Decree No. 118/2016/ND-CP amends and supplements certain articles of Decree No. 56/2008/NĐ-CP dated April 29, 2008, of the Government on the organization and operation of tissue banks and the National Center for Organ Transplantation.

DECREE

AMENDING AND SUPPLEMENTING CERTAIN PROVISIONS OF THE DECREE NO. 56/2008/NĐ-CP OF APRIL 29, 2008 ISSUED BY THE GOVERNMENT ON THE ORGANIZATION AND OPERATIONS OF THE TISSUE BANK AND THE NATIONAL CENTER FOR ORGAN TRANSPLANTATION

Pursuant to the Law on Government Organization dated June 19, 2015;

WHEREAS, the Law on Organ Donation, Transplantation, and Human Body Parts dated November 29, 2006,relating to organ transplantation, tissue grafting, and human body parts, and corpse donation on November 29, 2006;Clause of Decree No. 56/2008/NĐ-CP dated April 29, 2008 of the Government stipulating the organization and operation of tissue banks and the National Center for Organ Transplantation;

At the proposal of the Minister of Health;

The Government promulgates this Decree to amend and supplement certain provisions of Decree No. 56/2008/NĐ-CP dated April 29, 2008 issued by the Government on the organization and operations of tissue banks and the National Center for Organ Transplantation. sửa đổi một số relating to human body parts; organization and activities of tissue banks and the National Center for Human Organ Transplantation;transplantation of human body parts;people; .

Article 1. Amending and Supplementing Certain Provisions of Decree No. 56/2008/NĐ-CP dated April 29, 2008 issued by the Government

1. Market management agencies at all levels include: the Department of Domestic Market Management and Development under the Ministry of Industry and Trade; the Market Management Business Unit under the Department of Domestic Market Management and Development; the Market Management Sub-department under the Department of Industry and Trade of provinces and centrally-administered cities; and the Market Management Team under the Market Management Sub-department.

"Article 2. Forms of tissue banks A tissue bank is a healthcare facility organized in two forms as follows:
1. A tissue bank within the organizational structure of a healthcare facility, medical university, or medical and pharmaceutical university of the state or private sector; or within the National Center for Organ Transplantation (hereinafter referred to as a tissue bank within a healthcare facility). 2. An independent tissue bank with its own organizational structure of the state or private sector (hereinafter referred to as an independent tissue bank)."

2. Supplementing Article 2a after Article 2 as follows:

"Article 2a. Scope of Professional Activities of Tissue Banks
1. Receiving, preserving, storing, and transporting tissues.
2. Supplying tissues to medical facilities, research institutions, and medical training centers.
3. Supplying and exchanging tissues with other tissue banks.
4. Cooperating with foreign agencies, organizations, and individuals in the exchange of tissues for diagnostic, treatment, training, and medical research purposes. 5. Tissue banks meeting the conditions stipulated in Clause 3, Article 3a of this Decree are permitted to extract corneas from deceased donors."

3. Amend and supplement Article 3 as follows:

"Article 3. Establishment of Tissue Banks
1. Agencies, organizations, and individuals have the right to establish tissue banks when they meet the required conditions as stipulated.
2. Conditions, authority, and procedures for establishing state tissue banks shall be carried out in accordance with Decree No. 55/2012/NĐ-CP dated June 28, 2012 issued by the Government on the establishment, restructuring, and dissolution of public health facilities. 3. Conditions, authority, and procedures for establishing private tissue banks shall be carried out in accordance with the Enterprise Law and related detailed regulations implementing the Enterprise Law."

National defense works are structures in the form of buildings or other structural forms (which may be independent works or a combination of works) serving national defense purposes, including:

"Article 3a. Conditions for Operation and Issuance of Operating License for Tissue Banks
1. Conditions for operation of a tissue bank: A tissue bank may only operate after obtaining a Tissue Banking Operation Permit issued by the Ministry of Health.
2. Conditions for issuing a Tissue Banking Operation Permit:
a) Decision on the establishment of a tissue bank or the inclusion of the tissue bank in the organizational structure of a healthcare facility as specified by the competent authority for state tissue banks; Business Registration Certificate for private tissue banks.
b) Minimum physical infrastructure must include the following components: - Technical room with a minimum area of 12 square meters for receiving, processing, storing, and supplying tissues; - Laboratory room with a minimum area of 12 square meters. For tissue banks within healthcare facilities, laboratory testing can be shared with the facility's laboratory department; - Administrative area with a minimum area of 12 square meters for general management, record keeping, and counseling. - The facility must be constructed solidly, well-lit, with dust-resistant ceilings, walls, and floors made of easy-to-clean materials; ensuring proper handling of biomedical waste, infection control, fire prevention according to legal regulations; ensuring adequate electricity, water, and other necessary conditions for professional activities.
c) Minimum human resources: - The professional manager of the tissue bank must meet the requirements stipulated in Clause 4, Article 35 of the Law on Organ Donation, Transplantation, and Human Body Parts; - One doctor or bachelor’s degree holder in laboratory science with a practicing license for diagnosis and treatment; - Two technicians or nurses with at least a college degree in a relevant field and a practicing license for diagnosis and treatment; - One administrative staff member. For tissue banks within healthcare facilities, personnel may hold concurrent positions, except for technicians or nurses who must work exclusively in their roles.
d) Equipment: Must have all equipment listed in the Appendix I attached to this Decree. For tissue banks within healthcare facilities, shared equipment with the healthcare facility is allowed. If the tissue bank operates in cornea-related activities, it must meet the conditions set forth in Clause 3 of this Article.
3. Conditions for Issuing an Operating License for Cornea Banks (tissue banks that only operate in cornea-related activities):
a) Physical Infrastructure: Must meet the conditions stipulated in Clause 2 of this Article.
b) Equipment: Must have all equipment as prescribed in Appendix I attached to this Decree.
c) Human Resources: - Must have sufficient personnel as stipulated in Clause 2 of this Article; - Personnel extracting corneas must have at least a college degree and training in cornea extraction and preservation.

