0A4F4F9BD490A749D5437F821CF06DF1
Law on Transplantation of Human Tissues and Cells (2010)
http://www.vladars.net/sr-SP-Cyrl/Vlada/Ministarstva/MZSZ/Documents/Zakon%20o%20transplantaciji%20ljudskih%20tkiva%20i%20celija.pdf
http://leaux.net/URLS/ConvertAPI Text Files/D7B9BDC8FC814BB60D0FC391A598A55B.en.txt
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
Searching for indicator criminal:
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p.(None): procedures.
p.(None): (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.
p.(None): Article 61
p.(None): When importing and exporting human tissues and cells, the Bank, or its authorized distributor, must
p.(None): fulfill the conditions prescribed by this law.
p.(None): Article 62
p.(None): (1) The Ministry of Health and Social Welfare of the Republic of Srpska shall supervise the implementation of this Law
p.(None): competent health and sanitary inspection.
p.(None): (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
p.(None): prescribed by law, is also authorized to:
p.(None): a) prohibit the transplantation activity if it determines that the transplantation activity is performed and not completed
p.(None): conditions for its performance, and within the given deadline, the irregularities identified were not eliminated and
p.(None): b) prohibit the performance of the transplant business if it determines that the activity is performed and the conditions are not fulfilled
p.(None): for its performance, thereby endangering the lives and health of the people or when it comes to the protection of the public interest.
p.(None): VIII PENALTY PROVISIONS
p.(None): Article 63
p.(None): Whoever, contrary to this law, performs transplantation and taking of human tissues and cells, shall be punished according to the Criminal Code
p.(None): Law of the Republika Srpska (Official Gazette of the Republika Srpska, Nos. 49/03, 108/04, 37/06 and 70/06).
p.(None): Article 64
p.(None): (1) A fine from 20,000 KM to 100,000 KM shall be imposed on a health institution for a misdemeanor if:
p.(None): a) does not determine the brain death of the person from whom the human tissues and cells were taken (Article 35),
p.(None): b) does not detect brain death in a person in deep coma who has no spontaneous breathing and has clearly demonstrated
p.(None): a cause capable of explaining this condition (Article 36) i
p.(None): 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
p.(None): The Coordination Center or if it does not preserve it or record it properly in the documentation (Article 40).
p.(None): (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.
p.(None): health institutions.
p.(None): Article 65
p.(None): (1) A fine of KM 5,000 to KM 10,000 shall be imposed on a doctor of medicine who has:
p.(None): a) place the recipient on the waiting list in the opposite order of urgency according to clinical indications and provisions
p.(None): of this Law (Article 17),
p.(None): b) perform the transplant without the consent of the recipient or his parent or guardian when the recipient
p.(None): a minor or a person without legal capacity (Article 25),
p.(None): v) transplant or perform a transplant, and there is no finding by a medical doctor that they will
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Political / political affiliation
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p.(None): (1) The Bank shall be obliged to ensure that all procedures related to the storage or preservation of human tissues and
p.(None): cells shall be documented and performed in accordance with standard operating procedures.
p.(None): (2) The Bank shall ensure that all storage or safekeeping operations are carried out under controlled conditions.
p.(None): (3) The bank is obliged to apply all procedures of control of packaging and storage facilities in order to
p.(None): prevent phenomena that may adversely affect the functioning or integrity and quality of human tissues and
p.(None): cell.
p.(None): (4) The treated human tissues and cells shall not be distributed until the conditions prescribed by this Law are fulfilled.
p.(None): (5) In the event of termination of the Bank for any reason, it shall be stored
p.(None): transfer human tissues and cells to another Bank.
p.(None): (6) The Minister shall prescribe in an ordinance the manner, procedure and conditions of storage of human tissues and cells
p.(None): Article 58
p.(None): (1) The bank is obliged to ensure that the procedure for donating human tissues and cells and receiving them into the same
p.(None): mark appropriately, as well as appropriate documentation.
p.(None): (2) The bank shall provide appropriate packaging for human tissues and cells.
p.(None): (3) The Minister shall prescribe by an ordinance the conditions, manner and procedure for marking, documenting and packaging for
p.(None): human tissues and cells.
p.(None): Article 59
p.(None): (1) The bank shall ensure the quality and safety of human tissues and cells during distribution.
p.(None): (2) The Minister shall prescribe in an ordinance the conditions, manner and procedure for the distribution of human tissues and cells.
p.(None): Article 60
p.(None): (1) The Bank shall be obliged to enter into a written agreement with a third party for the performance of all activities affecting it
p.(None): the quality and safety of human tissues and cells, which are handled in collaboration with third parties, especially in
p.(None): in the following cases:
p.(None): a) The bank entrusts one of the stages in the processing of human tissues and cells to a third party,
p.(None): b) the third party supplies products or services that affect the quality and safety of human tissues; and
p.(None): cells, including their distribution,
p.(None): v) The Bank provides services to another Bank and
p.(None): g) The bank distributes human tissues and cells processed by a third party.
p.(None): (2) The bank shall evaluate and select a third party with whom it concludes the agreement referred to in paragraph
p.(None): 1 of this Article on the basis of its ability to satisfy the conditions prescribed by this Law.
p.(None): (3) The Bank shall keep a list of all agreements referred to in paragraph 1 of this Article.
p.(None): (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
p.(None): procedures.
p.(None): (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.
p.(None): Article 61
p.(None): When importing and exporting human tissues and cells, the Bank, or its authorized distributor, must
p.(None): fulfill the conditions prescribed by this law.
p.(None): Article 62
p.(None): (1) The Ministry of Health and Social Welfare of the Republic of Srpska shall supervise the implementation of this Law
p.(None): competent health and sanitary inspection.
p.(None): (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
p.(None): prescribed by law, is also authorized to:
p.(None): a) prohibit the transplantation activity if it determines that the transplantation activity is performed and not completed
p.(None): conditions for its performance, and within the given deadline, the irregularities identified were not eliminated and
p.(None): b) prohibit the performance of the transplant business if it determines that the activity is performed and the conditions are not fulfilled
p.(None): for its performance, thereby endangering the lives and health of the people or when it comes to the protection of the public interest.
p.(None): VIII PENALTY PROVISIONS
p.(None): Article 63
p.(None): Whoever, contrary to this law, performs transplantation and taking of human tissues and cells, shall be punished according to the Criminal Code
p.(None): Law of the Republika Srpska (Official Gazette of the Republika Srpska, Nos. 49/03, 108/04, 37/06 and 70/06).
p.(None): Article 64
p.(None): (1) A fine from 20,000 KM to 100,000 KM shall be imposed on a health institution for a misdemeanor if:
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Health / Comatose
Searching for indicator coma:
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p.(None): Article 33
p.(None): (1) A doctor of medicine who performs the taking of human tissues and cells is obliged to instruct the living donor of the purpose
p.(None): and the need to take it, as well as the possible consequences and risk of transplantation.
p.(None): (2) The lesson referred to in paragraph 1 of this Article shall not be suggestive or in any way affect the decision.
p.(None): a living donor, giving consent to take human tissues and cells.
p.(None): (3) A living donor of human tissues and cells has the right to an expert opinion from a healthcare professional with
p.(None): the required experience in the field of transplantation, which does not participate in the uptake or implantation of human tissues and cells.
p.(None): Article 34
p.(None): (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
p.(None): tissues and cells.
p.(None): (2) The consent shall be withdrawn in writing and a copy thereof shall be submitted to the Coordination
p.(None): center.
p.(None): VI TAKING HUMAN TISSUES AND CELLS FROM THE DEAD GIVER
p.(None): Article 35
p.(None): The removal of human tissues and cells from a deceased donor may be performed after, based on medical criteria,
p.(None): in the manner and according to the procedure prescribed by this Law, the brain death of the same was determined.
p.(None): Article 36
p.(None): (1) The intensive care unit of the third- and fourth-level hospitals must determine brain death
p.(None): in a person in deep coma who does not have spontaneous breathing, and there is a clearly proven cause that can explain this condition.
p.(None): (2) The institution referred to in paragraph 1 of this Article must immediately report suspected brain death to the Coordination Center.
p.(None): Article 37
p.(None): (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
p.(None): medicine, appointed by the director of the health care facility.
p.(None): (2) A record on the determined brain death shall be drawn up and signed by all members of the commission
p.(None): medical record and kept in accordance with applicable regulations.
p.(None): (3) Doctor of medicine who is involved in the transplantation procedure from a deceased person or is responsible for the care of a possible
p.(None): the recipient may not participate in the work of the commission referred to in paragraph 1 of this Article.
p.(None): (4) The Minister shall prescribe in an ordinance the manner and medical criteria for determining brain death.
p.(None): Article 38
p.(None): (1) In the process of taking human tissues and cells from a deceased person who did not give his written consent for life, but
p.(None): he did not explicitly object to this, the consent of an adult family member is obtained.
p.(None): (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
p.(None): consent.
