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THE NATIONAL ASSEMBLY
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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Law No. 105/2016/QH13
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Hanoi, April 06, 2016
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LAW
ON PHARMACY
Pursuant
to the Constitution of Socialist Republic of Vietnam;
The National
Assembly promulgates the Law on Pharmacy.
Chapter I
GENERAL PROVISIONS
Article 1. Scope and regulated entities
1. This
Law provides for policies of the State on pharmacy and development of pharmacy
industry; pharmacy practice; pharmacy business; registration, sale, recall of
drug and medicinal materials; herbal materials and traditional drugs; drug
information, pharmacovigilance, drug advertising; clinical pharmacology;
management of drugs in health facilities; clinical trial of drugs (hereinafter
referred to as clinical trial) and bioequivalence study of drugs; management of
drug quality, medicinal materials, and drug prices.
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Article 2. Definitions
For the
purpose of this Law, the terms below are construed as follows:
1.
Pharmaceuticals are drugs and medicinal materials.
2. Drug means a preparation
that contains active ingredients or herbal materials used for prevention,
diagnosis, treatment, alleviation of diseases in humans, regulation of human
physiological functions, including chemical drugs, herbal drugs, traditional
drugs, vaccines, and biologicals.
3.
Medicinal material means an ingredient incorporated into the drug which may
be an active ingredient, herbal material, excipient, or capsule shells used
during the manufacture of drugs.
4.
Active ingredient means a substance or mixture of substances used for the
manufacture of drugs and has pharmacological effects or direct effects in
prevention, diagnosis, treatment, alleviation of diseases, or regulation of
human physiological functions.
5.
Herbal material means a medicinal material which is derived from plants,
animals, minerals and satisfy standards for drug manufacture.
6. Chemical
drug means a drug that contain active ingredients whose composition,
formula, purity are determined and are qualified for medicinal use, including
injectable drugs derived from herbal materials, drugs that combine active
ingredients and herbal materials whose safety and efficacy have been proven.
7. Herbal
drug means a drug whose ingredients are derived from herbal materials and
its effects are supported by scientific evidence, except for traditional drugs
mentioned in Clause 8 of this Article.
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9. Prepared
traditional medicinal material means an herbal material that is processed
according to traditional drug principles and methods and is used for production
of traditional drugs, prevention or treatment of diseases.
10. Biological
(also biopharmaceutical) means a drug that is the product of a
technological or biological process from a macromolecular substance or mixture
of macromolecular substances extracted from biological sources, including
derivatives of human blood and plasma.
Biologicals
do not include antibiotics and substances derived from biological sources that
have small molecular weights and can be subdivided into pure substances and in
vitro diagnostic reagents.
11.
Reference biological means a biological granted the marketing authorization
in Vietnam based on sufficient data about its quality, safety, and efficacy.
12.
Similar biological means a biological whose quality, safety, and efficacy
are similar to those of a reference biological.
13.
Vaccine means a drug that contains antigens which helps the body develop
immunity and is used for prevention or treatment of diseases.
14. New
drug means a drug that contains a new active ingredient or an herbal
material which is medicinally used in Vietnam for the first time; a drug that
has a new combination of licensed active ingredients or herbal materials that
have been medicinally used in Vietnam.
15. Generic
drug means a drug that has the same active ingredients, content, dosage
form as those of the original brand name drug and is a substitute for the
original brand name drug.
16. Original
brand name drug means the first drug that is granted the marketing
authorization based on sufficient data about its quality, safety, and efficacy.
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18. Psychotropic
drug means a drug that contains any psychoactive substance or hallucinogen
that can cause addiction if used many times on the List of psychotropic
substances promulgated by the Minister of Health.
19.
Precursor drug means a drug that contains any precursor on the List of drug
precursors promulgated by the Minister of Health.
20.
Combination drug that contain narcotic ingredients means a drug that
contain various active ingredients including narcotic ingredients with the
content specified by the Ministry of Health.
21.
Combination drug that contain psychotropic substances means a drug that
contain various active ingredients including psychotropic ingredients with the
content specified by the Ministry of Health.
22.
Combination drug that contain precursors means a drug that contain various
active ingredients including precursors with the content specified by the
Ministry of Health.
23. Radiopharmaceutical
means a drug that contains radionuclides used for diagnosis, treatment of
diseases in humans or medical-biological research, including radioactive
isotopes or radioactive isotopes combined with tracers.
24.
Radioactive isotope means the isotope of an element the nucleus of which is
instable and emitting ionizing irradiation while undergoing radioactive decay
in order to be stable.
25. Tracer
(also carrier) means a substance or compound used for compounding or
combination with radioactive isotopes to create radiopharmaceuticals.
26. Controlled
drugs and medicinal materials include:
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b)
Medicinal materials that are psychotropic ingredients, narcotic substances,
drug precursors, or radioactive substances for manufacture of drugs specified
in Clauses 17, 18, 19, 20, 21, 22, 23 and 24 of this Article;
c) Toxic
drugs, toxic medicinal materials on the List promulgated by the Minister of
Health;
d) Drugs,
active ingredients on the List of banned substances in some fields and sectors
promulgated by the Government.
27. Over-the-counter
(OTC) drug means a drug that may be dispensed, retailed, and used without a
prescription and is included in the list of OTC drugs promulgated by the
Minister of Health.
28. Prescription
drug means a drug that requires a medical prescription to be dispensed,
retailed, or used because the misuse of which might be dangerous to the user’s
health or life.
29. Essential
drug means a drug that satisfies the need for healthcare of the majority of
people on the List of essential drugs promulgated by the Minister of Health.
30. Rare
drug means a drug that is used for prevention, diagnosis, treatment of a
rare disease or not always available prescribed by the Minister of Health.
31. Shelf
life of a drug means the predetermined period of time after which the drug
must not be used.
The shelf
life may be expressed as a period of time from the date of manufacture to the
date of expiry, or as an expiry date. Where the shelf life is expressed as the
month and year of expiry, it may be used until the last day of such month.
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33.
Counterfeit drug means a drug that:
a) does
not contain any active ingredients or herbal materials;
b)
contains active ingredients other than those written on its label or registered
standards or import license;
c)
contains active ingredients or herbal materials whose content or concentration
is different from the registration or the import license, except for
substandard drugs mentioned in Clause 32 of this Article during the storage or
distribution; or
d) is
manufactured, displayed, or labeled in a way that impersonates another
manufacturer or country of manufacture or country of origin.
34. Counterfeit
herbal material means an herbal material that:
a) is of
a different species, part, or origin from that written by the seller on the
label or attached document;
b) is
deliberately mixed or replaced with an ingredient other than that written on
the label; is used for extraction of active ingredients;
c) is
manufactured, displayed, or labeled in a way that impersonates another
manufacturer or country of manufacture or country of origin.
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36. Pharmacy
practice means the application of a person’s expertise to pharmacy business
and clinical pharmacology.
37. Good
practice means a set of principles and standards for manufacture,
preservation, testing, sale of drugs, prescription, clinical trial, cultivation
and collection of herbal materials, and other sets of principles and standards
promulgated or applied by the Minister of Health in accordance with
instructions of World Health Organization (WHO) or other international
organizations accredited or participated in by Vietnam.
38.
Bioavailability means an indicator of degree and rate at which an active
ingredient or substance in a drug is absorbed into the body for it to be
available at the site of physiological activity inside the body.
39. Bioequivalence
means the equivalence of bioavailability between two drugs under the same
conditions.
40. Clinical
pharmacology means scientific research and pharmacy practice related to
consultancy on reasonable, safe, and effective use of drugs for optimizing the
use of drugs.
41. Pharmacovigilance
means the discovery, assessment, and prevention of adverse effects related
to the use of drugs
42. Primary
package means the package that contains the drugs and is in direct physical
contact with the drug and form the shape or wrap around the shape of the drug
inside.
43. Pharmacy
business means one, some or all stages of the investment process, including
inter alia manufacture, sale, provision of services related to drugs and
medicinal materials on the market for with an aim to make a profit.
Article 3. National reserves of drugs and medicinal
materials
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a)
Disease prevention and control, disaster recovery;
b)
Assurance of national defense and security;
c)
Prevention, diagnosis, and treatment of rare diseases;
d) Use in
case of unavailability of drugs.
2. The
building up, organization, management, and use of drugs and medicinal materials
from the national reserves shall comply with regulations of law on national
reserves.
Article 4. Pharmacy authorities
1. The
Government shall uniform state management of pharmacy.
2. The
Ministry of Health is responsible to the Government for state management of
pharmacy.
3. Other Ministries
and ministerial agencies shall carry out state management of pharmacy ex
officio and cooperate with the Ministry of Health in state management of
pharmacy as assigned by the Government.
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Article 5. Pharmacy associations
1.
Pharmacy associations are socio-professional organizations engaged in pharmacy
industry.
2. Every
organization and individual engaged in the pharmacy industry is entitled to
participate in and establish pharmacy associations.
3.
Organization and operation of pharmacy associations shall comply with this Law
and regulations of law on associations.
4.
Responsibilities and entitlements of a pharmacy association:
a) Promulgate
the code of ethics for pharmacy practitioners on be basis of the code of ethics
promulgated by the Minister of Health;
b)
Participate in development, implementation, and supervision of implementation
of legislative documents on pharmacy;
c) Participate
in supervision of pharmacy practice and adherence to the code of ethics for
pharmacy practitioners and social criticism related to pharmacy;
d)
Participate in training program and refresher program in pharmacy;
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Article 6. Prohibited acts
1.
Running a pharmacy business without the Certificate of eligibility for pharmacy
business or while being suspended or while the Certificate of eligibility for
pharmacy business is suspended.
2.
Running a pharmacy business at a location other than the registered business
location.
3.
Dealing in drugs and medicinal materials specified in Clause 26 Article 2
hereof, other drugs and medicinal materials for improper purposes or providing drugs
and medicinal materials for entities that are not permitted by competent
authorities.
4.
Running a pharmacy business beyond the scope written in the Certificate of
eligibility for pharmacy business.
5.
Running a pharmacy business that involves:
a) Counterfeit
drugs or medicinal materials;
b)
Substandard drugs or medicinal materials; drugs or medicinal materials that
have to be recalled as requested by a competent authority; drugs or medicinal
materials of unknown origins; expired drugs or medicinal materials;
c) Drugs
or medicinal materials on the List of drugs and medicinal materials banned from
import or manufacture;
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dd) Drugs
or medicinal materials as samples for registration, testing, scientific
research, or display at a fair or exhibition;
e) Drugs
or medicinal materials that have not been granted the marketing authorization;
g) Drugs
that belong to a National Target Program, drugs as aid and other drugs banned
from selling;
h)
Retailing prescription drugs without prescription; retailing vaccines;
i)
Selling drugs at higher prices that declared or listed prices.
6.
Forging, falsifying documents or certificates of competent authorities and
other entities in pharmacy activities.
7. Changing,
falsifying shelf life of drugs except for those specified in Clause 3 Article
61 of this Law.
8.
Holding the positions specified in Article 11 of this Law without a pharmacy
practice certificate or while the pharmacy practice certificate is suspended.
9.
Renting, borrowing, leasing out, lending the pharmacy practice certificate or
Certificate of eligibility for pharmacy business, or allowing another person to
use it to practice pharmacy or do pharmacy business.
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a)
Advertising drugs before a competent authority certify the advertising content
or against the contents certified by the competent authority;
b) Using
a certificate not recognized by the Ministry of Health; using material
benefits, reputation of an organization or individual, symbols, images,
positions, mails, letters of thanks to advertise drugs;
c) Using
results of clinical trial or pre-clinical trial, testing results, results of
bioequivalence study that are not recognized by the Ministry of Health to
advertise drugs.
11.
Running sale promotion of drugs against the law.
12.
Profiteering by prescribing drugs.
13.
Manufacturing, compounding, selling traditional medicines combines with active
ingredients without permission by a competent authority.
14.
Dispensing, selling expired drugs or drugs that are not stored in accordance
with instructions on the labels, drugs that have to be recalled as requested by
a competent authority, drugs of unknown origins.
15.
Providing information, advertising, marketing, prescribing, counseling,
labeling, giving instructions that non-medicinal products can be used for
prevention, treatment, diagnosis, alleviation of diseases or regulating human
physiological functions, except for medical equipment.
16.
Exporting herbal materials on the List of controlled rare and special herbs
before being licensed by a competent authority.
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STATE POLICIES ON PHARMACY AND DEVELOPMENT
OF PHARMACY INDUSTRY
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 while taking
into account the disease situation, national defense and security requirements,
need for disease prevention and control, disaster recovery, and rare drugs.
2. Ensure
the reasonable, safe, and effective use of drugs; give priority to clinical
pharmacology and pharmacovigilance activities.
3.
Provide incentives for manufacture of drugs, medicinal materials, essential
drugs, drugs for prevention and treatment of sexually transmitted diseases,
vaccines, biologicals, herbal drugs, traditional drugs, rare drugs; provide
incentives for scientific research into concoction technology and biotechnology
for creation of new drugs.
4. With
regard to purchases of drugs funded by state budget, health insurance fund,
revenue from medical examination and treatment services, and other lawful
sources of income of public health facilities:
a) Do not
offer imported drugs on the List promulgated by the Minister of Health while
domestically produced drugs still meet the treatment, pricing, and supply
requirements.
Priority
shall be given to purchase of generic drugs and biosimilars that are
domestically produced and granted marketing authorizations in Vietnam; herbal
drugs, traditional drugs derived from domestic herbal materials; drugs using
active ingredients, excipients, capsule shells, or primary packages
manufactured by domestic facilities that fulfills Good Manufacturing Practice
(GMP) requirements; fresh herbal materials; herbal drugs and traditional drugs
manufactured as a result of national, ministerial, or provincial science and
technology missions;
b) Do not
offer imported herbal materials on the List promulgated by the Minister of
Health while herbal materials domestically cultivated and obtained still meet
the treatment, pricing, and supply requirements.
