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Safety, management, etc. of human tissue act

제35편 의사․약사 인체조직안전 및 관리 등에 관한 법률

SAFETY, MANAGEMENT, ETC. OF HUMAN TISSUE ACT

Act No. 7097, Jan. 20, 2004

Amended by Act No. 7375, Jan. 27, 2005

Act No. 8852, Feb. 29, 2008

CHAPTER Ⅰ GENERAL PROVISIONS

Article 1 (Purpose)

The purpose of this Act is to provide matters necessary for donation, management and transplant of human tissue for the purpose of physical
completion and recovery of biological functions, to promote balanced supply and safety of human tissue, and to contribute to the improvement of public
health.

Article 2 (Basic Ideology)

(1) Donation, management and transplant of human tissue shall be carried out in a humanitarian spirit.
(2) Expression of intentions regarding donation of human tissue of a person
shall be respected. In such cases, such intention shall be voluntary.
(3) A person in need of a transplant of human tissue shall have an equal opportunity to receive transplant regardless of social or economic conditions.
(4) Donation, management and transplant of human issue shall be conducted in ethically reasonable and medically accepted manners.

Article 3 (Definitions)

For the purposes of this Act: <AmendedbyActNo. 7375, Jan.27, 2005;ActNo.

8852, Feb. 29, 2008>

1. The term “human tissue” means any of the following items (hereinafter
referred to as “tissue”), which is not an organ under subparagraph
1 of Article 3 of the Internal Organs, etc. Transplant Act:
(a) Bones, joints, myofascia, skin, amnion, ligament, and tendon;
(b) Heart valves and veins;

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SAFETY, MANAGEMENT, ETC. OF HUMAN TISSUE ACT

(c) Body parts which may be recovered and transplanted for a person's
health, physical recovery and prevention of disability, and which may be determined by Presidential Decree;
2. The term “tissue donor” means a person who donates specific tissue without compensation under Ordinance of the Ministry for Health,
Welfare and Family Affairs;
3. The term “tissue transplant” means transplantation of tissue which is donated from a tissue donor and safety of which is guaranteed for
the purpose of treatment of illness of a patient;
4. The term “tissue bank” means an institution authorized under Article
13 (1) for the management of tissue for the purpose of transplantation;
5. The term “tissue management” means recovery, storage, processing,
preservation, and allocation of tissue;
6. Article 3 of the Internal Organs, etc. Transplant Act shall apply mutatis

mutandis to the definitions of the terms “living donor,” “brain-dead

donor,” “family,” or “surviving family member.”

Article 4 (Applicability)

This Act shall apply to tissue produced within Korea, or imported from outside of Korea, for donation from a living donor, a brain-dead donor,
or a deceased donor, for management, or for transplantation for the purposes of physical completion and recovery of biological functions: Provided, That
each of the following subparagraphs shall be excluded:
1. Tissue for self-transplant;
2. Items to which the Pharmaceutical Affairs Act, the Medical Appliances
Act, and other Acts and subordinate statutes apply.

Article 5 (Prohibition of Purchase or Sale, etc. of Tissue)

(1) No one shall do or promise to do any of the following acts in exchange for money, financial gain, or other consideration:
1. Giving tissue of a brain-dead donor or a deceased donor to a third
person, receiving such tissue to give to a third person, or promising to do either act;
2. Giving one's own tissue to another person, receiving tissue from another
to transplant into one's own body, or promising to do either act;
3. Assisting another to do any act under subparagraph 1 or 2.
(2) No person aware of an act in violation of paragraph (1) shall manage
or transplant any tissue relating to such act.

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제35편 의사․약사 인체조직안전 및 관리 등에 관한 법률

Article 6 (Human Tissue Safety and Management Advisory Committee) (1) The Human Tissue Safety and Management Advisory Committee (hereinafter referred to as “Committee”) shall be established in the Ministry of Health, Welfare and Family Affairs, to deliberate on the following matters when the Minister of Health, Welfare and Family Affairs requests consultation in connection with donation, management and transplantation of tissue:

<Amended by Act No. 8852, Feb. 29, 2008>

1. Matters concerning authorization criteria for tissue banks and their
operation;
2. Matters concerning management plans for imported tissue;
3. Matters concerning accuracy evaluation of tissue quality, tissue testing, or tissue management (hereinafter referred to as "quality control").
4. Other matters submitted by the Minister of Health, Welfare and Family
Affairs in connection with surveys, research, etc. on donation, management and transplantation of tissue.
(2) Matters necessary for organization and operation of the Committee shall be prescribed by Presidential Decree.

