HUMAN TISSUES AND CELLS TRANSPLANTATION LAW
(Official Gazette of the Republika Srpska No. 14/10)
AND BASIC PROVISIONS
Article 1.
This Law governs transplantation of human tissues and cells (hereinafter referred to as: transplantation), principles
transplantation, organization of performing professional medical tasks in the field of transplantation, procedure
transplants, taking human tissues and cells from a living donor, taking human tissues and cells from
the deceased donor, the establishment and organization of the Biological Material Bank and the Stem Cell Bank (hereinafter referred to as "the donor")
(Bank), as well as other transplant issues.
Article 2
(1) Transplantation shall be carried out only in the manner and under the conditions prescribed by this Law.
(2) The provisions of this Law shall not apply to industrial products obtained from human tissues and cells,
intended for administration to humans, autologous transplants in the same surgical procedure, to human tissues, and
cells taken for scientific research purposes, reproductive cells, human organs and parts of human organs, and on
blood and blood components.
Article 3
Some terms used in this law have the following meaning:
a) transplantation is a medical procedure of taking human tissues and cells from a living or dead face and incorporating it into the body
of another person, including all procedures for donating, taking, processing, testing, preserving, insulating,
the storage, distribution, incorporation and monitoring of serious adverse events and serious adverse reactions,
b) cells are single human cells or sets of human cells unconnected by connective tissue,
v) tissue is an integral part of the human body made up of cells,
g) the donor is a living or deceased person who gives, or from whose body human tissue and cells are taken for implantation in
the recipient body,
d) the recipient is a living person who is implanted with human tissue and donor cells,
e) donation is the donation of human tissues and cells free of charge, from a living or deceased person for incorporation into another person's body
for the purpose of healing,
e) The taking of human tissues and cells is a medical procedure by which it is removed from the body
living or deceased person comes to human tissues and cells for incorporation into another person's body,
g) processing is any operation performed during preparation, handling, preservation and packaging
human tissues and cells intended for healing purposes,
z) testing is the process of typing human tissues and recipient cells and conducting tests for determination
the matching of human tissues and cells of donor and recipient, which are performed before transplantation,
i) preservation is the use of chemical agents, altered environmental conditions or other means of processing, how
to prevent or slow down the biological or physical degradation of human tissues and cells,
j) Isolation or quarantine is the medical process of separating human tissues and cells physically or otherwise
a way of awaiting a decision on their acceptance or rejection,
k) storage is the preservation of human tissues and cells under appropriate controlled conditions until distribution,
l) distribution means the transport and delivery of human tissues and cells from the place where they are taken to the place where they are implanted
directly or indirectly through the Bank,
lj) implantation is a medical procedure of transferring taken human tissues and cells of one person into the body of another
faces,
m) serious adverse event is any unexpected occurrence related to a transplant that may lead to
transmission of infectious diseases, death or endangerment of life and occurrence of disability, or extension of disease or
hospitalization of the recipient,
n) a serious adverse reaction is an unexpected response in connection with a transplant, which may lead to
infectious disease, death or endangerment of the life of the donor or recipient, as well as the occurrence of disability or extension
diseases or hospitalizations thereof,
nj) The bank referred to in Article 1 of this Law is a type of health care institution where processing operations are performed,
testing, preservation, isolation or quarantine, storage or storage and distribution of human tissues; and
cell,
o) quality system is the process of determining responsibilities, procedures, processes and management tools
quality and includes all activities that contribute to quality,
p) standard operating procedures are written instructions that describe the steps in a particular process
including the materials and methods used, as well as the expected outcome,
r) validation is the production of documented evidence that, with a high degree of certainty, provides assurances that
a particular process, standard operating procedures, equipment, or environment consistently delivers a product that satisfies
predefined specifications and quality features, with the process being validated to evaluate
the performance of the system in terms of its effectiveness for the intended purpose,
s) traceability is the ability to identify donors and recipients of human tissues and cells and locate them at each stage of
donation to implantation, or rejection of human tissues and cells that are implanted, as well as the ability to locate all
relevant data relating to products and materials that come in contact with human tissues and cells,
t) a family member is a spouse or spouse, relatives in a straight line, regardless of the degree of kinship,
in a sloping line to the second degree of kinship, adopter, adopter and guardian i
Ć) promotion of transplantation is the continuous provision of information to citizens on opportunities and conditions
for donation of human tissues and cells, so that citizens for life decide to become donors, or how
to introduce to their family members and legal representatives their desire to be human tissue and cell donors,
as well as providing the necessary information to healthcare professionals.