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p.(None): fulfill the conditions prescribed by this law.
p.(None): Article 62
p.(None): (1) The Ministry of Health and Social Welfare of the Republic of Srpska shall supervise the implementation of this Law
p.(None): competent health and sanitary inspection.
p.(None): (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
p.(None): prescribed by law, is also authorized to:
p.(None): a) prohibit the transplantation activity if it determines that the transplantation activity is performed and not completed
p.(None): conditions for its performance, and within the given deadline, the irregularities identified were not eliminated and
p.(None): b) prohibit the performance of the transplant business if it determines that the activity is performed and the conditions are not fulfilled
p.(None): for its performance, thereby endangering the lives and health of the people or when it comes to the protection of the public interest.
p.(None): VIII PENALTY PROVISIONS
p.(None): Article 63
p.(None): Whoever, contrary to this law, performs transplantation and taking of human tissues and cells, shall be punished according to the Criminal Code
p.(None): Law of the Republika Srpska (Official Gazette of the Republika Srpska, Nos. 49/03, 108/04, 37/06 and 70/06).
p.(None): Article 64
p.(None): (1) A fine from 20,000 KM to 100,000 KM shall be imposed on a health institution for a misdemeanor if:
p.(None): a) does not determine the brain death of the person from whom the human tissues and cells were taken (Article 35),
p.(None): b) does not detect brain death in a person in deep coma who has no spontaneous breathing and has clearly demonstrated
p.(None): a cause capable of explaining this condition (Article 36) i
p.(None): 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
p.(None): The Coordination Center or if it does not preserve it or record it properly in the documentation (Article 40).
p.(None): (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.
p.(None): health institutions.
p.(None): Article 65
p.(None): (1) A fine of KM 5,000 to KM 10,000 shall be imposed on a doctor of medicine who has:
p.(None): a) place the recipient on the waiting list in the opposite order of urgency according to clinical indications and provisions
p.(None): of this Law (Article 17),
p.(None): b) perform the transplant without the consent of the recipient or his parent or guardian when the recipient
p.(None): a minor or a person without legal capacity (Article 25),
p.(None): v) transplant or perform a transplant, and there is no finding by a medical doctor that they will
p.(None): to improve the recipient's health from such treatment (Article 27) and
p.(None): 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
p.(None): transplantation risk (Article 33).
p.(None): Article 66
p.(None): (1) A legal person dealing with public shall be fined from 10,000 KM to 50,000 KM.
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Health / Mentally Disabled
Searching for indicator disability:
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p.(None): for the purpose of healing,
p.(None): e) The taking of human tissues and cells is a medical procedure by which it is removed from the body
p.(None): living or deceased person comes to human tissues and cells for incorporation into another person's body,
p.(None): g) processing is any operation performed during preparation, handling, preservation and packaging
p.(None): human tissues and cells intended for healing purposes,
p.(None): z) testing is the process of typing human tissues and recipient cells and conducting tests for determination
p.(None): the matching of human tissues and cells of donor and recipient, which are performed before transplantation,
p.(None): i) preservation is the use of chemical agents, altered environmental conditions or other means of processing, how
p.(None): to prevent or slow down the biological or physical degradation of human tissues and cells,
p.(None): j) Isolation or quarantine is the medical process of separating human tissues and cells physically or otherwise
p.(None): a way of awaiting a decision on their acceptance or rejection,
p.(None): k) storage is the preservation of human tissues and cells under appropriate controlled conditions until distribution,
p.(None): 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
p.(None): directly or indirectly through the Bank,
p.(None): lj) implantation is a medical procedure of transferring taken human tissues and cells of one person into the body of another
p.(None): faces,
p.(None): m) serious adverse event is any unexpected occurrence related to a transplant that may lead to
p.(None): transmission of infectious diseases, death or endangerment of life and occurrence of disability, or extension of disease or
p.(None): hospitalization of the recipient,
p.(None): n) a serious adverse reaction is an unexpected response in connection with a transplant, which may lead to
p.(None): infectious disease, death or endangerment of the life of the donor or recipient, as well as the occurrence of disability or extension
p.(None): diseases or hospitalizations thereof,
p.(None): nj) The bank referred to in Article 1 of this Law is a type of health care institution where processing operations are performed,
p.(None): testing, preservation, isolation or quarantine, storage or storage and distribution of human tissues; and
p.(None): cell,
p.(None): o) quality system is the process of determining responsibilities, procedures, processes and management tools
p.(None): quality and includes all activities that contribute to quality,
p.(None): p) standard operating procedures are written instructions that describe the steps in a particular process
p.(None): including the materials and methods used, as well as the expected outcome,
p.(None): r) validation is the production of documented evidence that, with a high degree of certainty, provides assurances that
p.(None): a particular process, standard operating procedures, equipment, or environment consistently delivers a product that satisfies
p.(None): predefined specifications and quality features, with the process being validated to evaluate
p.(None): the performance of the system in terms of its effectiveness for the intended purpose,
p.(None): s) traceability is the ability to identify donors and recipients of human tissues and cells and locate them at each stage of
p.(None): donation to implantation, or rejection of human tissues and cells that are implanted, as well as the ability to locate all
p.(None): relevant data relating to products and materials that come in contact with human tissues and cells,
p.(None): t) a family member is a spouse or spouse, relatives in a straight line, regardless of the degree of kinship,
p.(None): in a sloping line to the second degree of kinship, adopter, adopter and guardian i
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Health / Motherhood/Family
Searching for indicator family:
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p.(None): n) a serious adverse reaction is an unexpected response in connection with a transplant, which may lead to
p.(None): infectious disease, death or endangerment of the life of the donor or recipient, as well as the occurrence of disability or extension
p.(None): diseases or hospitalizations thereof,
p.(None): nj) The bank referred to in Article 1 of this Law is a type of health care institution where processing operations are performed,
p.(None): testing, preservation, isolation or quarantine, storage or storage and distribution of human tissues; and
p.(None): cell,
p.(None): o) quality system is the process of determining responsibilities, procedures, processes and management tools
p.(None): quality and includes all activities that contribute to quality,
p.(None): p) standard operating procedures are written instructions that describe the steps in a particular process
p.(None): including the materials and methods used, as well as the expected outcome,
p.(None): r) validation is the production of documented evidence that, with a high degree of certainty, provides assurances that
p.(None): a particular process, standard operating procedures, equipment, or environment consistently delivers a product that satisfies
p.(None): predefined specifications and quality features, with the process being validated to evaluate
p.(None): the performance of the system in terms of its effectiveness for the intended purpose,
p.(None): s) traceability is the ability to identify donors and recipients of human tissues and cells and locate them at each stage of
p.(None): donation to implantation, or rejection of human tissues and cells that are implanted, as well as the ability to locate all
p.(None): relevant data relating to products and materials that come in contact with human tissues and cells,
p.(None): t) a family member is a spouse or spouse, relatives in a straight line, regardless of the degree of kinship,
p.(None): in a sloping line to the second degree of kinship, adopter, adopter and guardian i
p.(None): Ć) promotion of transplantation is the continuous provision of information to citizens on opportunities and conditions
p.(None): for donation of human tissues and cells, so that citizens for life decide to become donors, or how
p.(None): to introduce to their family members and legal representatives their desire to be human tissue and cell donors,
p.(None): as well as providing the necessary information to healthcare professionals.
p.(None): Article 4
p.(None): The grammatical terminology of using masculine or feminine gender in the text of the law implies the inclusion of both
p.(None): Stork.
p.(None): II TRANSPLANTATION PRINCIPLES
p.(None): Article 5
p.(None): The principle of transplantation availability is achieved in such a way as to provide equal opportunity for transplantation
p.(None): transplantation to all recipients for whom this is the only treatment, with due regard for medical justification and in accordance with
p.(None): medical standards.