CHAPTER Ⅱ MANAGEMENT OF TISSUE

Article 7 (Consent to Donate Tissue)

(1) Article 11 of the Internal Organs, etc. Transplant Act shall apply mutatis

mutandis to consent to donate tissue.

(2) Consent under paragraph (1) shall include the following matters: <Amended

by Act No. 8852, Feb. 29, 2008>

1. The period of preservation of tissue and other matters concerning such
preservation;
2. Matters concerning the right of the person who consents to donation, such as revocation of consent, and confidentiality of information;
3. Other matters prescribed by the Minister of Health, Welfare and Family
Affairs.
(3) When consent under paragraph (1) is obtained, a person who intends to recover tissue shall fully explain matters under paragraph (2) in advance.
(4) Matters necessary for consent forms, preservation of tissue, etc. shall be prescribed by Ordinance of the Ministry of Health, Welfare and Family
Affairs. <Amended by Act No. 8852, Feb. 29, 2008>

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SAFETY, MANAGEMENT, ETC. OF HUMAN TISSUE ACT

Article 8 (Requirements for Recovery of Tissue)

(1) Tissue may be recovered from a brain-dead donor or a deceased donor only in cases falling under either of the following: Provided, That, in cases of a mentally ill person or a developmentally disabled person, tissue may
recovered only under subparagraph 1:
1. Cases where a person consents to recovery of tissue before brain death or death: Provided, That cases where such person's family or surviving
family members clearly express objection to recovery of tissue, etc. shall be excluded;
2. Cases where it is unclear whether a person consented or objected to
recovery of tissue before brain death or death and the person's family or surviving family members consent to recovery of tissue: Provided,
That the parents' consent to recovery is required, in cases where a person is under 16 years of age.
(2) Where tissue is recovered from a living donor, the persons' consent is required: Provided, That, in cases where tissue is recovered from a minor,
the parent's consent is required in addition to the persons' consent.
(3) A person who consents to recovery under paragraph (1) or (2) may revoke his or her consent to recovery anytime before surgery for tissue recovery.

Article 9 (Prohibition of Allocation or Transplant of Tissue)

No tissue falling under any of the following subparagraphs shall be allocated nor transplanted: <AmendedbyActNo.7375,Jan.27,2005;ActNo.8852,Feb.29,

2008>

1. Tissue infected or suspected of being infected with contagious diseases
unsuitable for transplant, such as hepatitis B or C, shyphilis, Acquired
Immune Deficiency Syndrome;
2. Tissue from a donor having Alzheimer's disease or a degenerative neurological disease;
3. Tissue from a donor with certain cause of death;
4. Tissue from a donor exposed to hazardous substances;
5. Tissue from a donor whose cancer might have spread and affected such
tissue;
6. Tissue that is equivalent to those under subparagraphs 1 through 5, that is deemed unsuitable for transplant due to risk of causing harm
to the life or body of a transplant recipient, and that is determined as such by Ordinance of the Ministry of Health, Welfare and Family

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제35편 의사․약사 인체조직안전 및 관리 등에 관한 법률

Affairs.

Article 10 (Guarantee of Safety of Tissue)

(1) The Minister of Health, Welfare and Family Affairs shall screen and test tissue processed by domestic tissue banks and tissue imported from outside
of Korea for suitability of tissue for transplant, as prescribed by Ordinance of the Ministry of Health, Welfare and Family Affairs, and shall order destruction
of tissue the safety of which is not ensured. <AmendedbyActNo.8852,Feb.29,

2008>

(2) The criteria for determination of suitability of tissue transplants under
paragraph (1) shall be prescribed by Ordinance of the Ministry of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008>

Article 11 (Quality Control of Tissue Banks)

(1) The Minister of Health, Welfare and Family Affairs may order a tissue bank to be subject to quality control and may disclose the results of quality control. <Amended by Act No. 8852, Feb. 29, 2008>
(2) The procedures for quality control under paragraph (1), the disclosure
of the results of quality control, and other matters necessary for quality control shall be prescribed by Ordinance of the Ministry of Health, Welfare and Family
Affairs.

