishments and drug wholesale establishments
which wish to retail drugs must set up drug-retailing establishments.
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Article 25.- Professional qualifications of owners of
drug-retailing establishments or drug retailers
1.
Professional qualifications of owners of drug-retailing establishments are
stipulated as follows:
a/ Drugstores
must be owned by pharmacists of university degree;
b/
Dispensaries must be owned by pharmacists of intermediate or higher degree;
c/ Drug sale
agents of enterprises must be owned by persons having professional
qualifications of assistant pharmacist or higher qualifications;
d/ Drug
cabinets of health stations must be owned by persons having professional
qualifications of assistant pharmacist or higher qualifications; in the absence
of such a person, drug cabinets of health stations must be owned by persons
having professional qualifications of assistant doctor or higher
qualifications;
e/
Drug-retailing establishments, which are specialized in selling traditional
medicaments or drugs from materia medica, must be owned by pharmacists of
intermediate or higher degree or persons having diplomas or certificates of
traditional medicine or traditional pharmacy.
2. Drug
retailers at drug-retailing establishments defined at Points a, b, c and e, Clause
1 of this Article must have professional qualifications of assistant pharmacist
or higher qualifications; drug retailers at those defined at Point d, Clause 1
of this Article must be professionally qualified in medicine or pharmacy.
Article 26.- Operation scope of drug-retailing establishments
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a/ Drugstores
are allowed to retail finished drugs and prepare drugs according to
prescriptions;
b/
Dispensaries are allowed to retail finished drugs;
c/ Drug sale
agents of enterprises are allowed to retail drugs on the list of essential
drugs;
d/ Drug
cabinets of health stations are allowed to sell drugs on the list of essential
drugs used for commune-level healthcare establishments;
e/
Traditional medicament- and herbal drug-retailing establishments are allowed to
sell traditional medicaments and drugs from materia medica.
2.
Drug-retailing establishments defined at Points b, c, d and e, Clause 1 of this
Article are not allowed to sell habit-forming drugs and radioactive drugs.
Drug-retailing
establishments are not allowed to sell pharmaco-chemical raw materials for drug
manufacture.
3. The Health
Minister shall provide for conditions for drugstores to prepare drugs according
to prescriptions.
Article 27.- Rights of drug retailers and owners of
drug-retailing establishments
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a/ To retail
drugs to users;
b/ To refuse
to sell drugs when prescriptions are improperly made or drug buyers are
incapable of following necessary instructions;
c/ Drug
retailers who are pharmacists of university degree shall have the right to
substitute one drug with another having the same active ingredients,
preparation form and dose when buyers so agree;
d/ To
exercise the rights of an owner of a drug-retailing establishment within the
ambit of authorization.
2. Owners of
drug-retailing establishments shall have the following rights:
a/ The rights
defined at Points a and b, Clause 1 of this Article;
b/ To buy
drugs from drug wholesale establishments for retail, and to buy raw materials
for preparation of drugs according to prescriptions;
c/ To
authorize their staffs who have the equivalent or higher professional
qualifications to administer their establishments in their absence.
Article 28.- Obligations of drug retailers and owners of
drug-retailing establishments
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a/ To check
prescriptions before selling drugs;
b/ To clearly
write the names and concentrations of drugs on their packing when retailed
drugs are not contained in their outer packing;
c/ To sell
only drugs indicated in prescriptions, except for cases specified at Point c,
Clause 1, Article 27 of this Law;
d/ In cases
where drugs are substituted under the provisions at Point c, Clause 1, Article
27 of this Law, they are obliged to clearly write the names, contents,
concentrations, quantities and use methods of substitute drugs in prescriptions
and bear responsibility for such substitution;
e/ To be
answerable to owners of drug-retailing establishments for their acts within the
ambit of authorization.
2. Owners of
drug-retailing establishments shall have the following obligations:
a/ To
personally manage and administer all activities of their establishments;
b/ To post up
the time of selling drugs; to affix retail prices on products, except where
retail prices have been printed on products; not to sell drugs at prices higher
than posted-up prices;
c/ To be
responsible before law for all activities of their establishments, even in case
of authorization.
