|
MINISTRY OF
HEALTH
-------
|
SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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|
No.:
31/2018/TT-BYT
|
Hanoi, October
30, 2018
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CIRCULAR
ON
FREE OF CHARGE MEDICINE PROGRAMS
Pursuant to the Law on Pharmacy No. 105/2016/QH13
dated April 06, 2016;
Pursuant to the Government’s Decree No.
75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and
organizational structure of the Ministry of Health;
At the request of the Director of Health
Insurance Department;
The Minister of Health promulgates a Circular
providing for the implementation of free of charge medicine programs by
pharmacy business establishments.
Article 1. Scope and regulated
entities
1. Scope:
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2. Regulated entities:
a) Health facilities implementing free of charge
medicine programs;
b) Patients whether having health insurance cards
or not;
c) Medical personnel joining free of charge
medicine programs;
d) Pharmacy business establishments implementing
free of charge medicine programs;
dd) Other relevant entities.
Article 2. Interpretation of
terms
For the purpose of this Circular, the terms below
are construed as follows:
1. “free of charge medicine program” means a
pharmacy business establishment's provision of medicines free of charge for
patients who are receiving treatment in health facilities for a specific
treatment period with the aims of relieving their financial burden and
assisting health facilities in providing care and treatment for their patients.
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Article 3. Principles of free
of charge medicine programs
1. A free of charge medicine program must be implemented
under a contract signed by and between the pharmacy business establishment and
the health facility, and include no term and condition that forces the related
health facility and patients to relinquish, reject or change drugs or treatment
methods.
2. Health facilities participating in free of
charge medicine programs must have appropriate licensed business scope and have
personnel, equipment and facilities conformable with indications and usage of
drugs provided free of charge.
3. Pharmacy business establishments must have the
certificate of eligibility for pharmacy business, and ensure quality and origin
of drugs provided free of charge for health facilities.
4. Patients using medicines provided free of charge
must be the ones eligible to benefit the free of charge medicine program and
have been diagnosed with diseases the treatment of which requires drugs
provided free of charge in the program; they must be provided with sufficient
information and advice, and voluntarily participate in the free of charge
medicine program according to the form provided in the Appendix 01 enclosed
herewith.
5. Prescribers must comply with regulations on
prescription and requirements laid down in the free of charge medicine program,
and participate in the program according to the written assignment by the head
of the health facility.
6. Drugs provided free of charge in the program
must be licensed for free sale in Vietnam by the Ministry of Health.
7. The implementation of the partially free of
charge medicine program requires the approval from the Ministry of Health.
8. Funding for the free of charge medicine program
shall be subject to agreement reached by the pharmacy business establishment
and the related health facility.
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1. Entirely free of charge provision of medicines:
a) Scope: All drug products;
b) Form: The pharmacy business establishment shall
provide free of charge the entire amount of drugs used to treat patients within
the scope of the program.
2. Partially free of charge provision of medicines:
a) Scope: Exclusively protected proprietary drugs;
or drugs whose generic drugs having the same active ingredients or dosage form
are not available in Vietnam;
b) Form: The pharmacy business establishment shall
provide free of charge a part of drugs that a patient must use during a course
of treatment or after the patient has finished a specific course of treatment.
Article 5. Application for
approval for partially free of charge medicine programs without using foreign
non-governmental aid
An application for approval for a partially free of
charge medicine program includes:
1. The written request for approval for a partially
free of charge medicine program made by the pharmacy business establishment.
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3. The certified copy of the Certificate of
eligibility for pharmacy business of the pharmacy business establishment.
4. The certified copy of the Operating license,
enclosed with the statement of licensed operating scope, of the health facility
participating in the program.
5. The certified copy of the Certificate of
registration in Vietnam or the import license of drugs.
6. The written undertaking to participate in the
free of charge medicine program made by the health facility.
7. The draft contract made between the pharmacy
business establishment and the health facility. The draft contract must include
the primary contents prescribed in the Appendix 03 enclosed herewith.
Article 6. Procedures for
approval for partially free of charge medicine programs without using foreign
non-governmental aid
1. The pharmacy business establishment (the
applicant) shall submit an application, which must sufficiently include the
documents prescribed in Article 5 hereof, to the Health Insurance Department
affiliated to the Ministry of Health.