Article 12 (Priority for Tissue Transplant)

Where a tissue bank distributes tissue among medical institutions that perform tissue transplants (hereinafter referred to as "tissue transplant hospital"),
such tissue bank shall apply the priority ranking for distribution in consideration
of the gravity of the urgency and expected results of tissue transplant in medical respect.

Article 13 (Authorization for Tissue Bank)

(1) A person who intends to establish a tissue bank shall acquire the facilities, equipment, human resources, quality control system, etc. prescribed by Presidential Decree and shall obtain authorization from the Minister of Health,
Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008>
(2) A person falling under any of the following subparagraphs may be granted authorization for a tissue bank: Provided, That no person falling under
subparagraph 3 or 4 may engage in tissue donation or tissue recovery:
1. Medical institutions under Article 3 of the Medical Services Act;
2. Non-profit corporations whose main purpose of establishment is a business relating to human tissue;

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SAFETY, MANAGEMENT, ETC. OF HUMAN TISSUE ACT

3. Tissue processing business operators;
4. Tissue importers.
(3) Activities of tissue banks shall be as follows:
1. Recovery, storage, processing, preservation and distribution of tissue;
2. Management of tissue donors and public relations work and consultation for tissue donation;
3. Selection of tissue donors and guaranteeing tissue quality;
4. Other matters necessary for ensuring safety of tissue transplants prescribed by Presidential Decree.

Article 14 (Renewal of Authorization for Tissue Bank)

(1) The Minister of Health, Welfare and Family Affairs may order an authorized tissue bank to renew its authorization every three years. <AmendedbyActNo.

8852, Feb. 29, 2008>

(2) Matter necessary for the criteria and procedures for authorization renewal
under paragraph (1) shall be prescribed by Presidential Decree.

Article 15 (Tissue Bank Rules)

(1) A tissue bank shall comply with detailed operating guidelines prescribed by the Minister of Health, Welfare and Family Affairs in order to endure
tissue safety. <Amended by Act No. 8852, Feb. 29, 2008>
(2) Where a tissue bank carries out activities in cooperation with other tissue banks, their cooperative relationship and contract relationship shall be clearly
set forth.
(3) A tissue bank shall comply with non-profit principles in provision to a tissue transplant hospital of tissue necessary for surgery: Provided, That
a tissue bank may demand such tissue transplant hospital to reimburse the costs for donation, preservation, transplant, etc., as prescribed by Ordinance of the Ministry of Health, Welfare and Family Affairs. <Amended by Act No.

8852, Feb. 29, 2008>

(4) Medical practitioners who handle tissue and other employees, prescribed
by Ordinance of the Ministry of Health, Welfare and Family Affairs, employed
at a tissue bank shall receive a required training prescribed by Ordinance of the Ministry of Health, Welfare and Family Affairs. <Amended by Act No.

8852, Feb. 29, 2008>

(5) The procedures for provision of tissue, the volume of tissue preservation,
the persons in charge of management, the reporting of management status,
and other necessary matters shall be prescribed by Ordinance of the Ministry

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제35편 의사․약사 인체조직안전 및 관리 등에 관한 법률

of Health, Welfare and Family Affairs. <AmendedbyActNo.8852,Feb.29,2008>

Article 16 (Rules regarding Recovery of Tissue)

(1) A tissue bank which intends to recover tissue shall comply with the following subparagraphs:
1. A tissue bank shall confirm consent under Articles 7 and 8 (1) and
(2);
2. A tissue bank shall fully explain the following matters to donors or
persons who are authorized to give consent:
(a) Matters relating to the completion of questionnaires on medical history, blood serum test, etc.;
(b) Details of surgery for tissue recovery;
(c) Advance explanation of funeral procedures after tissue donation; (d) Other matters a person must be aware of before tissue donation.
(2) The details of the procedures, matters to be explained and other necessary matters, which shall be complied with when an explanation under paragraph
(1) is given to donors and persons who are authorized to give consent, shall
be prescribed by Ordinance of the Ministry of Health, Welfare and Family
Affairs. <Amended by Act No. 8852, Feb. 29, 2008>

Article 17 (Importation of Tissue)

(1) No one, other than tissue banks, may import tissue.
(2) Specific matters concerning tissue importation shall be prescribed by
Presidential Decree.