p.(None): Article 6
p.(None): The principle of medical justification for transplantation is achieved if it is the most appropriate treatment, in accordance with
p.(None): 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
p.(None): if all have been done previously
p.(None): medical tests that can predict the safety of the donor and the recipient, as well as the success
p.(None): interventions.
p.(None): Article 7
p.(None): The safety principle is achieved by performing the transplant procedure in accordance with a professional one
p.(None): medical science standards, standardized operating procedures, and ethical principles.
p.(None): Article 8
p.(None): The principle of non - discrimination is achieved by prohibiting all forms of discrimination when performing actions on
p.(None): the basis of this law and regulations made thereunder.
p.(None): Article 9
...
p.(None): Waiting list, for recipients of human tissues and cells in the Republic.
p.(None): (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.
p.(None): center.
p.(None): (3) The Minister shall prescribe in an ordinance the manner and procedure for drawing up and maintaining the Waiting List.
p.(None): Article 18
p.(None): (1) For human tissues and cells taken, no compensation or acquisition of any kind shall be allowed.
p.(None): other benefits.
p.(None): (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
p.(None): transplantation and reimbursement for travel expenses related to the donation of human tissues and cells.
p.(None): (3) The donor is entitled to free healthcare in connection with the donation of human tissues and cells, as well as
p.(None): treatment of possible consequences of which it is the cause.
p.(None): Article 19
p.(None): For healthcare related to the transplant procedure, for the purpose of treatment, as well as for health monitoring
p.(None): pre- and post-transplant conditions, funds are provided in accordance with health regulations
p.(None): insurance.
p.(None): Article 20
p.(None): It is prohibited to advertise or supply human tissue and cell needs.
p.(None): Article 21
p.(None): Trafficking in human tissues and cells is prohibited.
p.(None): Article 22
p.(None): (1) Information on the donor and recipient of human tissues and cells is protected and is an official and professional secret.
p.(None): (2) Information about the donor cannot be communicated to the recipient, and information about the recipient cannot be communicated to family members
p.(None): of the deceased donor.
p.(None): (3) In order to protect personal data and prevent unauthorized use, certain personal data must be provided
p.(None): replace with the identification code that the sender or recipient receives when registering and entering data into
p.(None): a unique database, maintained at the Coordination Center.
p.(None): (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.
p.(None): Article 23
p.(None): Information on the donor and the recipient, ie all medical and other documentation on transplantation and mediation in
p.(None): transplantation is kept for 30 years in a healthcare facility that has taken or implanted human tissues and
p.(None): cells and shall be destroyed within one year from the expiry of the said period.
p.(None): Article 24
p.(None): (1) The healthcare provider involved in the transplant procedure must complete all tests and procedures necessary for success
p.(None): procedure.
p.(None): (2) The Minister shall prescribe by an ordinance the criteria for testing donors for transmissible diseases
p.(None): by transplantation.
p.(None): Article 25
p.(None): (1) The implantation of human tissues and cells may be performed only with the written consent of the recipient, or both
p.(None): parents or guardians, if the recipient is a minor or a person deprived of legal capacity.
...
p.(None): The removal of human tissues and cells from a deceased donor may be performed after, based on medical criteria,
p.(None): in the manner and according to the procedure prescribed by this Law, the brain death of the same was determined.
p.(None): Article 36
p.(None): (1) The intensive care unit of the third- and fourth-level hospitals must determine brain death
p.(None): in a person in deep coma who does not have spontaneous breathing, and there is a clearly proven cause that can explain this condition.
p.(None): (2) The institution referred to in paragraph 1 of this Article must immediately report suspected brain death to the Coordination Center.
p.(None): Article 37
p.(None): (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
p.(None): medicine, appointed by the director of the health care facility.
p.(None): (2) A record on the determined brain death shall be drawn up and signed by all members of the commission
p.(None): medical record and kept in accordance with applicable regulations.
p.(None): (3) Doctor of medicine who is involved in the transplantation procedure from a deceased person or is responsible for the care of a possible
p.(None): the recipient may not participate in the work of the commission referred to in paragraph 1 of this Article.
p.(None): (4) The Minister shall prescribe in an ordinance the manner and medical criteria for determining brain death.
p.(None): Article 38
p.(None): (1) In the process of taking human tissues and cells from a deceased person who did not give his written consent for life, but
p.(None): he did not explicitly object to this, the consent of an adult family member is obtained.
p.(None): (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
p.(None): consent.
p.(None): (3) Unless there is the written consent of an adult family member, the proceedings may not be initiated
p.(None): uptake of human tissues and cells.
p.(None): Article 39
p.(None): (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
p.(None): on the basis of written and given written consent for the life of the donor and with the consent of the family.
p.(None): (2) The written consent referred to in paragraph 1 of this Article shall be given before the authorized person of the Coordination
p.(None): 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
p.(None): institution of the third level, appointed by the director.
p.(None): (3) On the basis of written and given written consent, the Coordination Center or health institution referred to in paragraph
p.(None): 2 of this Article, issues to the potential donor a donor card in which the consent is recorded.
p.(None): Article 40
p.(None): Written statement on non-donation of human tissues and cells to an adult capable of reasoning gives to the elect
p.(None): doctor of medicine at the primary level of health care, which must be recorded in the medical record and immediately
p.(None): submits to the Coordination Center.
p.(None): Article 41
p.(None): Taking human tissues and cells from a deceased minor donor and adult donor may be
p.(None): only if both the parent or his legal representative or guardian gives written consent.
p.(None): Article 42
p.(None): (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
p.(None): there is consent from the Ethics Committee.
p.(None): (2) A doctor of medicine, a specialist in gynecology and obstetrics who performed a termination of pregnancy, may not participate in
p.(None): implantation of human tissues and cells resulting from termination of pregnancy, or in any way related to and
p.(None): interested in transplantation.
p.(None): Article 43
p.(None): 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
p.(None): and which has not given written consent under this law, human tissues and cells may be taken for the sake of
p.(None): implantation to another person for the purpose of treatment, only with the written consent of a family member.
p.(None): Article 44
p.(None): An authorized healthcare professional can begin the process of taking human tissues and cells from a deceased person if:
p.(None): a) have at his disposal evidence of the written consent of the deceased person, or a donor card,
p.(None): b) in conversation with a family member, verify that the deceased person has not changed his or her consent to donate for life
p.(None): tissues and cells,
p.(None): v) received the written consent of a family member and
p.(None): g) obtain information on the records of the deceased person in the Unified Register of Donors.
p.(None): Article 45
p.(None): The taking of human tissues and cells, if the circumstances surrounding the death of which are due to an autopsy, may be performed
p.(None): only upon the permission of the pre-trial judge.
p.(None): Article 46
p.(None): When taking human tissues and cells, all participants in this procedure are required to treat the body of the deceased donor with
p.(None): respect and take all necessary measures to restore the appearance of the deceased.
p.(None): Article 47
p.(None): If the authorized health institution referred to in Article 10 of this Law determines that for human tissues and cells of a deceased donor,
p.(None): 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
p.(None): human tissues and cells, the same may be offered to an international transplant organization of which
p.(None): The Republic of Bosnia and Herzegovina is a member or health institution with which the exchange agreement is concluded
p.(None): of human tissues and cells for the purpose of treatment, on the principle of reciprocity.
p.(None): VII ESTABLISHMENT AND ORGANIZATION OF THE BANK
p.(None): Article 48
p.(None): The activity of processing, testing, preserving or insulating, storing or storing and distributing human
p.(None): tissues and cells, performed by the Bank.
p.(None): Article 49
p.(None): The Bank shall be established, organized and ceased to operate in accordance with the law governing the field of health
p.(None): protection and this law.