2. Upon the receipt of the application, the Health
Insurance Department affiliated to the Ministry of Health shall give the
written receipt of application made according to the form provided in the
Appendix 04 enclosed herewith to the applicant.
3. If the application is adequate:
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b) If the inspection record indicates that the
application is satisfactory without requesting for any modification or addition
of documents: Within 10 business days from the date of the inspection record,
the Health Insurance Department affiliated to the Ministry of Health shall
request the head of the Ministry of Health to give a written approval for the
free of charge medicine program;
c) If the inspection record indicates that the
application is satisfactory but needs to be modified or supplemented: Within 10
business days from the date of the inspection record, the Health Insurance
Department affiliated to the Ministry of Health shall request the head of the
Ministry of Health to make the written request for modification or provision of
the documents specified in the inspection record;
Within 60 business days from the day on which the
modification or addition of documents is requested by the Ministry of Health,
if the applicant fails to complete the application as requested, procedures for
applying for approval for the free of charge medicine program must be repeated
from the first steps;
d) After receiving the modified or supplemented
application, the Health Insurance Department affiliated to the Ministry of
Health shall consider and process the received application according to the
inspection record;
dd) Within 10 business days from the day on which
the modified or supplemented application is considered satisfactory, the Health
Insurance Department affiliated to the Ministry of Health shall request the
head of the Ministry of Health to give a written approval for the free of
charge medicine program. If an application is refused, a written response in
which the reasons for such refusal must be stated shall be given to the
applicant.
4. If the application is inadequate:
a) Within 30 business days from the date specified
in the written receipt of application, the Ministry of Health shall request the
applicant in writing to complete the application. Such written request must
specify contents to be revised;
Within 60 business days from the day on which the
modification or addition of application documents is requested by the Ministry of
Health, if the applicant fails to complete the application as requested,
procedures for applying for approval for the free of charge medicine program
must be repeated from the first steps;
b) After receiving the modified or supplemented
application, the Health Insurance Department affiliated to the Ministry of
Health shall consider and process the received application according to
regulations herein;
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d) If the application is still not satisfactory,
the Health Insurance Department affiliated to the Ministry of Health shall continue
requesting the applicant in writing to complete the application.
Article 7. Application and
procedures for approval for partially free of charge medicine programs funded
by foreign non-governmental aid
1. In addition to the required documents for
approval for the foreign non-governmental aid, the application for approval for
the free of charge medicine program must also include:
a) Contents of the partially free of charge
medicine program requiring approval (made according to the form provided in the
Appendix 02 enclosed herewith);
b) The certified copy of the Certificate of
eligibility for pharmacy business of the pharmacy business establishment;
c) The written undertaking to participate in the
free of charge medicine program made by the health facility;
d) The draft contract made between the pharmacy
business establishment and the health facility. The draft contract must include
the primary contents prescribed in the Appendix 03 enclosed herewith.
2. Procedures for approval for the free of charge
medicine program shall conform to applicable regulations on management of aid
provided by foreign non-governmental organizations.
3. The pharmacy business establishment shall submit
the application which must sufficiently include the documents prescribed in
Article 1 hereof to the Planning & Finance Department affiliated to the
Ministry of Health.
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1. Drugs must be used for the intended purposes,
prescribed and dispensed by medical personnel to the eligible patients.
2. When drugs provided under the program are
prescribed, the fact that drugs are provided free of charged by the pharmacy
business establishment must be specified in the patient’s medical record or
prescription.
3. Drugs provided according to the free of charge
medicine program must be kept at a separate place and clearly marked.
4. If the amount of drugs dispensed free of charge
is not completely used, the patient or his/her family must return the unused
drugs to the health facility.
5. Destruction of expired drugs, unqualified drugs,
damaged or broken drugs, and drugs returned by patients or their families shall
conform to the Ministry of Health’s regulations. The entity responsible for
destruction of drugs and funding thereof shall comply with the contract signed
by and between the pharmacy business establishment and the health facility.