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c) Give
priority to purchase of drugs on the List of national products.
5. Facilitate
procedures for application for submitting application forms for marketing of
generic drugs whose patents are going to expire soon, biosimilars; facilitate
procedures for marketing authorization and application for licenses to import
rare drugs and the vaccines that have been pre-qualified by WHO.
6.
Combine investment from state budget and investment from other sources in
development of the manufacture of vaccines, biologicals, herbal materials, traditional
drugs, drugs whose patents are going to expire soon; cultivation and production
of herbal materials; discovery, conservation and application of science and
technology to research and development of genetic resources of rare and special
herbal materials.
7.
Support and facilitate the discovery, clinical trial, registration of
protection of intellectual property rights, marketing authorization and
registration of 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 of herbal
materials, herbal drugs and traditional drugs;
8.
Introduce policies to protect confidentiality of information about concoction
and 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;
9.
Encourage technology transfers in drug manufacture; develop the network of
distribution, drugstores, storage and supply of drugs towards professionalism,
modernity, and efficiency; ensure timely and adequate supply of drugs with good
quality to meet the people’s need for drugs; encourage drugstores and
dispensaries to open 24/24.
Give
priority to investment in and support for the drug supply system, mobile drug
retailers for ethnic minorities, people in highlands, on islands, and in
extremely disadvantaged areas.
10.
Request military health facilities to participate in supply of drugs and
cultivation of herbal materials to meet the need for prevention and treatment
of diseases of ethnic minorities, people living in highlands, on islands, and
in extremely disadvantaged areas.
11.
Introduce policies on improvement of pharmacy human resources; give priority to
people who obtain pharmacy practice certificates by passing examinations as
prescribed by the Government.
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1.
Research into manufacture of medicinal materials from herbal materials
available in Vietnam to serve concoction and manufacture of herbal drugs and
traditional drugs.
2.
Manufacture of drugs as soon as the patent expires, vaccines, biologicals,
herbal materials, herbal drugs, traditional drugs, rare drugs.
3.
Development of sources of herbal materials and herbal material farming areas;
conservation of genetic resources and development of rare or special species of
herbal materials.
4.
Investment incentives and investment support for prioritized fields related to
development of pharmacy industry shall comply with regulations of law on
investment.
Article 9. Master plan for pharmacy industry development
1. The
master plan for pharmacy industry development consists of plans for
manufacture, distribution, storage, testing of drugs and medicinal materials,
development of herbal material sources and herbal material cultivation areas.
2. The
master plan for pharmacy industry development must:
a) comply
with this Law and relevant regulations of law;
b) comply
with the effective national socio-economic development strategy; ensure
environmental protection and safety equipment;
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d)
contains scientific forecasts, satisfy practical requirements and be suitable
for the tendency of development and international integration.
3. Apart
from the provisions of Clause 2 above, the plans for manufacture of herbal
materials, herbal drugs, traditional drugs, development of herbal material
sources and herbal material cultivation areas must:
a)
specify the reasonable extraction of natural resources in a way that is
appropriate for the climate, ecology, natural and social conditions of each
area;
b) orient
the industrial manufacture of herbal materials, development of herbal material
cultivation areas, conservation of genetic resources, development of rare and
special species of herbs on the basis of enhanced investment in technology
combined with traditional experience.
4. The
formulation, approval, and management of the master plan for pharmacy industry
development shall comply with law.
Article 10. Responsibility for development of pharmacy industry
1. The
Ministry of Health has the responsibilities to:
a) Take
charge and cooperate with other relevant Ministries, ministerial agencies,
Governmental agencies in promulgating or proposing the promulgation and
organizing the implementation of legislative documents, strategies, policies,
master plans, and plans for pharmacy industry development;
b) Take
charge and cooperate with the Ministry of Education and Training in formulating
plans for training and employment regarding research into and manufacture of
generic drugs, vaccines, biologicals, herbal drugs, traditional drugs, rare
drugs;
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d) Take
charge and cooperate with the Ministry of Agriculture and Rural Development,
other Ministries, ministerial agencies and Governmental agencies in
promulgating the List of controlled rare and special herbs.
2. The
Ministry of Industry and Trade shall take charge and cooperate with other relevant
Ministries, ministerial agencies, Governmental agencies in promulgating or
proposing the promulgation and organizing the implementation of legislative
documents, master plans, and plans for development of pharmaceutical chemistry
industry;
3. The Ministry
of Agriculture and Rural Development has the responsibilities to:
a) Take
charge and cooperate with the Ministry of Health, the Ministry of Science and
Technology in research into selection, creation, cultivation and harvest of
herb varieties; research into and dissemination of knowledge about cultivation
and protection of medicinal plants and animals;
b) Take
charge and cooperate with other relevant Ministries, ministerial agencies and
Governmental agencies in proposing the policies on varieties, capital, and
technology in cultivation and harvest of herbal materials.
4. The
Ministry of Natural Resources and Environment shall take charge and cooperate
with other relevant Ministries, ministerial agencies and Governmental agencies
in proposing policies on access to herb genetic resources and sharing benefits
from the use of such resources.
5. The
Ministry of Planning and Investment has the responsibilities to:
a)
Provide and balance sources of investment in pharmacy industry development;
attract foreign investments in pharmacy industry development;
b) Take
charge and cooperate with the Ministry of Finance, other relevant Ministries,
ministerial agencies and Governmental agencies in developing and proposing
regulations and policies on incentives and support for investment in pharmacy
as prescribed in Article 8 hereof.
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a) Take
charge and cooperate with other relevant Ministries, ministerial agencies,
Governmental agencies in developing and proposing a financial mechanism for
attracting and maintaining resources for implementation of master plans and
plans for pharmacy industry development;
b) Take
charge and cooperate with the Ministry of Industry and Trade, the Ministry of
National Defense, the Ministry of Health, the People’s Committees of bordering
provinces in management, control of import of drugs and medicinal materials
that have not been granted the marketing authorization, import of herbal
materials that have not been permitted by competent authority, export of herbal
materials on the List of controlled rare and special herbs.
7. The
Ministry of Science and Technology has the responsibilities to:
a)
Request or provide annual funding from state budget for scientific activities
serving research application of research findings in manufacture of drugs,
especially those on the List of national products;
b) Take
charge and cooperate with the Ministry of Agriculture and Rural Development,
the Ministry of Health in conducting research, conserving genetic resources,
and developing sources of rare and special herbal materials;
c) Take
charge and cooperate with the Ministry of Health in developing policies on
protection of intellectual property of traditional drugs.
8. The
People’s Committees of provinces have the responsibilities to:
a)
Formulate, approve provincial master plans and plans for pharmacy industry
development, herbal material development (including extraction and conservation
of natural herbal material sources) in accordance with national master plans
and plans for pharmacy industry development, socio-economic development
targets, and local advantages;
b)
Provide land for construction of factories and pharmaceutical industrial parks;
give priority to allocation of land to projects on development of herbal
materials and herbal material cultivation areas in accordance with regulations
of law on land.
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PHARMACY PRACTICE
Section 1. PHARMACY PRACTICE CERTIFICATE
Article 11. Positions requiring pharmacy practice
certificates
1. The
chief pharmacist of a pharmacy business establishment.
2. The
person in charge of quality assurance of a facility manufacturing drugs or
medicinal materials.
3. The
person in charge of clinical pharmacology of a health facility.
Article 12. Issuance, reissuance, adjustment of pharmacy
practice certificate
1. The
pharmacy practice certificate shall be issued with or without an examination
to:
a) A
person who applies for the pharmacy practice certificate for the first time;
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If the
pharmacy practice certificate is withdrawn in the cases specified in Clause 4, 6,
10, or 11 of Article 28 hereof, it shall only be issued after 12 months from
the revocation date.
2. The
pharmacy practice certificate shall be reissued if it is lost or damaged.
3. The
pharmacy practice certificate shall be adjusted if there are changes to its
holder’s scope of practice or method of issuance of the certificate or its
holder’s information.
Article 13. Conditions for issuance of a pharmacy practice
certificate
To be
issued with a pharmacy practice certificate, a person must:
1. Has
any qualifications issued or recognized in Vietnam suitable for his/her
position and the pharmacy business establishment. Such qualifications include:
a)
Bachelor’s degree in pharmacy (hereinafter referred to as pharmacist degree);
b)
Bachelor’s degree in general medicine;
c)
Bachelor’s degree in traditional medicine or traditional pharmacy;
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dd)
Bachelor’s degree in chemistry;
e)
College degree in pharmacy;
g)
Associate degree in pharmacy;
h)
College degree or associate degree in medicine;
i)
Associate degree in traditional medicine or traditional pharmacy;
k) Basic
diploma in pharmacy;
l)
Certificate of traditional physician or pharmacist, certificate of hereditary
remedy, or other traditional medicine qualifications issued before the
effective date of this Law.
The
products qualifications specified in Point 1 of this Clause required as a
condition shall be specified by the Ministry of Health according to
socio-economic development, the people’s need for medical examination and treatment
in each area and each period.
2. Has
served an apprenticeship at a pharmacy business establishment, the pharmacy of
a health facility, a pharmacy training school, a pharmacy research institute, a
facility specialized in testing drugs and medicinal materials, a pharmacy
authority, or a representative office in Vietnam of a foreign trader engaged in
pharmacy (hereinafter referred to as pharmacy establishment); a health facility
suitable for the practitioner’s expertise as follows:
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b) For a
person having a postgraduate degree suitable for the scope of practice, the
apprenticeship duration may be shortened as prescribed by the Government;
c) For a
person having any of the qualifications specified in Point l Clause 1 Article
13 hereof, the apprenticeship duration shall be specified by the Minister of
Health.
3. Has a
certificate of suitable health for pharmacy practice issued by a competent
health facility.
4. Not:
a) be
facing a criminal prosecution, serving a court’s sentence or ruling; be
suspended from practice or doing works related to pharmacy under the court’s
sentence or ruling;
b) have
limited legal capacity.
5. Any
person who wishes to take an examination to obtain a pharmacy practice
certificate must fully satisfy the conditions specified in this Article.
Article 14. Conditions for issuance of pharmacy practice
certificates in Vietnam to foreigners and Vietnamese citizens residing overseas
1. Fully
satisfy the conditions specified in Article 13 hereof.
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Article 15. Conditions to be satisfied by the chief
pharmacist and the person in charge of quality assurance of a facility
manufacturing drugs and medicinal materials
1.
Conditions to be satisfied by chief pharmacist of a facility manufacturing
drugs and medicinal materials that are active ingredients, excipients, or
capsule shells:
a) The
chief pharmacist of a facility manufacturing drugs must have any of the
qualifications specified in Point a Clause 1 Article 13 hereof and at least 05
years’ apprenticeship at a suitable pharmacy establishment, except for the case
in Point c of this Clause;
b) The
chief pharmacist of a facility manufacturing medicinal materials that are
active ingredients, excipients, or capsule shells must have any of the qualifications
specified in Point a or Point dd Clause 1 Article 13 hereof and at least 03
years’ apprenticeship at a suitable pharmacy establishment;
c) The
chief pharmacist of a facility manufacturing vaccines, biologicals, and
ingredients thereof must have any of the qualifications specified in Point a, b
or d Clause 1 Article 13 hereof and at least 05 years’ apprenticeship at a
suitable pharmacy establishment.
2.
Conditions to be satisfied by the person in charge of quality assurance of a
facility manufacturing drugs and medicinal materials that are active
ingredients, excipients, capsule shells:
a) The
person in charge of quality assurance of a facility manufacturing drugs must
have any of the qualifications specified in Point a Clause 1 Article 13 hereof
and at least 05 years’ apprenticeship at a drug-manufacturing facility or
drug-testing facility, except for the case in Point b and c of this Clause;
b) The
person in charge of quality assurance of a facility manufacturing vaccines or
biologicals must have any of the qualifications specified in Point a, b or d
Clause 1 Article 13 hereof and at least 05 years’ apprenticeship at a facility
manufacturing or testing vaccines or biologicals;
c) The
person in charge of quality assurance of a facility manufacturing medicinal
materials that are active ingredients, excipients, or capsule shells must have
any of the qualifications specified in Point a or dd Clause 1 Article 13 hereof
and at least 03 years’ apprenticeship at a facility manufacturing drugs or
medicinal materials or a drug-testing facility.
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a) The
chief pharmacist and the person in charge of quality assurance of a facility
manufacturing herbal materials must have any of the qualifications specified in
Point a or Point c Clause 1 Article 13 hereof and at least 02 years’
apprenticeship at a suitable pharmacy establishment, except for the case in
Point b of this Clause;
b) The
chief pharmacist and the person in charge of quality assurance of business
household or cooperative manufacturing herbal materials must have any of the
qualifications specified in Point a, c, e, g, i or l Clause 1 Article 13 hereof
and at least 02 years’ apprenticeship at a suitable pharmacy establishment,
except for the case in Point c Clause 2 Article 13 hereof;
c) The
chief pharmacist of a facility manufacturing herbal materials may also be in
charge of quality assurance therein.
Article 16. Conditions to be satisfied by the chief
pharmacist of a wholesaler of drugs/medicinal materials
1. The
chief pharmacist of a wholesaler of drugs/medicinal materials must have any of
the qualifications specified in Point a Clause 1 Article 13 hereof and at least
02 years’ apprenticeship at a suitable pharmacy establishment, except for the
case in Clause 2 and Clause 3 of this Article.
2. The
chief pharmacist of a wholesaler of vaccines/biologicals must have any of the
qualifications specified in Point a, b or d Clause 1 Article 13 hereof and at
least 02 years’ apprenticeship at a suitable pharmacy establishment.
3. The
chief pharmacist of a wholesaler of herbal materials, herbal drugs, or
traditional drugs must have any of the qualifications specified in Point a, c,
I or l Clause 1 Article 13 hereof and at least 02 years’ apprenticeship at a
suitable pharmacy establishment, except for the case in Point c Clause 2
Article 13 hereof.