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Section VI. DRUG PRESERVATION SERVICES
Article 29.- Conditions on enterprises providing drug
preservation services
Enterprises
providing drug preservation services must attain the standards on good practice
in drug preservation.
Article 30.- Rights of enterprises providing drug
preservation services
1. To undertake
to preserve drugs for organizations and individuals under preservation
contracts.
2. To
transport and deliver drugs to organizations and individuals when so authorized
by service hirers.
3. To enjoy
charges for drug preservation services.
Article 31.- Obligations of enterprises providing drug
preservation services
1. To
preserve drugs according to preservation requirements inscribed on drug labels
and in contracts between parties.
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Section VII. DRUG ASSAY SERVICES
Article 32.- Conditions on enterprises providing drug assay
services
Enterprises
providing drug assay services must meet the standards on good practice in drug
assay. In cases where assay laboratories of drug-trading enterprises wish to
provide drug assay services, such enterprises shall have to carry out
procedures for adding the function of providing drug assay services to their
certificates of satisfaction of drug trading conditions as provided for by law.
Article 33.- Rights of enterprises providing drug assay
services
1. To assay
raw materials for drug manufacture, semi-finished drugs and finished drugs.
2. To notify
assay results of assayed drug samples.
3. To enjoy charges
for drug assay services.
Article 34.- Obligations of enterprises providing drug assay
services
1. To bear
responsibility for assay results of assayed drug samples.
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Chapter III
DRUG REGISTRATION AND
CIRCULATION
Article 35.- Drug registration
1. Bases for
drug registration includes:
a/ Results of
clinical trials of the effectiveness and safety of drugs, except for those
exempt from clinical trials defined in Article 55 of this Law;
b/ Technical
documents on drugs;
c/ Vietnam's
national policies on drugs.
2.
Establishments registering drugs must pay registration fee upon filing of
dossiers according to the provisions of law.
3. Within six
months after receiving complete and valid dossiers, the Health Minister shall
grant drug registration numbers. In case of refusal to grant registration
numbers, he/she shall have to reply in writing, clearly stating the reasons
therefor.
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Article 36.- Drug circulation
1. Drugs
circulated in the market must fully satisfy the following conditions:
a/ Being up
to the registered quality standards;
b/ Fully
satisfying requirements on labeling of drugs according to the provisions of
Article 37 of this Law and other provisions of law;
c/ Being
packed with materials and in a form as required to ensure drug quality;
d/ Having a
registration number, or having no registration number but being imported
according to the provisions at Points a and b, Clause 2, Article 20 of this
Law;
e/ Having
their prices declared according to the provisions of this Law; for imported
drugs, their prices must not be higher than those of drugs imported into
regional countries with the healthcare and commercial conditions similar to
those of Vietnam at the same time.
2. Home-made
drugs for national health programs and imported drugs specified at Points c, d,
e and f, Clause 2, Article 20 of this Law must be used for proper purposes and
objects; drug labels must comply with the provisions of Article 37 of this Law;
and retail packing of such drugs must be printed with the words "Not for
sale" except for cases defined at Point e, Clause 2, Article 20 of this
Law.
Article 37.- Labels of drugs circulated in the market
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a/ The names
of the drug;
b/ The
preparation form;
c/ The
composition of the drug;
d/ Packing
specifications;
e/ The name
and address of the manufacturing establishment;
f/ The
registration number, serial number of the manufacture lot, date of manufacture,
expiry date.
g/ Conditions
for drug preservation and other necessary information.
For specifics
which are composed of single substances, their original names or international
generic names must be shown below their specific names.
2. Drugs must
have use instructions in Vietnamese.
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1. Drugs
circulated in the market shall be withdrawn in the following cases:
a/ They are
not of the right categories due to mistakes in the course of dispensing,
delivery and receipt;
b/ They fail
to fully satisfy the conditions specified at Points a, b, c and d, Clause 1,
Article 36 of this Law;
c/ There are
drug withdrawal notices of manufacturing establishments or Vietnamese or foreign
agencies in charge of state management over pharmacy.