5. Amend and supplement Article 4 as follows:

"Article 4. Documents and Procedures for Applying for an Operating License for Tissue Banks
a) A request form for a Tissue Banking Operation Permit according to the prescribed model at
a) Application form for an operating license for a tissue bank according to the model prescribed in Appendix II attached to this Decree;
b) Certified copy or photocopied original for comparison of the decision on the establishment of the tissue bank or the document of the competent authority listing the tissue bank in the organizational structure of the healthcare facility for state tissue banks or the business registration certificate for private tissue banks;
c) Declaration of physical infrastructure and medical equipment to prove compliance with the conditions stipulated in Article 3a of this Decree;
d) Declaration of human resources of the tissue bank to prove compliance with the conditions stipulated in Article 3a of this Decree. For the professional manager, a certified copy of academic credentials and certificates, confirmation of working period, health certificate, curriculum vitae, and criminal record check must also be provided.
2. Procedures for Applying for an Operating License for Tissue Banks:
a) Agencies, organizations, or individuals submit one set of application documents for an operating license as stipulated in Clause 1 of this Article to the Ministry of Health through administrative channels or directly;
b) After receipt, within five working days, the Ministry of Health is responsible for examining the validity of the documents. In case the documents are incomplete, the Ministry of Health must issue a written notice guiding the agency, organization, or individual to complete the documents;
c) Within five working days from the date of receiving complete and valid documents, the Minister of Health issues a Decision to establish a Review Board for issuing operating licenses for tissue banks. The Review Board must consist of at least five members representing relevant units of the Ministry of Health, medical experts, and legal experts.
d) Within twenty days from the date of the Decision on establishment, the Council shall conduct an examination at the tissue bank, prepare an examination record, and report the examination results to the Minister of Health;
đ) Within five working days from the date of the examination record, the Minister of Health shall issue the Operating Permit for the tissue bank according to the form prescribed in Appendix III attached to this Decree. If the Operating Permit is not issued, a written response with specific reasons must be provided.

Article 2. Transitional Provisions

A tissue bank that has been granted an operating permit in accordance with Decree No. 56/2008/NĐ-CP dated April 29, 2008 of the Government regarding the organization and operation of tissue banks and the National Center for Organ Transplantation may continue its operations until June 30, 2017. From July 1, 2017, the tissue bank must obtain an Operating Permit in accordance with the conditions and procedures stipulated in this Decree.

Article 3. Effectiveness

This Decree takes effect from September 15, 2016.

Article 4. Responsibilities for Implementation

The Ministers, Heads of ministerial-level agencies, Heads of agencies under the Government, Chairpersons of provincial and municipal people's committees directly under the central government shall be responsible for enforcing this Decree./.

ANNEX I

LIST OF EQUIPMENT FOR TISSUE BANKS
(Attached to Decree No. 118/2016/NĐ-CP dated July 22, 2016 of the Government)

ANNEX II

SAMPLE APPLICATION FOR LICENSE TO OPERATE A TISSUE BANK
(Attached to Decree No. 118/2016/NĐ-CP dated July 22, 2016 of the Government)

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

……..¹……., day … month … year 20…

PETITION FOR APPLICATION

Issuance of Operating Permit for tissue bank

To: Ministry of Health (Department of Medical Examination and Treatment).

Name of tissue bank requesting issuance of Operating Permit: …² ………………………

Type of tissue bank (independent or affiliated with a healthcare facility): ...

Name of healthcare facility (if the tissue bank is affiliated with a healthcare facility) ³ …………………………………….

Location: ...

Phone: …Email (if any): …

Please submit along with this application a dossier including the following documents:

We respectfully request the Ministry of Health to consider and issue the license to operate.

___________________

¹ Place name.

² Name of tissue bank applying for operation.

³ State the healthcare facility, outpatient and treatment facility, medical university, pharmaceutical university establishing the tissue bank if it is a tissue bank subordinate to a healthcare facility.

ANNEX III

LICENSE TO OPERATE A TISSUE BANK
(Attached to Decree No. 118/2016/NĐ-CP dated July 22, 2016 of the Government)

LICENSE TO OPERATE A TISSUE BANK

THE MINISTER OF HEALTH

- Based on the Law on Donating, Removing, and Transplanting Tissue and Organs from the Human Body and Donating and Removing Corpses;

- Pursuant to Decree No. ... /2016/NĐ-CP dated ... month ... year 2016 of the Government amending and supplementing some articles of Decree No. 56/2008/NĐ-CP dated April 29, 2008 of the Government on the organization and operation of tissue banks and the National Center for Organ Transplantation;

- Considering the proposal of …,

ISSUE LICENSE TO OPERATE A TISSUE BANK

Name of tissue bank: …

Name of professional manager:…

Type of tissue bank: …¹………………………….

Place of operation: …²……………………………………

Scope of professional activities:…³…………………………………….

________________

¹ State whether the tissue bank is independent or subordinate to a healthcare facility.

² Address of the tissue bank.

³ Specify the scope of professional activities of the tissue bank based on Article 2a of Decree No.  /2016/NĐ-CP dated    month    year 2016 of the Government.