Article 17. Conditions to be satisfied by the chief
pharmacist of an exporter or importer of drugs/medicinal materials
1. The
chief pharmacist of an exporter or importer of drugs/medicinal materials must
have any of the qualifications specified in Point a Clause 1 Article 13 hereof
and at least 02 years’ apprenticeship at a suitable pharmacy establishment,
except for the case in Clause 2 and Clause 3 of this Article.
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3. The
chief pharmacist of an exporter or importer of herbal materials, herbal drugs,
or traditional drugs must have any of the qualifications specified in Point a
or Point c Clause 1 Article 13 hereof and at least 02 years’ apprenticeship at
a suitable pharmacy establishment.
Article 18. Conditions to be satisfied by the chief
pharmacist of a drug retailer
1. The
chief pharmacist of a drugstore must have any of the qualifications specified
in Point a Clause 1 Article 13 hereof and at least 02 years’ apprenticeship at
a suitable pharmacy establishment. c) The chief pharmacist of a drugstore may
also be in charge of clinical pharmacology therein.
2. The
chief pharmacist of a dispensary must have any of the qualifications specified
in Point a, e or g Clause 1 Article 13 hereof and at least 18 months’
apprenticeship at a suitable pharmacy establishment.
3. The
chief pharmacist of the dispensary of the medical station of a commune must have
any of the qualifications specified in Point a, e g or k Clause 1 Article 13
hereof and at least 01 year’s apprenticeship at a suitable pharmacy
establishment or a health facility; If the medical station is located in an
ethnic minority area, highland, island, extremely disadvantaged area, the chief
pharmacist must have any of the qualifications specified in Point b or Point h
Clause 1 Article 13 of this Article and at least 01 year’s apprenticeship at a
health facility.
4. The
chief pharmacist of a retailer of herbal materials, herbal drugs, or
traditional drugs must have any of the qualifications specified in Point a, c,
e, g, i, or l Clause 1 Article 13 hereof and at least 01 year’s apprenticeship
at a pharmacy establishment or health facility applying traditional medicine,
except for the case in Point c Clause 2 Article 13 hereof.
Article 19. Conditions to be satisfied by the chief
pharmacist of a provider of drug/medicinal material testing services
1. The chief
pharmacist of a provider of drug/medicinal material testing services must have
any of the qualifications specified in Point a Clause 1 Article 13 hereof and
at least 03 years’ apprenticeship at a suitable pharmacy establishment, except
for the case in Clause 2 of this Article.
2. The
chief pharmacist of a provider of vaccine/biological testing services must have
any of the qualifications specified in Point a, b or d Clause 1 Article 13
hereof and at least 03 years’ apprenticeship at a suitable pharmacy
establishment.
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1. a) The
chief pharmacist of a provider of clinical trial or bioequivalence study
services for drugs must have any of the qualifications specified in Point a or
Point b Clause 1 Article 13 hereof and at least 03 years’ apprenticeship at a
suitable pharmacy establishment or a hospital or institute having providing
inpatient treatment, except for the case in Clause 2 of this Article.
2. The
chief pharmacist of a provider of clinical trial or bioequivalence study
services for herbal drugs or traditional drugs must have any of the
qualifications specified in Point a, b or c Clause 1 Article 13 hereof and at
least 03 years’ apprenticeship at a suitable pharmacy establishment or a
hospital or institute having providing inpatient treatment.
Article 21. Conditions to be satisfied by the person in
charge of clinical pharmacology of a health facility
1. The
person in charge of clinical pharmacology of health facility must have any of
the qualifications specified in Point a Clause 1 Article 13 hereof and at least
02 years’ apprenticeship at a suitable pharmacy establishment or a hospital or
institute having providing inpatient treatment, except for the case in Clause 2
of this Article.
2. The
person in charge of clinical pharmacology of health facility applying
traditional medicine must have any of the qualifications specified in Point c
Clause 1 Article 13 hereof and at least 02 years’ apprenticeship at a suitable
pharmacy establishment or a hospital or institute having providing inpatient
treatment that apply traditional medicine.
Article 22. Conditions to be satisfied by the chief
pharmacist of a provider of drug/medicinal material storage services
1. The
chief pharmacist of a provider of drug/medicinal material storage services must
have any of the qualifications specified in Point a Clause 1 Article 13 hereof
and at least 02 years’ apprenticeship at a suitable pharmacy establishment,
except for the case in Clause 2 of this Article.
2. The
chief pharmacist of a provider of vaccine/biological storage services must have
any of the qualifications specified in Point a, b or d Clause 1 Article 13
hereof and at least 02 years’ apprenticeship at a suitable pharmacy
establishment.
Article 23. The power to issue, reissue, adjust, revoke
pharmacy practice certificates
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The
Director of each Service of Health shall establish an advisory council
participated by representatives of a pharmacy association to advise the
Director of the Service of Health about the issuance, reissuance, and revocation
of pharmacy practice certificates.
2. The
Ministry of Health shall issue pharmacy practice certificates that require an
examination.
Article 24. Application for pharmacy practice certificate
1. An
application form having the applicant’s picture which is taken within the last
06 months.
2.
Certified true copy of the qualification.
3. A
certificate of suitable health for pharmacy practice issued by a competent
health facility.
4.
Certificate of apprenticeship issued by the head of the establishment at which
the applicant serves his/her apprenticeship.
5.
Certificate of completion of training program and refresher program in pharmacy
if the applicant had his/her pharmacy practice certificate revoked as
prescribed in Clause 9 Article 28 of this Law.
6.
Certified true copy of the applicant's ID paper or passport.
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8. The
applicant whose pharmacy practice certificate is revoked as prescribed in
Clause 3 Article 28 hereof is only required to submit the application form
mentioned in Clause 1 of this Article.
Article 25. Application for reissuance of pharmacy practice
certificate
1. An
application form having the applicant’s picture which is taken within the last
06 months.
2. Copy
of the issued pharmacy practice certificate; the applicant’s commitment is
required if the pharmacy practice certificate is lost.
Article 26. Application for adjustments to pharmacy
practice certificate
1. An
application form for adjustments to the pharmacy practice certificate having
the applicant’s picture which is taken within the last 06 months.
2. Copies
of documents proving the changes.
3. Copy of
the pharmacy practice certificate issued.
Article 27. Procedures for issuance, reissuance, adjustment
of pharmacy practice certificate
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Within 20
days from the day on which the satisfactory application for issuance of the
certificate is received (10 days for applications for reissuance or adjustment
of the certificate), the head of the issuing authority shall issue the pharmacy
practice certificate, or provide explanation if the application is rejected.
2. The
time limit for issuing the pharmacy practice certificate specified in Clause 8
Article 24 hereof is 05 working days from the day on which the application is
received.
Article 28. Cases in which the pharmacy practice
certificate is revoked
1. The
pharmacy practice certificate is issued ultra vires.
2. The
holder of the pharmacy practice certificate requests its revocation.
3. The
pharmacy practice certificate is incorrect because of the issuing authority.
4. The
application for the pharmacy practice certificate contains counterfeit
documents.
5. A
person has more than one pharmacy practice certificate.
6. The
holder of a pharmacy practice certificate rents it, lends it, leases it,
borrows it or allows another person to use it.
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8. A
person issued with the pharmacy practice certificate fails to practice for 12
consecutive months.
9. A
pharmacy practitioner does not have the certificate of completion of training
program and refresher program in pharmacy within 03 years from the issuance
date of the pharmacy practice certificate or the issuance date of the latest
certificate of completion of training program and refresher program in
pharmacy.
10. The
certificate holder violates the code of ethics for pharmacy practitioners and
causes harm to other people’s health or life.
11. A
person has had his/her pharmacy practice certificate revoked more than once for
the same violation.
Article 29. Management of pharmacy practice certificates
1. A
person shall be issued with only one pharmacy practice certificate. The
pharmacy practice certificate shall specify the scope of practice within which
the certificate holder is allowed to practice. A pharmacy practice certificate
does not have an expiration date and is recognized nationwide.
A
pharmacy practice certificate expires when its holder is dead or missing under
a court’s decision or fails to have the certificate of completion of training
program and refresher program in pharmacy within 03 years from the issuance
date of the pharmacy practice certificate or the issuance date of the latest
certificate of completion of training program and refresher program in
pharmacy.
2. The
recognition of pharmacy practice certificates among countries complies with
international agreements and treaties to which Vietnam is a signatory.
3. Basic
content of a pharmacy practice certificate:
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b) The
holder’s qualification(s);
c) Type
of practice;
d) Scope
of practice;
dd)
Method of issuance of the pharmacy practice certificate (with or without an
examination, time of examination);
e)
Issuance date, issuing authority, and effective date.
4. The
Government shall provide for documentation, procedures for issuance, reissuance,
adjustment, revocation of pharmacy practice certificate and the template
thereof; pharmacy training institutions, training programs, and training time;
standardization of qualifications and professional titles; templates of the
certificate of completion of training program and refresher program in
pharmacy, certificate of apprenticeship; apprenticeship duration applied to
people having postgraduate degrees; issuance of pharmacy practice certificates
that require examination.
Section 2. RIGHTS AND OBLIGATIONS OF PHARMACY PRACTITIONERS
Article 30. Rights of pharmacy practitioners
1. Be
provided with training in pharmacy; exchange professional knowledge and law
about pharmacy.
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3. The
person in charge of expertise a pharmacy business establishment may authorize a
holder of a pharmacy practice certificate to take charge in his/her stead as
prescribed when he/she is absent.
4. The
chief pharmacist of a drugstore may replace drugs in a prescription with other
drugs that have the same active ingredients, usage, and dose if agreed by the
buyer and is responsible for such replacement.
5. Refuse
to act against regulations of law or code of ethics.
Article 31. Obligations of pharmacy practitioners
1. Adhere
to the code of ethics for pharmacy practitioners.
2. The
person in charge of expertise of a drug retailer must be present throughout its
operation, except for the case specified in Clause 3 Article 30 hereof.
3. Only
take charge of one pharmacy business establishment at one pharmacy business
location.
4.
Practice pharmacy within the scope written on the pharmacy practice certificate
and technical regulations.
5. Comply
with decisions of competent authorities in case of an epidemic or disaster.
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7. Notify
competent authorities or persons of violations against the law or code of
ethics committed by other pharmacy practitioners and take responsibility for
such information.
Chapter IV
PHARMACY BUSINESS
Section 1. PHARMACY BUSINESS ESTABLISHMENT AND CONDITIONS
FOR RUNNING PHARMACY BUSINESS
Article 32. Pharmacy business activities and pharmacy
business establishments
1.
Business activities include:
a)
Trading in drugs/medicinal materials;
d)
Provision of drug/medicinal material storage services;
c)
Provision of drug/medicinal material testing services;
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dd)
Provision of bioequivalence study services.
2. Pharmacy
business establishments include:
a)
Manufacturers of drugs/medicinal materials;
b)
Exporters, importers of drugs/medicinal materials;
c)
Providers of drug/medicinal material storage services;
d)
Wholesalers of drugs/medicinal materials;
dd) Drug retailers,
including drugstores, dispensaries of hospitals and medical stations of
communes, retailers of herbal materials, herbal drugs, traditional drugs;
e)
Providers of drug/medicinal material testing services;
g)
Providers of clinical trial services;
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Article 33. Conditions for issuance of Certificate of
eligibility for pharmacy business
1.
Infrastructure, equipment, and personnel conditions:
a) Every
manufacturer of drugs/medicinal materials must have the premises, factory,
laboratory, storage of drugs/medicinal materials, auxiliary systems, equipment,
machinery for manufacture, testing, storage of drugs, quality control system,
technical documents and personnel that fulfill GMP requirements;
b) Every
importer and exporter of drugs/medicinal materials, provider of drug/medicinal
material storage services must have the premises, drug storage, storage
equipment, transportation, quality control system, technical documents and
personnel that fulfill Good Storage Practice requirements;
c) Every
wholesaler of drugs/medicinal materials have the premises, drug storage,
storage equipment, transportation, quality control system, technical documents
and personnel that fulfill Good Distribution Practice requirements;
d) Every
drug retailer must have the premises, a storage area, storage equipment,
technical documents and personnel that fulfill Good Retailing Practice
requirements; Retailers of herbal materials, herbal drugs, traditional drugs
shall comply with Point b Clause 2 Article 69 hereof;
dd) Every
provider of drug/medicinal material testing services must have the premises, a
chemical/microbiological/biological laboratory, auxiliary systems, testing
equipment, chemicals, reagents, quality control system, technical documents and
personnel that fulfill Good Laboratory Practice requirements;
e) Every
provider of clinical trial services must have the premises, a clinical
laboratory, testing laboratory, bio-chemical testing equipment, quality control
system, technical documents and personnel that fulfill Good Clinical Practice
requirements;
g) Every
provider of bioequivalence services must have the premises, a laboratory for
biological fluid analysis, equipment for biological fluid analysis, an area for
drug users to stay and undergo bioequivalence assessment, quality control
system, technical documents and personnel that fulfill Good Laboratory Practice
requirements in the biological fluid analysis stage and fulfill Good Clinical
Practice requirements in the clinical trial stage.
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2. The
chief pharmacist and the persons holding the positions specified in Article 11
of this Law must pharmacy practice certificates suitable for the pharmacy
business establishments as prescribed in Clause 2 Article 32 hereof.
3. The
assessment of infrastructure, equipment and personnel specified in Clause 1 of
this Article shall be carried out every 03 years or on an ad hoc basis under
regulations of the Minister of Health or international treaties to which
Vietnam is a signatory.
Article 34. Conditions for trading in controlled drugs and
drugs restricted from retailing
1. Any
establishment trading in controlled drugs must be approved in writing by a
pharmacy authority. Such approval is granted on the basis of:
a)
Fulfillment of every condition specified in Article 33 hereof corresponding to
the conditions of each establishment;
b)
Availability of measures for protecting controlled drugs/medicinal materials
from loss;
c) Every
establishment trading in radiopharmaceuticals shall satisfy the conditions
specified in the Law on Atomic Energy and relevant legislative documents.