Article 4
The grammatical terminology of using masculine or feminine gender in the text of the law implies the inclusion of both
Stork.
II TRANSPLANTATION PRINCIPLES
Article 5
The principle of transplantation availability is achieved in such a way as to provide equal opportunity for transplantation
transplantation to all recipients for whom this is the only treatment, with due regard for medical justification and in accordance with
medical standards.
Article 6
The principle of medical justification for transplantation is achieved if it is the most appropriate treatment, in accordance with
the rules of the medical profession if the transplantation does not lead to an unacceptable risk to the life of the donor and recipient; and
if all have been done previously
medical tests that can predict the safety of the donor and the recipient, as well as the success
interventions.
Article 7
The safety principle is achieved by performing the transplant procedure in accordance with a professional one
medical science standards, standardized operating procedures, and ethical principles.
Article 8
The principle of non - discrimination is achieved by prohibiting all forms of discrimination when performing actions on
the basis of this law and regulations made thereunder.
Article 9
The principle of protection of the identity, interests and dignity of the donor and recipient is established in the transplant process, in the manner
which ensures and guarantees their respect
III ORGANIZATION OF PROFESSIONAL MEDICAL OPERATIONS IN THE FIELD OF TRANSPLANTATION
Article 10
(1) Transplantation may be performed in health institutions that meet the requirements in terms of space, personnel and equipment
for transplant business.
(2) The taking of human tissues and cells may also be carried out in a non-implantable health institution that fulfills
conditions regarding space, personnel and equipment for performing human tissue and cell collection activities.
(3) The Minister of Health and Social Welfare (hereinafter: the Minister), on the basis of the conditions laid down in para.
1 and 2 of this Article shall issue a decision for performing the transplantation activity as well as for performing it
human tissue and cell collection activities, at the proposal of the Transplantation Coordination Center (hereinafter:
Coordination Center).
(4) The decision referred to in paragraph 3 of this Article shall be subject to revision after the expiration of a period of four years from its adoption.
(5) The decision of the Minister referred to in paragraph 4 of this Article is final and an administrative dispute may be instituted against it.
(6) The costs of the procedure for determining the eligibility for transplantation, as well as the taking of human tissues and cells
they are borne by health institutions and they represent the revenue of the Republika Srpska budget.
(7) The amount of the costs of the procedure referred to in paragraph 6 of this Article shall be determined by a decision of the Minister.
(8) The Minister shall prescribe in an ordinance the conditions referred to in para. 1 and 2 of this Article.
Article 11
(1) Performing transplantation as well as taking human tissues and cells referred to in Article 10, para.
1 and 2 of this Law, shall terminate if the health institution ceases to meet the prescribed conditions for
performing approved activity.
(2) The Minister shall issue a decision on the termination of the activities referred to in paragraph 1 of this Article.
(3) The decision of the Minister referred to in paragraph 2 of this Article is final and an administrative dispute may be instituted against it.
Article 12
(1) The health institution that performs the transplant procedure, as well as the health institution that performs the taking
of human tissues and cells, is obliged to monitor serious adverse reactions as well as serious adverse events in
the donor or recipient and to notify the Coordination Center of suspicion thereof without delay.
(2) The health care institution referred to in paragraph 1 of this Article must keep a record of serious adverse reactions and serious
adverse events for each donor or recipient of human tissues and cells.
(3) Based on the records referred to in paragraph 1 of this Article, the health institution shall be obliged to, at the end of the calendar year
Provide the coordination center with an analysis of data on serious adverse reactions and serious adverse events for
certain types of human tissues and cells that have been transplanted, proposing measures to prevent them.