Article 9. Reporting
1. Entirely free of charge medicine programs:
a) When implementing free of charge medicine
programs, health facilities are required to inform and submit the free of
charge medicine programs made according to the form provided in the Appendix 05
enclosed herewith to Provincial Departments of Health if they are affiliated to
Provincial Departments of Health or local armed forces or public security
forces, or to the Ministry of Health if they are affiliated to the Ministry of
Health;
b) Upon the completion of free of charge medicine
programs, health facilities are required to submit reports on implemented free
of charge medicine programs to Provincial Departments of Health if they are
affiliated to Provincial Departments of Health or local armed forces or public
security forces, or to the Ministry of Health if they are affiliated to the
Ministry of Health. In case a free of charge medicine program lasts more than
01 year, the health facility must submit the annual report on the program by
January 15 of the following year. The report includes the duration of the free
of charge medicine program, number of patients received drugs free of charge,
the amount of drugs used and the amount of drugs to be provided free of charge,
and difficulties arising during the implementation of the program.
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a) Before implementing the program, the pharmacy business
establishment must obtain an approval for the program from the Ministry of
Health. The application and procedures for applying for approval for the
program shall conform to Articles 5, 6 and 7 hereof;
b) Upon the completion of the program:
The health facility shall submit the report on
results of the partially free of charge medicine program without using foreign
non-governmental aid to the Health Insurance Department affiliated to the
Ministry of Health, and to the Provincial Department of Health (if it is
affiliated to the Provincial Department of Health or to local armed forces or
public security forces). In case a partially free of charge medicine program
lasts more than 01 year, the health facility must submit the annual report on
the program by January 15 of the following year.
The health facility shall submit the report on
results of the partially free of charge medicine program funded by foreign
non-governmental aid to the Planning & Finance Department affiliated to the
Ministry of Health, and to the Provincial Department of Health (if it is
affiliated to the Provincial Department of Health or to local armed forces or
public security forces). In case a partially free of charge medicine program
lasts more than 01 year, the health facility must submit the annual report on
the program by January 15 of the following year.
The report includes the duration of the partially
free of charge medicine program, number of patients received drugs free of
charge, the amount of drugs used and the amount of drugs to be provided free of
charge, and difficulties arising during the implementation of the program.
Article 10. Implementation
1. Responsibilities of units affiliated to the
Ministry of Health:
a) Health Insurance Department shall:
- Play the leading role and cooperate with the
Planning & Finance Department, the Medical Examination and Treatment
Administration, the Drug Administration of Vietnam and relevant units in
requesting the head of the Ministry of Health to establish a council in charge of
inspecting partially free of charge medicine programs without using foreign
non-government aid, and submitting the list of qualified programs to the head
of the Ministry of Health for approval.
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b) Planning & Finance Department shall:
- Play the leading role and cooperate with the
Health Insurance Department, the Medical Examination and Treatment
Administration, the Drug Administration of Vietnam and relevant units in
considering and inspecting partially free of charge medicine programs funded by
foreign non-government aid, and submitting the list of qualified programs to
the head of the Ministry of Health for approval.
- Receive and consolidate reports submitted by
heath facilities; inspect partially free of charge medicine programs funded by
foreign non-government aid every year or an ad hoc basis (where necessary).
2. Vietnam Social Security shall:
a) Instruct the North Center for Medical Review and
Tertiary Care Payment, the South Center for Medical Review and Tertiary Care
Payment, Social Security Offices of provinces and central-affiliated cities,
and relevant units in making medical review and payment for covered healthcare
services for patients of free of charge medicine programs;
b) Cooperate with the Ministry of Health in dealing
with queries arising from the payment for covered healthcare services to
patients of free of charge medicine programs.
3. Each Provincial Department of Health shall:
a) Instruct local health facilities within its
competence to comply with regulations hereof;
b) Receive and consolidate reports on contents and
results of free of charge medicine programs submitted by local health
facilities.
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a) Establish a specific department in charge of
implementing free of charge medicine programs or assign a specific ward or
division to manage the free of charge medicine program;
b) Submit reports in accordance with regulations
laid down in Article 9 hereof.
5. Each pharmacy business establishment implementing
free of charge medicine programs shall:
a) Not take advantage of free of charge medicine
programs to conduct advertising, marketing or promotion of its drug products to
health facilities or patients;
b) Provide sufficiently and punctually qualified
drugs according to the signed contracts;
c) Directly manage or hire qualified entities to
manage free of charge medicine programs.
Article 11. Effect
This Circular comes into force from January 01,
2019.
2. Partially free of charge programs which have
been implemented without the approval from the Ministry of Health before the
effective date of this Circular shall be continued provided that, from the
effective date of this Circular, procedures for applying for approval from the
Ministry of Health for such programs must be carried out, and drugs and reports
in such programs must be managed and made in accordance with regulations
herein.
