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THE NATIONAL ASSEMBLY
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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Law No. 44/2024/QH15
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Hanoi, November 21, 2024
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LAW
AMENDMENTS TO CERTAIN ARTICLES OF
THE LAW ON PHARMACY
Pursuant
to the Constitution of the Socialist Republic of Vietnam;
The National
Assembly hereby promulgates the Law on amendments to certain Articles of the
Law on Pharmacy No. 105/2016/QH13 amended by the Law No. 28/2018/QH14.
Article 1. Amendments to certain Articles of the Law on
Pharmacy
1.
Several clauses of Article 2 are amended as follows:
a) Clause
5 is amended as follows:
“5. “herbal
material” (including prepared traditional medicinal materials) means
a medicinal material which is derived from plants, animals, minerals and
mushrooms and satisfy standards for drug manufacture.”;
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“8. “traditional
drug” means a drug composed of one or more herbal materials which are
combined according to traditional medicine theories principles or folk
experience, processed and prepared according to traditional medicine methods;
it may have a traditional or modern dosage form.
9. “prepared
traditional medicinal material” means a herbal material undergoing primary
processing and processing according to traditional medicine theories or folk experience
for production and preparation of traditional drugs.
10. “biological”
(also biopharmaceutical) means a drug that is the product of a
bio-technological or biological process from a macromolecular substance or
mixture of macromolecular substances extracted from biological sources,
including microorganisms and derivatives of human blood and plasma.
Biologicals
do not include in vitro diagnostic reagents, antibiotics and substances derived
from biological sources that have small molecular weights and can be subdivided
into pure substances.”;
c)
Clauses 17, 18 and 19 are amended as follows:
“17. “narcotic
drug” means a drug containing any active ingredient with neural
stimulation or inhibition effects that easily causes addiction to its users and
is included in the List of narcotic active ingredients promulgated by the
Minister of Health, except for combination drugs that contain narcotic active
ingredients specified in clause 20 of this Article.
18. “psychotropic drug” means
a drug containing any active ingredient with neural stimulation or inhibition
effects or hallucinogen that may cause addiction to its users if used many
times and is included in the List of psychotropic active ingredients
promulgated by the Minister of Health, except for combination drugs that
contain psychotropic active ingredients specified in clause 21 of this Article.
19. “precursor
drug” means a drug that contains any precursor on the List of drug
precursors promulgated by the Minister of Health, except for combination drugs containing
precursors specified in clause 22 of this Article.”;
d) Clause
27 is amended as follows:
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dd)
Clause 37 is amended as follows:
“37. “Good practice” means a set of principles
and standards for manufacture, preservation, testing, wholesale and retail of
drugs and medicinal materials; prescription, clinical trial; cultivation and
collection of herbal materials, and other sets of principles and standards
promulgated or accredited by the Minister of Health for application.”;
e)
Clauses 44 through 50 are added after clause 43 as follows:
“44. “intended
wholesale price” of a drug means the maximum wholesale price which is
imposed by a drug importer or drug manufacturer before the first shipment is
sold wholesale on the market. Drug business establishments must not sell the
drug at a wholesale price higher than this.
45.
“announcement of intended wholesale price” of a drug means a drug importer
or drug manufacturer sending a notification of intended wholesale price to the Ministry
of Health before selling the first drug shipment on the market so that it is
publicly made available on the web portal of the Ministry of Health.
46. “re-announcement
of intended wholesale price” of a drug means a drug importer or drug
manufacturer sending a notification of intended wholesale price to the Ministry
of Health upon a change to the announced intended wholesale price so that it is
publicly made available on the web portal of the Ministry of Health.
47. “similar
drugs” means the drugs with the same active ingredients, medicinal
materials, dosage form and technical criteria.
48. “pharmacy
chain” means a system of pharmacies operated by one facility organizing the
pharmacy chain under a unified quality management system and a single trade
name.
49. “substandard
medicinal material” means a medicinal material that fails to meet the
quality standards registered with or announced to a competent authority.
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2. Clause
3 of Article 4 is amended as follows:
“3. Other
Ministries and ministerial agencies shall, within their jurisdiction, perform
state management of pharmacy and management of banned substances that may only
be used as medicinal materials and cooperate with the Ministry of Health in
state management of pharmacy as per regulations of the Government.”.
3. Several
points and clauses of Article 6 are amended as follows:
a) Clause
2 is amended as follows:
“2.
Running a pharmacy business at a location other than the business location
written on the Certificate of eligibility for pharmacy business or licensed by
a competent authority, except for trading by e-commerce method.”;
b) Point
i of clause 5 is amended as follows:
“i)
Selling prescription drugs wholesale at prices higher than the announced or
re-announced intended wholesale prices; selling drugs wholesale and retailing
drugs at prices higher than listed prices.”;
c) Clause
8 is amended as follows:
“8.
Practicing pharmacy in the working positions specified in Article 11 of this
Law without a pharmacy practice certificate or outside the scope written on the
pharmacy practice certificate or during the period of suspension of the
pharmacy practice certificate.
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“17.
Retailing the following drugs by e-commerce method:
a)
Prescription drugs, except during medical isolation after an epidemic of a
Group A infectious disease is declared in accordance with regulations of law on
prevention and control of infectious diseases;
b)
Controlled drugs;
c) Drugs
on the List of drugs restricted from retailing.
18. Retailing
controlled drugs by e-commerce method.
19.
Trading in drugs and medicinal materials by e-commerce method through means
other than e-commerce trading platforms, e-commerce sales applications or
websites (also e-commerce websites) with an online ordering function.”.
4.
Article 7 is amended as follows:
“Article
7. State policies on pharmacy
1. Ensure
adequate and timely supply of drugs of good quality at reasonable prices to
serve the people’s need for prevention and treatment of diseases, suit the disease
structure and meet the requirements for national defense and security, incident
and disaster recovery, disease prevention and control.
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3. Provide incentives and assistance to develop the
pharmaceutical industry into a spearhead industry.
4. Regulations of law on bidding and incentives in drug
procurement shall apply to the procurement of the following drugs funded by
state budget or other lawful funding sources of public health facilities:
a) Drugs
researched and manufactured domestically from domestic materials, original
brand-name drugs transferred to Vietnam under technology transfer contracts,
the first domestically manufactured generic drugs, the first domestically
manufactured biosimilars;
b) Herbal
drugs, traditional drugs manufactured from domestic herbal materials satisfying
Good Agricultural and Collection Practices for Herbal Materials;
c) Herbal
drugs, traditional drugs manufactured as a result of accepted national,
ministerial or provincial science and technology missions;
d) Drugs
on the List of national products approved by the Prime Minister.