2. Every
retailer that retails drugs on the List of drugs restricted from retailing
promulgated by the Minister of Health shall satisfy all conditions specified in
Point d Clause 1 Article 33 hereof and obtains a written approval from the
Provincial Department of Health. Such approval is granted on be basis of
disease situation and drug availability in the province as instructed by the
Minister of Health.
3. The
Government shall provide for procedures for granting permission for controlled
drugs and drugs restricted from retailing; measures for protecting controlled
drugs/medicinal materials from loss
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1.
Pharmacy establishments that are not required to obtain a Certificate of
eligibility for pharmacy business include:
a) Every non-commercial
pharmacy establishment;
b) Any
business establishment that has a drug cabinet;
c) Herbal
material cultivation establishments;
d) Any
military health facility supplying drugs in ethnic minority areas, highlands, islands,
or extremely disadvantaged areas.
2.
Conditions to be satisfied by the establishments specified in Clause 1 of this
Article:
a) The
establishments mentioned in Point a Clause 1 of this Article shall satisfy the
conditions specified in Clause 1 Article 33 hereof;
b) The
establishments mentioned in Point b Clause 1 of this Article must be
registered, satisfy storage conditions written on drug labels, the person in
charge of which must have at least a basic diploma in pharmacy, and may only
sell drugs on the List of permissible cabinet drugs promulgated by the Minister
of Health;
c) Herbal
material cultivation establishments shall fulfill Good Farming Practice
requirements;
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3. The
Minister of Health shall elaborate this Article.
Section 2. CERTIFICATE OF ELIGIBILITY FOR PHARMACY BUSINESS
Article 36. Issuance, reissuance, adjustment of Certificate
of eligibility for pharmacy business
1. The
Certificate of eligibility for pharmacy business shall be issued to:
a) Any
establishment applying for the certificate for the first time;
b) Any
establishment that already has a Certificate of eligibility for pharmacy
business but then changes its scope of business and thus changes the applicable
conditions; or changes the business location;
c) Any
establishment whose Certificate of eligibility for pharmacy business is revoked
as prescribed in Article 40 hereof.
2. The
Certificate of eligibility for pharmacy business shall be reissued when:
a) The
Certificate of eligibility for pharmacy business is lost or damaged;
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3. The
Certificate of eligibility for pharmacy business shall be adjusted in case of
changes to the name of the establishment, business location, person in charge,
or scope of pharmacy business without changing the conditions for pharmacy
business.
Article 37. The power to issue, reissue, adjust, revoke
Certificates of eligibility for pharmacy business
1. The
Minister of Health shall issue, reissue, adjust, revoke Certificates of
eligibility for pharmacy business of the pharmacy business establishments
mentioned in Point a, b, c, e, g, and h Clause 2 of Article 32 hereof.
2.
Directors of Provincial Departments of Health shall issue, reissue, adjust,
revoke Certificates of eligibility for pharmacy business of the pharmacy
business establishments mentioned in Point d and dd Clause 2 of Article 32
hereof.
Article 38. Application for issuance, reissuance,
adjustment of Certificate of eligibility for pharmacy business
1. An
application for the Certificate of eligibility for pharmacy business in the
cases mentioned in Point a and Point c Clause 1 Article 36 hereof consists of:
a) An
application form for issuance of the Certificate of eligibility for pharmacy
business;
b)
Corresponding technical documents of the pharmacy business establishment
specified in Clause 2 Article 32 hereof;
c) A
certified true copy of the certificate of enterprise registration or legal
documents proving the existence of the establishment;
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2. An
application for the Certificate of eligibility for pharmacy business in the
cases mentioned in Point b Clause 1 Article 36 hereof consists of:
a) An
application form for issuance of the Certificate of eligibility for pharmacy business;
b)
Technical documents corresponding to the changes;
c) A
certified true copy of the certificate of enterprise registration or legal
documents proving the existence of the establishment;
d) A
certified true copy of the pharmacy practice certificate.
3. An
application for reissuance of a Certificate of eligibility for pharmacy
business consists of:
a) An
application form for reissuance of the Certificate of eligibility for pharmacy
business;
b) The
Certificate of eligibility for pharmacy business that is incorrect because of
the issuing authority in the case mentioned in Point b Clause 2 Article 36
hereof.
4. An
application for adjustments to a Certificate of eligibility for pharmacy
business consists of:
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b) A
certified true copy of the pharmacy practice certificate if the position that
requires the pharmacy practice certificate is changed;
c) A
certified true copy of the certificate of enterprise registration or legal
documents proving the change in the name or address of the establishment.
5. The
Government shall elaborate this Article.
Article 39. Procedures for issuance, reissuance, adjustment
of Certificate of eligibility for pharmacy business
1. An application
for issuance, reissuance, or adjustment of Certificate of eligibility for
pharmacy business shall be submitted to a competent authority specified in
Article 37 hereof.
2. Within
30 days from the day on which the satisfactory application for issuance of the
certificate is received (20 days for applications for reissuance or adjustment
of the certificate), the Minister of Health or Director of the Provincial
Department of Health shall ex officio consider issuing the Certificate of
eligibility for pharmacy business, or provide explanation in writing if the
application is rejected.
In case
of reissuance or an incorrect certificate because of the fault of the issuing
authority, the applicant shall follow the instructions in Clause 3 Article 38
hereof. The time limit for issuing a Certificate of eligibility for pharmacy
business is 07 working days from the day on which the satisfactory application
is received.
Article 40. Cases in which the Certificate of eligibility
for pharmacy business is revoked
1. The
pharmacy business is shut down.
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3. The
Certificate of eligibility for pharmacy business is issued ultra vires or
against the law.
4. The
pharmacy business is not operating for 12 consecutive months without notifying
a pharmacy authority.
Article 41. Management of Certificates of eligibility for
pharmacy business
1. A
Certificate of eligibility for pharmacy business does not have an expiry date.
2. The
Government shall elaborate the following contents:
a)
Applications and procedures for issuance, reissuance, adjustment, revocation of
Certificates of eligibility for pharmacy business;
b) Areas
and scope of business of dispensaries of hospitals and medical stations of
communes;
c)
Roadmap for pharmacy business establishment to fulfill Good Practice
requirements.
Section 3. RIGHTS AND OBLIGATIONS OF PHARMACY BUSINESS
ESTABLISHMENTS
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1. A
pharmacy business establishment has the rights to:
a) Carry
on one or some or all pharmacy business activities if corresponding conditions
of this Law are satisfied;
b) Be offered
incentives for pharmacy business as prescribed by law;
c)
Receive information and advertise drugs as prescribed by law;
d)
Provide complimentary drugs for health facilities for treatment as prescribed
by the Minister of Health;
dd)
Establish mobile drug retailers in ethnic minority areas, highlands, islands,
and extremely disadvantaged areas as prescribed by the Government.
2. A
pharmacy business establishment is required to:
a) Have a
Certificate of eligibility for pharmacy business and adhere to the type, scope,
and location of business written therein;
b)
Maintain the fulfillment of conditions for pharmacy business specified in this
law throughout the business operation;
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d) Pay
compensation for organizations and individuals that suffer damage caused by the
pharmacy business establishment;
dd)
Comply with decisions of competent authorities on supply of drugs/medicinal
materials in case of an epidemic or disaster;
e) Report
to the Ministry of Health or Provincial Department of Health and fulfill the
obligations in case of suspension for 06 months or longer or shutdown;
g)
Notify, update the list of practitioners having pharmacy practice certificates
to the competent authority as prescribed by the Minister of Health;
h) Openly
post the pharmacy practice certificates and Certificate of eligibility for
pharmacy business in the premises;
i) Submit
annual and ad hoc reports to competent pharmacy authorities;
k) Comply
with regulations of the Ministry of Health on trading in drugs restricted from
retailing;
l) Post
wholesale and retail prices where drugs are sold in a way that they are
recognizable by customers and competent authorities, and comply with other
regulations on drug price management;
m) Retail
documents about each batch/shipment of drugs/medicinal materials for at least
01 years from their expiration dates;
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o)
Specify the drug name, content, and expiry date when retailing drugs without
secondary packages; specify the dose and usage when selling drugs without a
prescription;
p)) Only
retail prescription drugs when a prescription is presented.
3. Apart
from the obligations specified in Clause 2 of this Article, the pharmacy
business establishment also has the following obligations when selling
controlled drugs:
a) Submit
annual reports, export and import reports, and ad hoc reports to competent
authorities;
b)
Prepare, retain documents about each type of drug/medicinal material as
prescribed by the Ministry of Health.
Article 43. Rights and obligations of manufacturers of
drugs/medicinal materials
1. A
manufacturer of drugs/medicinal materials has the following rights:
a) The
rights specified in Clause 1 Article 42 hereof;
b)
Research, carry out pilot production; manufacture drugs/medicinal materials;
grant and acquire franchise for drug manufacture; process drugs/medicinal
materials;
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d)
Import, purchase medicinal materials serving manufacture; import
drugs/medicinal materials serving research, testing, or as samples for
obtainment of marketing authorization;
dd) Sell
medicinal materials imported to serve manufacture of drugs to be sold to other
drug manufacturers;
e) Sell
drugs/medicinal materials wholesale to drug wholesalers, drug retailers, and
health facilities;
g) Export
drugs/medicinal materials specified in Clause 4 and Clause 5 Article 60 hereof.
2. A
manufacturer of drugs/medicinal materials has the following obligations:
a)
Relevant obligations specified in Points a, b, c, d, dd, e, g, h, i, k, l, m n
of Clause 2 Article 42 hereof;
b)
manufacture drugs/medicinal materials in accordance with the manufacturing process
and quality standards registered or announced;
c) Take
responsibility for the origin, quality of drugs/medicinal materials it
manufactures; only allow the release of drugs/medicinal materials that meet the
registered quality standards;
d)
monitor the quality, safety, efficacy of drugs/medicinal materials it products
while they are being sold on the market; recall drugs/medicinal materials in
accordance with this Law;
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Article 44. Rights and obligations of exporters and
importers of drugs/medicinal materials
1. An
exporter or importer of drugs/medicinal materials has the following rights:
a) The
rights specified in Point a, b, c, d of Clause 1 Article 42 hereof;
b) Import
drugs/medicinal materials in accordance with Article 60 hereof;
d) Obtain
marketing authorization for drugs/medicinal materials; transfer marketing
authorization; request revocation of marketing authorization; request recall of
drugs/medicinal materials in accordance with this Law;
d) Sell
imported drugs/medicinal materials to drug wholesalers, drug retailers, drug
manufacturers, and health facilities. If the right to distribute drugs in
Vietnam is not granted, the exporter or importer may sell imported
drugs/medicinal materials in accordance with regulations of the Minister of
Health;
dd)
Export drugs/medicinal materials specified in Clause 4 and Clause 5 Article 60
hereof.
2. An exporter
or importer of drugs/medicinal materials has the following obligations:
a) The
obligations specified in Points a, b, c, d, dd, e, g, h, i, k, l, m n of Clause
2 Article 42 hereof;
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Article 45. Rights and obligations of providers of
drug/medicinal material storage services
1. A
provider of drug/medicinal material storage services has the following rights:
a) The
rights specified in Point a, b, c of Clause 1 Article 42 hereof;
b)
Provide drug/medicinal material storage services for other organizations and
individuals;
c) Export
drugs/medicinal materials specified in Clause 4 and Clause 5 Article 60 hereof.
2. A
provider of drug/medicinal material storage services has the obligations
specified in Points a, b, c, d, dd, e, g, h, i, m, n of Clause 2 Article 42
hereof.
Article 46. Rights and obligations of wholesalers of
drugs/medicinal materials
1. A
wholesaler of drugs/medicinal materials has the following rights:
a) The
rights specified in Clause 1 Article 42 hereof;
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c)
Purchase drugs/medicinal materials;
d) Obtain
marketing authorization for drugs/medicinal materials; transfer marketing
authorization; request revocation of marketing authorization; request recall of
drugs/medicinal materials in accordance with this Law;
dd)
Export drugs/medicinal materials specified in Clause 4 and Clause 5 Article 60
hereof.
2. A
wholesaler of drugs/medicinal materials has the following obligations:
a) The
obligations specified in Points a, b, c, d, dd, e, g, h, i, k, l, m n of Clause
2 Article 42 hereof;
b) Ensure
that the delivery, receipt, storage of drugs/medicinal materials are carried
out by qualified people.
Article 47. Rights and obligations of drugstores
1. A
drugstore has the following rights:
a) The
rights specified in Points a, b, c, d of Clause 1 Article 42 hereof;
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c)
Purchase drugs for retailing, except for vaccines; sell controlled drugs and
drugs restricted from retailing in accordance with Article 34 hereof;
d)
Dispense drugs covered by insurance, medical programs/projects when the
conditions of such insurance policies or program/project are satisfied;
dd) A
person having a bachelor’s degree in pharmacy may replace drugs in a prescription
with other drugs that have the same active ingredients, administration route,
and dose if agreed by the buyer and is responsible for such replacement.
2. A
drugstore has the following obligations:
a) The
obligations specified in Clause 2 Article 42 and Clause 2 Article 81 hereof;
b)
Maintain the drug compounding conditions in accordance with regulations of the
Minister of Health;
c) Do not
sell drugs/medicinal materials, except for herbal materials.
Article 48. Rights and obligations of dispensaries
1. A
dispensary has the following rights:
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b)
Purchase and retail drugs on the List of essential medicines and List of OTC
drugs, except for vaccines; sell controlled drugs and drugs restricted from
retailing in accordance with Article 34 hereof. Dispensaries in ethnic minority
areas, highlands, islands, and extremely disadvantaged areas may sell more
types of drugs prescribed by the Minister of Health;
c)
Dispense drugs covered by insurance, medical programs/projects when the
conditions of such insurance policies or program/project are satisfied.
