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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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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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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- 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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- 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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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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+ 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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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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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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- 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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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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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)
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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……………[location & date]

RECEIPT

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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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▪ Contents of the partially free of charge medicine program requiring approval

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▪ The certified copy of the Certificate of eligibility for pharmacy business of the pharmacy business establishment

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▪ 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): …………………………………………..

…………………………………………………………………………………………

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▪ The certified copy of the lawful license to distribute drug in Vietnam

□

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▪ The draft contract made between the pharmacy business establishment and the health facility

□

▪ Other documents (specified):

……………………………………………………………………………………….

……………………………………………………………………………………….

……………………………………………………………………………………….

……………………………………………………………………………………….

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RECIPIENT
(signature and full name) 

APPENDIX 05

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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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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)

Thông tư 31/2018/TT-BYT quy định về thực hiện chương trình hỗ trợ thuốc miễn phí cho cơ sở khám bệnh, chữa bệnh để điều trị cho người bệnh do Bộ trưởng Bộ Y tế ban hành