5. Give priority
to the administrative procedures below:
a)
Sequence, procedures and time for grant of drug/medicinal material marketing
authorizations to new drugs; original brand-name drugs; rare drugs; vaccines;
the first domestically manufactured generic drugs; the first domestically
manufactured biosimilars; high tech drugs; drugs that have undergone clinical
trial in Vietnam; drugs manufactured from herbal materials that satisfy Good
Agricultural and Collection Practices for Herbal Materials; drugs and medicinal
materials manufactured as a result of accepted national, ministerial or
provincial science and technology missions; drugs satisfying requirements for
national defense and security, incident and disaster recovery, disease
prevention and control;
b) Criteria,
sequence, procedures and time for licensing import of new drugs; rare drugs;
vaccines that have been pre-qualified by World Health Organization (WHO); high
tech drugs; drugs that have undergone clinical trial in Vietnam; drugs
satisfying requirements for national defense and security, incident and
disaster recovery, disease prevention and control.
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a)
Research into, development, clinical trial, technology transfer, manufacturing
and commercialization of medicinal materials, new drugs, vaccines, biologicals,
high-tech drugs, the first domestically manufactured generic drugs, traditional
drugs in modern dosage forms, herbal drugs manufactured as a result of accepted
national or ministerial science and technology missions;
b)
Investment in establishment and development of clinical trial centers in
development of new drugs, in vivo bioequivalence studies, and biosimilar
studies.
7.
Combine investment from state budget and investment from other sources in
development of the manufacture of vaccines, biologicals, herbal drugs,
traditional drugs, drugs manufactured from domestic herbal materials, the first
domestically manufactured generic drugs; cultivation and production of herbal
materials; discovery, conservation and application of science and technology to
research into and development of genetic resources of rare and special herbal
materials.
8.
Support and facilitate the discovery, clinical trial, marketing authorization,
registration of protection of intellectual property rights and inheritance of
traditional drugs and herbal drugs manufactured as a result of accepted
national or ministerial science and technology missions; exploration,
collection and use of new herbal materials; export of cultivated herbal materials;
acclimatization of herbs; reasonable collection of natural herbal materials;
research, survey and investigation into appropriate species of herbal materials
for cultivation in localities; development of herbal material cultivation
areas; modernization of the manufacture and formulation of trade promotion
policies for export of herbal drugs and traditional drugs.
9.
Introduce policies to protect confidentiality of information about
concoction and data on clinical trial of traditional drugs; accord reasonable
treatment to donors of precious traditional remedies to the State; facilitate
the issuance of traditional medicine practice certificates to holders of
hereditary remedies recognized by the Ministry of Health.
10.
Encourage development of the drug supply system towards professionalism,
modernity and efficiency; ensure timely and adequate supply of drugs of good
quality to meet the people’s need for drugs; encourage pharmacies and
dispensaries to open 24/7.
Provide
incentives and support for development of the drug supply system and mobile
drug retailers in ethnic minority areas, in mountainous areas, on islands, in
disadvantaged areas and extremely disadvantaged areas.
11. Mobilize health facilities of the people’s armed forces
and military-civil medical examination and treatment facilities to participate
in supply of drugs and cultivation of herbal materials to meet the needs for
prevention and treatment of diseases of the people in ethnic minority areas, in
mountainous areas, on islands, in disadvantaged areas and extremely
disadvantaged areas.
12. Introduce policies to improve quality of pharmacy human
resources, support training of high quality human resources in research into,
development, receipt and transfer of technology, production and trial of new
drugs, original brand-name drugs, high-tech drugs, herbal drugs and traditional
drugs.
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14. Implement policies to control the quantity of marketing
authorizations for drugs with the same active ingredients and herbal materials
suitable for the socio-economic conditions from time to time.
15. Give priority to investment in development of
information technology infrastructure and digital transformation in pharmacy
activities.
16. The Government shall elaborate this Article.”.
5.
Article 8 is amended as follows:
“Article
8. Investment incentives and assistance in development of pharmaceutical
industry
1.
Provide investment incentives and assistance to investment projects in the
pharmacy field in accordance with regulations of law on investment.
2. Each
project on investment in establishment (including the expansion of such
establishment project) in development of pharmaceutical industry which has a
total investment capital of at least VND 3,000 billion and disburses at least
VND 1,000 billion within 03 years from the issuance date of the investment registration
certificate or the approval for investment guidelines will be eligible for the
special investment incentives and assistance applied to the object specified in
point a clause 2 Article 20 of the Law on Investment, including:
a)
Research into and development of technology, manufacture or transfer of
technology for manufacture of herbal drugs, traditional drugs manufactured from
domestic herbal materials, active ingredients, new drugs, original brand-name
drugs, rare drugs, the first domestically manufactured generic drugs, high-tech
drugs, vaccines, biologicals;
b)
Cultivation of herbal materials in disadvantaged areas or extremely
disadvantaged areas;
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3. The
Government shall elaborate this Article.”.
6.
Several points and clauses of Article 10 are amended as follows:
a) Point
a of clause 3 is amended as follows:
“a)
Preside over and cooperate with the Ministry of Health and Ministry of Science
and Technology in formulating legislative documents serving the management and organization
of selection and creation of varieties of herbal materials, cultivation and
collection of herbal materials; dissemination of techniques for cultivation,
prevention and control of diseases and pests on medicinal plants and animals;”;
b) Point
a of clause 6 is amended as follows:
“a)
Request competent authorities to provide or provide within its power funding
for implementation of plans and programs for development of pharmaceutical industry
in accordance with regulations of the Law on State Budget;”;
c) Clause
7 is amended as follows:
“7. The
Ministry of Science and Technology has the responsibilities to:
a)
Request competent authorities to provide or provide within its power annual
funding from state budget for scientific and technological activities to
conduct research and apply research findings to manufacture of drugs as
prescribed by law, especially those on the List of national products;
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c)
Preside over and cooperate with the Ministry of Health in developing mechanisms
and policies for protection of intellectual property of traditional drugs;
d)
Preside over and cooperate with other Ministries and ministerial agencies
concerned in formulating mechanisms and policies for application of science and
technology for development of the pharmaceutical chemistry industry.”;
d) Point
b of clause 8 is amended as follows:
“b)
Provide land for construction of factories, pharmaceutical industrial parks,
projects on development of herbal materials and herbal material cultivation
areas in accordance with regulations of law on land.”.
7. Point
b clause 1 of Article 12 is amended as follows:
“b) A person whose pharmacy practice certificate is revoked
as prescribed in Article 28 hereof.
The pharmacy practice certificate shall only be issued
after 24 months from the revocation date in the cases where it is revoked as
prescribed in clauses 4, 6, 10 and 11 Article 28 hereof.”.
8.
Article 17a is added after Article 17 as follows:
“Article
17a. Conditions to be satisfied by the chief pharmacist of a facility
organizing the pharmacy chain or a pharmacy in the pharmacy chain
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2. The
chief pharmacist of each pharmacy in the pharmacy chain must satisfy the
conditions set out under clause 1 Article 18 hereof.”.
