Circular 31/2018/TT-BYT free drug support programs for medical examination and treatment establishments for patient treatment

THE MINISTRY OF HEALTH -------	THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness --------------
No. 31/2018/TT-BYT	Hanoi, October 30, 2018

 

 

CIRCULAR

On implementation the free drug support programs for medical examination and treatment establishments for patient treatment

 

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 proposal of the Director of Department of Health Insurance;

The Minister of Health hereby promulgates the Circular on implementation the free drug support programs for medical examination and treatment establishments for patient treatment.

 

Article 1. Scope of regulation and subjects of application

1. Scope of regulation:

This Circular prescribes the implementation of programs providing free-of-charge support for all or part of the quantity of drugs used during a treatment cycle or treatment course for medical examination and treatment establishments for patient treatment, as implemented by pharmaceutical business establishments (hereinafter referred to as drug support programs). Such regulations include principles for implementation of drug support programs, forms of support, dossiers and procedures for approval of drug support programs, requirements for drug management and use, approval and reporting requirements, and responsibilities of the parties involved.

2. Subjects of application:

a) Medical examination and treatment establishments implementing free drug support programs;

b) Patients with or without health insurance cards;

c) Healthcare personnel participating in drug support programs;

d) Pharmaceutical business establishments implementing drug support programs;

dd) Other relevant units.

Article 2. Interpretation of terms

In this Circular, the terms below shall be construed as follows:

1. Free drug support program means an activity whereby a pharmaceutical business establishment provides drug support to patients receiving treatment at a medical examination and treatment establishment during a specified period, for the purpose of reducing patients’ financial burden and supporting their treatment and care.

2. Treatment cycle or treatment course means the frequency of drug administration per day, week, or month; the total number of treatment days in a treatment episode; and the total number of treatment episodes.

Article 3. Principles for drug support programs

1. A drug support program shall be implemented on the basis of a contract between a pharmaceutical business establishment and a medical examination and treatment establishment and must not impose any condition requiring the medical examination and treatment establishment or the patient to discontinue, decline, substitute, or alter the use of a drug or to change to another treatment modality.

2. Medical examination and treatment establishments participating in drug support programs shall have an appropriate professional scope of practice and satisfy personnel and equipment requirements consistent with the indications and use of the supported drugs.

3. Pharmaceutical business establishments must satisfy all legal requirements applicable to pharmaceutical business activities and ensure the quality and origin of drugs provided under the support program.

4. Patients participating in a drug support program must fall within the program’s eligible beneficiary population and must have a confirmed diagnosis consistent with the approved indication scope of the program. Patients must receive complete information and counseling and must provide informed and voluntary consent to participate in the drug support program using the form set out in Appendix I to this Circular.

5. Prescribers shall comply with applicable laws governing prescription of drugs and the requirements of the program and must be formally assigned in writing by the head of the medical examination and treatment establishment to participate in the drug support program.

6. Drugs included in a drug support program must be lawfully authorized for circulation in Vietnam by the Ministry of Health.

7. A partial free drug support program must obtain approval of its program content from the Ministry of Health before implementation.

8. Program administration costs shall be determined by mutual agreement between the pharmaceutical business establishment and the medical examination and treatment establishment.

Article 4. Forms of drug support

1. Entirely free drug support:

a) Scope of application: Applicable to all drug products;

b) Form: The pharmaceutical business establishment shall provide, free of charge, the entire quantity of drugs used during the treatment course within the scope committed under the program for the patient.

2. Partial free drug support:

a) Scope of application: Applicable to originator drugs that remain within the period of exclusivity protection, or to drugs for which no generic drug containing the same active ingredient or dosage form is available in Vietnam;

b) Form: The pharmaceutical business establishment shall provide, free of charge, a portion of the total quantity of drugs that the patient is expected to use during a treatment cycle or treatment course, or after the patient has completed a specified number of treatment cycles or treatment courses.

Article 5. Application for approval for partial free drug support programs without using foreign non-governmental aid

An application dossier for approval for a partial free drug support program includes:

1. The written request for approval for a partial free drug support program made by the pharmaceutical business establishment.

2. Contents of the partial free drug support program requiring approval (made according to the form set out in Appendix 02 to this Circular).