p.(None): Article 50
p.(None): (1) The Bank shall keep a record of all the activities in its business that provide information on types and
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Health / Physically Disabled
Searching for indicator physically:
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p.(None): the storage, distribution, incorporation and monitoring of serious adverse events and serious adverse reactions,
p.(None): b) cells are single human cells or sets of human cells unconnected by connective tissue,
p.(None): v) tissue is an integral part of the human body made up of cells,
p.(None): g) the donor is a living or deceased person who gives, or from whose body human tissue and cells are taken for implantation in
p.(None): the recipient body,
p.(None): d) the recipient is a living person who is implanted with human tissue and donor cells,
p.(None): 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
p.(None): for the purpose of healing,
p.(None): e) The taking of human tissues and cells is a medical procedure by which it is removed from the body
p.(None): living or deceased person comes to human tissues and cells for incorporation into another person's body,
p.(None): g) processing is any operation performed during preparation, handling, preservation and packaging
p.(None): human tissues and cells intended for healing purposes,
p.(None): z) testing is the process of typing human tissues and recipient cells and conducting tests for determination
p.(None): the matching of human tissues and cells of donor and recipient, which are performed before transplantation,
p.(None): i) preservation is the use of chemical agents, altered environmental conditions or other means of processing, how
p.(None): to prevent or slow down the biological or physical degradation of human tissues and cells,
p.(None): j) Isolation or quarantine is the medical process of separating human tissues and cells physically or otherwise
p.(None): a way of awaiting a decision on their acceptance or rejection,
p.(None): k) storage is the preservation of human tissues and cells under appropriate controlled conditions until distribution,
p.(None): 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
p.(None): directly or indirectly through the Bank,
p.(None): lj) implantation is a medical procedure of transferring taken human tissues and cells of one person into the body of another
p.(None): faces,
p.(None): m) serious adverse event is any unexpected occurrence related to a transplant that may lead to
p.(None): transmission of infectious diseases, death or endangerment of life and occurrence of disability, or extension of disease or
p.(None): hospitalization of the recipient,
p.(None): n) a serious adverse reaction is an unexpected response in connection with a transplant, which may lead to
p.(None): infectious disease, death or endangerment of the life of the donor or recipient, as well as the occurrence of disability or extension
p.(None): diseases or hospitalizations thereof,
p.(None): nj) The bank referred to in Article 1 of this Law is a type of health care institution where processing operations are performed,
p.(None): testing, preservation, isolation or quarantine, storage or storage and distribution of human tissues; and
p.(None): cell,
p.(None): o) quality system is the process of determining responsibilities, procedures, processes and management tools
p.(None): quality and includes all activities that contribute to quality,
p.(None): p) standard operating procedures are written instructions that describe the steps in a particular process
p.(None): including the materials and methods used, as well as the expected outcome,
...
Health / stem cells
Searching for indicator stem cells:
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p.(None): to all healthcare institutions involved in transplantation in the environment and relevant international organizations.
p.(None): (2) In addition to the tasks referred to in paragraph 1 of this Article, the Coordination Center shall also perform the following tasks:
p.(None): a) adopt and organize the Transplant Program in the Republika Srpska (hereinafter: the Republic),
p.(None): b) provides uninterrupted work of his service, 24 hours a day, 7 days a week, v) maintains a database of recipients
p.(None): human tissues and cells,
p.(None): g) maintains a database of persons who oppose the donation of human tissues and cells after death,
p.(None): d) maintains a Unified Register of Human Tissue and Cell Providers, who have given written consent to be taken
p.(None): human tissues and cells in the event of their death, for incorporation into the body of another person for healing,
p.(None): f) keep a Single Register of Banks, in which the activity and responsible person are entered,
p.(None): e) Ensures that the donor information is transmitted to the transplant teams; g) prepares a single List
p.(None): waiting lists (hereinafter referred to as waiting lists) for
p.(None): transplantation in urgent order according to clinical indications, and deliver it in a timely manner to healthcare institutions which
p.(None): dealing with picking up or embedding,
p.(None): z) propose health facilities where human tissues and cells are taken and a hospital coordinator;
p.(None): i) control and harmonize transplant programs with international standards,
p.(None): j) promote transplantation,
p.(None): k) inform the public and the medical profession about the donation of human tissues and cells and stem cells; and
p.(None): the results of the transplant program,
p.(None): l) Coordinate and organize the distribution of human tissues and cells to the health care facilities they perform
p.(None): and transplantation to Banks through a fourth level hospital based in Banja Luka and
p.(None): lj) submit an annual report to the Minister on the performance of his / her duties and the results of the program
p.(None): transplants, serious adverse reactions and serious adverse events of human tissues and cells that are
p.(None): transplanted, with the proposal of measures to prevent them, through a fourth-level hospital based in Banja Luka.
p.(None): (3) The Minister shall prescribe in an ordinance:
p.(None): a) the manner and procedure of work of hospital transplant coordinators; and b) the manner and procedure of maintaining the Unified Register
p.(None): donors.
p.(None): Article 15
p.(None): The Coordination Center, through a fourth level hospital based in Banja Luka, proposes that the Minister should join
p.(None): Republics to international organizations for transplantation and conclusion of agreements with foreign legal entities and
p.(None): organization, for the exchange of human tissues and cells taken.
p.(None): IV TRANSPLANTATION PROCEDURE
p.(None): Article 16
p.(None): The donation process for human tissues and cells is voluntary.
p.(None): Article 17
p.(None): (1) In order to ensure the accessibility of human tissues and cells and the fairness of the transplantation procedure,
p.(None): Waiting list, for recipients of human tissues and cells in the Republic.
p.(None): (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.
p.(None): center.
p.(None): (3) The Minister shall prescribe in an ordinance the manner and procedure for drawing up and maintaining the Waiting List.
p.(None): Article 18
...
p.(None): 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
p.(None): the condition of the recipient, applying such treatment.
p.(None): Article 28
p.(None): (1) In the process of taking human tissues and cells from a living donor, his consent must be obtained in writing, which
p.(None): is an expression of free will.
p.(None): (2) The written consent of the donor referred to in paragraph 1 of this Article shall refer to the planned medical one
p.(None): intervention, that is, taking certain human tissues and cells.
p.(None): (3) A living donor may require that the transplantation of human tissues and cells be performed to a specific recipient.
p.(None): (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
p.(None): in accordance with the law.
p.(None): (5) The health institution referred to in paragraph 4 of this Article shall submit a copy of the written consent to the Coordination
p.(None): center.
p.(None): Article 29
p.(None): (1) The taking of human tissues and cells cannot be carried out by a living juvenile or adult donor who
p.(None): is devoid of legal capacity.
p.(None): (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
p.(None): transplant, take and store stem cells, with the written consent of the parents.
p.(None): (3) The Minister shall prescribe in an ordinance the manner and procedure for taking blood from the umbilical cord of an infant for separation
p.(None): stem cells, and the conditions of storage or storage and distribution of stem cells.
p.(None): Article 30
p.(None): (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
p.(None): with the second degree of kinship.
p.(None): (2) By way of derogation from paragraph 1 of this Article, a living donor may be a spouse or extramarital partner,
p.(None): adopter, adopter and guardian.
p.(None): Article 31
p.(None): (1) The taking of human tissues and cells from a living donor requires the approval of the Ethics Committee established in
p.(None): the health institution where the transplantation is performed, in accordance with the law.
p.(None): (2) The Ethics Committee shall approve on the basis of an insight into the medical records of the living donor or recipient of human
p.(None): tissues and cells after obtaining the written consent of the living donor as well as the written consent of the recipient
p.(None): human tissues and cells, which are given in accordance with this law.
p.(None): Article 32
p.(None): (1) Prior to taking human tissues and cells from a living donor, a medical doctor who performs human taking
p.(None): tissues and cells must perform appropriate medical tests to assess the health risks of the living donor and
p.(None): take action to reduce it.
p.(None): (2) The effects of taking human tissues and cells on the health of a living donor must not be disproportionate to the
p.(None): the expected improvement in the recipient's health.
p.(None): Article 33
p.(None): (1) A doctor of medicine who performs the taking of human tissues and cells is obliged to instruct the living donor of the purpose
...
p.(None): Article 53
p.(None): (1) The Bank shall appoint a responsible person who fulfills the following conditions:
p.(None): a) a medical college with a relevant specialization or another college where they are admitted
p.(None): knowledge in the field of medicine or biology with appropriate specializations in the field of human tissues and cells
p.(None): i
p.(None): b) at least two years of experience in the field of work with human tissues and cells.
p.(None): (2) The responsible person referred to in paragraph 1 of this Article shall:
p.(None): a) ensure that human tissues and cells intended for transplantation are treated, tested, preserved, isolated,
p.(None): warehouse or store and distribute in accordance with this Law,
p.(None): b) collects, analyzes and delivers information on serious adverse reactions and serious adverse events,
p.(None): The Coordination Center,
p.(None): v) performs tasks related to the evaluation and selection of providers in accordance with this Law;
p.(None): g) supervise and train the Bank's employees in the processing, testing, canning, isolation,
p.(None): the storage or storage and distribution of human tissues and cells,
p.(None): d) ensure the implementation of agreements between the Bank and third parties in accordance with this Law; and
p.(None): f) perform other tasks in accordance with this Law.