9. Clause
7 of Article 24 is amended as follows:
“7. A
criminal record, except where the criminal record database is updated and
shared with the application receiving authority in accordance with the
Government's regulations.
If the
applicant is a foreigner or overseas Vietnamese, it is required to have a
criminal record or certification issued by a foreign competent authority that
the applicant is not a criminal or facing criminal prosecution, not banned from
pharmacy practice or banned from doing pharmaceutical works under a court’s
judgment or decision.”.
10.
Clause 8 of Article 28 is amended as follows:
“8. A
person issued with the pharmacy practice certificate fails to conduct any
activity within the scope written on the pharmacy practice certificate practice
for 24 consecutive months.”.
11.
Several clauses of Article 31 are amended as follows:
a) Clause
3 is amended as follows:
“3. Be
only responsible for professional activities of only one pharmacy business
establishment and at only one pharmacy business location, except for the case
specified in clause 3a of this Article.”;
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“3a.
The chief pharmacist of a facility organizing the pharmacy chain must be the
chief pharmacist of the entire pharmacy chain.”.
12.
Several points and clauses of Article 32 are amended as follows:
a) Point
a of clause 1 is amended as follows:
“a)
Trading in drugs and medicinal materials, including trading in drugs and
medicinal materials by e-commerce method on e-commerce trading platforms,
e-commerce sales applications or e-commerce sales websites with an online
ordering function;”;
b) Point
i is added after point h of clause 2 as follows:
“i)
Facilities organizing pharmacy chain.”.
13. Point
h is added after point g clause 2 of Article 33 as follows:
“h) Every
facility organizing pharmacy chain must satisfy the conditions prescribed in
point c of this clause, have at least 02 affiliated pharmacies issued with the
Certificate of eligibility for pharmacy business and a uniform quality
management system to be applied to all pharmacies in the chain.”.
14. Point
d clause 1 of Article 35 is amended as follows:
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15. Clause 3 of Article 36 is amended as follows:
“3. The Certificate of
eligibility for pharmacy business shall be adjusted in the following cases:
a) Change
of the name of the establishment or business location;
b) Change
to the scope of pharmacy business without changing the conditions for pharmacy
business;
c) Change
to information about the chief pharmacist written on the Certificate of
eligibility for pharmacy business, except for secondment of chief pharmacists
among pharmacies in the pharmacy chain.”
16. Clause 1 of Article 37 is amended as follows:
“1. The Minister of Health shall issue, re-issue, adjust and
revoke Certificates of eligibility for pharmacy business of the pharmacy business
establishments mentioned in point a, b, c, e, g, h and i clause 2 of Article 32
hereof.”.
17. Several points are added to Article 38 as follows:
a) Point dd is added after point d of clause 1 as follows:
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b) Point dd is added after point d of clause 2 as follows:
“dd) A
list of pharmacies in the pharmacy chain issued with the Certificate of
eligibility for pharmacy business by the time of submission if the applicant is
a facility organizing the pharmacy chain.”.
18.
Several points and clauses of Article 42 are amended as follows:
a) Point
dd of clause 1 is amended and point e is added after point dd of clause 1 as
follows:
“dd)
Establish mobile drug retailers in ethnic minority areas, in mountainous areas,
on islands, in disadvantaged areas and extremely disadvantaged areas as
prescribed by the Government;
e)
Purchase and sell prescription drugs from the date on which the Ministry of
Health receives the dossiers on announcement or re-announcement of intended
wholesale prices from drug manufacturers and importers.”;
b) Point
q is added after point p of clause 2 as follows:
“a) Take legal responsibility for the accuracy, legitimacy
and truthfulness of the documents provided to competent authorities.”;
c) Clause
4 is added after clause 3 as follows:
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a) Comply
with regulations of law on e-transactions, law on e-commerce, law on
advertising, law on protection of consumers’ rights and other relevant
regulations of law;
b) Ensure
confidentiality of information of purchasers as prescribed by law;
c) Fully
post information on the Certificate of eligibility for pharmacy business and
pharmacy practice certificate of its chief pharmacist and information about
approved drugs as prescribed by the Government;
d) Notify
the pharmacy business by e-commerce method to competent authorities in
accordance with regulations imposed by the Minister of Health;
dd) Each
drug retailer must provide online advice and instructions for drug use to drug
purchasers and deliver drugs to purchasers in accordance with regulations
imposed by the Minister of Health;
e) Only
retail OTC drugs which are not controlled drugs and not included in the List of
drugs restricted from retailing.
Retail
prescription drugs as prescribed by the Minister of Health in the case of
medical isolation after an epidemic of a Group A infectious disease is declared
in accordance with regulations of law on prevention and control of infectious
diseases;
g) Only
sell drugs and medicinal materials other than controlled drugs wholesale;
h) Comply
with other Government's regulations on selling drugs and medicinal materials
and drugs wholesale by e-commerce method.”.
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a) Point
e of clause 1 is amended as follows:
“e) Sell
wholesale drugs and medicinal materials which it manufactures to medical
examination and treatment facilities, immunization facilities and other health
facilities; rehabilitation centers; state-owned drug and medicinal material
testing facilities; science and technology organizations, training institutions
conducting research and teaching activities related to pharmacy; pharmacy
business establishments specified in clause 2 Article 32 of this Law;
establishments that have been granted a Certificate of registration of
investment in drug manufacture but have not been granted a Certificate of
eligibility for pharmacy business for experimental production of drugs and
evaluation of the drug manufacturing process;”;
b) Point
e is added after point dd of clause 2 as follows:
“e)
Announce and re-announce intended wholesale prices of drugs as prescribed in
this Law.”.
20.
Several points and clauses of Article 44 are amended as follows:
a) Point
a of clause 1 is amended as follows:
“a) The
rights specified in points a, b, c, d and e clause 1 Article 42 hereof;”;
d) Point
d of clause 1 is amended as follows:
“d) Sell
wholesale drugs and medicinal materials which it imports to medical examination
and treatment facilities, immunization facilities and other health facilities;
rehabilitation centers; state-owned drug and medicinal material testing
facilities; science and technology organizations, training institutions
conducting research and teaching activities related to pharmacy; pharmacy
business establishments specified in clause 2 Article 32 of this Law;
establishments that have been granted a Certificate of registration of
investment in drug manufacture but have not been granted a Certificate of
eligibility for pharmacy business for experimental production of drugs and
evaluation of the drug manufacturing process;”;
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“c)
Announce and re-announce intended wholesale prices of drugs as prescribed in
this Law.”.
21.