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PP. MINISTER
DEPUTY MINISTER
Pham Le Tuan
APPENDIX 01
VOLUNTARY REGISTRATION FOR FREE OF CHARGE MEDICINE
PROGRAM
(Enclosed with the Circular No. 31/2018/TT-BYT dated October 30, 2018 of the
Minister of Health)
Name of health facility
Telephone: ……………………………….
VOLUNTARY
REGISTRATION
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Patient’s full name:
……………………….. Year of birth: ……………………. Gender: Male/
Female
Patient’s ID: ………………………
Program’s code (if any): ……………………………………………….
Number of health insurance code
(if any) ……………………….. Contact telephone: ………………………
Diagnostic result:
…………………………………………………………………………………………..
Full name of attending physician:
……………………………………………………………
After getting advice about
diagnostic result and treatment indications and information about
requirements and benefits of the free of charge medicine program with respect
to ……………. (…………) (hereinafter referred to as the “Program”), I agree to
participate in the Program and undertake that:
1. I have
been sufficiently provided with information and clearly understood about
procedures, requirements and benefits of the Program.
2. I
participate in the Program of my own free will.
3. I will go
to all scheduled appoints and undergo any necessary tests as requested by the
physician.
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5. I will
inform the attending physician of unwanted effects as well as abnormal signs
or symptoms experienced while taking drugs. I agree to let the attending
physician or the Program coordinator (if any) record and share information
about drug safety (if any) for the purpose of monitoring drug safety.
6. I will
not give up my treatment. If I stop using drugs, I or my relative shall
inform the attending physician of reasons thereof and return the unused drugs
to the health facility.
7. I agree
to terminate the participation in the Program in case the attending physician
decides to stop using drugs for the purpose of treatment efficiency and
safety or I or my relative fails to comply with regulations on receipt and
use of drugs under the Program.
Patient’s
signature
Signature
of patient’s relative (if any)
Signature
of attending physician
Signature
of Program’s coordinator (if any)
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(full
name)
(date)
(full
name)
(date)
(full
name)
(date)
(full
name)
(date)
Notes:
(1) Trade name of drug
(2) Name of active ingredient
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APPENDIX 02
CONTENTS OF A PARTIALLY FREE OF CHARGE MEDICINE PROGRAM
REQUIRING APPROVAL
(Enclosed with the Circular No. 31/2018/TT-BYT dated October 30, 2018 of the
Minister of Health)
PROPOSAL
For approval for the Program for partially free of charge provision of …(1)…..
( ….(2)...) for ....(3)... implemented by ...(4)...
PROPOSING PHARMACY BUSINESS ESTABLISHMENT
(Signature and seal)
[location & date]
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(1) Trade name of drug;
(2) Name of active ingredient;
(3) Eligible patients;
(4) Name of pharmacy business
establishment.
A.
CONTACT INFORMATION
1. The
pharmacy business establishment in charge of the partially free of charge medicine
program (hereinafter referred to as the “Program”)
- Name:
………………………………………………………………………………………………
- Address: …………………………………………. Email:
………………………………………
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- In-charge person:
Full name: ………………………………………………
Position: …………………………………
Telephone: ……………………………….. Mobile:
…………………. Email: ……………….
2. Manufacturer
- Name:
………………………………………………………………………………………………
- Address:
……………………………………………………………………………………………
3. Entity
carrying out drug registration
- Name:
…………………………………………………………………………………………………
- Address: ……………………………………………..
Email: ……………………………………..
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- In-charge person:
Full name: ………………………………………………..
Position: …………………………………
Mobile: ……………………………………………….
Email: ……………………………………
B.
CONTENTS
I. CONTENTS OF THE PROGRAM
1. Name of the
Program
2. Form of
medicine provision
3. Scope
- Duration of
the Program
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4. Eligible
entities
- Eligible
patients
- Drug
indications
5. Involved
parties
- The pharmacy
business establishment
- The health
facility
- Other
relevant parties (if any)
II. PATHOLOGICAL INFORMATION
1. Pathological
summary (including epidemiological information, information relating to medical
conditions, etc.)