2. A
dispensary has the following obligations:
a) The
obligations specified in Clause 2 Article 42 hereof;
b) Do not
sell medicinal materials, except for herbal materials.
Article 49. Rights and obligations of dispensaries of
commune medical stations
1. A
dispensary of a commune medical station has the following rights:
a) The rights
specified in Points a, b, c, d of Clause 1 Article 42 hereof;
b)
Purchase and retail drugs on the List of essential medicines suitable for its
level, except for vaccines; sell controlled drugs and drugs restricted from
retailing in accordance with Article 34 hereof.
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2. A
dispensary of a medical station has the following obligations:
a) The
obligations specified in Clause 2 Article 42 hereof;
b) Do not
sell medicinal materials, except for herbal materials.
Article 50. Rights and obligations of retailers of herbal
materials, herbal drugs, traditional drugs
1. A
retailer of herbal materials, herbal drugs, traditional drugs has the following
rights:
a) The
rights specified in Points a, b, c, d of Clause 1 Article 42 hereof;
b) Retail
herbal materials, herbal drugs, traditional drugs;
c)
Purchase herbal materials, herbal drugs, traditional drugs for retailing;
d)
Dispense drugs covered by insurance, medical programs/projects when the
conditions of such insurance policies or program/project are satisfied.
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a) The
obligations specified in Clause 2 Article 42 hereof;
b) Do not
sell modern medicines, vaccines, biologicals, and medicinal materials that are
active ingredients, excipients, or capsule shells.
Article 51. Rights and obligations of providers of
drug/medicinal material testing services
1. A
provider of drug/medicinal material testing services has the following rights:
a) The
rights specified in Point a and Point b Clause 1 Article 42 hereof;
c) Carry
out drug/medicinal material testing as prescribed;
c) Issue
certificates of test results to the samples of drugs/medicinal materials that
are tested;
d)
Import, purchase chemicals, reference materials, samples of drugs/medicinal
materials serving the testing drugs/medicinal materials at the facility.
2. A
provider of drug/medicinal material testing services has the following
obligations:
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b) Ensure
truthfulness and objectivity in testing drugs/medicinal materials;
c) Take responsibility
for the test results it produced.
Article 52. Rights and obligations of providers of clinical
trial services
1. A
provider of clinical trial services has the following rights:
a) The
rights specified in Point a and Point b Clause 1 Article 42 hereof;
b) Carry
out clinical trials of drugs as prescribed;
c)
Import, purchase chemicals, reference materials, and drug samples serving
clinical trials;
d) Use
clinical trial results under agreements with the owner of the drug undergoing clinical
trials (hereinafter referred to as the sponsor).
2. A
provider of clinical trial services has the following obligations:
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b) Take
responsibility for the clinical trial result;
c) Take
responsibility for the safety of clinical trial subjects and pay compensation
for those who suffer injuries for which the clinical trial service provider is
responsible;
d) Ensure
truthfulness and objectivity in clinical trials;
dd) Be
independent in terms of finance and personnel from the owners of drugs
undergoing clinical trials.
Article 53. Rights and obligations of providers of
bioequivalence study services
1. A
provider of bioequivalence study services has the following rights:
a) The
rights specified in Point a and Point b Clause 1 Article 42 hereof;
b) Carry
out clinical trial and biological fluid analysis in bioequivalence study.
If only
biological fluid analysis is carried out, it may sign a contract or cooperate with
a provider of clinical trial services that fulfill Good Clinical Practice
requirements to carry out clinical trial in the process of bioequivalence
study;
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d) Import,
purchase chemicals, reference materials, and drug samples serving
bioequivalence study;
dd) Use
bioequivalence study results under agreements with owners of the drugs
undergoing bioequivalence study (hereinafter referred to as the sponsor).
2. A provider
of bioequivalence study services has the following obligations:
a) The
obligations specified in Points a, b, c, d, e, g, h, i, m, n of Clause 2
Article 42 hereof;
b) Take
responsibility for the bioequivalence study results;
c) Take
responsibility for the safety of test subjects and pay compensation for those
suffer injuries for which the clinical trial service provider is responsible;
d) Ensure
truthfulness and objectivity in bioequivalence testing;
d) Be
independent in terms of finance and personnel from the sponsor.
Chapter V
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Section 1. OBTAINING MARKETING AUTHORIZATIONS FOR DRUGS AND
MEDICINAL MATERIALS
Article 54. Drugs and medicinal materials to be granted marketing authorizations
1.
Marketing authorization must be obtained for drugs before being marketed in
Vietnam, except for:
a) Drugs
compounded at drugstores as specified in Point b Clause 1 Article 47; drugs
manufactured or compounded at health facilities as specified in Article 85
hereof;
b)
Imported drugs specified in Clause 2 Article 60 hereof;
c)
Traditional drugs specified in Clause 1 and Clause 2 Article 70 hereof.
2.
Marketing authorization must be obtained for medicinal materials before being
marketed in Vietnam, except for:
a)
Medicinal materials that are active ingredients for drug manufacture according
to marketing applications that are granted marketing authorizations in Vietnam;
b)
Imported medicinal materials specified in Clause 3 Article 60 hereof.
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a) Any
establishment manufacturing, wholesaling, exporting, importing drugs/medicinal
materials in Vietnam;
b) Any
foreign establishment trading in drugs/medicinal materials and having a
representative office in Vietnam.
4. A drug
or medicinal material shall be granted the marketing authorization in Vietnam
when the following requirements are satisfied:
a) Safety
and efficacy requirements are satisfied;
b) It is
manufactured by a manufacturer that satisfies the conditions specified in this
Law.
c) It is
manufactured according to manufacture procedures and satisfy quality standards
prescribed in Article 102 and Article 103 hereof.
5. When
obtaining marketing authorization in Vietnam for an imported drug or medicinal
material, its foreign manufacturer must assess the fulfillment of GMP
requirements using any of the following methods:
a) Assessing
documents about manufacturing conditions;
b) Mutual
recognition of inspection results given by pharmacy authorities regarding the
fulfillment of GMP requirements;
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6. The
Government shall provide for registration of herbal materials, excipients and
capsule shells, and elaborate Clause 5 of this Article.
Article 55. Methods for obtaining marketing authorization
for drugs and medicinal materials
1.
Marketing authorization shall be obtained for a drug or medicinal material by
either:
a)
Issuance of a marketing authorization;
b)
Renewal of a marketing authorization;
c)
Adjustment of a marketing authorization.
2. A
marketing authorization shall be issued in the following cases:
a) The
drug or medicinal material has not been issued with any marketing authorization
in Vietnam;
b) The
drug already has a marketing authorization but there are changes to its active
ingredients, herbal materials or concentrations thereof, dosage form,
administration route, manufacturer (except for secondary packaging facility,
releasing facility, or releasing location);
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3. A
marketing authorization issued in Vietnam may be adjusted before its expiry,
except for the cases in Point b and Point c Clause 2 of this Article.
4. A
marketing authorization shall be renewed when it expires, including
drugs/medicinal materials whose administrative documents are changed on the
renewal date.
Article 56. Required documentation and procedures for
issuing, renewing, adjusting marketing authorization
1. The Minister
of Health shall issue, reissue, and adjust a marketing authorization through
document assessment and consultancy of the advisory council.
Application
for issuance, renewal, adjustment of marketing authorization shall be submitted
to the Ministry of Health.
2. An
application for issuance of a marketing authorization consists of:
a)
Administrative documents, including an application form, certified true copy of
the unexpired license for establishment of representative office (for foreign applicants)
or unexpired Certificate of eligibility for pharmacy business (for Vietnamese
applicants); original or certified true copy of the unexpired Certificate of
imported pharmaceutical products (for imported drugs); sample label of
drug/medicinal material, and other documents about manufacture and sale of the
drug or medicinal material;
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, vaccines, herbal drugs for treatment of diseases on the List
promulgated by the Minister of Health, 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 bioequivalence study, it is required
to have a report on their bioequivalence study;
c) A
sample label of the drug or medicinal material marketed in the home country or
reference country (for imported drugs).
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a) An
application form for renewal of a marketing authorization;
b)
Certified true copy of the unexpired license for establishment of
representative office (for foreign applicants) or unexpired Certificate of
eligibility for pharmacy business (for Vietnamese applicants);
c)
Original or certified true copy of the unexpired Certificate of imported
pharmaceutical products (for imported drugs);
d) A
report on sale of the drug or medicinal materials;
dd) A
report on safety and efficacy of the drug if its safety and efficacy still has
to be monitored;
e) A copy
of the marketing authorization in Vietnam;
4. An
application for adjustment of a marketing authorization consists of:
a) An
application for adjustment of the marketing authorization:
b)
Technical documents about the changes to the marketing authorization;
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5. Time
limit for issuing, renewing, or adjusting a marketing authorization:
a) 12
months from the receipt of a satisfactory application for issuance of a
marketing authorization of a drug/medicinal material, new drug, reference
biological, vaccine, or herbal drug for treatment of diseases on the List
promulgated by the Minister of Health;
b) 03
months from the receipt of the satisfactory application for renewal or
adjustment of a marketing authorization;
c) Where
an application for issuance, renewal, or adjustment of a marketing
authorization is rejected, or any of the conditions for it is not satisfied, a
written explanation must be provided.
6. A
marketing authorization is valid for 05 years from its issuance or renewal
date.
A
marketing authorization of a drug whose safety and efficacy still has to be
monitored is 03 years from its issuance date.
7. The
Minister of Health shall provide for required documentation and procedures for
issuing, renewing, adjusting marketing authorization.
Article 57. Rights and obligations of applicants
1. An
applicant for drug/medicinal material marketing authorization has the rights
to:
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b)
Request revocation of the marketing authorization issued.
2. An
applicant for drug/medicinal material marketing authorization has the
obligations to:
a) Notify
the regulatory body of the drug or medicinal material that is granted the
marketing authorization is recalled in any country in the world, is suspended
from manufacture, supply, of the scarcity or threat of scarcity of the drug or
medicinal material; changes to the applicant while the marketing authorization
is still unexpired;
b) Fully
archive drug/medicinal drug marketing applications and provide them to
competent authorities at their request;
c)
Inspect or assess the manufacturing facility when requested by competent
authorities.
Article 58. Revocation of marketing authorization
1. A
marketing authorization shall be revoked in the following cases:
a) The
drug is recalled due to a first-degree violation;
b) 02
batches of drug are recalled within 60 months due to a second-degree violation,
or 03 batches of drug are of poor quality;
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d) The
marketing authorization is issued according to counterfeit documents;
dd) The
drug/medicinal material is not manufactured at the address in
the marketing application;
e) The
active ingredients, herbal materials or drug contains active ingredients,
herbal materials that are not recommended by WHO or a Vietnamese competent
authority or its country of origin in terms of safety and efficacy;
g) The
manufacturer or applicant requests the revocation of the marketing
authorization.
2. The
Minister of Health shall provide for required documentation and procedures for
revocation of marketing authorization.
Section 2. MARKETING AUTHORIZATION OF DRUGS AND MEDICINAL
MATERIALS
Article 59. Marketing authorization of drugs and medicinal
materials
1. The
drugs/medicinal materials permitted for marketing authorization include:
a) Drugs
and medicinal materials granted marketing authorizations;
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c) The drugs
specified in Point b Clause 1 Article 47, Clause 1 and Clause 2 Article 70, and
Clause 3 Article 85 hereof;
d) Drugs
and medicinal materials domestically manufactured may be sold sale until their
expiry dates if they are manufactured before the expiry dates of marketing
authorization;
dd)
Imported drugs and medicinal materials may be sold until their expiry dates if
they are delivered at the port of departure in the exporting country before the
expiry dates of marketing authorization;
e) Drugs
or medicinal materials domestically manufactured or imported before the
revocation date of the marketing authorization as prescribed in Article 58
hereof, except for recalled drugs and medicinal materials specified in Article
62 hereof.
2. A drug
must satisfy the following requirements to be sold on the market:
a) It
meets quality standards and ensures safety and efficacy;
b) It
complies with regulations on drug labeling in Article 61 hereof and relevant
regulations of law;
c) The
packaging material and method ensure drug quality.
3. A
medicinal material must satisfy the following requirements to be sold on the
market:
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b) It
complies with regulations on drug labeling in Article 61 hereof and relevant
regulations of law;
c) The
packaging material and method ensure medicinal material quality.
Article 60. Drugs/medicinal materials permitted for import
and export
1.
Drugs/medicinal materials that are active ingredients granted marketing
authorizations in Vietnam, medicinal materials that are active ingredients for
drug manufacture granted marketing authorizations in Vietnam may be imported
without licensing, except for the drugs and medicinal materials specified in
Clause 4 of this Article.
2. A drug
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:
a) It
contains an active ingredient that is not granted a marketing authorization or
granted a marketing authorization but the quantity is not sufficient for
treatment;
b) It
contains an active ingredient that is medicinally used in Vietnam for the first
time or was medicinally used in Vietnam but the quantity not sufficient for
treatment;
c) It
serves purposes related to national defense and security, disease prevention
and control, disaster recovery, or need for special treatment;
d) It is
a rare drug;
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e) It
serves a health program of the State;
g) It
serves as humanitarian aid;
h) It is
used for clinical trial, 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.
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:
a) It is
used as a sample for registration, testing, drug study, or display at an
exhibition or fair;
b) It is
used for manufacture of drugs for export, drugs serving purposes related to
national defense and security, disease prevention and control, or disaster
recovery.
4.
Controlled drugs may only be imported/exported under an import/export license
with a quantity not exceeding that written on the license.
The
Government shall specify the types of drugs and medicinal materials subject to
import control depending on socio-economic development of Vietnam.
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6. The
Ministry of Health shall publish information about drugs permitted for import
as prescribed in Point a through d of Clause 2 of this Article, including
information about importers, manufacturers, quantities, drug names, import
license numbers; numbers of marketing authorization for each active ingredient.