Several points and clauses of Article 46 are amended as follows:
a) Point
b of clause 1 is amended as follows:
“b) Sell
drugs and medicinal materials wholesale to medical examination and treatment
facilities, immunization facilities and other health facilities; rehabilitation
centers; state-owned drug and medicinal material testing facilities; science
and technology organizations, training institutions conducting research and
teaching activities related to pharmacy; pharmacy business establishments
specified in clause 2 Article 32 of this Law; establishments that have been
granted a Certificate of registration of investment in drug manufacture but
have not been granted a Certificate of eligibility for pharmacy business for
experimental production of drugs and evaluation of the drug manufacturing
process;”;
b) Point
c is added after point b of clause 2 as follows:
“c)
Declare drug wholesale prices of drugs as prescribed in clause 5 Article 107
hereof.”.
22.
Several points and clauses of Article 47 are amended as follows:
a) Point
b of clause 1 is amended as follows:
“b) Purchase medicinal materials to compound drugs and sell them
or the right specified in point b clause 3 Article 47a of this Law. The chief
pharmacist of a pharmacy shall directly manage compounding of drugs therein.”.
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“d)
Declare drug retail prices as prescribed in clause 5 Article 107 hereof.”.
23.
Article 47a is added after Article 47 as follows:
“Article
47a. Rights and responsibilities of facilities organizing pharmacy chain,
pharmacies in pharmacy chain
1. A facility
organizing the pharmacy chain has the following rights:
a) The
rights specified in clause 1 Article 42 hereof;
b)
Purchase medicinal materials to deliver them to pharmacies in the pharmacy
chain to compound drugs and sell them at the compounding pharmacies;
c)
Purchase drugs to deliver them to pharmacies in the pharmacy chain for retail,
except for vaccines. In case of purchasing controlled drugs and drugs on the
List of drugs restricted from retailing, comply with the regulations set out
under Article 34 of this Law;
b)
Circulate drugs between drug warehouses of the facility organizing the pharmacy
chain and pharmacies in the pharmacy chain, except for compounded drugs. The
drug circulation shall be coordinated by the chief pharmacist of the facility
organizing pharmacy chain;
dd)
Second chief pharmacists of pharmacies in the pharmacy chain.
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a) The
responsibilities specified in points a, b, c, d, dd, h, k, l, m, n and q clause
2 Article 42 hereof;
b) Tailor
a quality management system for the pharmacy chain, including organizational
structure, processes, personnel, documents, information system, administration
system, technical infrastructure and systematic activities, which satisfies
Good Practices and suits the scope of business;
c) Manage
all activities related to the supply, circulation, preservation of drugs and
medicinal materials and customer-related data at all pharmacies in the pharmacy
chain by unified processes;
d) Supply
the entire drugs and medicinal products to pharmacies in the pharmacy chain;
dd) Take
total responsibility for activities of pharmacies in the pharmacy chain;
e) Report
to the Ministry of Health or Department of Health of the province where the
pharmacy in the pharmacy chain operates and fulfill the obligations as
prescribed by law in the cases where any pharmacy in the pharmacy chain has
suspended its operation for at least 06 months or shut down;
g) Comply
with regulations of the Minister of Health on notifying and updating the
following to the competent authority: the list of pharmacies in the pharmacy
chain; list of practitioners having pharmacy practice certificates at the
facility organizing pharmacy chain and pharmacies in the pharmacy chain;
secondment of chief pharmacists among pharmacies in the pharmacy chain;
h) Submit
to competent pharmacy authorities annual and ad hoc reports on operations of
the facility organizing pharmacy chain and pharmacies in the pharmacy chain;
notify the Ministry of Health within 03 working days from the date on which a
pharmacy in the pharmacy chain incurs a penalty for administrative violations
in the field of pharmacy.
3. A
pharmacy in the pharmacy chain has the following rights:
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b)
Receive medicinal materials from the facility organizing pharmacy chain to
compound drugs and sell them at the pharmacy. The chief pharmacist of a
pharmacy shall directly manage compounding of drugs therein;
c)
Receive drugs from the facility organizing pharmacy chain for retail, except
for vaccines; in case of purchasing controlled drugs and drugs on the List of
drugs restricted from retailing, comply with the regulations set out under
Article 34 of this Law.
4. A
pharmacy in the pharmacy chain has the following responsibilities:
a) The
responsibilities specified in points a, b, c, d, dd, e, h, k, l, m, n, o, p and
q clause 2 Article 42, points b, c and d clause 2 Article 47 and clause 2
Article 81 of this Law;
b) Only
trade in drugs supplied by the facility organizing pharmacy chain;
c) Comply
with the quality management system built by the facility organizing pharmacy
chain;
d)
Suspend its operation in case the facility organizing pharmacy chain has suspended
its operation for at least 06 months;
dd) Shut
down in case the facility organizing pharmacy chain shuts down.”.
24. Point
c is added after point b clause 2 of Article 48 as follows:
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25. Point
c is added after point b clause 2 of Article 49 as follows:
“c)
Declare drug retail prices as prescribed in clause 5 Article 107 hereof.”.
26. Point
c is added after point b clause 2 of Article 50 as follows:
“d)
Declare retail prices of herbal drugs and traditional drugs as prescribed in
clause 5 Article 107 hereof.”.
27.
Article 53a is added after Article 53 in Chapter IV as follows:
“Article
53a. Rights and responsibilities of foreign-invested pharmacy business
establishments
1. The
pharmacy business establishments that are prescribed in points a, b, e, g and h
clause 2 Article 32 of this Law and have foreign investment have the following
rights:
a) The
rights specified in points b, c and d clause 1 Article 42 hereof;
b) The
rights corresponding to the type of pharmacy business establishments specified
in points b, c, d, dd and g clause 1 Article 43, points b, c and dd clause 1
Article 44, points b, c and d clause 1 Article 51, points b, c and d clause 1
Article 52, and points b, c, d and dd clause 1 Article 53 of this Law.
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a) Sell
wholesale, deliver and transport drugs and medicinal materials which they
manufacture or are obtained by the manufacturers under processing contracts or
transferred to Vietnam under technology transfer contracts to medical
examination and treatment facilities, immunization facilities and other health
facilities; rehabilitation centers; state-owned drug and medicinal material
testing facilities; science and technology organizations, training institutions
conducting research and teaching activities related to pharmacy; pharmacy
business establishments specified in clause 2 Article 32 of this Law;
establishments that have been granted a Certificate of registration of
investment in drug manufacture but have not been granted a Certificate of
eligibility for pharmacy business for experimental production of drugs and
evaluation of the drug manufacturing process.
In case
of selling prescription drugs, the drug manufacturers are entitled to sell them
from the date on which the Ministry of Health receives the dossiers on
announcement or re-announcement of intended wholesale prices of drugs;
b)
Deliver and transport drugs under sponsorship, aid, humanitarian aid, and
disease prevention and control programs to health facilities receiving
sponsorship.