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3. Treatment
methods
4. Drugs used
and treatment regimen
III. DRUGS PROVIDED UNDER THE
PROGRAM
1. Drug the
cost of which is paid by the Health insurance fund or/and the patient
a) Name of the drug
- Name of
active ingredient
- Trade name
b) Registration number/Import
license number
- Registration
number or import license number
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- The year and
the country in which the drug is licensed for marketing for the first time
- The year in
which the drug is granted the registration number/the license to be imported
into Vietnam for the first time
c) Administration route, dosage
form, concentration
d) Manufacturer, manufacturing
country
dd) Intellectual property
□ Proprietary drug
□ Generic drug
□ Drug whose intellectual property
protection is still in force
□ Drug whose term of intellectual
property protection expires
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+ Protected types (active
ingredient, dosage form, product, manufacturing process, etc.)
+ Protection term and expiration of
each protected type
- Intellectual
property-related information of drug in manufacturing country
+ Protected types (active
ingredient, dosage form, product, manufacturing process, etc.)
+ Protection term and expiration of
each protected type
e) Generic drugs that have the same
active ingredient or dosage form in Vietnam
□ Generic
drugs that have the same active ingredient are not available in Vietnam
□ Generic drugs
that have the same active ingredient are available (trade name, registration
number, manufacturer, manufacturing country are specified) but those that have
the same dosage form are not available in Vietnam
g) Pharmacology and mechanism of
action
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
i) Dose, directions
- Dose per day
- Dose per
cycle of treatment
- Directions
for use
- Use duration
of drug/ course of treatment
k) Cautions
l) Contraindications
m) Drug interactions
n) Adverse effects
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
p) Subclinical tests and technical
services required to reach decision on use of the drug and monitor and evaluate
effectiveness of the drug.
q) Summarized findings of
researches on effectiveness of the drug in Vietnam and those of foreign
countries (reference documents are specified).
r) Costs of the drug and costs of
treatment
- The costs of
a smallest package unit
- The cost of
drug for a treatment day
- The cost of
drug for a cycle of treatment
- The cost of
drug for all cycles of treatment
2. Drug
provided under the Program (if it is different from the drug the cost of which
is paid by the Health insurance fund or/and the patient)
a) Name of the drug
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Trade name
b) Registration number/Import
license number
- Registration
number or import license number
- The year and
the country in which the drug is granted registration number for the first time
- The year in
which the drug is granted the registration number/the license to be imported
into Vietnam for the first time
c) Administration route, dosage
form, concentration
d) Manufacturer, manufacturing
country
dd) Its differences from the drug
provided without using foreign non-governmental aid
e) Dose, directions
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Dose per
cycle of treatment
- Directions
for use
- Use duration
of drug/ course of treatment
g) Cautions
h) Contraindications
i) Drug interactions
k) Adverse effects
l) Summarized findings of
researches on effectiveness of the drug in Vietnam and those of foreign
countries (reference documents are specified).
m) Effectiveness and safety of the
drug in comparison with those of the drug provided without using the foreign
non-governmental aid
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Estimated
value of the Program
- Estimated
quantity of drugs used in the Program
- Estimated
quantity of patients participating in the Program
- Estimated
total value of the Program
2. Impacts of
the program on patients
- Changes in
the cost of drug incurred by a patient when the Program is implemented (in
comparison with that when the Program is not implemented)
+ The cost of drug during a cycle
of treatment
+ The cost of drug during a year of
treatment
+ The cost of drug of all cycles of
treatment
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
+ Estimated quantity of patients
having access to the treatment when the Program is not implemented;
+ Estimated quantity of patients
having access to the treatment when the Program is implemented;
2. Impacts of
the Program on the Health insurance fund (if any)
a) Estimated cost of the drug to be
covered by the Health insurance fund when the Program is not implemented;
b) Estimated cost of the drug to be
covered by the Health insurance fund when the Program is implemented;
c) Estimated changes in costs to be
covered by the Health insurance fund when the Program is implemented.
Notes: The
value and impacts of the program shall be estimated and assessed for every year
and for total years of the Program corresponding to the proposing duration of
the Program.