7. The
Government shall elaborate the following contents:
a)
Criteria, required documentation, 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;
b) Import
of herbal materials, excipients, capsule shells, primary packages of drugs.
Article 61. Labels of drugs and medicinal materials being
sold on the market
1. The
label of a drug or medicinal material being sold on the market must have:
a) Name
of the drug or medicinal material;
b) Dosage
form, except for medicinal materials;
c)
Composition, concentrations of active ingredients, herbal materials in the drug
or medicinal material; labels of traditional drugs on the list of State secrets
and labels of hereditary remedy are allowed to omit certain herbal materials and
concentrations and shall have the text “Công thức sản xuất thuốc là bí mật nhà
nước” (“The formula is state secret”) or “Công thức sản xuất thuốc là bí mật
gia truyền” (“The formula is hereditary secret”)
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dd) Name and
address of the manufacturer;
e) Name
and address of the importer (for imported drugs and medicinal materials);
g) Number
of the marketing authorization or import license, batch number, date of
manufacture;
h) Expiry
date of the drug/medicinal material;
i)
Storage conditions and other necessary information as prescribed.
2. The
package insert is an integral part of the label and must contain every
information specified in Points a, b, c, d, đ, h, i of Clause 1 of this Article
in Vietnamese language, except for information that cannot be translated into
Vietnamese.
3. The
Minister of Health shall provide for contents of drug/medicinal material
labels, package inserts; changes to expiry dates on drug labels for reason of
national defense and security, disease prevention and control, or disaster
recovery.
Section 3. RECALLING DRUGS AND MEDICINAL MATERIALS
Article 62. Cases in which a drug or medicinal material is
recalled
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a) It is not
permitted for marketing authorization as prescribed in Clause 1 Article 59
hereof;
b) Its
marketing authorization is revoked in any of the cases specified in Point a
through e Clause 1 of Article 58 hereof;
c) The
requirements specified in Clause 4 Article 54 or Clause 2 Article 59 hereof are
not fully satisfied;
d) The
drug fails to meet the quality standards or derived from a medicinal material
that fails to meet the quality standards;
dd) A
competent authority concludes that the drug is not safe or effective as
required;
e) There
is no evidence that the drug has undergone quality inspection during the
manufacture process an before release;
g) A
foreign pharmacy authority notifies a recall of the drug.
2. A
medicinal material being sold on the market shall be recalled in the following
cases:
a) It is
used for improper purposes;
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c) The
requirements specified in Clause 4 Article 54 or Clause 3 Article 59 hereof are
not fully satisfied;
d) The
medicinal material is not qualified for drug manufacture; the medicinal
material is not conformable with the import license or its origin is different
from that written on the marketing authorization;
dd) There
is no evidence that the medicinal material has undergone quality inspection
during the manufacture process an before release;
e) A
foreign pharmacy authority notifies a recall of the medicinal material.
Article 63. Types of recall, classification of violations,
scope and time of recall, and disposal of recall drugs
1. Types
of recall:
a)
Voluntary recall means a voluntary recall announced by the applicant,
manufacturer, importer, or import entrustor;
b)
Mandatory recall means a recall under a decision of a competent authority in
any of the cases specified in Article 62 hereof.
2.
Classification of violations:
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b) Second-degree
violation is a violation where there is evidence that the drug does not
guarantee effective treatment or is unsafe for users but does not cause harm to
the users’ health or life;
c)
Third-degree violations are violations other than those specified in Point a
and Point b of this Clause that do not affect the treatment ability and safety
of the drug.
3. Scope
and time of drug recall:
a) In
case of a first-degree violation, the drug shall be recalled from every
pharmacy business establishment, health facility, and user within 03 days from
the day on which the recall is announced;
b) In
case of a second-degree violation, the drug shall be recalled from every
pharmacy business establishment, health facility, and user within 15 days from
the day on which the recall is announced;
c) In
case of a third-degree violation, the drug shall be recalled from every
pharmacy business establishment within 30 days from the day on which the recall
is announced;
d) In
case of a first-degree violation where the recall is beyond the capacity of the
domestic manufacturer or importer or import entrustor, or not conducted by the
deadline by the domestic manufacturer or importer or import entrustor, the
recall shall be enforced as prescribed by law.
A
competent authority in charge of organizing the recall, the domestic
manufacturer or importer or import entrustor shall pay the costs of recall and
dispose of the recalled drug.
4. Recall
drugs shall be disposed of as follows:
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b) Drugs
recalled in the cases mentioned in Point c Clause 2 of this Article may be
reprocessed, re-exported, or destroyed if cannot be reprocessed.
Article 64. Responsibility for recalling drugs
1. The
applicant, domestic manufacturer, preparing facility, importer or import
entrustor whose drug is recalled has the responsibility to:
a)
Suspend the manufacture/trade in the drug recalled;
b) Take
charge and cooperate with relevant entities in publishing information about the
recall drug, organize the recall, and receive recall drug;
c)
Dispose of recalled drug;
d) Pay
the costs of drug recall and disposal, pay compensation as prescribed by law;
dd)
Submit a report to the Ministry of Health about the recall and its result;
e) In
case of voluntary recall, the trade in such drug must be suspended and a report
must be submitted to the Ministry of Health before conducting the recall.
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a) Stop
selling and dispensing the drug recalled;
b) Notify
and organize the recall, receive drug returned by traders and users;
c) Return
the drug 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.
3. Health
facilities and drug users have responsibility to:
a) Stop
prescribing, selling, dispensing and using the drug recalled;
b) Return
the drug to the suppliers.
4. The
Ministry of Health has the responsibilities to:
a) Decide
drug recalls and disposal of recall drugs nationwide in consideration of the
degree of violations in terms of drug quality, safety, and efficacy;
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c) Inspect
and supervise the recalls; take actions against violators as prescribed by law;
d)
Publish information about recalled drugs due to first-degree violations on the
website of the Ministry of Health, Vietnam Television, Voice of Vietnam right
after the announcement of such recalls.
5.
Vietnam Television and Voice of Vietnam shall publish information about drug
recalls due to first-degree violations free of charge.
Article 65. The power to decide drug recalls and procedures
for recalling drugs
1. The
Ministry of Health shall issue a decision on drug recall in case of a mandatory
recall or voluntary recall due to first-degree or second degree violation. The
decision on drug recall shall be issued within 24 hours after it is concluded
that the drug has to be recalled or the voluntary recall is not appropriate for
the degree of violation.
2. The
head of the applicant for drug marketing authorization, manufacturer, preparing
facility, importer or import entrustor shall issues the decision on voluntary
drug recall in case of a third-degree violations after the Ministry of Health
comments. Such decision shall be issued within 24 hours since the Ministry of
Health comments.
3. 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,
and disposal of recalled drugs.
4. The
Government shall provide for the power, methods, and procedures for recalling
medicinal materials, and disposal of recalled medicinal materials.
Chapter VI
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Section 1. HERBAL MATERIALS
Article 66. Farming, harvesting, and processing herbs
1. The
farming and harvesting of herbs shall fulfill Good Farming Practice
requirements.
2. The
processing of natural herbal materials must be suitable for the category,
method, time, and storage condition of each kind.
3. The
Minister of Health shall provide for a roadmap for following Good Farming
Practice guidelines and promulgate rules and standards for harvesting natural
herbs appropriate for the current level of socio-economic development.
Article 67. Herbal material storage
1. Herbal
material storage shall fulfill Good Storage Practice requirements.
2. Herbal
materials being sold on the market shall be packaged with qualified materials
and labeled in accordance with regulations of the Minister of Health.
Article 68. Herbal material quality
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2.
Manufacturers, importers, processors and suppliers of herbal materials must
announce herbal material standards in accordance with regulations of law on
standards and technical regulations if the herbal materials do not have
marketing authorization and take responsibility for their origins and quality;
submit reports to pharmacy authorities on quantities of herbal materials
imported for trading, drug manufacture, and drug compounding.
3. The
Minister of Health shall elaborate this Article.
Section 2. TRADITIONAL DRUGS
Article 69. Trading in traditional drugs
1.
Chapter IV of this Law shall apply to traditional drug trading.
2.
Manufacturers of traditional drugs sold nationwide and retailers of traditional
drugs must satisfy the following conditions:
a) A
manufacturer of traditional drugs must have the premises, factory, laboratory, storage
of drugs and medicinal materials, auxiliary systems, equipment, machinery for
manufacture, testing, storage of drugs, quality control system, technical
documents and personnel that fulfill Good Manufacturing Practice requirements
applied to traditional drugs;
b) A
retailer of herbal materials, herbal drugs, or traditional drugs must comply
with regulations on the premises, storage area, storage equipment, technical
documents and personnel;
c) The
chief pharmacist and the person in charge of quality assurance of a
manufacturer of traditional drugs must have any of the qualifications specified
in Point a or Point c of Clause 1 Article 13 hereof and at least 02 years’
apprenticeship at a suitable pharmacy establishment, except for the case in
Point d of this Clause. The chief pharmacist of a manufacturer of traditional
drugs being sold nationwide may also be in charge of quality assurance therein;
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dd) The
chief pharmacist of a retailer of traditional drugs shall comply with
provisions of Clause 4 Article 18 hereof.
3. The
Government shall provide for traditional drug trading and management of
imported traditional drugs.
Article 70. Supply, processing, preparation, and use of
traditional drugs in health facilities
1. A
health facility applying traditional medicine may prepare, use, and retail
traditional drugs within the facility.
2.
Traditional drugs prepared by a health facility applying traditional medicine
of provincial level or above may be sold to other health facilities applying
traditional medicine in the same province where they are used to treat patients
in such facilities.
3. The
head of a health facility preparing traditional drugs is responsible for the
quality, safety, and efficacy of such drugs.
4. The
Minister of Health shall provide for conditions for preparation of traditional
drugs and management of traditional drugs.
Article 71. Registration, sale, recall of traditional drugs
1. The
registration, sale, and recall of traditional drugs being sold on the market shall
comply with Chapter V of this Law, except for Clause 2 of this Article.
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a) 06
months from the receipt of the satisfactory application for issuance of a marketing
authorization of a traditional drug;
b) 12
months from the receipt of the satisfactory application for issuance of a
marketing authorization or a traditional drug that require clinical trial;
c) 01
month from the receipt of the satisfactory application for renewal or
adjustment of a marketing authorization of a traditional drug;
d) Where
an application for issuance, renewal, or adjustment of a marketing
authorization of a traditional drug is rejected, or any of the conditions for
it is not satisfied, a written explanation must be provided.
3.
Marketing authorization is not required to be obtained for traditional drugs
prepared and prescribed within a health facility specified in Clause 1 and
Clause 2 Article 70 of this Law. The head of the health facility is responsible
for recalling drugs that are found unqualified, unsafe, or ineffective.
Article 72. Clinical trial of traditional drugs before obtaining marketing authorization
1.
Traditional drugs might or might not be exempt from clinical trials.
2. A
traditional drug is exempt from clinical trial if:
a) It is
recognized by the Ministry of Health;
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3. The
Minister of Health shall provide for the criteria for partial exemption of
clinical trial in Vietnam.
Article 73. Traditional drug quality
1.
Traditional drugs prepared and prescribed within a health facility as specified
in Clause 1 and Clause 2 Article 70 of this Law must have satisfactory quality
as prescribed by the Ministry of Health.
2.
Traditional drugs sold nationwide must have satisfactory quality as prescribed
in Article 102 and Article 103 hereof.
3. The
Minister of Health shall provide for recognition of traditional drugs,
permissible remedies; instructions on drug preparation or mixture using
traditional methods; instructions on traditional drugs in modern dosage forms.
Chapter VII
PRESCRIPTION AND USE OF DRUGS
Article 74. Prescription
1. A prescription
is the basis for selling, dispensing, compounding, preparing, and using drugs.
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Article 75. Use of drugs
1. The
use of drugs in health facilities shall comply with regulations of law on
medical examination and treatment.
2.
Regarding the use of drugs outside health facilities:
a) The
user is entitled to decide on the drug retailer and shall comply with the
instructions written in the prescription or package inserts, or instructions provided
by the drug retailer;
b) The
prescriber shall provide instructions on the use of prescribed drugs and take
responsibility for such prescription;
c) The
drug retailer shall provide instructions on how to use drugs for the user.
3. The
Minister of Health shall provide for establishment of an interdisciplinary
council responsible for finding the causes and responsible entities in case of
drugs causing serious harm to a user’s health or life.
Chapter VIII
DRUG INFORMATION, PHARMACOVIGILANCE, AND
DRUG ADVERTISEMENTS
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1. Drug
information is meant to provide medical practitioners and drug users with
instructions on how to use the drug reasonably, safely, and effectively.
2. Drug
information must be up-to-date, unequivocal, adequate, and accurate based on
evidence, understandable and suitable for intended information recipients.
3. The
following documents are the basis for providing drug information, except for
information specified in Point c Clause 5 and Point a Clause 6 of this Article:
a)
Vietnam’s National Pharmacopoeia;
b) The
package insert approved by the Ministry of Health;
c)
Instructional documents related to the drugs issued or recognized by the
Ministry of Health.
4.
Vietnam’s National Pharmacopoeia is the official guide to reasonable, safe, and
effective use of drugs. The Minister of Health shall issue and update the
National Pharmacopoeia.
5.
Content of drug information:
a)
Information for medical practitioners: the drug name, composition,
concentrations, dosage form, indications, contraindications, dosage, route of
administration, use of the drug in special cases, warnings, drug safety
information, and other necessary information;
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c)
Information for pharmacy authorities: updated information about the quality,
safety, efficacy of the drug.
6.
Responsibility to provide drug information:
a)
Pharmacy business establishments, representative offices of foreign pharmacy
traders in Vietnam, applicants for marketing authorization shall update
pharmacy authorities on information about drugs being sold on the market;
b) Pharmacy
business establishments, representative offices of foreign traders engaged in
pharmacy in Vietnam, applicants for drug marketing authorization shall provide
drug information in accordance with Clause 3 of this Article for medical
practitioners and drug users.