3. Drug and medicinal material importers that have foreign
investment have the rights specified in clause 1 of this Article and the
following rights:
a) Sell wholesale drugs and medicinal materials which the
importers import to wholesalers of drugs and medicinal materials. In case of
selling prescription drugs, the drug importers are entitled to sell them from
the date on which the Ministry of Health receives the dossiers on announcement
or re-announcement of intended wholesale prices of drugs;
b) Repurchase drugs and medicinal materials which are
transferred to Vietnam by the importers under technology transfer contracts;
sell drugs and medicinal materials which are obtained by the importers under
processing contracts or transferred to Vietnam by the importers under
technology transfer contracts to wholesalers of drugs and medicinal materials;
c) Import medicinal materials within the scope mentioned in
the Certificate of eligibility for pharmacy business to supply them to
manufacturers of drugs which are obtained by the importers under processing
contracts or transferred to Vietnam by the importers under processing contracts
or technology transfer contracts;
d) Deliver and transport drugs and medicinal materials
which the importers import, are obtained by the importers under processing
contracts or are transferred to Vietnam by the importers under technology
transfer contracts from the importers’ warehouses of drugs and medicinal
materials to wholesalers of drugs and medicinal materials;
dd) Deliver and transport drugs under sponsorship, aid,
humanitarian aid, and disease prevention and control programs to health
facilities receiving sponsorship;
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4. The
pharmacy business establishments specified in points a, b, e, g and h clause 2
Article 32 that have foreign investment have the responsibilities corresponding
to each type of pharmacy business establishment specified in clause 2 Article
42, clause 2 Article 43, clause 2 Article 44, clause 2 Article 51, and clause 2
Article 53 of this Law and are not permitted to conduct activities directly
related to distribution of drugs and medicinal materials, including:
a) Selling, delivering and transporting drugs and medicinal
materials, except for the case specified in clauses 2 and 3 of this Article;
b)
Preserving drugs and medicinal materials which the importers do not import or
manufacture, are not obtained by the importers under processing contracts or
are not transferred to Vietnam by the importers under technology transfer
contracts;
c) Receiving orders and payments for drugs and medicinal
materials from medical examination and treatment facilities, retailers, individuals,
organizations other than wholesalers of drugs and medicinal materials, except
for the case specified in clause 2 of this Article;
d)
Determining and impose selling prices of drugs and medicinal materials distributed
by other pharmacy business establishments, except where regulations on drug
price management in this Law are implemented;
dd)
Determining and impose selling prices of drugs and medicinal materials
distributed by other pharmacy business establishments, except where regulations
on drug price management in this Law are implemented;
e)
Formulating plans for supply of drugs and medicinal materials of medical
examination and treatment facilities in Vietnam;
g)
Providing financial support in any shape or form to organizations and
individuals directly purchasing drugs and medicinal materials of the pharmacy
business establishments for the purpose of manipulating the distribution of
imported drugs and medicinal materials.
5.
Foreign-invested pharmacy business establishments are not permitted to retail
drugs and sell drugs and medicinal materials wholesale, except for the case
specified in clauses 2 and 3 of this Article.”.
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“b)
Imported drugs prescribed in clauses 2 and 5a Article 60 hereof;”.
29. Point
b and point c clause 2 of Article 55 are amended as follows:
“b) The
drug already has a marketing authorization but there are changes to its active
ingredients, herbal materials; contents, concentrations, weight of active
ingredients or herbal materials in a dosage unit; dosage form; manufacturer,
except for change or addition of packaging facility, releasing facility, or
releasing location;
c) The medicinal material already has a marketing
authorization but there is a change or addition of its manufacturer, except for
change or addition of a packaging facility, releasing facility, or releasing
location.”.
30. Article 56 is amended as follows:
“Article
56. Power, documentation requirements, procedures and time limit for issuing,
renewing and revising marketing authorizations
1. The
Ministry of Health shall issue, renew and revise marketing authorizations of
drugs and medicinal materials through application validation and consultancy of
the Marketing Authorization Advisory Board, except for the case specified in
point b clause 9 of this Article.
2. The
Ministry of Health shall publish the following information on its web portal:
a)
Information about issuance, renewal or revision of marketing authorizations of
drugs and medicinal materials;
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c) OTC
drugs after being granted the drug marketing authorization.
3. An
application for issuance of marketing authorization of a drug or medicinal
material consists of:
a)
Administrative documents, including an application form; unexpired license for
establishment of representative office (for foreign applicants) or unexpired
Certificate of eligibility for pharmacy business (for Vietnamese applicants);
unexpired Certificate of pharmaceutical product (for imported drugs); sample
label of drug/medicinal material; information about the drug and other
documents about trading and marketing authorization of the drug or medicinal
material.
In case
of serving the purpose of meeting the needs for prevention and treatment of any
group A infectious disease that causes an epidemic which has been declared in
accordance with regulations of law on prevention and control of infectious
diseases, the certificate of pharmaceutical product may be replaced by another
document issued by a competent authority confirming that the drug is permitted
for marketing authorization and use in the home country and fully stating
information about name and address of the manufacturing facility and conditions
for licensing;
b)
Technical documents proving that the drug or medicinal material satisfies the
conditions in clause 4 Article 54 of this Law; for new drugs, reference
biologicals and vaccines, it is required to have clinical documents proving their
safety and efficacy; for biosimilars, it is required to have documents proving
their quality, safety and efficacy in comparison to a reference biological; for
drugs requiring in vivo bioequivalence study, it is required to have a report
on data on their bioequivalence study; in case the applicant wishes to use
reference to the result of validation of the marketing authorization
application, it is required to have documents on the validation results of a
Stringent Regulatory Authority (SRA) or a regulatory authority recognized by
the Ministry of Health based on the WHO classification.
For new
domestically manufactured drugs (except vaccines) that have indications for use
in prevention and treatment of any group A infectious disease that causes an
epidemic which has been declared in accordance with regulations of law on
prevention and control of infectious diseases and have the same active
ingredients, dosage form and administration route as those of the drugs granted
a marketing authorization or license for use in case of emergency or granted a
conditional marketing authorization or license for conditional use by one of
the stringent regulatory authorities (SRAs) or a regulatory authority
recognized by the Ministry of Health based on the WHO classification, the
clinical document in a marketing authorization application will be exempt;
c) A
sample label of the drug or medicinal material marketed in the home country or
reference country (for imported drugs).
4. An application for renewal of marketing authorization of
a drug or medicinal material consists of:
a) An application form for renewal;
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dd) A
report on safety and efficacy of the drug during its marketing.
5. An application
for revision of marketing authorization of a drug or medicinal material
consists of:
a) A form
for application for revision;
b)
Tehnical documents about the variations.