Article 18 (Priority of Autopsy or Postmortem Examination)

No recovery of tissue may be performed before autopsy or postmortem examination in cases where an autopsy or postmortem examination is
required under the Criminal Act or the Quarantine Act: Provided, that
tissue recovery may be performed with authorization by a public prosecutor
of a competent District Public Prosecutors' Office or its branch office or the director of a competent quarantine station and with consent of the
surviving family members, in cases where a medical care provider making diagnosis determines that there is no correlation between the tissue to
be recovered and the cause of death and that, if recovery is delayed until
after autopsy or postmortem examination, tissue might not be recovered at all within the period that allows recovery.

Article 19 (Compilation, Reporting, etc. of Records)

(1) A tissue bank shall keep records of data relating to donation, management

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SAFETY, MANAGEMENT, ETC. OF HUMAN TISSUE ACT

and transplantation of tissue and report to the Minister of Health, Welfare
and Family Affairs annually, as prescribed by Ordinance of the Ministry of
Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008>
(2) A tissue transplant hospital shall notify tissue banks of the results of transplant, as prescribed by Ordinance of the Ministry of Health, Welfare
and Family Affairs. The tissue bank so notified shall include such notice in
its report submitted under paragraph (1). <AmendedbyActNo. 8852,Feb.29,

2008>

(3) Where any serious side effects prescribed by Ordinance of the Ministry
of Health, Welfare and Family Affair, such as infection, occur in connection with a tissue transplant, tissue banks and tissue transplant hospitals shall
immediately report such occurrence to the Minister of Health, Welfare and
Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008>

Article 20 (Maintenance of Records)

The head of a tissue bank or tissue transplant hospital shall maintain the records relating to donation, management and transplantation of tissue for
10 years, as prescribed by the Minister of Health, Welfare and Family Affairs.

<Amended by Act No. 8852, Feb. 29, 2008>

Article 21 (Perusal, etc. of Records)

Where a donor or a donor's surviving family member demands perusal of, or issuance of copies of, the records relating to recovery or transplant of relevant
tissue, the head of the relevant tissue bank shall allow perusal or issue copies of the records of overall process of tissue donation or the records relating
to transplant: Provided, That, when a medical care provider making diagnosis
determines that such act might seriously interfere with the treatment or recovery
of a tissue donor or a tissue recipient, such medical care provider may refuse to allow perusal or issuance of copies of the records.

Article 22 (Confidentiality)

(1) Unless otherwise provided for in this Act, a person who is employed by a tissue bank or a tissue transplant hospital or who engages in business relating
to donation, management or transplantation of tissue shall not convey
information falling under any of the following subparagraphs to persons other than those who engage in business relating to recovery and transplant of
tissue of a relevant tissue donor:
1. Matters concerning tissue donors and recovered tissue;
2. Matters concerning transplant recipients and transplanted tissue;

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제35편 의사․약사 인체조직안전 및 관리 등에 관한 법률

3. Matters concerning persons who wish to donate tissue.
(2) Paragraph (1) shall not apply to the following cases:
1. Where a criminal investigation agency requests data relating to recovery
or transplant of tissue;
2. Where a judge requests, in connection with a trial, any data relating to recovery or transplant of tissue.

CHAPTER Ⅲ SUPERVISION

Article 23 (Reporting, Inspection, etc.)

(1) The Minister of Health, Welfare and Family Affairs may issue the head of a tissue bank or a tissue transplant hospital or its employee necessary
orders relating to his/her duties or may order reporting or submission of relevant
documents, where the Minister deems it necessary in relation to donation, management or transplant of tissue. <AmendedbyActNo.8852, Feb. 29, 2008>
(2) The Minister of Health, Welfare and Family Affairs may order relevant
public officials to inspect relevant documents of tissue banks, etc. under paragraph (1), as prescribed by Ordinance of the Ministry of Health, Welfare
an Family Affairs. In such cases, the relevant public officials in charge of
inspection shall carry proof of authority and shall produce such proof to relevant persons. <Amended by Act No. 8852, Feb. 29, 2008>
(3) The head of a tissue bank or a tissue transplant hospital or its employee
shall comply with an order or cooperate with inspection under paragraphs
(1) and (2), unless justifiable grounds exist to the contrary.

Article 24 (Corrective Orders)

Where the head of a tissue bank or a tissue transplant hospital or its employee falls under any of the following subparagraphs, the Minister of Health, Welfare and Family Affairs may order the head of a relevant organization to make
corrections within a set period: <Amended by Act No. 8852, Feb. 29, 2008>
1. Failing to file a report under Article 19;
2. Failing to maintain the records under Article 20.