Employees
of pharmacy business establishments shall introduce drugs to medical
practitioners in accordance with regulations of the Minister of Health;
c)
Medical practitioners shall provide relevant drug information for drug users in
the course of treatment;
d)
Pharmacy authorities shall ex officio provide information about drug quality,
safety, and efficacy.
7. Drug
suppliers are responsible for information they provide.
Article 77. Pharmacovigilance
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a)
Monitoring, discovering, notifying adverse effects of drugs, drug-related
errors, suspected counterfeit drugs, substandard drugs, and information about
ineffective drugs;
b)
Collecting, processing information mentioned in Point a of this Clause; assessing
the benefits, risks, making conclusion and managing drug-related risks;
c)
Announcing conclusions of competent authorities about drug safety.
2. Any
drug user who has unusual signs while using drugs must directly notify his/her
physician or drug retailer where the drug was sold, and visit a health facility
for prompt treatment.
3.
Medical practitioners have the responsibilities to:
a)
Monitor, discover unusual signs, drug-related errors, suspicious drug quality
and efficacy in their practice;
b) Take
actions and precautious measures when finding unusual signs or errors or when
receiving information from drug users as prescribed in Clause 2 of this
Article;
c) Notify
a competent authority of information collected while performing the tasks
specified in Point a and Point b of this Clause.
4. Drug
retailers have the responsibilities to:
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b)
Collect information about unusual signs shown during the use of drugs and
notify it to a competent authority.
5.
Manufacturers and applicants for drug marketing authorization have the
responsibilities to:
a)
Organize the monitoring of quality, safety, and efficacy of drugs when they are
put on the market;
b) Update
competent authorities on information about quality, safety, and efficacy of
drugs which they produce, compound, or process or for which they obtain
marketing authorization.
6. The
Minister of Health shall provide for suspension and storage of drugs that are
suspected to be unsafe.
Article 78. Organizing provision of drug information and
pharmacovigilance
1.
Pharmacy business establishments and health facilities shall organize internal
provision of drug information and pharmacovigilance.
2. The
Minister of Health shall organize a system of drug information and
pharmacovigilance.
3. The
Government shall provide for the power, documentation, procedures for
receiving, verifying, and certifying drug information.
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1. Drug
advertisements must comply with the advertisement contents approved by the
Ministry of Health and relevant regulations of law on advertising.
Within 15
days from the day on which the satisfactory application for approval for drug
advertisement contents is received, the Ministry of Health shall consider
issuing the certificate of drug advertisement contents. If the application is
rejected or the advertisement contents need revising, the Ministry of Health
shall provide explanation in writing.
2. A drug
must satisfy the following conditions to be advertised:
a) It is
on the List of OTC drugs;
b) It is
not restricted from use or subject to physician’s supervision as recommended by
a competent authority;
c) Its
marketing authorization is unexpired in Vietnam.
3. The
Government shall provide for drug advertisement contents, documentation,
procedures for receiving, verifying, and certifying drug advertisement
contents.
Chapter IX
CLINICAL PHARMACOLOGY
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1.
Providing consultancy during the compilation of List of drugs at health
facilities to ensure reasonable, safe, and effective use of drugs.
2.
Providing consultancy and supervising the prescription and use of drugs.
3.
Providing information and instructions on how to use drugs for medical
practitioners, drug users, and the public.
4.
Participate in development of procedures and guidelines for use of drugs and
supervise the adherence to such procedures.
5.
Analyzing, assessing efficacy of drugs at health facilities.
6. Participating
in monitoring and supervising of adverse effects of drugs.
7.
Participating in scientific research related to reasonable, safe, and effective
use of drugs.
Article 81. Deployment of clinical pharmacology activities
1. The
head of the health facility using drugs shall organize and deploy clinical
pharmacology activities in accordance with Article 80 hereof.
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a)
Provide consultancy and information about drugs for drug buyers and drug users;
b)
Provide consultancy and discuss with prescribers about unreasonable
prescriptions of drugs;
c)
Participating in monitoring and supervising of adverse effects of drugs.
3. The
Government shall provide for clinical pharmacology activities at health
facilities, including military health facilities.
Article 82. Rights and obligations of the person in charge
of clinical pharmacology
1. The person
in charge of clinical pharmacology at a health facility has the following
rights and obligations:
a)
Contact patients, access medical records and prescriptions to counsel
prescribers;
b)
Discuss with other medical practitioners about reasonable, safe, and efficacy
drug prescription.
c)
Comments about clinical pharmacology in medical records and prescriptions;
notify the Drug and Treatment Council of the health facility or the head of the
health facility of conflicting opinions about drug prescription;
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dd)
Participate in the development of Standard Treatment Guidelines; the List of
drugs at the health facility; and professional procedures related to drugs;
e)
Participating in monitoring and supervising of adverse effects of drugs;
g)
Exercise other rights and perform other obligations prescribed by law.
2. The
person in charge of clinical pharmacology at a drugstore has the following
rights and obligations:
a)
Provide consultancy and information about drugs for drug buyers and drug users;
b)
Provide consultancy and discuss with prescribing persons about unreasonable
prescriptions of drugs;
c)
Participating in monitoring and supervising of adverse effects of drugs;
d)
Exercise other rights and perform other obligations prescribed by law.
Article 83. State policies on clinical pharmacology
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2. Invest
in infrastructure, equipment, and human resources of state-owned institutions
providing training in clinical pharmacology; provide funding from state budget
for clinical pharmacology students.
3.
Organizations and individuals are encouraged by the State to participate in
provision of training in clinical pharmacology, invest in infrastructure and
equipment serving clinical pharmacology.
Chapter X
MANAGEMENT OF DRUGS IN HEALTH FACILITIES
Article 84. Supply, storage, dispensing, and use of drugs
1. The
head of the health facility shall ensure adequate supply of quality drugs
serving emergency treatment, medical examination and treatment at the health
facility; organize overnight sale of drugs at health facilities of
district-level and above.
2.
Storage of drugs in health facilities shall fulfill Good Storage Practice
requirements and comply with relevant regulations of law.
3. Drug
dispensing in a health facility shall comply with medical instructions or
prescriptions; the drug name and concentrations shall be specified on the drug
packages; instructions shall be provided for drug users.
4.
Radiopharmaceuticals may only be used at a health facility having a physician
specialized in nuclear medicine and licensed by the Ministry of Science and
Technology to do radiological works as prescribed by regulations of law on
atomic energy.
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Article 85. Producing and compounding drugs in health
facilities
1. The
head of a health facility producing or compounding drugs that are used therein
is responsible for the quality and management of such drugs.
2. Health
facilities are permitted to produce and compound drugs to serve their need for
treatment when the conditions specified by the Ministry of Health are fully
satisfied.
3. Health
facilities that produce or compound radiopharmaceuticals shall take security
measures to prevent loss of radiopharmaceuticals and ingredients thereof, and
have to obtain a license to do radiological works in accordance with
regulations of law on atomic energy apart from the provisions in Clause 1 and
Clause 2 of this Article.
Drugs
produced and compounded as prescribed in this Clause may be provided for other
health facilities in accordance with regulations of the Minister of Health.
Chapter XI
CLINICAL TRIAL AND BIOEQUIVALENCE STUDY
Section 1. Clinical trial
Article 86. Phases of clinical trial
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2. Phase
2 is meant to determine the optimal dose for clinical trial and prove the
safety and efficacy of the drug, including the ability of the vaccine to
stimulate development of immunity in users.
3. Phase
3 is carried out on large scale to determine the stability of the formula, the
overall safety and efficacy of the drug, or to assess the protective effect and
safety of vaccine in users.
4. Phase
4 is carried out after the drug is permitted for marketing authorization in
order to keep assessing its safety and efficacy or monitor the protective
effect of the vaccine after it is widely used under prescribed conditions.
Article 87. Clinical trial for drug marketing authorization
1. Phase
1, 2, and 3 clinical trials shall be carried
out before obtaining drug marketing authorization.
2. Phase
4 clinical trials shall be carried out after
obtaining drug marketing authorization at the request of a competent pharmacy
authority.
Article 88. Requirements applied to drugs undergoing
clinical trial
1. A drug
undergoing clinical trial must satisfy the following conditions:
a) It has
undergone pre-clinical trial;
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c) It
meets quality standards according to the application for clinical trial.
2. On the
label of the drug used for clinical trial must have the text “Thuốc dùng cho
thử lâm sàng. Cấm dùng cho Mục đích khác” (“For clinical trial only”).
Article 89. Drugs required to undergo clinical trial and
drugs exempt from clinical trials
1. The
following drugs must undergo all phases of clinical trial:
a) New
drugs, except for the cases specified in Point a Clause 2 and Point b Clause 3
of this Article;
b) Herbal
drugs with new combination of herbal materials that were medicinally used in
Vietnam and meant to treat diseases on the List promulgated by the Minister of
Health, except for the cases specified in Point b Clause 2 and Point c Clause 3
of this Article;
c)
Vaccines granted the marketing authorization in Vietnam for the first time,
except for the case specified in Point c Clause 2 of this Article.
2. The
following drugs are exempt from certain phases of clinical trial:
a) Any
new drug granted a marketing authorization in at least a country but clinical
data about its safety and efficacy is insufficient;
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c) Any
vaccine granted a marketing authorization in at least a country and there is
clinical data about its safety and efficacy.
3. The
following drugs are fully exempt from clinical trial:
a)
Generic drugs;
b) Any
new drug granted a marketing authorization in at least a country and there is
clinical data about its safety and efficacy, except for vaccines;
c) Any
herbal drug granted a marketing authorization before the effective date of this
Law, except for the drugs used for treatment of diseases on the List
promulgated by the Minister of Health.
4. The
Minister of Health shall provide for clinical data about drug safety and
efficacy, criteria for partial or full exemption from clinical trial in
Vietnam, and drugs required to undergo phase 4 of clinical trial.
Article 90. Conditions for a person to participate in
clinical trial
1. The
clinical trial subject must be a volunteer who satisfy clinical trial
requirements, signs an agreement on voluntary participation in the clinical
trial with the provider of clinical trial services, except for people who have limited
legal capacity or have no legal capacity.
2. If a
clinical trial subject is a minor, has limited legal capacity or has no legal
capacity, it is required to have his/her guardian’s consent as prescribed by
law.
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Article 91. Rights and obligations of clinical trial
subjects
1. A
clinical trial subject has the rights to:
a) Be
adequately and truthfully informed of the risks before the clinical trial;
b)
Receive compensation from the sponsor for any harm incurred;
c) Have
relevant personal information kept confidential;
d) Take
no responsibility when unilaterally terminate the participation in the clinical
trial;
dd) File
a complaint or lawsuit against any illegal acts committed by the sponsor and
the clinical trial service provider (hereinafter referred to as the
investigator).
2.
Clinical trial subjects have the responsibility to comply with instructions of
researchers according to approved clinical trial documents.
Article 92. Rights and obligations of the sponsor
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a) Select
a qualified organization in terms of equipment and personnel to run the
clinical trial;
b)
Acquire the full ownership of the clinical trial result.
2. The
sponsor has the obligations to:
a) Pay
compensation to clinical trial subjects for any harm they incur because of the
clinical trial as prescribed by law;
b) Sign a
clinical trial contract with the investigator;
c) Take
legal responsibility for the quality and safety of the drug provided.
Article 93. Rights and obligations of the investigator
1. The
investigator has the rights to:
a) Carry
out clinical trials of drugs as prescribed;
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c) Use
clinical trial results under agreements with the sponsors.
2. The
investigator has the obligations to:
a) Take
responsibility for the clinical trial results;
b) Take
responsibility for the safety of clinical trial subjects and pay compensation
for those who suffer injuries for which the investigator is responsible;
c) Ensure
truthfulness and objectivity in clinical trials;
d) Be
independent in terms of finance and personnel from the sponsors.
Article 94. Principles and the power to approve clinical
trial services
1. A
clinical trial may only be carried out after a National Biomedical Ethics Committee
assesses its scientificity and ethical aspects according to clinical trial
documents and the Minister of Health grants an approval in writing.
2. The
clinical trial, the assessment of its scientificity and ethical aspects and the
grant of approval for a clinical trial shall comply with the following
principles:
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b) Ensure
that the trial offers more benefits than risks; the risks are carefully
considered and minimized according to standards;
c) Ensure
that rights and obligations of clinical trial subjects are equal; benefits and
risks are equally shared among the clinical trial subjects;
d) Ensure
the completion of clinical trial phases and fulfillment of Good Clinical
Practice requirements.
3.
Biomedical Ethics Committees are independent national and internal committees
established to protect the rights, safety, and health of clinical trial
subjects.
The
Minister of Health shall provide for the establishment, functions, tasks, and
entitlements of Biomedical Ethics Committees.
Article 95. Documentation and procedures for carrying out
clinical trials
1.
Documents about a clinical trial include:
a) An
application for permission for clinical trial;
b)
Documents containing information about the drug;
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b) The
clinical trial outlines and description;
dd)
Academic records of researchers;
e)
Registration forms of clinical trial subjects;
g) Record
on scientific and ethical assessment prepared by the internal Biomedical Ethics
Committee;
h) Label
of the drug.
2.
Clinical trial procedures:
a)
Register the clinical trial;
b)
Approve the clinical trial;
c)
Conduct the clinical trial;
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3. The
Minister of Health shall elaborate this Article.
Section 2. BIOEQUIVALENCE STUDY
Article 96. Phases of bioequivalence study and drugs
required to undergo bioequivalence study
1. A
bioequivalence study consists of the following phases:
a)
Clinical trial phase: a phase in which a comparative drug and a the tested drug
which is proven safe and effective are tested to compare their bioavailability
in the subjects;
b) Human
biological fluid analysis: a phase in which concentrations of a comparative drug
and a the tested drug in specimens of the subjects are analyzed in order to
compare their bioavailability and prove their bioequivalence;
2. A
generic drug must undergo bioequivalence study if it contains an active
ingredient or has a dosage form that is on the List of active ingredients and
dosage forms required to undergo bioequivalence studies promulgated by the
Minister of Health.