2. For cases
of drug withdrawal defined at Points b and c, Clause 1 of this Article, before
the withdrawal, there must be circulation termination decisions of the
Vietnamese agency in charge of state management over pharmacy.
3. Upon
receipt of drug withdrawal notices of manufacturing establishments or
circulation termination decisions of the Vietnamese agency in charge of state
management over pharmacy, drug-trading organizations or individuals, medical
examination and treatment establishments, drug prescribers and drug users shall
have to immediately terminate the trading, information, advertising,
prescription, dispensing and use of the drugs stated in withdrawal notices.
4.
Establishments importing, manufacturing, registering or supplying drugs shall
have to organize the withdrawal subject to circulation termination and pay
damages according to the provisions of law.
The agency in
charge of state management over pharmacy shall have to inspect the organization
of drug withdrawal.
5. The Health
Minister shall specify the order and procedures of drug withdrawal,
classification of withdrawal, scope of drug circulation termination and
disposal of withdrawn drugs.
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TRADITIONAL MEDICAMENTS
AND DRUGS FROM MATERIA MEDICA
Article 39.- Planting of medicinal herbs and raising of
medicinal animals
The planting
of medicinal herbs and rearing of medicinal animals and the process of
harvesting and exploiting their products for manufacture of drugs must comply
with the standards on good practice in, planting, rearing and harvesting of
materia medica.
Article 40.- Quality of materia medica
Materia
medica put in the manufacture and processing or weighed into traditional
medicament doses must satisfy the quality standards. Organizations and
individuals that supply materia medica must bear responsibility for the origin
and quality of such materia medica.
Article 41.- Preservation of materia medica
1. Materia
medica must be processed and preserved according to regulations after they are
exploited or harvested. The level of residues of plant protection chemicals and
preservatives must not exceed the permitted level.
The Health
Minister shall specify the conditions for processing and preservation of
materia medica and the permitted level of residues of plant protection
chemicals and preservatives in materia medica.
2. When
transported, materia medica must be packaged. Packing of materia medica must be
affixed with labels showing the names of materia medica, places of manufacture,
quality and packaging date.
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Traditional
medicine doctors, traditional medicine assistant doctors and herbalists working
at medical examination and treatment establishments are allowed to retail
traditional medicaments and drugs from materia medica at such medical
examination and treatment establishments.
Article 43.- Registration and circulation of traditional
medicaments and drugs from materia medica
1. The
registration of traditional medicaments and drugs from materia medica shall
comply with the provisions of Article 35 of this Law and the following regulations:
a/
Traditional medicaments and drugs from materia medica manufactured at home or
imported for circulation in the market must all be registered;
b/
Traditional medicament doses weighed according to prescriptions at traditional
medicine examination and treatment establishments, unprocessed materia medica
and processed pellets shall not have to be registered. Owners of retail
establishments or medical examination and treatment establishments must bear
responsibility for the quality of such types of drugs.
c/ The
circulation and withdrawal of traditional medicaments and drugs from materia
medica shall comply with the provisions of Articles 36 and 38 of this Law.
3. Drugs
which are combinations of materia medica and pure active ingredients extracted
from natural substances or synthetic chemical active ingredients shall comply
with the provisions of this Law and not be allowed to be registered as
traditional medicaments or drugs from materia medica.
Article 44.- Manufacture of traditional medicaments and drugs
from materia medica
1.
Establishments manufacturing traditional medicaments and drugs from materia
medica from the stage of preparing finished products to the stage of packaging
must abide by the regulations on good practice in manufacture of traditional
medicaments and drugs from materia medica, and comply with the provisions of
Section II, Chapter II of this Law.
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3. The Health
Minister shall promulgate a list and regulations on management of materia
medica containing toxic substances, habit-forming substances, psychotrops and
pre-substances.
Article 45.- Export, import, wholesale or retail of
traditional medicaments and drugs from materia medica
The export,
import, wholesale or retail of traditional medicaments and drugs from materia
medica shall comply with the provisions of Sections III, IV and V, Chapter II
of this Law.
Chapter V
PRESCRIPTIONS AND USE OF
DRUGS
Article 46.- Prescriptions
1.