(4) The healthcare institution referred to in paragraph 1 of this Article shall ensure the traceability of human tissues and cells
who are transplanted.
Article 13
(1) Performing professional-medical and organizational adjustments, directing work and activities in the field of transplantation
performed by the Coordination Center.
(2) The coordination center is a part of the fourth level hospital with headquarters in Banja Luka.
Article 14
(1) The Coordination Center shall perform the tasks of collecting, processing and exchanging data relevant for transplantation with
to all healthcare institutions involved in transplantation in the environment and relevant international organizations.
(2) In addition to the tasks referred to in paragraph 1 of this Article, the Coordination Center shall also perform the following tasks:
a) adopt and organize the Transplant Program in the Republika Srpska (hereinafter: the Republic),
b) provides uninterrupted work of his service, 24 hours a day, 7 days a week, v) maintains a database of recipients
human tissues and cells,
g) maintains a database of persons who oppose the donation of human tissues and cells after death,
d) maintains a Unified Register of Human Tissue and Cell Providers, who have given written consent to be taken
human tissues and cells in the event of their death, for incorporation into the body of another person for healing,
f) keep a Single Register of Banks, in which the activity and responsible person are entered,
e) Ensures that the donor information is transmitted to the transplant teams; g) prepares a single List
waiting lists (hereinafter referred to as waiting lists) for
transplantation in urgent order according to clinical indications, and deliver it in a timely manner to healthcare institutions which
dealing with picking up or embedding,
z) propose health facilities where human tissues and cells are taken and a hospital coordinator;
i) control and harmonize transplant programs with international standards,
j) promote transplantation,
k) inform the public and the medical profession about the donation of human tissues and cells and stem cells; and
the results of the transplant program,
l) Coordinate and organize the distribution of human tissues and cells to the health care facilities they perform
and transplantation to Banks through a fourth level hospital based in Banja Luka and
lj) submit an annual report to the Minister on the performance of his / her duties and the results of the program
transplants, serious adverse reactions and serious adverse events of human tissues and cells that are
transplanted, with the proposal of measures to prevent them, through a fourth-level hospital based in Banja Luka.
(3) The Minister shall prescribe in an ordinance:
a) the manner and procedure of work of hospital transplant coordinators; and b) the manner and procedure of maintaining the Unified Register
donors.
Article 15
The Coordination Center, through a fourth level hospital based in Banja Luka, proposes that the Minister should join
Republics to international organizations for transplantation and conclusion of agreements with foreign legal entities and
organization, for the exchange of human tissues and cells taken.
IV TRANSPLANTATION PROCEDURE
Article 16
The donation process for human tissues and cells is voluntary.
Article 17
(1) In order to ensure the accessibility of human tissues and cells and the fairness of the transplantation procedure,
Waiting list, for recipients of human tissues and cells in the Republic.
(2) The waiting list referred to in paragraph 1 of this Article, by the type of human tissues and cells required, shall be drawn up and maintained by the Coordination Committee.
center.
(3) The Minister shall prescribe in an ordinance the manner and procedure for drawing up and maintaining the Waiting List.
Article 18
(1) For human tissues and cells taken, no compensation or acquisition of any kind shall be allowed.
other benefits.
(2) The prohibition referred to in paragraph 1 of this Article shall not apply to the remuneration and payment of medical and technical services in connection with
transplantation and reimbursement for travel expenses related to the donation of human tissues and cells.
(3) The donor is entitled to free healthcare in connection with the donation of human tissues and cells, as well as
treatment of possible consequences of which it is the cause.
Article 19
For healthcare related to the transplant procedure, for the purpose of treatment, as well as for health monitoring
pre- and post-transplant conditions, funds are provided in accordance with health regulations
insurance.
Article 20
It is prohibited to advertise or supply human tissue and cell needs.
Article 21
Trafficking in human tissues and cells is prohibited.
Article 22
(1) Information on the donor and recipient of human tissues and cells is protected and is an official and professional secret.
(2) Information about the donor cannot be communicated to the recipient, and information about the recipient cannot be communicated to family members
of the deceased donor.