p.(None): Article 54
p.(None): Persons employed by the Bank engaged in processing, testing, canning, insulation,
p.(None): by storing or storing and distributing human tissues and cells, they must have appropriate education, with
p.(None): with additional transplant training.
p.(None): Article 55
p.(None): (1) The bank shall carry out laboratory testing of donated human tissues and cells and stem cells.
p.(None): (2) The Bank shall confirm and record the fact that the packaging of donated tissue and cells and stem cells is in accordance with
p.(None): donation process, into the same.
p.(None): (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.
p.(None): (4) The Bank shall keep records on the acceptance or rejection of human tissues and cells.
p.(None): (5) Human tissues and cells shall be kept in the Bank in isolation until all conditions for their incorporation have been fulfilled.
p.(None): Article 56
p.(None): (1) The bank shall have standard operating procedures for each process of human tissue and cell processing,
p.(None): which ensures their quality and safety.
p.(None): (2) The bank shall ensure that all human tissue and cell processing operations are performed in a controlled manner.
p.(None): conditions.
p.(None): (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
p.(None): operating procedures to ensure the quality and safety of human tissues and cells.
p.(None): (4) The standard operating procedures referred to in para. 1 and 2 of this Article refer to the processing of human tissues and
p.(None): cells, validation and control of equipment, space and work processes, as well as the handling of discarded human tissues
p.(None): and cells, to prevent contamination of other human tissues and cells, processing equipment, or employees
p.(None): faces.
p.(None): (5) The Minister shall prescribe in an ordinance the manner, procedure and conditions for the treatment of human tissues and
p.(None): cell.
p.(None): Article 57
p.(None): (1) The Bank shall be obliged to ensure that all procedures related to the storage or preservation of human tissues and
p.(None): cells shall be documented and performed in accordance with standard operating procedures.
...
p.(None): v) transplant or perform a transplant, and there is no finding by a medical doctor that they will
p.(None): to improve the recipient's health from such treatment (Article 27) and
p.(None): 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
p.(None): transplantation risk (Article 33).
p.(None): Article 66
p.(None): (1) A legal person dealing with public shall be fined from 10,000 KM to 50,000 KM.
p.(None): informing or transmitting news that advertises the offer or need for human tissues and cells (Article
p.(None): 20).
p.(None): (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
p.(None): KM 2,000 to KM 10,000, which deals with public information or news transmission, which announces an offer or
p.(None): the need for human tissues and cells (Article 20).
p.(None): XI TRANSITIONAL AND FINAL PROVISIONS
p.(None): Article 67
p.(None): The Minister shall, within one year from the day this Law enters into force, issue ordinances on:
p.(None): a) the conditions of the premises, personnel and equipment, as well as the verification procedure for the health care institution that performs it
p.(None): transplantation or human tissue and cell collection (Article 10),
p.(None): b) the manner and procedure of work of the transplant coordinator (Article 14); v) the manner and procedure of keeping the Unified Register
p.(None): donors (Article 14), g) the manner and procedure of compiling and maintaining the Checklist (Article 17),
p.(None): d) criteria for testing donors for transplantable diseases (Article 24),
p.(None): e) the manner and procedure of taking blood from the umbilical cord of a newborn to extract stem cells, and
p.(None): conditions of storage or storage and distribution of stem cells (Article 29),
p.(None): e) the manner and medical criteria for determining brain death (Article 37); g) the manner and procedure of record keeping
p.(None): (Article 50),
p.(None): z) the manner, procedure and conditions of treatment of human tissues and cells (Article 56),
p.(None): i) the manner, procedure and conditions of storage of human tissues and cells (Article 57),
p.(None): j) the manner, procedure and conditions for marking, documenting and packaging human tissues and cells. (Article 58) i
p.(None): k) the manner, procedure and conditions of distribution of human tissues and cells (Article 59).
p.(None): Article 68
p.(None): Until the adoption of the by-laws established by this Law, the Ordinance on working conditions will apply
p.(None): healthcare organizations that perform the activities of taking, transplanting, processing - typing and keeping parts
p.(None): the human body (Official Gazette of the SFRY, No. 64/91) and the Ordinance on the Close Medical Criteria,
p.(None): the manner and procedure for determining the death of a person whose body parts may be taken for transplantation ("Official
p.(None): SFRY Gazette ", No. 64/91).
p.(None): Article 69
p.(None): On the day this Law enters into force, the Law on Conditions for Taking and Transplanting ceases to be valid
p.(None): parts of the human body (Official Gazette of the SFRY, Nos. 63/90 and 22/91).
p.(None): Article 70
p.(None): This Law shall enter into force on the eighth day after its publication in the Official Gazette of the Republika Srpska.
p.(None): No: 01-105 / 10 THE PRESIDENT
p.(None): Date: 25 January 2010 NATIONAL ASSEMBLY
...
Social / Access to Social Goods
Searching for indicator socialXwelfare:
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p.(None): Article 6
p.(None): The principle of medical justification for transplantation is achieved if it is the most appropriate treatment, in accordance with
p.(None): 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
p.(None): if all have been done previously
p.(None): medical tests that can predict the safety of the donor and the recipient, as well as the success
p.(None): interventions.
p.(None): Article 7
p.(None): The safety principle is achieved by performing the transplant procedure in accordance with a professional one
p.(None): medical science standards, standardized operating procedures, and ethical principles.
p.(None): Article 8
p.(None): The principle of non - discrimination is achieved by prohibiting all forms of discrimination when performing actions on
p.(None): the basis of this law and regulations made thereunder.
p.(None): Article 9
p.(None): The principle of protection of the identity, interests and dignity of the donor and recipient is established in the transplant process, in the manner
p.(None): which ensures and guarantees their respect
p.(None): III ORGANIZATION OF PROFESSIONAL MEDICAL OPERATIONS IN THE FIELD OF TRANSPLANTATION
p.(None): Article 10
p.(None): (1) Transplantation may be performed in health institutions that meet the requirements in terms of space, personnel and equipment
p.(None): for transplant business.
p.(None): (2) The taking of human tissues and cells may also be carried out in a non-implantable health institution that fulfills
p.(None): conditions regarding space, personnel and equipment for performing human tissue and cell collection activities.
p.(None): (3) The Minister of Health and Social Welfare (hereinafter: the Minister), on the basis of the conditions laid down in para.
p.(None): 1 and 2 of this Article shall issue a decision for performing the transplantation activity as well as for performing it
p.(None): human tissue and cell collection activities, at the proposal of the Transplantation Coordination Center (hereinafter:
p.(None): Coordination Center).
p.(None): (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.
p.(None): (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.
p.(None): (6) The costs of the procedure for determining the eligibility for transplantation, as well as the taking of human tissues and cells
p.(None): they are borne by health institutions and they represent the revenue of the Republika Srpska budget.
p.(None): (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.
p.(None): (8) The Minister shall prescribe in an ordinance the conditions referred to in para. 1 and 2 of this Article.
p.(None): Article 11
p.(None): (1) Performing transplantation as well as taking human tissues and cells referred to in Article 10, para.
p.(None): 1 and 2 of this Law, shall terminate if the health institution ceases to meet the prescribed conditions for
p.(None): performing approved activity.
p.(None): (2) The Minister shall issue a decision on the termination of the activities referred to in paragraph 1 of this Article.
p.(None): (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.
p.(None): Article 12
p.(None): (1) The health institution that performs the transplant procedure, as well as the health institution that performs the taking
...
p.(None): the quality and safety of human tissues and cells, which are handled in collaboration with third parties, especially in
p.(None): in the following cases:
p.(None): a) The bank entrusts one of the stages in the processing of human tissues and cells to a third party,
p.(None): b) the third party supplies products or services that affect the quality and safety of human tissues; and
p.(None): cells, including their distribution,
p.(None): v) The Bank provides services to another Bank and
p.(None): g) The bank distributes human tissues and cells processed by a third party.
p.(None): (2) The bank shall evaluate and select a third party with whom it concludes the agreement referred to in paragraph
p.(None): 1 of this Article on the basis of its ability to satisfy the conditions prescribed by this Law.