Article 25 (Revocation of Authorization)

(1) Where a tissue bank falls under any of the following subparagraphs, the Minister of Health, Welfare and Family Affairs may revoke authorization for the tissue bank or may fully or partially suspend the business for a set period
of not more than one year, as prescribed by Ordinance of the Ministry of

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SAFETY, MANAGEMENT, ETC. OF HUMAN TISSUE ACT

Health, Welfare and Family Affairs: <AmendedbyAct No. 8852, Feb. 29, 2008>
1. Failing to acquire facilities, equipment, human resources, quality control system, etc. under Article 13 (1);
2. Failing to comply with an order under Article 23 (1) or failing to cooperate with inspection under paragraph (2) of the same Article;
3. Failing to comply with a corrective order under Article 24.
(2) Where a tissue bank carries out its business in violation of an order of business suspension under paragraph (1), the Minister of Health, Welfare
and Family Affairs may revoke authorization for such tissue bank. <Amended

by Act No. 8852, Feb. 29, 2008>

(3) No tissue bank whose authorization is revoked under paragraph (1) or
(2) may obtain authorization for tissue bank within one year after the date on which such authorization is revoked.
(4) Detailed guidelines regarding administrative dispositions under paragraph
(1) shall be prescribed by Ordinance of the Ministry of Health, Welfare and
Family Affairs in consideration of the types and degree of violations. <Amended

by Act No. 8852, Feb. 29, 2008>

Article 26 (Reporting Termination of Business, etc. and Transfer of Data) (1) Where a tissue bank intends to terminate its business, such tissue bank shall report to the Minister of Health, Welfare and Family Affairs the matters relating to tissue donors and processed or preserved tissue. <AmendedbyAct No. 8852, Feb. 29, 2008>

(2) The head of a tissue bank which terminates its business under paragraph
(1) or whose authorization is revoked under Article 25 shall transfer relevant data to the Minister of the Minister of Health, Welfare and Family Affairs,
as prescribed by Presidential Decree. <AmendedbyActNo.8852,Feb.29,2008>

CHAPTER Ⅳ SUPPLEMENTARY PROVISIONS

Article 27 (Aid for Tissue Banks, etc.)

The State or local governments may provide necessary aid for tissue banks or tissue donors within budget limits.

Article 28 (Delegation of Authority)

The Minister of Health, Welfare and Family Affairs may delegate part of his/her authority to the head of a subordinate agency, the Administrator of the Korea

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제35편 의사․약사 인체조직안전 및 관리 등에 관한 법률

Food and Drug Administration, the Special Metropolitan City Mayor, the
Metropolitan City Mayor, the DoGovernor, the head of a Si/Gun/Gu(referring
to the head of an autonomous Gu; hereinafter the same shall apply), as
prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008>

Article 29 (Obligation to Cooperate)

The Minister of Health, Welfare and Family Affairs may request the heads of relevant agencies to take measures necessary for safe and speedy recovery,
transport or transplant of tissue. In such cases, the heads of relevant agencies shall comply with such request unless justifiable grounds exist to the contrary.

<Amended by Act No. 8852, Feb. 29, 2008>

Article 30 (Hearings)

When the Minister of Health, Welfare and Family Affairs intends to revoke authorization for a tissue bank under Article 25, he/she shall hold a hearing.

<Amended by Act No. 8852, Feb. 29, 2008>

Article 31 (Responsibility for Costs)

(1) A person who receives tissue transplant shall bear the costs of recovery and transplant of tissue: Provided, that the payment of such costs shall be
made as prescribed by other Acts and subordinate statutes if such other Acts and subordinates statutes expressly provide otherwise.
(2) Computation of costs under paragraph (1) shall be made under the National
Health Insurance Act: Provided, That computation of costs not provided for
in the National Health Insurance Act shall be made as prescribed by Ordinance
of the Ministry of Health, Welfare and Family Affairs. <Amended by Act No.

8852, Feb. 29, 2008>

CHAPTER Ⅴ PENAL PROVISIONS

Article 32 (Penal Provision)

A person who distributes tissue falling under any subparagraph of Article
9 for transplantation into another person or who transplants such tissue, in violation of Article 9, shall be punished by imprisonment for life or
imprisonment for not less than two years.

Article 33 (Penal Provisions)

(1) A person who gives, receives, or promises to give or receive money, etc. and violates Article 5 (1) 1 or 3 shall be punished by imprisonment for not
more than seven years.
(2) A person who gives, receives, or promises to give or receive money, etc.