3. The certified copy of the Certificate of eligibility for pharmaceutical business of the pharmaceutical business establishment.

4. The certified copy of the Operating license, enclosed with the statement of licensed operating scope, of the medical examination and treatment establishment participating in the program.

5. The certified copy of the Certificate of registration in Vietnam or the import permit of drugs.

6. The written undertaking to participate in the free drug support program made by the medical examination and treatment establishment.

7. The draft contract made between the pharmaceutical business establishment and the medical examination and treatment establishment. The draft contract shall contain, at a minimum, the information prescribed in the Appendix 03 to this Circular.

Article 6. Procedures for approval for partial free drug support programs without using foreign non-governmental aid

1. The pharmaceutical business establishment (the applicant) shall submit an application dossier, which shall sufficiently include the documents prescribed in Article 5 of this Circular, to the Department of Health Insurance under the Ministry of Health.

2. Upon the receipt of the application dossier, the Department of Health Insurance under the Ministry of Health shall issue the dossier receipt form made according to the form set out in Appendix IV issued together with this Circular.

3. If the application dossier is complete:

a) Within 30 days from the date indicated on the Dossier Receipt Form for the application for approval of the drug support program, the Ministry of Health shall conduct a review of the dossier and prepare a dossier review record;

b) Where the review results are satisfactory and no amendment or supplementation of the dossier is required, within 10 working days from the date of the dossier review record, the Department of Health Insurance, Ministry of Health, shall submit the matter to the leadership of the Ministry of Health for issuance of a written approval of the drug support program;

c) Where the review results are satisfactory but amendment or supplementation of the dossier is required, within 10 working days from the date of the dossier review record, the Department of Health Insurance, Ministry of Health, shall submit the matter to the leadership of the Ministry of Health for issuance of a written request requiring the pharmaceutical business establishment to amend or supplement the dossier in accordance with the requirements specified in the dossier review record;

Where the Ministry of Health has issued a written request for amendment or supplementation of the dossier and the pharmaceutical business establishment fails to submit the required amendments or supplements within 60 days from the date of such request, the approval application procedure for the drug support program must be recommenced from the beginning;

d) Upon receipt of the amended or supplemented dossier submitted by the pharmaceutical business establishment, the Department of Health Insurance, Ministry of Health, shall review the dossier and verify compliance with the requirements specified in the dossier review record;

dd) Within 10 working days from the date of receipt of an amended or supplemented dossier that satisfies the prescribed requirements, the Department of Health Insurance, Ministry of Health, shall submit the matter to the leadership of the Ministry of Health for issuance of a written approval of the drug support program. In the event the drug support program is not approved, a written response stating the reasons therefor shall be issued.

4. If the application dossier is inadequate:

a) Within 30 days from the date indicated on the Dossier Receipt Form for the application for approval of the drug support program, the Ministry of Health shall issue a written request requiring the pharmaceutical business establishment to amend or supplement the dossier. Such written request must clearly specify the contents requiring amendment or supplementation.

Where the Ministry of Health has issued a written request for amendment or supplementation of the dossier and the pharmaceutical business establishment fails to submit the required amendments or supplements within 60 days from the date of such request, the approval application procedure for the drug support program must be recommenced from the beginning;

b) Upon receipt of the amended or supplemented dossier submitted by the pharmaceutical business establishment, the Department of Health Insurance, Ministry of Health, shall review the dossier and assess its compliance with the provisions of this Circular;

c) Where the dossier satisfies the prescribed requirements, the Department of Health Insurance, Ministry of Health, shall proceed in accordance with Clause 3 of this Article; d) If the application is still not satisfactory, the Department of Health Insurance under the Ministry of Health shall continue requesting the applicant in writing to complete the application.

d) Where the dossier continues not to satisfy the prescribed requirements, the Department of Health Insurance, Ministry of Health, shall issue a written request requiring the pharmaceutical business establishment to continue amending and supplementing the dossier.