6. Time
limit for issuing, renewing or revising a marketing authorization of a drug or
medicinal material is prescribed as follows:
a) Within 12 months from the date of receiving a sufficient
application specified in clause 3 of this Article, except for the cases
specified in points b and e of this clause;
b) Within
09 months from the date of receiving a sufficient application specified in
clause 3 of this Article in case of using reference to the validation result;
c) Within 03 months from the date of receiving a sufficient
application specified in clause 4 of this Article;
d) Within 03 months from the date of receiving a sufficient
application specified in clause 5 of this Article, except for the case
specified in point dd of this clause;
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e) Within 15 days from the date of receiving a sufficient
application specified in clause 3 of this Article regarding the application for
marketing authorization of a new drug which has indications for use in
prevention and treatment of any group A infectious disease that causes an
epidemic which has been declared in accordance
with regulations of law on prevention and control of infectious diseases, is
granted a marketing authorization or license for use in case of emergency is
granted a conditional marketing authorization or license for conditional use by
one of the stringent regulatory authorities (SRAs) or a regulatory authority
recognized by the Ministry of Health based on the WHO classification.
7. The Ministry of Health shall issue, renew and revise
marketing authorizations of drugs and medicinal materials within the time
limits specified in clause 6 of this Article; in case an application for
issuance, renewal or revision of a marketing authorization of drug or medicinal
material is rejected, a written explanation must be provided.
In case a
drug has been granted the marketing authorization but has not been marketed
within 05 years from the effective date of the drug marketing authorization, it
is not permitted to renew the marketing authorization of the drug, except for
rare drugs or any drug that has no more than 03 drugs (having the same active
ingredients, dosage form, contents or concentrations of active ingredients,
weight of medicinal materials in a dosage unit) of 03 manufacturers that have
been granted the drug marketing authorization which remains effective.
8.
Effective period of a marketing authorization of a drug or medicinal material
is prescribed as follows:
a) A
marketing authorization of a drug or medicinal material is valid for 05 years
from its issuance or renewal date, except for the cases in points b and c of
this clause;
b) A
marketing authorization of a drug whose safety and efficacy still has to be
monitored is valid for 03 years from its issuance or renewal date;
c) When a
marketing authorization of drug or medicinal material expires after the
Ministry of Health receives an application for renewal thereof, it may be used
until it is officially renewed or the Ministry of Health issues a notification
that the application is rejected or the marketing authorization is suspended in
case the drug or medicinal material is found potentially unsafe for users or
legal documents are suspected of being forged.
9. The
Minister of Health shall elaborate required documentation for issuance, renewal
and revision of marketing authorizations of drugs and medicinal materials
specified in clauses 3, 4 and 5 of this Article and specify the following
regulations:
a)
Procedures for issuance, renewal and revision of marketing authorizations of
drugs and medicinal materials;
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c) Cases
where the marketing authorization is granted to a new drug which has
indications for use in prevention and treatment of any group A infectious
disease that causes an epidemic which has been declared in accordance with
regulations of law on prevention and control of infectious diseases on the
basis of recognizing the result given by one of the stringent regulatory
authorities (SRAs) or a regulatory authority recognized by the Ministry of
Health based on the WHO classification without validating technical documents
and inspecting the compliance with Good Manufacturing Practice.”.
31. Point b clause 1 of Article 59 is amended as follows:
“b) Imported drugs and medicinal materials prescribed
in clauses 1, 2, 3, 4 and 5a Article 60 hereof;”.
32.
Several points and clauses of Article 60 are amended as follows:
a) Points
h and i of clause 2 are amended as follows:
“h) It is
used for in vivo bioequivalence study, bioavailability assessment, as a sample
for registration, testing, scientific research, or display at a fair or
exhibition;
i) It is
used for other non-commercial purposes, including the case where it is imported
by a medical examination and treatment facility to serve its patients' needs
for special treatment.”;
b) Clause
3 is amended as follows:
“3. A
medicinal material that is an active ingredient that does not have a marketing
authorization in Vietnam shall be licensed for import with a quantity not exceeding
that written on the import license in the following cases:
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b) It is
used for manufacture of drugs for export, semi-finished drugs for export, drugs
serving purposes related to national defense and security, prevention and
treatment of any group A infectious disease that causes an epidemic which has
been declared in accordance with regulations of law on prevention and control
of infectious diseases, or incident and disaster recovery; manufacture and
compounding in service of needs for medical treatment at medical examination
and treatment facilities.”;
c)
Clauses 5a and 5b are added after clause 5 as follows:
“5a.
Drugs that have not been granted a drug marketing authorization in Vietnam and
are used for clinical trial may be imported without the import license with the
quantity and type published on the web portal of the Ministry of Health on the
basis of the clinical trial protocol approved by the Ministry of Health, except
for drugs specified in clause 4 of this Article.
5b. The
Minister of Health shall consider and decide the use of active ingredients and
herbal materials for manufacture of drugs granted the marketing authorization
and having indications for use in prevention and treatment of any group A
infectious disease that causes an epidemic which has been declared in
accordance with regulations of law on prevention and control of infectious
diseases with regard to active ingredients and herbal materials licensed for
import to be used for other purposes.”;
d) Clause
6a is added after clause 6 as follows:
“6a.
The Ministry of Finance shall periodically share data on controlled drugs
granted customs clearance for export and import with the Ministry of Health in
accordance with the Government’s regulations.”
dd)
Clause 7 is amended as follows:
“7. The
Government shall elaborate the following contents:
a)
Criteria, documentation requirements, procedures, time limit for issuance of
export licenses and import licenses regarding the drugs mentioned in clause 2
through 5 of this Article and the List of drugs and medicinal materials banned
from import and/or production;
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c) Forms
for the import of drugs as specified in clause 5a, documentation requirements,
procedures and time limit for the repurposing of materials as specified in
clause 5b of this Article;
d) The
transfer of drugs specified in point c clause 2 of this Article; the supply of
drugs imported by medical examination and treatment facilities to serve special
treatment needs specified in point i clause 2 of this Article to other medical
examination and treatment facilities.”.
33.
Clause 3 is added after clause 2 of Article 62 as follows:
“3. The
Government shall elaborate the recall of medicinal materials and disposal of
recalled medicinal materials.”.
34.