Article 97. Conditions, rights and obligations of subjects
of bioequivalence studies
1. Every
subject of a bioequivalence must satisfy the conditions specified in Article 90
hereof.
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Article 98. Rights and obligations of the sponsor
1. The
sponsor has the rights to:
a) Select
a qualified organization in terms of equipment and personnel to run the
bioequivalence study;
b)
Acquire the full ownership of the bioequivalence study result.
2. The
sponsor has the obligations to:
a) Pay compensation
for the subjects who suffer injuries because of the bioequivalence study;
b) Sign a
bioequivalence study contract with the investigator;
c) Take
legal responsibility for the quality and safety of the drug provided.
Article 99. Rights and obligations of the investigator
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a) Carry
out clinical trial and biological fluid analysis in bioequivalence testing.
If only
biological fluid analysis is carried out, it may sign a contract or cooperate
with a provider of clinical trial services that fulfills Good Clinical Practice
requirements to carry out clinical trial in the process of bioequivalence
study;
b)
Conduct bioequivalence studies as prescribed;
c)
Import, purchase chemicals, reference materials, and drug samples serving
bioequivalence studies;
d) Use
bioequivalence study results under agreements with the sponsors.
2. The
investigator has obligations to:
a) Take
responsibility for the bioequivalence study results;
b) Take
responsibility for the safety of subjects and pay compensation for those who
suffer injuries for which the investigator is responsible;
c) Ensure
truthfulness and objectivity in bioequivalence studies;
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Article 100. Rules for approving bioequivalence studies
1. The
bioequivalence study may only be conducted after the internal Biomedical Ethics
Committee assesses the scientificness and ethics of the bioequivalence study
documents and the person in charge of expertise of the investigator grants a
written approval.
2. The
bioequivalence study shall comply with the following principles:
a) The
principles specified in Point a, b, c of Clause 2 Article 94 hereof;
b) Fulfillment
of Good Clinical Practice and Good Laboratory Practice requirements in
biological fluid analysis, and compliance with guidelines on bioequivalence
studies promulgated by the Minister of Health.
3. The
internal Biomedical Ethics Committee shall assess the scientificness and ethics
of the bioequivalence study documents and approve the study outlines.
Article 101. Documentation and procedures for
bioequivalence studies
1.
Bioequivalence study documents include:
a) An
application for permission for bioequivalence study;
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c) The
bioequivalence study outlines and description;
d)
Academic records of researchers;
dd)
Registration forms of the subjects;
e) Drug
label.
2.
Procedures for bioequivalence study:
a)
Register the bioequivalence study;
b)
Approve the bioequivalence study;
c)
Conduct the bioequivalence study;
d)
Approve the bioequivalence study result;
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Chapter XII
QUALITY STANDARDS AND REGULATIONS; TESTING
OF DRUGS, MEDICINAL MATERIALS AND PRIMARY PACKAGES OF DRUGS
Article 102. Standards and regulations on quality of drugs,
medicinal materials and primary packages of drugs
1.
National Technical Regulations on drugs, medicinal materials and primary
packages of drugs include technical regulations on quality of drugs, medicinal
materials and primary packages of drugs and common testing methods specified in
Vietnam’s pharmacopoeia. The application of testing methods in each treatise of
drugs, medicinal materials and primary packages of drugs specified in Vietnam’s
pharmacopoeia shall be voluntary.
2.
Quality standards applied to drugs, medicinal materials and primary packages of
drugs:
a)
Vietnam’s Standards for drugs, medicinal materials, and primary packages of
drugs shall be developed by the Ministry of Health, assessed by the Ministry of
Science and Technology, and published in accordance with the Law on Technical
regulations and standards;
b)
Manufacturers of drugs, medicinal materials, and primary packages of drugs may
develop internally applied standards, provided they are not lower than
corresponding Vietnam’s Standards specified in Vietnam’s pharmacopoeia. Where
Vietnam’s pharmacopoeia does not have a corresponding National Technical
Regulation on drugs, medicinal materials, and primary packages of drugs, the
manufacturers shall develop their own standards according to research findings
or a foreign pharmacopoeia, and submit them to the Ministry of Health for
approval.
3. The
Minister of Health shall issue Vietnam’s pharmacopoeia according to Vietnam’s
Standards for drugs, medicinal materials, and primary packages of drugs, and
provide for the application of foreign pharmacopoeias in Vietnam.
Article 103. Testing drugs, medicinal materials and primary
packages of drugs
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2. Before
medicinal materials and primary packages of drugs must be tested by the drug
manufacturer and meet quality standards before their manufacture is commenced.
3. Finished
drugs, medicinal materials and primary packages of drugs must be tested by
their manufacturers and meet quality standards before being released.
4. Apart
from the test specified in Clause 3 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;
b)
Biologicals that are antisera;
c) Other
drugs specified by the Minister of Health according to result of assessment of
risks to drug quality and developments of quality of domestic and imported
drugs.
5. The
Minister of Health shall elaborate this Article.
Article 104. Facilities testing drugs and medicinal
materials (hereinafter referred to as drug-testing facilities)
1.
Drug-testing facilities include:
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b)
Providers of drug-testing services;
c)
Laboratories of pharmaceutical-trading establishments.
2.
State-owned drug-testing facilities have the responsibility to:
a) Test
the quality of drugs, medicinal materials and primary packages of drugs;
b) Test
the quality and assess quality standards applied to drugs, medicinal materials
and primary packages of drugs at the request of the Ministry of Health;
c)
Propose technical measures to the Minister of Health for enhancement of drug
quality control appropriate for current level of socio-economic development;
d) Ensure
truthfulness and objectivity in testing drugs, medicinal materials, and primary
packages of drugs;
dd) Take
responsibility for the test results produced.
3.
Providers of drug testing services have the responsibilities specified in
Clause 2 Article 51 hereof.
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5. The
Prime Minister shall promulgate a master plan for state-owned testing system,
providers of drug-testing services; provide for the organizational structure,
equipment, and activities of state-owned drug-testing facilities.
Article 105. Settlement of complaints against conclusion
about quality of drugs, medicinal materials or primary packages of drugs
1. A
pharmacy business establishment is entitled to file complaints against
conclusion about the quality of drugs, medicinal materials or primary packages
of drugs given by a pharmacy authority.
2. If
such complaint is filed, the Ministry of Health shall appoint a drug-testing
facility whose conditions are equal to or better than those of the
conclusion-making facility to retest the drug/medicinal material/primary
package.
3. The
power and procedures for settlement of such complaints shall comply with
regulations of law on complaints.
Chapter XIII
DRUG PRICE MANAGEMENT
Article 106. Rules of state management of drug prices
1. Drug
price management shall comply with market mechanism; respect the right to
pricing and price competition of drug-trading entities as prescribed by law.
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3. Protect
the lawful rights and interests of traders, consumers, and the State.
4. Take
measures to stabilize prices and other measures for drug price management
appropriate for socio-economic development.
Article 107. Measures for drug price management
1. Bidding
for supply of drugs in national reserve shall comply with the Law on Bidding
and regulations of law on national reserves; bidding for supply of drugs funded
by state budget, health insurance fund, revenue from medical examination and
treatment services, and other lawful sources of income of public health
facilities shall comply with the Law on Bidding, except for the case specified
in Clause 2 of this Article.
2. Drugs
procured through bidding or order placement or assignment to serve National
Target Programs, national defense and security, disease prevention and control,
or disaster recovery shall comply with regulations of law on provision of
public services and products.
3. Drug
prices shall be declared before drugs are put on the market, and declared again
whenever they are changed.
4.
Wholesale prices and retail prices in VND of drugs shall be posted where drugs
are sold; retail prices shall be printed, written, or attached on the primary
or secondary packages of drugs, publicly posted on a board, paper, or otherwise
posted.
5.
Measures for stabilization of prices of drugs on the List of essential drugs
shall be taken in accordance with the Law on pricing in case of unusual price
fluctuation which affects socio-economic stability.
6. Price
negotiation shall be carried out where bidding for supply of drugs or herbal
materials is only participated by 1 – 2 manufacturers, bidding for supply of
original brand name drugs, rare drugs, drugs whose patents are unexpired, drugs
with uncommon contents, and other special cases.
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8. The
Government shall elaborate this Article.
Article 108. Responsibility for state management of drug
pricing
1. The
Government shall uniform state management of drug pricing.
2. The
Ministry of Health is responsible to the Government for state management of
drug pricing.
3. Other
Ministries and ministerial agencies shall ex officio cooperate with the
Ministry of Health in state management of drug pricing.
4. The
People’s Committees or provinces shall ex officio carry out state management of
drug pricing within their provinces.
Article 109. Responsibility of the Ministry of Health for
state management of drug pricing
Take charge
and cooperate with the Ministry of Finance, other Ministries, ministerial
agencies, Governmental agencies and the People’s Committees of provinces in
state management of drug pricing and:
1.
Formulate, promulgate or propose policies and regulations of law on drug
prices;
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3.
Organize dissemination of drug pricing laws;
4. Take
charge and cooperate with the Ministry of Finance in taking measures for drug
price stabilization in accordance with pricing laws;
5. Take
charge and cooperate with the Ministry of Finance in providing for declaration
of drug prices, rules for reviewing and publishing drug prices declared by
manufacturers and importers;
6.
Organize review of prices of imported drugs declared by importers or import
authorizers; prices of domestic drugs declared by manufacturers;
7.
Provide guidelines for posting prices at medicine-trading establishments;
8.
Publish the following information on the website of the Ministry of Health:
a)
Declared wholesale prices and retail prices of drugs;
b)
Successful bids provided by Social Insurance Office and health facilities;
c) Drugs
on the List of essential drugs affected by unusual price fluctuation which
affects socio-economic stability;
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Article 110. Responsibility of the Ministry of Finance for
state management of drug pricing
1.
Cooperate with the Ministry of Health in:
a)
Providing for declaration of drug prices, rules for reviewing and publishing
drug prices declared by manufacturers and importers;
b) Taking
measures for drug price stabilization in accordance with pricing laws;
c)
Carrying out inspections and impose penalties for violations against
regulations of law on drug pricing.
2. Fixing
prices of drugs funded by central government budget ordered by competent
authorities.
3.
provide information about CIF prices of imported drugs for the Ministry of
Health.
Article 111. Responsibility of the Ministry of Industry and
Trade for state management of drug pricing
1.
Provide information about prices of drugs and medicinal materials in other
countries at the request of the Ministry of Health.
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Article 112. Responsibility of the People’s Committees of
provinces for state management of drug pricing
1. Carry
out state management of drug pricing within their provinces in accordance with
this Law and relevant regulations of law.
2. Submit
reports to the Ministry of Health and the Ministry of Finance on drug prices in
their provinces in case of unusual price fluctuation which affects
socio-economic stability.
3.
Organize review of prices of domestic drugs declared by local manufacturers and
submit reports to the Ministry of Health for publication on its website.
4. Carry
out inspections and impose penalties for violations against regulations of law
on drug pricing within their provinces.
Article 113. Responsibility of Vietnam Social Security for state management of drug pricing
Publish
successful bids on the website of Vietnam Social Security and notify them to
the Ministry of Health within 05 days from the day on which contractor
selection result is received from bidding organizers.
Article 114. Responsibility of bidding organizers
1. Within
10 days from the day on which the bidding result is available, the bidding
organizer under the management of the People’s Committee of a province shall
send the result to the Provincial Department of Health and social insurance
authority of the same province; other health facilities shall send the bidding
results to the Ministry of Health and Social Insurance Office.
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Chapter XIV
IMPLEMENTATION
Article 115. Transition
1.
Pharmacy business establishments granted Certificates of eligibility for
pharmacy business under the Law on Pharmacy No. 34/2005/QH11 may keep doing
pharmacy business until they expire.
Pharmacy
business establishments whose Certificates of eligibility for pharmacy business
do not specify the expiry date may operate until the expiry date of the Good
Practice Certificate.
2.
Applications for issuance and reissuance of pharmacy practice certificate and
Certificate of eligibility for pharmacy business and marketing applications
submitted before the effective date of this Law shall be processed in
accordance with the Law on Pharmacy No. 34/2005/QH11, unless the applicant
wishes to apply this Law. Pharmacy practitioners granted pharmacy practice
certificates under the Law on Pharmacy No. 34/2005/QH11 may keep practicing
until they expire.
3. For
holders of pharmacy practice certificates issued before the effective date of
this Law, the time limit for completing the refresher course begins on the
effective date of this Law.
4.
Pharmacy practice certificates that are issued before the effective date of this
Law and expire after such date shall be reissued in accordance with this Law.
5.
Holders of certificates of eligibility for pharmacy business that are issued
before the effective date of this Law and expire after such date shall apply
for the reissuance of the Certificate of eligibility for pharmacy business in
accordance with this Law.
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1. This
Law comes into force from January 01, 2017.
2.
Regulations on application of GMP guidelines at facilities manufacturing
medicinal materials; Certificates of eligibility for pharmacy business of
manufacturers of excipients and capsule shells; facilities manufacturing and
processing herbal materials; clinical pharmacology of health facilities,
drugstores, and other establishments prescribing drugs shall come into force
from January 01, 2021.
3. The
Government shall provide for the roadmap for implementation of Clause 2 of this
Article so that by January 01, 2021, all class 1 hospitals and above have
clinical pharmacology activities specified in Article 80 hereof, and people
holding the positions specified in Article 11 of this Law have pharmacy
practice certificates.
4. The
Law on Pharmacy No. 34/2005/QH11 is null and void from the effective date of
this Law.
5. The
Government and competent authorities shall elaborate the Articles and Clauses
within their responsibility.
This
Law is adopted by the 13th National Assembly of Socialist Republic
of Vietnam on this 6th of April 2016.
PRESIDENT OF THE NATIONAL ASSEMBLY
Nguyen Thi Kim Ngan
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