Article 7. Application dossier and procedures for approval for partial free drug support programs funded by foreign non-governmental aid

1. In addition to the required documents for approval for the foreign non-governmental aid, a dossier requesting approval of a drug support program shall include the following additional documents:

a) Contents of the partial free drug support program requiring approval (made according to the form set out in Appendix 02 to this Circular);

b) The certified copy of the Certificate of eligibility for pharmaceutical business of the pharmaceutical business establishment;

c) The written undertaking to participate in the drug support program made by the medical examination and treatment establishment;

d) The draft contract made between the pharmaceutical business establishment and the medical examination and treatment establishment. The draft contract shall contain, at a minimum, the information prescribed in the Appendix 03 to this Circular.

2. Approval procedures shall be carried out in accordance with laws governing management of foreign non-governmental aid.

3. The pharmaceutical business establishment shall submit a complete dossier in accordance with Clause 1 of this Article to the Department of Planning and Finance of the Ministry of Health.

Article 8. Management and use of drugs in medical examination and treatment establishments

1. Drugs shall be prescribed, dispensed, and used strictly for their intended purposes and for the appropriate eligible beneficiaries and shall be prescribed and dispensed by healthcare personnel.

2. When prescribing drugs under a drug support program, the medical record or prescription must clearly indicate that the drug is supplied from the drug support source provided by the pharmaceutical business establishment.

3. Drugs dispensed under a drug support program shall be stored and maintained in a separate designated area and shall bear identifying markings indicating that they are drugs provided under the program.

4. If the patient does not use the entire quantity of drugs dispensed, the patient or the patient’s family shall be responsible for returning all unused drugs to the medical examination and treatment establishment.

5. Disposal of expired drugs, drugs failing to meet quality standards, damaged or broken drugs, and drugs returned by patients or patients’ family members shall be carried out in accordance with regulations of the Ministry of Health. Responsibility for drug destruction and the costs associated with such destruction shall be determined in accordance with the agreement executed between the pharmaceutical business establishment and the medical examination and treatment establishment.

Article 9. Approval and reporting requirements

1. Entirely free drug support programs:

a) Upon implementation of a program, the medical examination and treatment establishment shall notify and submit the program content, using the form set out in Appendix V issued together with this Circular, to the Provincial-level Departments of Health in the case of medical examination and treatment establishments under the authority of the Department of Health or medical facilities within the military or public security systems located in the province or city, and to the Department of Health Insurance, Ministry of Health, in the case of medical examination and treatment establishments directly under the Ministry of Health;

b) Upon completion of the drug support program, the medical examination and treatment establishment shall submit a report on program implementation results to the Provincial-level Departments of Health in the case of medical examination and treatment establishments under the authority of the Department of Health or medical facilities within the military or public security systems located in the province or city, and to the Department of Health Insurance, Ministry of Health, in the case of medical examination and treatment establishments directly under the Ministry of Health. Where implementation of the drug support program extends beyond one year, the medical examination and treatment establishment shall submit an annual summary report no later than January 15 of the following year. The report shall include the program implementation period, the number of patients who received support, the quantity of drugs utilized, the quantity of drugs to continue to be provided under the program, and any difficulties or issues encountered during program implementation.

2. Partial free drug support programs:

a) Before implementing the program, the pharmaceutical business establishment shall obtain an approval for the program from the Ministry of Health. Dossiers and procedures shall be carried out in accordance with Articles 5, 6, and 7 of this Circular;

b) Upon the completion of the program:

For a partial free drug support program not constituting foreign non-governmental aid, the medical examination and treatment establishment shall report implementation results to the Department of Health Insurance, Ministry of Health, and concurrently submit such report to the Provincial-level Departments of Health in the case of establishments under the authority of the Department of Health or medical facilities within the military or public security systems located in the province or city. Where implementation of the program extends beyond one year, the medical examination and treatment establishment shall submit an annual summary report no later than January 15 of the following year.

For a partial free drug support program constituting foreign non-governmental aid, the medical examination and treatment establishment shall report implementation results to the Department of Planning and Finance, Ministry of Health, and concurrently submit such report to the Provincial-level Departments of Health in the case of establishments under the authority of the Department of Health or medical facilities within the military or public security systems located in the province or city. Where implementation of the program extends beyond one year, the medical examination and treatment establishment shall submit an annual summary report no later than January 15 of the following year.

The report shall include the program implementation period, the number of patients who received support, the quantity of drugs utilized, the quantity of drugs to continue to be provided under the program, and any difficulties or issues encountered during implementation of the program.