(3) In order to protect personal data and prevent unauthorized use, certain personal data must be provided
replace with the identification code that the sender or recipient receives when registering and entering data into
a unique database, maintained at the Coordination Center.
(4) The protection of personal data of the donor and the recipient shall be exercised in accordance with the regulation governing the protection of personal data.
Article 23
Information on the donor and the recipient, ie all medical and other documentation on transplantation and mediation in
transplantation is kept for 30 years in a healthcare facility that has taken or implanted human tissues and
cells and shall be destroyed within one year from the expiry of the said period.
Article 24
(1) The healthcare provider involved in the transplant procedure must complete all tests and procedures necessary for success
procedure.
(2) The Minister shall prescribe by an ordinance the criteria for testing donors for transmissible diseases
by transplantation.
Article 25
(1) The implantation of human tissues and cells may be performed only with the written consent of the recipient, or both
parents or guardians, if the recipient is a minor or a person deprived of legal capacity.
(2) The consent referred to in paragraph 1 of this Article must be an expression of free will arising after a complete explanation of
the nature and purpose of this treatment, the likelihood of its success, its consequences and risk, as well as others
treatment options
Article 26
The recipient and the living donor of human tissues and cells must be provided with appropriate medical attention
monitoring of post-transplant health, in accordance with the standards of the medical profession.
V TAKING HUMAN TISSUES AND CELLS FROM A LIVE GIVER
Article 27
The taking of human tissues and cells from a living donor is done unless there are adequate human ones
tissues and cells from the deceased donor, and there is a finding by a doctor of medicine that indicates that there will be an improvement in health
the condition of the recipient, applying such treatment.
Article 28
(1) In the process of taking human tissues and cells from a living donor, his consent must be obtained in writing, which
is an expression of free will.
(2) The written consent of the donor referred to in paragraph 1 of this Article shall refer to the planned medical one
intervention, that is, taking certain human tissues and cells.
(3) A living donor may require that the transplantation of human tissues and cells be performed to a specific recipient.
(4) The written consent referred to in paragraph 1 of this Article shall be kept in the health institution, as a medical document in the
in accordance with the law.
(5) The health institution referred to in paragraph 4 of this Article shall submit a copy of the written consent to the Coordination
center.
Article 29
(1) The taking of human tissues and cells cannot be carried out by a living juvenile or adult donor who
is devoid of legal capacity.
(2) By way of derogation from paragraph 1 of this Article, from the umbilical cord of an infant may be, for personal, related and unrelated
transplant, take and store stem cells, with the written consent of the parents.
(3) The Minister shall prescribe in an ordinance the manner and procedure for taking blood from the umbilical cord of an infant for separation
stem cells, and the conditions of storage or storage and distribution of stem cells.
Article 30
(1) A living donor may be a relative of the recipient in a straight line, regardless of the degree of kinship, as well as a sibling
with the second degree of kinship.
(2) By way of derogation from paragraph 1 of this Article, a living donor may be a spouse or extramarital partner,
adopter, adopter and guardian.
Article 31
(1) The taking of human tissues and cells from a living donor requires the approval of the Ethics Committee established in
the health institution where the transplantation is performed, in accordance with the law.
(2) The Ethics Committee shall approve on the basis of an insight into the medical records of the living donor or recipient of human
tissues and cells after obtaining the written consent of the living donor as well as the written consent of the recipient
human tissues and cells, which are given in accordance with this law.
Article 32
(1) Prior to taking human tissues and cells from a living donor, a medical doctor who performs human taking
tissues and cells must perform appropriate medical tests to assess the health risks of the living donor and
take action to reduce it.
(2) The effects of taking human tissues and cells on the health of a living donor must not be disproportionate to the
the expected improvement in the recipient's health.
Article 33
(1) A doctor of medicine who performs the taking of human tissues and cells is obliged to instruct the living donor of the purpose
and the need to take it, as well as the possible consequences and risk of transplantation.
(2) The lesson referred to in paragraph 1 of this Article shall not be suggestive or in any way affect the decision.
a living donor, giving consent to take human tissues and cells.