Prescriptions serve as a lawful basis for the sale of drugs, dispensing of
drugs, preparation of drugs, weighing of drugs according to prescriptions and
use of drugs. The name of a drug written in a prescription must include its
original name or international generic name, except for drugs containing many
active ingredients.
2. The Health
Minister shall specify prescriptions, groups of prescription drugs and the sale
of drugs according to prescriptions.
Article 47.- Use of drugs
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2. When using
prescription drugs, drug users must strictly follow instructions given in
prescriptions. When using non-prescription drugs, drug users must strictly
follow written use instructions as well as instructions of drug retailers.
3. After
taking drugs, if their bodies show abnormal signs, drug users should promptly
notify the nearest medical establishments, drug prescribers or drug retailers
thereof for timely remedies.
4. Drug
prescribers and owners of drug-retailing establishments shall have to notify
competent health agencies of abnormal signs of drug users. Drug prescribers
shall be held responsible for drug prescriptions they have made up.
Chapter VI
SUPPLY OF DRUGS IN
MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS
Article 48.- Conditions for supply of drugs
1. The supply
of drugs in medical examination and treatment establishments must comply with
regulations on good practice in distribution and preservation of drugs and
other relevant provisions of law.
2. Drug
dispensers in medical examination and treatment establishments must dispense
drugs strictly according to medical orders or drug prescriptions, clearly write
the names and concentrations of drugs on their packing and give instructions to
drug users.
3. Doctors,
assistant doctors, nurses, midwives and convalescent attendants must not sell
drugs to patients, except for cases specified in Article 42 of this Law.
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1. Medical
examination and treatment establishments shall have to assure the supply of
sufficient quality drugs on the list of main drugs for use in medical
examination and treatment establishments in service of emergency, medical
examination and treatment needs at such establishments.
The Health
Minister shall promulgate a list of drugs for emergency needs and their dose
quantities, a list of main drugs for use in medical examination and treatment
establishments, and the supply of drugs in state-owned medical establishments,
except for the purchase of drugs mentioned in Clause 2 of this Article.
2. The
purchase of drugs on the list of main drugs by state-owned medical
establishments and drugs paid with the state budget shall comply with the
provisions of bidding law and ensure the following principles:
a/ Priority
shall be given to purchase of home-made drugs of the same types, equivalent
quality and at prices not higher than those of imported drugs;
b/
Bid-winning drug prices must not be higher than drug prices periodically
announced by competent state agencies according to the provisions of Point d,
Clause 2, Article 5 of this Law.
The Health
Minister shall coordinate with the Planning and Investment Minister and the
Finance Minister in guiding the purchase of drugs according to the provisions
of this Clause.
Article 50.- Preparation of drugs in medical examination and
treatment establishments
1. Medical
examination and treatment establishments which fully satisfy the criteria and
conditions for preparation of drugs shall be allowed to prepare drugs according
to prescriptions for their treatment needs according to the provisions of
Article 17 of this Law.
2. The Health
Minister shall provide for the criteria and conditions for preparation of drugs
in medical examination and treatment establishments.
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DRUG INFORMATION AND
ADVERTISEMENT
Article 51.- Drug information
1. Drug
information aims to provide instructions on rational and safe use of drugs to
medical workers and drug users.
2. Drug
information must be adequate, objective, accurate, truthful, easy to understand
and not misleading.
3.
Responsibilities for drug information are provided for as follows:
a/
Establishments manufacturing, buying, selling and supplying drugs are
responsible for supplying drug information to medical officials and workers and
drug users;
b/ Medical
establishments are responsible for disseminating and managing drug information
within their units;
c/ Medical
officials and workers are responsible for supplying relevant drug information
to drug users in the course of medical examination and treatment;
d/ The state
management agency in charge of pharmacy is responsible for publicizing
information on drugs.
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a/ Medical
examination and treatment establishments, medical officials and workers are
responsible for monitoring and reporting to persons in charge of such
establishments and agencies competent to manage drugs on adverse reactions of
drugs;
b/ In the
course of circulation of drugs, drug-manufacturing and distributing
establishments must monitor and report to persons in charge of such
establishments and agencies competent to manage drugs on adverse reactions of
drugs they have manufactured and distributed.