Article 10. Implementation responsibilities

1. Responsibilities of units under the Ministry of Health:

a) The Department of Health Insurance:

- To act as the focal point and cooperate with the Department of Planning and Finance, 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 partial free drug support programs without using foreign non-government aid, and submitting the list of qualified programs to the head of the Ministry of Health for approval.

- To receive and consolidate reports submitted by medical examination and treatment establishments; inspect entirely free drug support programs and partial free drug support programs without using foreign non-government aid on annual basis or an ad hoc basis (where necessary);

b) The Department of Planning and Finance:

- To act as the focal point and cooperate with the Department of Health Insurance, the Medical Examination and Treatment Administration, the Drug Administration of Vietnam and relevant units in considering and inspecting partial free drug support programs funded by foreign non-government aid, and submitting the list of qualified programs to the head of the Ministry of Health for approval.

- To receive and consolidate reports submitted by medical examination and treatment establishments; inspect partial free drug support programs funded by foreign non-government aid on annual basis or an ad hoc basis (where necessary).

2. Vietnam Social Security:

a) To 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 drug support programs;

b) To cooperate with the Ministry of Health in dealing with queries arising from the payment for covered healthcare services to patients of drug support programs.

3. The Provincial-level Departments of Health:

a) To instruct local medical examination and treatment establishments within its competence to comply with this Circular;

b) To receive and consolidate reports on contents and results of drug support programs submitted by local medical examination and treatment establishments.

4. Medical examination and treatment establishments implementing drug support programs:

a) To establish a specific department in charge of implementing drug support programs or assign a specific ward or division to manage the drug support program;

b) To submit reports in accordance with Article 9 of this Circular.

5. Pharmaceutical business establishments implementing drug support programs:

a) Not to take advantage of free drug support programs to conduct advertising, marketing or promotion of its drug products to medical examination and treatment establishments or patients;

b) To provide sufficiently and punctually qualified drugs according to the signed contracts;

c) To directly manage or hire qualified units to manage free drug support programs.

Article 11. Effect

This Circular takes effect from January 01, 2019.

2. Partially free of charge programs implemented without the approval from the Ministry of Health before the effective date of this Circular shall continue to be implemented, provided that, from the effective date of this Circular, procedures for approval from the Ministry of Health for such programs shall be carried out, and drugs and reports in such programs shall be managed and made in accordance with this Circular.

Any difficulty arising in the course of implementation should be promptly reported to the Ministry of Health for consideration and settlement./.

 

FOR THE MINISTER THE DEPUTY MINISTER Pham Le Tuan

 

APPENDIX 01

PATIENT VOLUNTARY ENROLLMENT FORM FOR DRUG SUPPORT PROGRAM

(Attached to Circular No. 31/2018/TT-BYT dated October 30, 2018 of the Minister of Health)

 

Name of medical examination and treatment establishment Telephone: ………………………………. VOLUNTARY ENROLLMENT For drug support program with respect to ……(1)…….(……(2)…) Patient’s full name:   ……………………….. Year of birth: ……………………. Gender:   Male/ Female Patient Identification Number:  ……………………… Program’s code (if any): ………………………………………………. Number of health insurance card number (if any) ……………………….. Contact telephone number:  ……………………… Diagnosis:  ………………………………………………………………………………………….. Name of current treating and monitoring physician:  …………………………………………………………… Having received counseling regarding my diagnosis and prescribed treatment and having been provided with complete information concerning the requirements and benefits of the .......... Drug Support Program (..........) (hereinafter referred to as the “Program”), I hereby voluntarily agree and undertake as follows: 1. I acknowledge that I have been fully informed of and clearly understand the Program’s implementation procedures, requirements, and benefits. 2. I voluntarily agree to participate in the Program. 3. I will comply with scheduled medical appointments and undergo all necessary tests as directed by my physician. 4. I will comply with all requirements regarding receipt and use of supported drugs as communicated to me upon enrollment in the Program. I will use the supported drugs solely for the purposes of the Program and for no other purpose. 5. I will promptly inform my treating physician of any adverse drug reactions, unusual signs, or symptoms experienced during use of the drug. I authorize my treating physician and/or the Program coordinator (if any) to document and share drug safety information, where applicable, for purposes of pharmacovigilance and drug safety monitoring. 6. I will not discontinue treatment on my own initiative. If I stop using the drug, I or my family member will notify the treating physician of the reason for discontinuation and return all dispensed but unused drugs to the medical examination and treatment establishment. 7. My participation in the Program shall terminate if the treating physician determines that the drug should be discontinued for reasons related to safety or treatment effectiveness, or if I or my family member fails to comply with the Program’s requirements regarding receipt and use of supported drugs.   Patient’s signature Signature of patient’s relative (if any) Signature of attending physician Signature of Program’s coordinator (if any)         (full name) (date) (full name) (date) (full name) (date) (full name) (date)