(3) A living donor of human tissues and cells has the right to an expert opinion from a healthcare professional with
the required experience in the field of transplantation, which does not participate in the uptake or implantation of human tissues and cells.
Article 34
(1) The written consent referred to in Article 28 of this Law may be withdrawn by the living donor at any time until the commencement of the taking of human
tissues and cells.
(2) The consent shall be withdrawn in writing and a copy thereof shall be submitted to the Coordination
center.
VI TAKING HUMAN TISSUES AND CELLS FROM THE DEAD GIVER
Article 35
The removal of human tissues and cells from a deceased donor may be performed after, based on medical criteria,
in the manner and according to the procedure prescribed by this Law, the brain death of the same was determined.
Article 36
(1) The intensive care unit of the third- and fourth-level hospitals must determine brain death
in a person in deep coma who does not have spontaneous breathing, and there is a clearly proven cause that can explain this condition.
(2) The institution referred to in paragraph 1 of this Article must immediately report suspected brain death to the Coordination Center.
Article 37
(1) The brain death referred to in Article 36, paragraph 1 of this Law shall be determined by a committee composed of at least three doctors
medicine, appointed by the director of the health care facility.
(2) A record on the determined brain death shall be drawn up and signed by all members of the commission
medical record and kept in accordance with applicable regulations.
(3) Doctor of medicine who is involved in the transplantation procedure from a deceased person or is responsible for the care of a possible
the recipient may not participate in the work of the commission referred to in paragraph 1 of this Article.
(4) The Minister shall prescribe in an ordinance the manner and medical criteria for determining brain death.
Article 38
(1) In the process of taking human tissues and cells from a deceased person who did not give his written consent for life, but
he did not explicitly object to this, the consent of an adult family member is obtained.
(2) The adult member of the family shall be informed of the intended taking of human tissues and cells and his written record shall be taken
consent.
(3) Unless there is the written consent of an adult family member, the proceedings may not be initiated
uptake of human tissues and cells.
Article 39
(1) The taking of human tissues and cells from a deceased person for the purpose of transplantation for the purpose of treatment may be carried out
on the basis of written and given written consent for the life of the donor and with the consent of the family.
(2) The written consent referred to in paragraph 1 of this Article shall be given before the authorized person of the Coordination
of the center, appointed by the director of the fourth level hospital based in Banja Luka and before an authorized person in the health center
institution of the third level, appointed by the director.
(3) On the basis of written and given written consent, the Coordination Center or health institution referred to in paragraph
2 of this Article, issues to the potential donor a donor card in which the consent is recorded.
Article 40
Written statement on non-donation of human tissues and cells to an adult capable of reasoning gives to the elect
doctor of medicine at the primary level of health care, which must be recorded in the medical record and immediately
submits to the Coordination Center.
Article 41
Taking human tissues and cells from a deceased minor donor and adult donor may be
only if both the parent or his legal representative or guardian gives written consent.
Article 42
(1) The taking of human tissues and cells from dead fetuses may be carried out provided that the mother has given written consent and that
there is consent from the Ethics Committee.
(2) A doctor of medicine, a specialist in gynecology and obstetrics who performed a termination of pregnancy, may not participate in
implantation of human tissues and cells resulting from termination of pregnancy, or in any way related to and
interested in transplantation.
Article 43
From a deceased person who is not a citizen of Bosnia and Herzegovina and the Republic, or who does not have a permanent residence in the Republic
and which has not given written consent under this law, human tissues and cells may be taken for the sake of
implantation to another person for the purpose of treatment, only with the written consent of a family member.
Article 44
An authorized healthcare professional can begin the process of taking human tissues and cells from a deceased person if:
a) have at his disposal evidence of the written consent of the deceased person, or a donor card,
b) in conversation with a family member, verify that the deceased person has not changed his or her consent to donate for life
tissues and cells,
v) received the written consent of a family member and
g) obtain information on the records of the deceased person in the Unified Register of Donors.
Article 45
The taking of human tissues and cells, if the circumstances surrounding the death of which are due to an autopsy, may be performed
only upon the permission of the pre-trial judge.