p.(None): (3) The Bank shall keep a list of all agreements referred to in paragraph 1 of this Article.
p.(None): (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
p.(None): procedures.
p.(None): (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.
p.(None): Article 61
p.(None): When importing and exporting human tissues and cells, the Bank, or its authorized distributor, must
p.(None): fulfill the conditions prescribed by this law.
p.(None): Article 62
p.(None): (1) The Ministry of Health and Social Welfare of the Republic of Srpska shall supervise the implementation of this Law
p.(None): competent health and sanitary inspection.
p.(None): (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
p.(None): prescribed by law, is also authorized to:
p.(None): a) prohibit the transplantation activity if it determines that the transplantation activity is performed and not completed
p.(None): conditions for its performance, and within the given deadline, the irregularities identified were not eliminated and
p.(None): b) prohibit the performance of the transplant business if it determines that the activity is performed and the conditions are not fulfilled
p.(None): for its performance, thereby endangering the lives and health of the people or when it comes to the protection of the public interest.
p.(None): VIII PENALTY PROVISIONS
p.(None): Article 63
p.(None): Whoever, contrary to this law, performs transplantation and taking of human tissues and cells, shall be punished according to the Criminal Code
p.(None): Law of the Republika Srpska (Official Gazette of the Republika Srpska, Nos. 49/03, 108/04, 37/06 and 70/06).
p.(None): Article 64
p.(None): (1) A fine from 20,000 KM to 100,000 KM shall be imposed on a health institution for a misdemeanor if:
p.(None): a) does not determine the brain death of the person from whom the human tissues and cells were taken (Article 35),
p.(None): b) does not detect brain death in a person in deep coma who has no spontaneous breathing and has clearly demonstrated
p.(None): a cause capable of explaining this condition (Article 36) i
...
Social / Fetus/Neonate
Searching for indicator fetuses:
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p.(None): on the basis of written and given written consent for the life of the donor and with the consent of the family.
p.(None): (2) The written consent referred to in paragraph 1 of this Article shall be given before the authorized person of the Coordination
p.(None): 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
p.(None): institution of the third level, appointed by the director.
p.(None): (3) On the basis of written and given written consent, the Coordination Center or health institution referred to in paragraph
p.(None): 2 of this Article, issues to the potential donor a donor card in which the consent is recorded.
p.(None): Article 40
p.(None): Written statement on non-donation of human tissues and cells to an adult capable of reasoning gives to the elect
p.(None): doctor of medicine at the primary level of health care, which must be recorded in the medical record and immediately
p.(None): submits to the Coordination Center.
p.(None): Article 41
p.(None): Taking human tissues and cells from a deceased minor donor and adult donor may be
p.(None): only if both the parent or his legal representative or guardian gives written consent.
p.(None): Article 42
p.(None): (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
p.(None): there is consent from the Ethics Committee.
p.(None): (2) A doctor of medicine, a specialist in gynecology and obstetrics who performed a termination of pregnancy, may not participate in
p.(None): implantation of human tissues and cells resulting from termination of pregnancy, or in any way related to and
p.(None): interested in transplantation.
p.(None): Article 43
p.(None): 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
p.(None): and which has not given written consent under this law, human tissues and cells may be taken for the sake of
p.(None): implantation to another person for the purpose of treatment, only with the written consent of a family member.
p.(None): Article 44
p.(None): An authorized healthcare professional can begin the process of taking human tissues and cells from a deceased person if:
p.(None): a) have at his disposal evidence of the written consent of the deceased person, or a donor card,
p.(None): b) in conversation with a family member, verify that the deceased person has not changed his or her consent to donate for life
p.(None): tissues and cells,
...
Social / Infant
Searching for indicator infant:
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p.(None): V TAKING HUMAN TISSUES AND CELLS FROM A LIVE GIVER
p.(None): Article 27
p.(None): The taking of human tissues and cells from a living donor is done unless there are adequate human ones
p.(None): 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
p.(None): the condition of the recipient, applying such treatment.
p.(None): Article 28
p.(None): (1) In the process of taking human tissues and cells from a living donor, his consent must be obtained in writing, which
p.(None): is an expression of free will.
p.(None): (2) The written consent of the donor referred to in paragraph 1 of this Article shall refer to the planned medical one
p.(None): intervention, that is, taking certain human tissues and cells.
p.(None): (3) A living donor may require that the transplantation of human tissues and cells be performed to a specific recipient.
p.(None): (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
p.(None): in accordance with the law.
p.(None): (5) The health institution referred to in paragraph 4 of this Article shall submit a copy of the written consent to the Coordination
p.(None): center.
p.(None): Article 29
p.(None): (1) The taking of human tissues and cells cannot be carried out by a living juvenile or adult donor who
p.(None): is devoid of legal capacity.
p.(None): (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
p.(None): transplant, take and store stem cells, with the written consent of the parents.
p.(None): (3) The Minister shall prescribe in an ordinance the manner and procedure for taking blood from the umbilical cord of an infant for separation
p.(None): stem cells, and the conditions of storage or storage and distribution of stem cells.
p.(None): Article 30
p.(None): (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
p.(None): with the second degree of kinship.
p.(None): (2) By way of derogation from paragraph 1 of this Article, a living donor may be a spouse or extramarital partner,
p.(None): adopter, adopter and guardian.
p.(None): Article 31
p.(None): (1) The taking of human tissues and cells from a living donor requires the approval of the Ethics Committee established in
p.(None): the health institution where the transplantation is performed, in accordance with the law.
p.(None): (2) The Ethics Committee shall approve on the basis of an insight into the medical records of the living donor or recipient of human
p.(None): tissues and cells after obtaining the written consent of the living donor as well as the written consent of the recipient
p.(None): human tissues and cells, which are given in accordance with this law.
p.(None): Article 32
p.(None): (1) Prior to taking human tissues and cells from a living donor, a medical doctor who performs human taking
p.(None): tissues and cells must perform appropriate medical tests to assess the health risks of the living donor and
p.(None): take action to reduce it.
p.(None): (2) The effects of taking human tissues and cells on the health of a living donor must not be disproportionate to the
p.(None): the expected improvement in the recipient's health.
p.(None): Article 33
...
Social / Marital Status
Searching for indicator single:
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p.(None): HUMAN TISSUES AND CELLS TRANSPLANTATION LAW
p.(None): (Official Gazette of the Republika Srpska No. 14/10)
p.(None): AND BASIC PROVISIONS
p.(None): Article 1.
p.(None): This Law governs transplantation of human tissues and cells (hereinafter referred to as: transplantation), principles
p.(None): transplantation, organization of performing professional medical tasks in the field of transplantation, procedure
p.(None): transplants, taking human tissues and cells from a living donor, taking human tissues and cells from
p.(None): the deceased donor, the establishment and organization of the Biological Material Bank and the Stem Cell Bank (hereinafter referred to as "the donor")
p.(None): (Bank), as well as other transplant issues.
p.(None): Article 2
p.(None): (1) Transplantation shall be carried out only in the manner and under the conditions prescribed by this Law.
p.(None): (2) The provisions of this Law shall not apply to industrial products obtained from human tissues and cells,
p.(None): intended for administration to humans, autologous transplants in the same surgical procedure, to human tissues, and
p.(None): cells taken for scientific research purposes, reproductive cells, human organs and parts of human organs, and on
p.(None): blood and blood components.
p.(None): Article 3
p.(None): Some terms used in this law have the following meaning:
p.(None): a) transplantation is a medical procedure of taking human tissues and cells from a living or dead face and incorporating it into the body
p.(None): of another person, including all procedures for donating, taking, processing, testing, preserving, insulating,
p.(None): the storage, distribution, incorporation and monitoring of serious adverse events and serious adverse reactions,
p.(None): b) cells are single human cells or sets of human cells unconnected by connective tissue,
p.(None): v) tissue is an integral part of the human body made up of cells,
p.(None): g) the donor is a living or deceased person who gives, or from whose body human tissue and cells are taken for implantation in
p.(None): the recipient body,
p.(None): d) the recipient is a living person who is implanted with human tissue and donor cells,
p.(None): 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
p.(None): for the purpose of healing,
p.(None): e) The taking of human tissues and cells is a medical procedure by which it is removed from the body
p.(None): living or deceased person comes to human tissues and cells for incorporation into another person's body,
p.(None): g) processing is any operation performed during preparation, handling, preservation and packaging
p.(None): human tissues and cells intended for healing purposes,
p.(None): z) testing is the process of typing human tissues and recipient cells and conducting tests for determination
p.(None): the matching of human tissues and cells of donor and recipient, which are performed before transplantation,
p.(None): i) preservation is the use of chemical agents, altered environmental conditions or other means of processing, how
p.(None): to prevent or slow down the biological or physical degradation of human tissues and cells,
p.(None): j) Isolation or quarantine is the medical process of separating human tissues and cells physically or otherwise
p.(None): a way of awaiting a decision on their acceptance or rejection,
p.(None): k) storage is the preservation of human tissues and cells under appropriate controlled conditions until distribution,
...