Several points and clauses of Article 64 are amended as follows:
a) Points
dd and e of clause 1 are amended as follows:
“dd)
Submit a report on the drug recall and its result to the Ministry of Health and
also the Department of Health in case the latter issues a recall decision;
e) Submit
a report on voluntary recall of drugs to the Ministry of Health.”;
b) Clause
2 is amended as follows:
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a) Stop
selling, supplying and dispensing the drugs recalled;
b) Notify
and organize the recall and receipt of recalled drugs;
c) Return
recalled drugs to the supplier;
d) Pay
the costs of drug recall and disposal of recalled drugs, and pay compensation
in accordance with law in case they are at fault.”;
c) Points
a and b of clause 4 are amended as follows:
“a)
Decide drug recalls and disposal of recalled drugs nationwide in consideration
of the degree of violations in terms of drug quality, safety, and efficacy;
update information about recalled drugs and disposal thereof on the web portal of
the Ministry of Health and pharmacy information system in the national health
database;
b)
Re-determine the degree of violations and request pharmacy business
establishments to adjust the scope and time of recall in a manner that suits
the degree of violations re-determined as prescribed in clauses 2 and 3 Article
63 of this Law within 24 hours since the receipt of the report on voluntary
drug recall from the pharmacy business establishments;”;
d) Clause
4a is added after clause 4 as follows:
“4a.
Each Department of Health shall:
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b) Issue
notifications of suspension from marketing and recall of drugs in its locality
according to the drug recall decision issued by the Ministry of Health;
c)
Inspect and supervise the organization of drug recalls and recall drugs in its
locality and impose penalties on violators as prescribed by law.”.
35.
Article 65 is amended as follows:
“Article
65. Power to decide drug recalls and procedures for recalling drugs
1. The
Ministry of Health shall issue a decision on mandatory recall of a drug in the
following cases:
a) The
drug is involved in a first-degree violation;
b) The
drug is involved in a second- or third-degree violation through the
manufacturer’s or importer’s fault;
c) The
drug is recalled in at least 02 provinces or central-affiliated cities.
2. Every
Department of Health shall issue decisions on mandatory drug recall in case of
second- or third-degree violations found in its province and submit reports
thereon to the Ministry of Health.
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4. In
case additional information is needed to form a basis for determining the
degree of violation, within 24 hours after receiving a report from the
Department of Health or state-owned drug and medicinal material testing
facility, the Ministry of Health shall issue a written request for additional
information.
5. The
head of the applicant for drug marketing authorization, domestic manufacturer,
importer or import entrustor shall issues the decision on voluntary drug recall
within 24 hours after the issuing the recall decision.
6. The
Minister of Health shall elaborate the procedures for reaching the conclusion
that a drug has to be recalled and is involved in a violation to a certain
degree, recall of drugs and disposal of recalled drugs.”.
36.
Clause 2 of Article 74 is amended as follows:
“2. The
Minister of Health shall elaborate prescriptions, drug prescription,
application of information technology to drug prescription, sale of
prescription drugs and connection of data with the pharmacy information system
in the national health database.”.
37.
Several points and clauses of Article 76 are amended as follows:
a)
Clause 1 is amended as follows:
“1. Drug
information is meant to provide medical practitioners, pharmacy practitioners
and drug users with instructions on how to use the drug reasonably, safely, and
effectively.”;
b) Point
a of clause 5 is amended as follows:
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c) Point
d is added after point c of clause 5 as follows:
“d)
Content of drug information must not contain any information or image not
directly related to the drug or use of the drug.”;
d) Point
b of clause 6 is amended as follows:
“b)
Pharmacy business establishments, representative offices of foreign traders
engaged in pharmacy in Vietnam and applicants for drug marketing authorization
shall provide drug information in conformity with the documents specified in
clause 3 of this Article for medical practitioners, drug users and pharmacy
practitioners.
Employees
of pharmacy business establishments shall introduce drugs to medical
practitioners and pharmacy practitioners in accordance with regulations of the
Minister of Health;”;
dd) Point
dd is added after point d of clause 6 as follows:
“dd) The
organizations and individuals specified in points a, b and c of this clause
shall only provide information on the drugs granted the marketing authorization
in Vietnam.”.
38.
Clause 2 of Article 78 is amended as follows:
“2. The
Minister of Health shall organize a system of drug information and
pharmacovigilance; specify the forms and methods of providing drug
information.”.
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“3. The
Government shall elaborate drug advertisement contents, documentation,
procedures for receiving, verifying, and certifying drug advertisement
contents; define responsibilities of organizations and individuals advertising
and participate in advertising drugs.”.
40. Several clauses of
Article 87 are amended as follows:
a) Clause
1 is amended as follows:
“1. Phase
1, 2, and 3 clinical trials shall be carried out before obtaining drug
marketing authorization, except for the regulation in clause 1a of this
Article.”;
b) Clause
1a is added after clause 1 as follows:
“1a.
In order to meet the needs for prevention and treatment of any group A
infectious disease that causes an epidemic which has been declared in
accordance with regulations of law on prevention and control of infectious
diseases, the Minister of Health shall decide to grant the marketing
authorization to the drug which is undergoing a clinical trial but still has
its safety and efficacy monitored and its users, quantity and scope controlled
after being granted the marketing authorization if the following requirements
are satisfied:
a) Phase
3 interim assessment result for safety and treatment effectiveness of the drug
or protection effectiveness of the vaccine based on immunogenicity data
approved by the National Research Ethics Committee is available;
b)
Consent of the Marketing Authorization Advisory Board is obtained.”.
41. Point
b clause 3 of Article 89 is amended as follows:
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42.
Article 103 is amended as follows:
“Article
103. Testing drugs, medicinal materials and primary packages of drugs
1. Drugs,
medicinal materials and primary packages of drugs shall be tested by taking
samples, considering technical standards, run relevant and necessary tests to
determine whether they meet quality standards.
2. Drugs,
medicinal materials and primary packages of drugs must be tested according to
the following regulations:
a)
Medicinal materials and primary packages of drugs must be tested by the drug
manufacturer and meet quality standards before their manufacture is commenced;
b)
Finished drugs, medicinal materials and primary packages of drugs must be
tested by their manufacturers and meet quality standards before being released;
c)
Manufacturers of drugs and medicinal materials are allowed to apply quality
management measures that meet Good Manufacturing Practices for drugs and
medicinal materials to replace one or more tests for the inspection and
determination of the quality of and medicinal materials specified in points a
and b of this clause.
3. Apart
from the test specified in clause 2 of this Article, the following drugs must
also be tested by a testing facility appointed by a competent authority before
they are marketed:
a)
Vaccines;
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c) Other drugs
specified by the Minister of Health according to result of assessment of risks
to drug quality and developments of quality of manufactured and imported
drugs.
4.
Vaccines and biologicals that are antisera to be tested as prescribed in clause
3 of this Article shall be exempted from one or more or all of the tests in the
process of testing conducted at an appointed testing facility in any of the
following cases:
a) They
are imported from a country with which Vietnam signs a mutual recognition
agreement on drug testing laboratories and drug testing results or Vietnam
recognizes and acknowledges the drug quality assessment results given by a
competent authority on the issuance of quality certificates or release
certificates of the exporting country;
b) It is
needed to meet urgent needs for national defense and security, disaster
recovery, disease prevention and control or special treatment needs;
c) The
results of assessment of risks to drug quality and assessment of drug quality
trend under regulations of the Ministry of Health prove that the drug meets
quality standards during its production and marketing.