Article 46
When taking human tissues and cells, all participants in this procedure are required to treat the body of the deceased donor with
respect and take all necessary measures to restore the appearance of the deceased.
Article 47
If the authorized health institution referred to in Article 10 of this Law determines that for human tissues and cells of a deceased donor,
on the basis of blood type and tissue matching, there is no diseased person in the territory of the Republic to whom they can be implanted
human tissues and cells, the same may be offered to an international transplant organization of which
The Republic of Bosnia and Herzegovina is a member or health institution with which the exchange agreement is concluded
of human tissues and cells for the purpose of treatment, on the principle of reciprocity.
VII ESTABLISHMENT AND ORGANIZATION OF THE BANK
Article 48
The activity of processing, testing, preserving or insulating, storing or storing and distributing human
tissues and cells, performed by the Bank.
Article 49
The Bank shall be established, organized and ceased to operate in accordance with the law governing the field of health
protection and this law.
Article 50
(1) The Bank shall keep a record of all the activities in its business that provide information on types and
quantities of human tissues and cells that have been treated, tested, preserved, isolated,
stored, distributed or otherwise disposed of, as well as the origin and destination of human tissues and cells
intended for use in humans.
(2) The Bank shall submit to the Coordination Center, at least once a year, a report on the operations referred to in paragraph
1 of this Article.
(3) The Minister shall prescribe by an ordinance the procedure and manner of keeping records.
Article 51
practices.
(1) The bank shall establish and update a quality system based on the principles of good
(2) In managing the quality system, the Bank shall provide at least the following
documentation:
a) standard operating procedures, b) guidelines,
v) training manual and reference manual, g) reporting form,
d) records of the donor,
f) information on the final destination of human tissues and cells; and
e) other data for the provision and management of the quality system.
(3) In order to ensure the quality and traceability system, the Bank is obliged to keep the data within the period prescribed by this Law.
Article 52
(1) Human tissues and cells must be identified by a special label containing information on the collection procedure
human tissues and cells and their registration with the Bank, as well as data on processing, testing, canning, isolation,
storage and distribution thereof.
(2) The bank shall assign a unique identification code to donated human tissues and cells in order to
made possible by proper donor identification and traceability of donated human tissues and cells for delivery
information on the most important properties and properties of human tissues and cells.
(3) The unique identification code referred to in paragraph 2 of this Article must be harmonized with the country code system
Of the European Union for the field of human tissues and cells and shall contain at least the following information:
a) the identification of the donation with the Bank's unique identification number and identification; and
b) product identification with product code (basic nomenclature), lot subset number (if
applies) and expiry date.
Article 53
(1) The Bank shall appoint a responsible person who fulfills the following conditions:
a) a medical college with a relevant specialization or another college where they are admitted
knowledge in the field of medicine or biology with appropriate specializations in the field of human tissues and cells
i
b) at least two years of experience in the field of work with human tissues and cells.
(2) The responsible person referred to in paragraph 1 of this Article shall:
a) ensure that human tissues and cells intended for transplantation are treated, tested, preserved, isolated,
warehouse or store and distribute in accordance with this Law,
b) collects, analyzes and delivers information on serious adverse reactions and serious adverse events,
The Coordination Center,
v) performs tasks related to the evaluation and selection of providers in accordance with this Law;
g) supervise and train the Bank's employees in the processing, testing, canning, isolation,
the storage or storage and distribution of human tissues and cells,
d) ensure the implementation of agreements between the Bank and third parties in accordance with this Law; and
f) perform other tasks in accordance with this Law.
Article 54
Persons employed by the Bank engaged in processing, testing, canning, insulation,
by storing or storing and distributing human tissues and cells, they must have appropriate education, with
with additional transplant training.
Article 55
(1) The bank shall carry out laboratory testing of donated human tissues and cells and stem cells.
(2) The Bank shall confirm and record the fact that the packaging of donated tissue and cells and stem cells is in accordance with
donation process, into the same.
(3) All human tissues and cells that do not comply with the requirements of paragraph 1 of this Article shall be rejected by the Bank.
(4) The Bank shall keep records on the acceptance or rejection of human tissues and cells.