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SAFETY, MANAGEMENT, ETC. OF HUMAN TISSUE ACT

and violates Article 5 (1) 2 shall be punished by imprisonment for not more
than five years or by a fine not exceeding 30 million won, or may be punished by both such fine and imprisonment.
(3) Any money, financial gain, or other consideration exchanged in violation of paragraph (1) or (2) shall be confiscated: Provided, That, in cases where
such confiscation is not feasible, an amount equivalent to the value thereof shall be collected.

Article 34 (Penal Provisions)

A person falling under any of the following subparagraphs shall be punished by imprisonment for not more than two years or a fine not exceeding 10 million
won:
1. A person who manages or transplants tissue in violation of Article
5 (2);
2. A person who establishes a tissue bank without authorization, in violation of Article 13;
3. A person who conveys information relating to tissue donors or recovered
tissue in violation of Article 22.

Article 35 (Concurrent Imposition of Suspension)

Where a person who violates this Act is punished by imprisonment for a limited term, he/she may also be punished by suspension of qualification for not
more than 10 years.

Article 36 (Joint Penal Provision)

Where a representative of a corporation, or an agent, employee or other servant of a corporation or an individual violates Article 33 (2) or 34, in addition
to the punishment of such person, the corporation or the individual shall be punished by a fine under each relevant provision.

Article 37 (Fines for Negligence)

(1) A person who falls under any of the following subparagraphs shall be punished by a fine for negligence not exceeding five million won:
1. A person who fails to confirm consent or fails to give full explanation, in violation of Article 16 (1);
2. A person who recovers tissue in violation of the main sentence of Article
18.
(2) A person who falls under any of the following subparagraphs shall be
punished by a fine for negligence not exceeding three million won:
1. A person who fails to keep records or fails to report, in violation of

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제35편 의사․약사 인체조직안전 및 관리 등에 관한 법률

Article 19;
2. A person who fails to maintain records, in violation of Article 20;
3. A person who fails to comply with a request for perusal of records
or issuance of copies, in violation of the main sentence of Article 21;
4. A person who fails to comply with an order under Article 23 (1);
5. A person who fails to comply with an order under Article 24;
6. A person who fails to report or fails to transfer data, in violation of
Article 26.
Article 38 (Imposition of Fines for Negligence and Collection Procedure) (1) The Minister of Health, Welfare and Family Affairs, the head of a subordinate agency, the Special Metropolitan City Mayor, the Metropolitan City Mayor, the DoGovernor, or the head of a Si/Gun/Gu(hereinafter referred to as “imposing authority”) may impose and collect fines for negligence under Article 37, as prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008> (2) A person who is dissatisfied with a fine for negligence under paragraph (1) may raise an objection to the imposing authority within 30 days after the notice of fine.
(3) Where a person who has been punished by a fine for negligence under paragraph (1) raises an objection under paragraph (2), the imposing authority shall immediately notify the competent court of such fact; and the competent court in receipt of such notice shall proceed to a trial on the fine for negligence under the Non-Contentious Case Litigation Procedure Act.
(4) When a person fails to raise an objection or to pay the fine for negligence within the period under paragraph (2), the fine for negligence shall be collected in accordance with the practices of dispositions of default on national or local taxes.

ADDENDA

(1) (Enforcement Date) This Act shall enter into force on January 1, 2005. (2) (Preparation for Organization of Human Tissue Safety and Management Advisory Committee) The Minister of Health, Welfare and Family Affairs may carry out necessary duties for the purpose of organizing the Human Tissue Safety and Management Advisory Committee under Article 6 before the Act enters into force.
(3) (Preparation for Establishment of and Authorization for Tissue Bank) The

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SAFETY, MANAGEMENT, ETC. OF HUMAN TISSUE ACT

Minister of Health, Welfare and Family Affairs and the heads of tissue banks
may carry out duties necessary for the establishment and authorization of tissue banks under Article 13 before the Act enters into force.

ADDENDUM <Act No. 7375, Jan. 27, 2005>

This Act shall enter into force on the date of its promulgation.

ADDENDA <Act No. 8852, Feb. 29, 2008>

Article 1 (Enforcement Date)

This Act shall enter into force on the date of its promulgation. (Proviso
Omitted.)

Articles 2 through 7 Omitted.

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