p.(None): Provide the coordination center with an analysis of data on serious adverse reactions and serious adverse events for
p.(None): certain types of human tissues and cells that have been transplanted, proposing measures to prevent them.
p.(None): (4) The healthcare institution referred to in paragraph 1 of this Article shall ensure the traceability of human tissues and cells
p.(None): who are transplanted.
p.(None): Article 13
p.(None): (1) Performing professional-medical and organizational adjustments, directing work and activities in the field of transplantation
p.(None): performed by the Coordination Center.
p.(None): (2) The coordination center is a part of the fourth level hospital with headquarters in Banja Luka.
p.(None): Article 14
p.(None): (1) The Coordination Center shall perform the tasks of collecting, processing and exchanging data relevant for transplantation with
p.(None): to all healthcare institutions involved in transplantation in the environment and relevant international organizations.
p.(None): (2) In addition to the tasks referred to in paragraph 1 of this Article, the Coordination Center shall also perform the following tasks:
p.(None): a) adopt and organize the Transplant Program in the Republika Srpska (hereinafter: the Republic),
p.(None): b) provides uninterrupted work of his service, 24 hours a day, 7 days a week, v) maintains a database of recipients
p.(None): human tissues and cells,
p.(None): g) maintains a database of persons who oppose the donation of human tissues and cells after death,
p.(None): d) maintains a Unified Register of Human Tissue and Cell Providers, who have given written consent to be taken
p.(None): human tissues and cells in the event of their death, for incorporation into the body of another person for healing,
p.(None): f) keep a Single Register of Banks, in which the activity and responsible person are entered,
p.(None): e) Ensures that the donor information is transmitted to the transplant teams; g) prepares a single List
p.(None): waiting lists (hereinafter referred to as waiting lists) for
p.(None): transplantation in urgent order according to clinical indications, and deliver it in a timely manner to healthcare institutions which
p.(None): dealing with picking up or embedding,
p.(None): z) propose health facilities where human tissues and cells are taken and a hospital coordinator;
p.(None): i) control and harmonize transplant programs with international standards,
p.(None): j) promote transplantation,
p.(None): k) inform the public and the medical profession about the donation of human tissues and cells and stem cells; and
p.(None): the results of the transplant program,
p.(None): l) Coordinate and organize the distribution of human tissues and cells to the health care facilities they perform
p.(None): and transplantation to Banks through a fourth level hospital based in Banja Luka and
p.(None): lj) submit an annual report to the Minister on the performance of his / her duties and the results of the program
p.(None): transplants, serious adverse reactions and serious adverse events of human tissues and cells that are
p.(None): transplanted, with the proposal of measures to prevent them, through a fourth-level hospital based in Banja Luka.
p.(None): (3) The Minister shall prescribe in an ordinance:
p.(None): a) the manner and procedure of work of hospital transplant coordinators; and b) the manner and procedure of maintaining the Unified Register
p.(None): donors.
p.(None): Article 15
p.(None): The Coordination Center, through a fourth level hospital based in Banja Luka, proposes that the Minister should join
p.(None): Republics to international organizations for transplantation and conclusion of agreements with foreign legal entities and
p.(None): organization, for the exchange of human tissues and cells taken.
p.(None): IV TRANSPLANTATION PROCEDURE
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): intended for use in humans.
p.(None): (2) The Bank shall submit to the Coordination Center, at least once a year, a report on the operations referred to in paragraph
p.(None): 1 of this Article.
p.(None): (3) The Minister shall prescribe by an ordinance the procedure and manner of keeping records.
p.(None): Article 51
p.(None): practices.
p.(None): (1) The bank shall establish and update a quality system based on the principles of good
p.(None): (2) In managing the quality system, the Bank shall provide at least the following
p.(None): documentation:
p.(None): a) standard operating procedures, b) guidelines,
p.(None): v) training manual and reference manual, g) reporting form,
p.(None): d) records of the donor,
p.(None): f) information on the final destination of human tissues and cells; and
p.(None): e) other data for the provision and management of the quality system.
p.(None): (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.
p.(None): Article 52
p.(None): (1) Human tissues and cells must be identified by a special label containing information on the collection procedure
p.(None): human tissues and cells and their registration with the Bank, as well as data on processing, testing, canning, isolation,
p.(None): storage and distribution thereof.
p.(None): (2) The bank shall assign a unique identification code to donated human tissues and cells in order to
p.(None): made possible by proper donor identification and traceability of donated human tissues and cells for delivery
p.(None): information on the most important properties and properties of human tissues and cells.
p.(None): (3) The unique identification code referred to in paragraph 2 of this Article must be harmonized with the country code system
p.(None): Of the European Union for the field of human tissues and cells and shall contain at least the following information:
p.(None): a) the identification of the donation with the Bank's unique identification number and identification; and
p.(None): b) product identification with product code (basic nomenclature), lot subset number (if
p.(None): applies) and expiry date.
p.(None): Article 53
p.(None): (1) The Bank shall appoint a responsible person who fulfills the following conditions:
p.(None): a) a medical college with a relevant specialization or another college where they are admitted
p.(None): knowledge in the field of medicine or biology with appropriate specializations in the field of human tissues and cells
p.(None): i
p.(None): b) at least two years of experience in the field of work with human tissues and cells.
p.(None): (2) The responsible person referred to in paragraph 1 of this Article shall:
p.(None): a) ensure that human tissues and cells intended for transplantation are treated, tested, preserved, isolated,
p.(None): warehouse or store and distribute in accordance with this Law,
p.(None): b) collects, analyzes and delivers information on serious adverse reactions and serious adverse events,
p.(None): The Coordination Center,
p.(None): v) performs tasks related to the evaluation and selection of providers in accordance with this Law;
p.(None): g) supervise and train the Bank's employees in the processing, testing, canning, isolation,
p.(None): the storage or storage and distribution of human tissues and cells,
p.(None): d) ensure the implementation of agreements between the Bank and third parties in accordance with this Law; and
p.(None): f) perform other tasks in accordance with this Law.
p.(None): Article 54
p.(None): Persons employed by the Bank engaged in processing, testing, canning, insulation,
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): of the deceased donor.
p.(None): (3) In order to protect personal data and prevent unauthorized use, certain personal data must be provided
p.(None): replace with the identification code that the sender or recipient receives when registering and entering data into
p.(None): a unique database, maintained at the Coordination Center.
p.(None): (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.
p.(None): Article 23
p.(None): Information on the donor and the recipient, ie all medical and other documentation on transplantation and mediation in
p.(None): transplantation is kept for 30 years in a healthcare facility that has taken or implanted human tissues and
p.(None): cells and shall be destroyed within one year from the expiry of the said period.
p.(None): Article 24
p.(None): (1) The healthcare provider involved in the transplant procedure must complete all tests and procedures necessary for success
p.(None): procedure.
p.(None): (2) The Minister shall prescribe by an ordinance the criteria for testing donors for transmissible diseases
p.(None): by transplantation.
p.(None): Article 25
p.(None): (1) The implantation of human tissues and cells may be performed only with the written consent of the recipient, or both
p.(None): parents or guardians, if the recipient is a minor or a person deprived of legal capacity.
p.(None): (2) The consent referred to in paragraph 1 of this Article must be an expression of free will arising after a complete explanation of
p.(None): the nature and purpose of this treatment, the likelihood of its success, its consequences and risk, as well as others
p.(None): treatment options
p.(None): Article 26
p.(None): The recipient and the living donor of human tissues and cells must be provided with appropriate medical attention
p.(None): monitoring of post-transplant health, in accordance with the standards of the medical profession.
p.(None): V TAKING HUMAN TISSUES AND CELLS FROM A LIVE GIVER
p.(None): Article 27
p.(None): The taking of human tissues and cells from a living donor is done unless there are adequate human ones
p.(None): 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
p.(None): the condition of the recipient, applying such treatment.
p.(None): Article 28
p.(None): (1) In the process of taking human tissues and cells from a living donor, his consent must be obtained in writing, which
p.(None): is an expression of free will.
p.(None): (2) The written consent of the donor referred to in paragraph 1 of this Article shall refer to the planned medical one
p.(None): intervention, that is, taking certain human tissues and cells.
p.(None): (3) A living donor may require that the transplantation of human tissues and cells be performed to a specific recipient.