(5) Human tissues and cells shall be kept in the Bank in isolation until all conditions for their incorporation have been fulfilled.
Article 56
(1) The bank shall have standard operating procedures for each process of human tissue and cell processing,
which ensures their quality and safety.
(2) The bank shall ensure that all human tissue and cell processing operations are performed in a controlled manner.
conditions.
(3) For any change in the process of processing human tissues and cells referred to in paragraph 1 of this Article, the Bank shall have standard
operating procedures to ensure the quality and safety of human tissues and cells.
(4) The standard operating procedures referred to in para. 1 and 2 of this Article refer to the processing of human tissues and
cells, validation and control of equipment, space and work processes, as well as the handling of discarded human tissues
and cells, to prevent contamination of other human tissues and cells, processing equipment, or employees
faces.
(5) The Minister shall prescribe in an ordinance the manner, procedure and conditions for the treatment of human tissues and
cell.
Article 57
(1) The Bank shall be obliged to ensure that all procedures related to the storage or preservation of human tissues and
cells shall be documented and performed in accordance with standard operating procedures.
(2) The Bank shall ensure that all storage or safekeeping operations are carried out under controlled conditions.
(3) The bank is obliged to apply all procedures of control of packaging and storage facilities in order to
prevent phenomena that may adversely affect the functioning or integrity and quality of human tissues and
cell.
(4) The treated human tissues and cells shall not be distributed until the conditions prescribed by this Law are fulfilled.
(5) In the event of termination of the Bank for any reason, it shall be stored
transfer human tissues and cells to another Bank.
(6) The Minister shall prescribe in an ordinance the manner, procedure and conditions of storage of human tissues and cells
Article 58
(1) The bank is obliged to ensure that the procedure for donating human tissues and cells and receiving them into the same
mark appropriately, as well as appropriate documentation.
(2) The bank shall provide appropriate packaging for human tissues and cells.
(3) The Minister shall prescribe by an ordinance the conditions, manner and procedure for marking, documenting and packaging for
human tissues and cells.
Article 59
(1) The bank shall ensure the quality and safety of human tissues and cells during distribution.
(2) The Minister shall prescribe in an ordinance the conditions, manner and procedure for the distribution of human tissues and cells.
Article 60
(1) The Bank shall be obliged to enter into a written agreement with a third party for the performance of all activities affecting it
the quality and safety of human tissues and cells, which are handled in collaboration with third parties, especially in
in the following cases:
a) The bank entrusts one of the stages in the processing of human tissues and cells to a third party,
b) the third party supplies products or services that affect the quality and safety of human tissues; and
cells, including their distribution,
v) The Bank provides services to another Bank and
g) The bank distributes human tissues and cells processed by a third party.
(2) The bank shall evaluate and select a third party with whom it concludes the agreement referred to in paragraph
1 of this Article on the basis of its ability to satisfy the conditions prescribed by this Law.
(3) The Bank shall keep a list of all agreements referred to in paragraph 1 of this Article.
(4) The agreement referred to in paragraph 1 of this Article shall set out the obligations of the third party and the detailed standard operational ones
procedures.
(5) The Bank shall be obliged to provide the Minister with a copy of the agreement with the third party referred to in paragraph 1 of this Article.
Article 61
When importing and exporting human tissues and cells, the Bank, or its authorized distributor, must
fulfill the conditions prescribed by this law.
Article 62
(1) The Ministry of Health and Social Welfare of the Republic of Srpska shall supervise the implementation of this Law
competent health and sanitary inspection.
(2) In carrying out inspection supervision over the application of this Law, the competent inspector referred to in paragraph 1 of this Article, in addition to the authorization
prescribed by law, is also authorized to:
a) prohibit the transplantation activity if it determines that the transplantation activity is performed and not completed
conditions for its performance, and within the given deadline, the irregularities identified were not eliminated and
b) prohibit the performance of the transplant business if it determines that the activity is performed and the conditions are not fulfilled
for its performance, thereby endangering the lives and health of the people or when it comes to the protection of the public interest.