Notes:  

(1) Trade name of drug

(2) Name of active ingredient

 

APPENDIX 02

TEMPLATE FOR CONTENTS OF A PROPOSED PARTIAL FREE DRUG SUPPORT PROGRAM SUBMITTED FOR APPROVAL

(Attached to Circular No. 31/2018/TT-BYT dated October 30, 2018 of the Minister of Health)

 

PROPOSAL Partial Free Drug Support Program for …(1)….. ( ….(2)...) for ....(3)... implemented by ...(4)... PROPOSING PHARMACEUTICAL BUSINESS ESTABLISHMENT (Signature and seal)           [location & date]
Notes:	(1) Trade name of drug; (2) Name of active ingredient; (3) Eligible patients; (4) Name of pharmaceutical business establishment.

A. CONTACT INFORMATION

1.  The pharmaceutical business establishment responsible for the implementation of the partial free drug support program (Program)

- Name: ………………………………………………………………………………………………

- Address: …………………………………………. Email: ………………………………………

- Telephone: ………………………………………. Fax: ……………………………………….

- Contact person:

Full name: ……………………………………………… Position: …………………………………

Telephone: ……………………………….. Mobile:  …………………. Email: ……………….

2. Manufacturer information

- Name: ………………………………………………………………………………………………

- Address: ……………………………………………………………………………………………

3. Drug registration holder information

- Name: …………………………………………………………………………………………………

- Address: …………………………………………….. Email: ……………………………………..

- Telephone: ………………………………………… Fax: ………………………………………..

- Contact person:

Full name: ……………………………………………….. Position:  …………………………………

Mobile:  ………………………………………………. Email: ……………………………………

B. PROGRAM CONTENTS

I. CONTENTS OF THE PROGRAM

1. Name of the Program

2. Form of support

3. Scope 

- Duration of the Program

- Location

4. Applicable Beneficiaries

- Eligible patients

- Drug indications

5. Involved parties

- The pharmaceutical business establishment

- The medical examination and treatment establishment

- Other related parties (if any)

II. DISEASE INFORMATION

1. Summary of disease information (Including epidemiology, pathology, and related information)

2. Clinical and subclinical diagnosis

3. Treatment methods

4. Drugs used and treatment regimen

III. DRUGS PROVIDED UNDER THE PROGRAM

1. Drugs covered by the health insurance fund and/or paid by patients

a) Name of the drug

- Name of active ingredient

- Trade name

b) Registration number/Import permit number

-  Registration number or import permit number

- Effective period

- The year and country of first marketing authorization worldwide

- The year of first issuance of certificate of registration/import permit in Vietnam

c) Administration route, dosage form, concentration

d) Manufacturer, Country of manufacture

dd) Intellectual property

□ Proprietary drug	□ Generic drug
□ Drug whose intellectual property protection is still in force	□ Drug whose term of intellectual property protection expires

- Intellectual property-related information of drug in Vietnam:

+ 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 country of manufacture 

+ 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, country of manufacture are specified) but those that have the same dosage form are not available in Vietnam

g) Pharmacology and mechanism of action

h) Indications

i) Dose, directions

- Dose per day

- Dose per cycle of treatment

- Directions for use

- Use duration of drug/ treatment cycle or treatment course

k) Cautions

l) Contraindications

m) Drug interactions

n) Adverse effects

o) Recommendations on use of drug included in guidelines for diagnosis and treatment of Vietnam (of the Ministry of Health, Expert Councils, medical examination and treatment establishments, etc.) and of international organizations.