5.
Organizations and individuals providing drug information shall be held
responsible for such information.
6. The Health
Minister shall have to organize the drug information system and monitor adverse
reactions of drugs in order to assure the rational and safe use of drugs for
people; and regulations on activities of drug information in medical
establishments.
Article 52.- Drug advertisement
1. Drug
advertisement must be conducted by drug-trading establishments or advertising
service providers and comply with provisions of law on advertisement.
2. It is prohibited
to use material benefits, or take advantage of names of organizations and
individuals, assorted correspondence and clinical research results not yet
recognized by the Health Ministry and similar forms to advertise drugs.
Article 53.- Scope of drug advertisement
1.
Prescription drugs must not be advertised to the public in any form.
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a/ Having
active ingredients on the list of drugs permitted for advertisement on radio or
television, promulgated by the Health Ministry;
b/ Having
registration numbers in Vietnam which are still valid.
Chapter VIII
CLINICAL TRIALS
Article 54.- Drugs subject to clinical trial
1. New drugs
must be clinically tried.
2. Drugs
subject to clinical trial must satisfy the following requirements:
a/ Having
already been studied in the pre-clinical stage;
b/ Having a
stable preparation form;
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3. Labels of
drugs subject to clinical trial must have the words "Product for clinical
trial. Its use for other purposes is prohibited."
Article 55.- Drugs exempt from clinical trial
1. Drugs in
their original names.
2. Foreign
drugs which have not yet been granted numbers of registration in Vietnam but
have already been lawfully circulated for at least five years in such foreign
countries; have been widely used for many patients and certified as safe and
effective by competent state agencies of the countries of manufacture; have the
same way of taking, the same concentrations and indications in Vietnam
identical to indications in such countries.
3.
Traditional medicine recipes already recognized by the Health Ministry.
4. The Health
Minister shall specify cases where drugs are exempt from clinical trial or
exempt from a number of clinical trial stages.
Article 56.- Conditions of clinical trial participants
1. Clinical
trial participants must be volunteers, satisfy professional requirements and
enter into contracts with organizations undertaking to conduct clinical trials,
except for those who have restricted civil act capacity, lost civil act
capacity or no civil act capacity.
2. Where
clinical trial participants are minors or persons who have restricted civil act
capacity or lost civil act capacity, their representatives' consent is required
according to the provisions of law.
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Article 57.- Rights of clinical trial participants
1. To be
supplied with sufficient and truthful information on clinical trials before
such trials are conducted and possible risks.
2. To be compensated
for damage, if any, caused by clinical trials by organizations or individuals
having drugs subject to clinical trial.
3. To have
their relevant personal information kept secret.
4. To be free
from liability for unilateral termination of contracts for participation in
clinical trials.
5. To lodge
complaints or denunciations about law violations by organizations or
individuals having drugs subject to clinical trial or undertaking to conduct
clinical trial.
Article 58.- Rights of organizations or individuals having
drugs subject to clinical trial
1. To select
organizations satisfying requirements on material foundations and professional
personnel for clinical trial of drugs.
2. To own all
research results of clinically tried drugs.
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1. To apply
for written permits of the Health Minister before clinical trials are
conducted.
2. To pay
damages to clinical trial participants for risks caused by clinical trials
according to the provisions of law.
3. To enter
into contracts for clinical trials of drugs with organizations undertaking to
conduct such trials.
Article 60.- Rights of organizations undertaking to conduct
clinical trials of drugs
1. To be
supplied with drugs and money by organizations and individuals having drugs
subject to clinical trial strictly according to the provisions of law.
2. To use
research results of clinical trials of drugs according to agreements with
organizations or individuals having drugs subject to clinical trial.
Article 61.- Obligations of organizations undertaking to
conduct clinical trials of drugs
1. To comply
with regulations on good practice in clinical trials of drugs; to report on
clinical trial process and results and make urgent reports in case of necessity
to the Health Ministry.
2. To enter
into contracts for clinical trials of drugs with organizations and/or
individuals having drugs subject to clinical trial and with clinical trial
participants.