VIII PENALTY PROVISIONS
Article 63
Whoever, contrary to this law, performs transplantation and taking of human tissues and cells, shall be punished according to the Criminal Code
Law of the Republika Srpska (Official Gazette of the Republika Srpska, Nos. 49/03, 108/04, 37/06 and 70/06).
Article 64
(1) A fine from 20,000 KM to 100,000 KM shall be imposed on a health institution for a misdemeanor if:
a) does not determine the brain death of the person from whom the human tissues and cells were taken (Article 35),
b) does not detect brain death in a person in deep coma who has no spontaneous breathing and has clearly demonstrated
a cause capable of explaining this condition (Article 36) i
c) refuses to record the sole opposition of a person to the donation of human tissues and cells if he does not notify the statement
The Coordination Center or if it does not preserve it or record it properly in the documentation (Article 40).
(2) The responsible person shall also be fined for the misdemeanor referred to in paragraph 1 of this Article, in the amount of KM 2,000 to 10,000 KM.
health institutions.
Article 65
(1) A fine of KM 5,000 to KM 10,000 shall be imposed on a doctor of medicine who has:
a) place the recipient on the waiting list in the opposite order of urgency according to clinical indications and provisions
of this Law (Article 17),
b) perform the transplant without the consent of the recipient or his parent or guardian when the recipient
a minor or a person without legal capacity (Article 25),
v) transplant or perform a transplant, and there is no finding by a medical doctor that they will
to improve the recipient's health from such treatment (Article 27) and
g) fails to provide the donor with a complete explanation of the purpose and need of human tissue and cell collection, as well as the possible consequences, and
transplantation risk (Article 33).
Article 66
(1) A legal person dealing with public shall be fined from 10,000 KM to 50,000 KM.
informing or transmitting news that advertises the offer or need for human tissues and cells (Article
20).
(2) The responsible person in a legal person shall be fined for the offense referred to in paragraph 1 of this Article by a fine of
KM 2,000 to KM 10,000, which deals with public information or news transmission, which announces an offer or
the need for human tissues and cells (Article 20).
XI TRANSITIONAL AND FINAL PROVISIONS
Article 67
The Minister shall, within one year from the day this Law enters into force, issue ordinances on:
a) the conditions of the premises, personnel and equipment, as well as the verification procedure for the health care institution that performs it
transplantation or human tissue and cell collection (Article 10),
b) the manner and procedure of work of the transplant coordinator (Article 14); v) the manner and procedure of keeping the Unified Register
donors (Article 14), g) the manner and procedure of compiling and maintaining the Checklist (Article 17),
d) criteria for testing donors for transplantable diseases (Article 24),
e) the manner and procedure of taking blood from the umbilical cord of a newborn to extract stem cells, and
conditions of storage or storage and distribution of stem cells (Article 29),
e) the manner and medical criteria for determining brain death (Article 37); g) the manner and procedure of record keeping
(Article 50),
z) the manner, procedure and conditions of treatment of human tissues and cells (Article 56),
i) the manner, procedure and conditions of storage of human tissues and cells (Article 57),
j) the manner, procedure and conditions for marking, documenting and packaging human tissues and cells. (Article 58) i
k) the manner, procedure and conditions of distribution of human tissues and cells (Article 59).
Article 68
Until the adoption of the by-laws established by this Law, the Ordinance on working conditions will apply
healthcare organizations that perform the activities of taking, transplanting, processing - typing and keeping parts
the human body (Official Gazette of the SFRY, No. 64/91) and the Ordinance on the Close Medical Criteria,
the manner and procedure for determining the death of a person whose body parts may be taken for transplantation ("Official
SFRY Gazette ", No. 64/91).
Article 69
On the day this Law enters into force, the Law on Conditions for Taking and Transplanting ceases to be valid
parts of the human body (Official Gazette of the SFRY, Nos. 63/90 and 22/91).
Article 70
This Law shall enter into force on the eighth day after its publication in the Official Gazette of the Republika Srpska.
No: 01-105 / 10 THE PRESIDENT
Date: 25 January 2010 NATIONAL ASSEMBLY
Igor Radojicic, MSc