V. IMPLEMENTATION OF THE PROGRAM
1. Management
of the Program
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Contents and process of
management
c) Funding (if any)
2. Inspection
a) The entity in charge of
inspecting the implementation of the Program
b) Contents and process of
inspection
c) Funding (if any)
3. Responsibility
of relevant parties
a) Responsibility of the pharmacy
business establishment
b) Responsibility of the health
facility
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Responsibility of other entity
(if any)
Notes: Responsibility
to implement tasks and responsibility to pay costs other than costs of the drug
such as costs of transport, storage and destruction of drug, collection,
management and destruction of medicine containers, and costs of hiring
qualified entities to manage the Program (if any) should be clarified.
APPENDIX 03
CONTRACT SIGNED BETWEEN THE PHARMACY BUSINESS
ESTABLISHMENT AND THE HEALTH FACILITY
(Enclosed with the Circular No. 31/2018/TT-BYT dated October 30, 2018 of the
Minister of Health)
1. Legal
information of related parties
2. Contents of
the Program
a) Name of the Program
b) Information relating to the drug
provided under the Program
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Name of the
drug (trade name, name of active ingredient)
- Registration
number/ import license number, effective period
- Administration
route, dosage form, concentration
- Manufacturer,
manufacturing country
- Source of
the drug (whether the drug is provided with using foreign non-governmental aid
or not)
c) Contents of the Program
- Form of
medicine provision
- Duration of
the Program; location
- Eligible
entities; Indications
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Rights and
obligations of related parties
a) The pharmacy business
establishment
b) The health facility
c) Other entities (if any)
Responsibility to implement tasks
and responsibility to pay costs other than costs of the drug such as costs of
transport, storage and destruction of drug, collection, management and
destruction of medicine containers, and costs of hiring qualified entities to
manage the Program (if any) should be specified.
4. Implementation
of the Program
a) The Program’s regulations;
templates used, reporting;
b) Specific procedures (e.g.
procedures for selection of patients; provision and management of the drug;
reporting on unwanted effects of the drug; destruction of expired drug, damaged
or broken drug, and the drug returned by patients or their relatives)
5. Validity of
the contract
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
APPENDIX 04
RECEIPT OF APPLICATION FOR APPROVAL FOR A
PARTIALLY FREE OF CHARGE MEDICINE PROGRAM
(Enclosed with the Circular No. 31/2018/TT-BYT dated October 30, 2018 of the
Minister of Health)
MINISTRY
OF HEALTH
(Name of receiving unit)
-----------------
SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
---------------------
……………[location
& date]
RECEIPT
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Pharmacy
business establishment:
Name:
…………………………………………………………………………………………………………
Address:
……………………………………………………………………………………………………..
Telephone:
…………………………………………………………………………………………………
2. Name
of the Program:
……………………………………………………………………………………………………………….
……………………………………………………………………………………………………………….
3. List
of documents:
▪ The
written request for approval for a partially free of charge medicine
program prepared by the pharmacy business establishment
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
▪ Contents
of the partially free of charge medicine program requiring approval
□
▪ The
certified copy of the Certificate of eligibility for pharmacy business of
the pharmacy business establishment
□
▪ The
certified copy of the Operating license, enclosed with the statement of
licensed operating scope, of the health facility participating in the Program
(name of the health facility is specified): …………………………………………..
…………………………………………………………………………………………
□
▪ The
certified copy of the lawful license to distribute drug in Vietnam
□
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
………………………………………………………………………………………..
□
▪ The
draft contract made between the pharmacy business establishment and the
health facility
□
▪ Other
documents (specified):
……………………………………………………………………………………….
……………………………………………………………………………………….
……………………………………………………………………………………….
……………………………………………………………………………………….
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
□
□
□
□
RECIPIENT
(signature and full name)
APPENDIX 05
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Name of the
Program
2. Drug
provided under the Program
a) Name of the drug (trade name,
name of active ingredient)
b) Registration number/ import
license number, effective period
c) Administration route, dosage
form, concentration
d) Manufacturer, manufacturing
country
dd) Source of the drug (whether the
drug is provided with using foreign non-governmental aid or not)
e) Indications
g) Dose, directions for use
(Dose/day; Dose/treatment cycle; directions for use; use duration of the
drug/course of treatment)
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Form of medicine provision
b) Duration of the Program; location
c) Eligible entities; Indications
d) Quantity of drug, quantity of
patients, value of the drug provided (if any)
4. Contract
information (name, address, telephone number); rights and obligations of
involved parties
a) The health facility
b) Pharmacy business establishment
c) Other entities (if any)