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1. Clinical
trials of drugs must be conducted through various stages of and comply with
regulations on good practice of clinical trial of drugs.
2. The Health
Minister shall specify the conditions, dossiers, order and stages of clinical
trial of drugs.
Chapter IX
MANAGEMENT OF
HABIT-FORMING DRUGS, PSYCHOTROPS, PRE-SUBSTANCES USED AS DRUGS AND RADIOACTIVE
DRUGS
Article 63.- Drugs on the list of drugs subject to special control
1.
Habit-forming drugs, psychotrops, pre-substances used as drugs and radioactive
drugs are those on the list of drugs subject to special control.
2. The Health
Minister shall promulgate a list of drugs subject to special control in
compliance with treaties to which the Socialist Republic of Vietnam is a
contracting party.
Article 64.- Conditions for trading in and use of drugs on
the list of drugs subject to special control
1.
Establishments trading in, preparing or dispensing drugs on the list of drugs
subject to special control must satisfy the drug trading conditions provided
for by the Government.
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3. Drugs on
the list of drugs subject to special control shall be used for purposes of
prophylaxis, treatment, diagnosis of disease, modification of physiological
functions of human body and scientific research and must not be used for other
purposes.
Article 65.- Responsibilities of establishments trading in,
preparing or dispensing drugs on the list of drugs subject to special control
1.
Establishments trading in, preparing or dispensing drugs on the list of drugs
subject to special control have the following responsibilities:
a/ To make
periodical or extraordinary reports to competent state management agencies;
b/ To keep
vouchers and documents relating to each drug for at least two years after its
expiry date.
2. The
destruction of drugs on the list of drugs subject to special control must be
conducted in strict compliance with the set order and procedures and in
accordance with provisions of law.
Chapter X
QUALITY STANDARDS AND
ASSAY OF DRUGS
Article 66.- Quality standards of drugs
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2. The
national quality standards of drugs and methods of assaying drugs are specified
in the Pharmacopoeia of Vietnam.
Establishment
standards shall be formulated and publicized by drug manufacturing
establishments. Establishment standards must not be lower than the national
quality standards of drugs.
3. The
Government shall stipulate the promulgation of the Pharmacopoeia of Vietnam,
the application of foreign and international pharmacopoeias in Vietnam.
Article 67.- Drug assay
1. Drug assay
must be conducted in strict accordance with the registered drug quality
standards of manufacturing establishments. Where assay methods other than those
specified in the registered standards are applied, the Health Ministry's
approval is required.
2. Where
there is a doubt about the composition or quality of drugs, State-owned drug
assay establishments may apply methods other than those specified in the
registered standards to inspect and produce drug quality assay results.
3. The Health
Minister shall specify the order and procedures for sampling and keeping of
drug samples, and contents of drug quality assay.
Article 68.- Drug assay establishments
Drug assay
establishments include state-owned drug assay establishments, enterprises
providing drug assay services and drug assay laboratories of drug trading
establishments.
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1.
State-owned drug assay establishments assist the state management agency in
charge of pharmacy in ascertaining the quality of drugs.
2.
State-owned drug assay establishments have the same rights and obligations as
enterprises providing drug assay services defined in Articles 33 and 34 of this
Law.
3. The
Government provides for the organizational system and operation of State-owned
drug assay establishments.
Article 70.- Settlement of complaints about drug quality
conclusions
1. Drug
trading establishments are entitled to lodge complaints about drug quality
conclusions of the state management agency in charge of pharmacy.
2. The
Government shall specify the order and procedures and designate agencies for
settling complaints about drug quality conclusions.
Chapter XI
IMPLEMENTATION PROVISIONS
Article 71.- Transitional provisions
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Article 72.- Implementation effect
This Law
takes effect as of October 1, 2005.
All previous
stipulations which are contrary to this Law are hereby annulled.
Article 73.- Provisions on implementation detailing and
guidance
The
Government shall detail and guide the implementation of this Law.
This Law was
passed on June 14, 2005, by the XIth National Assembly at its 7th
session.
THE
NATIONAL ASSEMBLY
CHAIRMAN
Nguyen Van An
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