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

- Name of active ingredient

- Trade name

b) Registration number/Import permit number

-  Registration number or import permit 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, country of manufacture

dd) Its differences from the drug provided without using foreign non-governmental aid

e) Dose, directions

- Dose per day

- Dose per cycle of treatment

- Directions for use

- Use duration of drug/ treatment cycle or treatment course

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

IV. IMPACTS OF THE PROGRAM

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

- Changes in patients’ access to treatment

+ 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

a) The unit in charge of managing the Program

b) Contents and process of management

c) Funding (if any)

2. Inspection

a) The unit 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 pharmaceutical business establishment

b) Responsibility of the medical examination and treatment establishment

c) Responsibility of the unit carrying out drug registration in Vietnam

d) Responsibility of other unit (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 drug containers, and costs of hiring qualified units to manage the Program (if any) should be clarified.

 

APPENDIX 03

CONTRACT SIGNED BETWEEN THE PHARMACEUTICAL BUSINESS ESTABLISHMENT AND THE MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENT
(Attached to 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

(Note:  Information relating to the drug the cost of which is paid by the Health insurance fund or/and the patient and the drug provided under the Program shall be specified if different)

- Name of the drug (trade name, name of active ingredient)

- Registration number/ import permit number, effective period

- Administration route, dosage form, concentration

- Manufacturer, country of manufacture

- Source of the drug (whether the drug is provided with using foreign non-governmental aid or not)

c) Contents of the Program

- Form of drug support

- Duration of the Program; location

- Eligible units; Indications

- Quantity of drug, quantity of patients, value of the drug provided (if any)

3. Rights and obligations of related parties

a) The pharmaceutical business establishment

b) The medical examination and treatment establishment

c) Other units (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 drug containers, and costs of hiring qualified units 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

6. Other provisions (if any)

 

APPENDIX 04

 RECEIPT OF APPLICATION FOR APPROVAL FOR A PARTIAL FREE DRUG SUPPORT PROGRAM
(Attached to Circular No. 31/2018/TT-BYT dated October 30, 2018 of the Minister of Health)

 

THE MINISTRY OF HEALTH (Name of receiving unit) ----------------- THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------------------   ……………[location & date]   RECEIPT Application for approval for a partial free drug support program 1. Pharmaceutical business establishment: Name: ………………………………………………………………………………………………………… Address: …………………………………………………………………………………………………….. Telephone: ………………………………………………………………………………………………… 2. Name of the Program: ………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………. 3. List of documents: ▪ The written request for approval for a partial free drug support program prepared by the pharmaceutical business establishment □ ▪ Contents of the partial free drug support program requiring approval □ ▪ The certified copy of the Certificate of eligibility for pharmaceutical business of the pharmaceutical business establishment □ ▪ The certified copy of the Operating license, enclosed with the statement of licensed operating scope, of the medical examination and treatment establishment participating in the Program (name of the medical examination and treatment establishment is specified): ………………………………………….. ………………………………………………………………………………………… □ ▪ The certified copy of the lawful license to distribute drug in Vietnam □ ▪ The written undertaking to participate in the Program made by the medical examination and treatment establishment (name of the medical examination and treatment establishment is specified):  …………………… ……………………………………………………………………………………….. □ ▪ The draft contract made between the pharmaceutical business establishment and the medical examination and treatment establishment □ ▪ Other documents (specified): ………………………………………………………………………………………. ………………………………………………………………………………………. ………………………………………………………………………………………. ……………………………………………………………………………………….   □ □ □ □     RECIPIENT (signature and full name)

 

APPENDIX 05

CONTENTS OF THE ENTIRELY FREE DRUG SUPPORT PROGRAM
(Attached to Circular No. 31/2018/TT-BYT dated October 30, 2018 of the Minister of Health)

 

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 permit number, effective period

c) Administration route, dosage form, concentration

d) Manufacturer, country of manufacture

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/treatment cycle or treatment course)

3. Contents of the Program

a) Form of drug support

b) Duration of the Program; location

c) Eligible units; 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 medical examination and treatment establishment

b) Pharmaceutical business establishment

c) Other units (if any)