5. The
Minister of Health shall elaborate this Article.”.
43.
Article 107 is amended as follows:
“Article
107. Measures for drug price management
1. Bid
for supply of drugs in national reserve in compliance with the Law on Bidding
and regulations of law on national reserves.
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3.
Announce and re-announce intended wholesale prices of prescription drugs,
except for the case of exemption from announcement prescribed by the Government
with regard to domestically manufactured drugs or drugs imported for
non-commercial purposes.
4.
Comment on intended wholesale price of a drug announced or re-announced in the
process of drug marketing as the Ministry of Health finds that:
a) The
intended wholesale price is higher than the highest price of the similar drugs
announced or re-announced without a comment from the Ministry of Health unless
the establishment produces an explanatory report and documents proving the
reasonableness of the price fluctuation. In case the content or concentration
per dosage unit of the drug for which the intended wholesale price has been
fixed is different from that of the similar drugs, price comparison will be
made based on equivalent conversion; or
b) The
difference between the intended wholesale price of the drug and the successful
bid of that drug exceeds the maximum difference prescribed by the Government
unless the establishment produces an explanatory report and documents proving
the reasonableness of the price fluctuation; or
c) There
are no drugs marketed in Vietnam that are similar to the drug for which the
intended wholesale price announced or re-announced has been fixed and the price
announced or re-announced is higher than the selling price in the country of
origin or another country unless the establishment produces an explanatory
report and documents proving the reasonableness of the price fluctuation.
5.
Declare wholesale and retail prices of drugs on the List of essential drugs in
accordance with law on prices.
6. Post
wholesale and retail prices of drugs in accordance with law on prices.
7.
Stabilize drug prices in accordance with law on prices.
8.
Negotiate drug prices in accordance with law on prices.
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10.
Impose limits on retail surplus upon drug retailers within medical examination
and treatment facilities.
11. The
Government shall elaborate the announcement and re-announcement of intended
wholesale prices of prescription drugs, clauses 4 and 10 of this Article.”.
44. Article 109 is amended as follows:
“Article
109. Responsibility of the Ministry of Health for state management of drug
prices
The
Ministry of Health shall preside over and cooperate with other Ministries,
ministerial agencies, Governmental agencies and People’s Committees of
provinces in state management of drug prices and shall undertake the following
tasks:
1.
Preside over formulating, promulgate within its power or request competent
authorities to promulgate legislative documents on drug prices and organize the
implementation of policies and laws on drug prices;
2.
Request other Ministries, ministerial agencies, Governmental agencies and
People’s Committees of provinces to submit periodic and ad hoc reports on
management of drug prices;
3.
Preside over organizing dissemination and education of laws on drug prices;
4. Take
measures for drug price stabilization in accordance with law on prices;
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6.
Publish its comments on intended wholesale drug prices announced and
re-announced as prescribed in clause 4 Article 107 of this Law;
7. Carry
out examination and inspection, and impose penalties for violations of law on
drug prices.”.
45. Article 110 is amended as follows:
“Article 110. Responsibility of the Ministry of Finance for
state management of drug prices
Exercise its functions of state management of drug prices in
accordance with law on prices.”.
46. Clause 3 of Article 112 is amended as follows:
“3.
Organize receipt of dossiers on drug prices declared and re-declared by local
drug business establishments and update information and data on declared drug
prices to the national price database in accordance with law on prices.”.
47. Article 113 is amended as follows:
“Article 113. Responsibility of Vietnam Social Security for
state management of drug prices
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48.
Phrases in some points and clauses below are replaced and removed:
a) The phrase
“thuốc thuộc Danh mục thuốc phải kiểm soát đặc biệt và Danh mục thuốc hạn chế
bán lẻ” (“drugs on the List of controlled drugs and List of drugs restricted
from retailing”) in point b clause 1 of Article 47 and point b clause 1 of
Article 49 is replaced with the phrase “thuốc phải kiểm soát đặc biệt và thuốc
thuộc Danh mục thuốc hạn chế bán lẻ” (“controlled drugs and drugs on the List
of drugs restricted from retailing”);
b) The phrase
“m và n khoản 2 Điều 42 của Luật này” (“m and n clause 2 Article 42 of this
Law”) in point a clause 2 Article 43, point a clause 2 Article 44, clause 2
Article 45, point a clause 2 Article 46, point a clause 2 Article 51, point a
clause 2 Article 52 and point a clause 2 Article 53 is replaced with the phrase
“m, n và q khoản 2 Điều 42 của Luật này” (“m, n and q clause 2 Artile 42 of
this Law”).
c) The phrase
“Bản sao có chứng thực” (“Certified true copy”) are removed from clause 2 of
Article 24, points c and d clause 1, points c and d clause 2 and points b and c
clause 4 of Article 38;
d) The phrase
“Bản sao” (“Copy”) are removed from clause 2 of Article 25, and clauses 2 and 3
of Article 26.
49.
Clause 6 of Article 24, clause 3 of Article 78, point b clause 1 and point b
clause 2 of Article 89, and Article 114 are repealed.
Article 2. Amendments to the Law on Prices
No. 16/2023/QH15
Section 9
of the Appendix 01 - List of goods and services subject to price stabilization
promulgated together with the Law on Prices No. 16/2023/QH15 is amended as
follows:
“9. Drugs
on the List of essential drugs.”.
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1. This
Law comes into force from July 01, 2025, except for the case specified in
clause 2 of this Article.
2. The
following regulations come into force from January 01, 2025:
a) Point
a clause 19, point b clause 20 and point a clause 21 Article 1 of this Law;
b)
Regulations on renewal of marketing authorizations of drugs and medicinal
materials specified in clause 30 Article 1 of this Law.
3.
Transitional clauses:
a)
Applications for issuance or revision of marketing authorization of drug or
medicinal material and applications for certification or adjustment of content
of drug information which are submitted before July 01, 2025 but are yet to be
processed shall be processed as per regulations of the Law on Pharmacy No.
105/2016/QH13 amended by the Law No. 28/2018/QH14 unless the applicant requests
the application of this Law;
b) The
declared or re-declared drug price as prescribed in clause 3 Article 107 of the
Law on Pharmacy No. 105/2016/QH13 amended by the Law No. 28/2018/QH14 shall
continue to apply and be treated as the announced or re-announced intended
wholesale price as prescribed in this Law.
This
Law is adopted by the 15th National Assembly of Socialist Republic of Vietnam
on this 21st of November 2024 during its 8th session.
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CHAIRMAN OF THE NATIONAL ASSEMBLY
Tran Thanh Man