...
p.(None): uptake of human tissues and cells.
p.(None): Article 39
p.(None): (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
p.(None): on the basis of written and given written consent for the life of the donor and with the consent of the family.
p.(None): (2) The written consent referred to in paragraph 1 of this Article shall be given before the authorized person of the Coordination
p.(None): 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
p.(None): institution of the third level, appointed by the director.
p.(None): (3) On the basis of written and given written consent, the Coordination Center or health institution referred to in paragraph
p.(None): 2 of this Article, issues to the potential donor a donor card in which the consent is recorded.
p.(None): Article 40
p.(None): Written statement on non-donation of human tissues and cells to an adult capable of reasoning gives to the elect
p.(None): doctor of medicine at the primary level of health care, which must be recorded in the medical record and immediately
p.(None): submits to the Coordination Center.
p.(None): Article 41
p.(None): Taking human tissues and cells from a deceased minor donor and adult donor may be
p.(None): only if both the parent or his legal representative or guardian gives written consent.
p.(None): Article 42
p.(None): (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
p.(None): there is consent from the Ethics Committee.
p.(None): (2) A doctor of medicine, a specialist in gynecology and obstetrics who performed a termination of pregnancy, may not participate in
p.(None): implantation of human tissues and cells resulting from termination of pregnancy, or in any way related to and
p.(None): interested in transplantation.
p.(None): Article 43
p.(None): 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
p.(None): and which has not given written consent under this law, human tissues and cells may be taken for the sake of
p.(None): implantation to another person for the purpose of treatment, only with the written consent of a family member.
p.(None): Article 44
p.(None): An authorized healthcare professional can begin the process of taking human tissues and cells from a deceased person if:
p.(None): a) have at his disposal evidence of the written consent of the deceased person, or a donor card,
...
p.(None): VIII PENALTY PROVISIONS
p.(None): Article 63
p.(None): Whoever, contrary to this law, performs transplantation and taking of human tissues and cells, shall be punished according to the Criminal Code
p.(None): Law of the Republika Srpska (Official Gazette of the Republika Srpska, Nos. 49/03, 108/04, 37/06 and 70/06).
p.(None): Article 64
p.(None): (1) A fine from 20,000 KM to 100,000 KM shall be imposed on a health institution for a misdemeanor if:
p.(None): a) does not determine the brain death of the person from whom the human tissues and cells were taken (Article 35),
p.(None): b) does not detect brain death in a person in deep coma who has no spontaneous breathing and has clearly demonstrated
p.(None): a cause capable of explaining this condition (Article 36) i
p.(None): 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
p.(None): The Coordination Center or if it does not preserve it or record it properly in the documentation (Article 40).
p.(None): (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.
p.(None): health institutions.
p.(None): Article 65
p.(None): (1) A fine of KM 5,000 to KM 10,000 shall be imposed on a doctor of medicine who has:
p.(None): a) place the recipient on the waiting list in the opposite order of urgency according to clinical indications and provisions
p.(None): of this Law (Article 17),
p.(None): b) perform the transplant without the consent of the recipient or his parent or guardian when the recipient
p.(None): a minor or a person without legal capacity (Article 25),
p.(None): v) transplant or perform a transplant, and there is no finding by a medical doctor that they will
p.(None): to improve the recipient's health from such treatment (Article 27) and
p.(None): 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
p.(None): transplantation risk (Article 33).
p.(None): Article 66
p.(None): (1) A legal person dealing with public shall be fined from 10,000 KM to 50,000 KM.
p.(None): informing or transmitting news that advertises the offer or need for human tissues and cells (Article
p.(None): 20).
p.(None): (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
p.(None): KM 2,000 to KM 10,000, which deals with public information or news transmission, which announces an offer or
p.(None): the need for human tissues and cells (Article 20).
p.(None): XI TRANSITIONAL AND FINAL PROVISIONS
p.(None): Article 67
p.(None): The Minister shall, within one year from the day this Law enters into force, issue ordinances on:
p.(None): a) the conditions of the premises, personnel and equipment, as well as the verification procedure for the health care institution that performs it
p.(None): transplantation or human tissue and cell collection (Article 10),
p.(None): b) the manner and procedure of work of the transplant coordinator (Article 14); v) the manner and procedure of keeping the Unified Register
p.(None): donors (Article 14), g) the manner and procedure of compiling and maintaining the Checklist (Article 17),
p.(None): d) criteria for testing donors for transplantable diseases (Article 24),
...
Social / education
Searching for indicator education:
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p.(None): a) the identification of the donation with the Bank's unique identification number and identification; and
p.(None): b) product identification with product code (basic nomenclature), lot subset number (if
p.(None): applies) and expiry date.
p.(None): Article 53
p.(None): (1) The Bank shall appoint a responsible person who fulfills the following conditions:
p.(None): a) a medical college with a relevant specialization or another college where they are admitted
p.(None): knowledge in the field of medicine or biology with appropriate specializations in the field of human tissues and cells
p.(None): i
p.(None): b) at least two years of experience in the field of work with human tissues and cells.
p.(None): (2) The responsible person referred to in paragraph 1 of this Article shall:
p.(None): a) ensure that human tissues and cells intended for transplantation are treated, tested, preserved, isolated,
p.(None): warehouse or store and distribute in accordance with this Law,
p.(None): b) collects, analyzes and delivers information on serious adverse reactions and serious adverse events,
p.(None): The Coordination Center,
p.(None): v) performs tasks related to the evaluation and selection of providers in accordance with this Law;
p.(None): g) supervise and train the Bank's employees in the processing, testing, canning, isolation,
p.(None): the storage or storage and distribution of human tissues and cells,
p.(None): d) ensure the implementation of agreements between the Bank and third parties in accordance with this Law; and
p.(None): f) perform other tasks in accordance with this Law.
p.(None): Article 54
p.(None): Persons employed by the Bank engaged in processing, testing, canning, insulation,
p.(None): by storing or storing and distributing human tissues and cells, they must have appropriate education, with
p.(None): with additional transplant training.
p.(None): Article 55
p.(None): (1) The bank shall carry out laboratory testing of donated human tissues and cells and stem cells.
p.(None): (2) The Bank shall confirm and record the fact that the packaging of donated tissue and cells and stem cells is in accordance with
p.(None): donation process, into the same.
p.(None): (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.
p.(None): (4) The Bank shall keep records on the acceptance or rejection of human tissues and cells.
p.(None): (5) Human tissues and cells shall be kept in the Bank in isolation until all conditions for their incorporation have been fulfilled.
p.(None): Article 56
p.(None): (1) The bank shall have standard operating procedures for each process of human tissue and cell processing,
p.(None): which ensures their quality and safety.
p.(None): (2) The bank shall ensure that all human tissue and cell processing operations are performed in a controlled manner.
p.(None): conditions.
p.(None): (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
p.(None): operating procedures to ensure the quality and safety of human tissues and cells.
p.(None): (4) The standard operating procedures referred to in para. 1 and 2 of this Article refer to the processing of human tissues and
p.(None): cells, validation and control of equipment, space and work processes, as well as the handling of discarded human tissues
p.(None): and cells, to prevent contamination of other human tissues and cells, processing equipment, or employees
p.(None): faces.
...
Social / employees
Searching for indicator employees:
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p.(None): made possible by proper donor identification and traceability of donated human tissues and cells for delivery
p.(None): information on the most important properties and properties of human tissues and cells.
p.(None): (3) The unique identification code referred to in paragraph 2 of this Article must be harmonized with the country code system
p.(None): Of the European Union for the field of human tissues and cells and shall contain at least the following information:
p.(None): a) the identification of the donation with the Bank's unique identification number and identification; and
p.(None): b) product identification with product code (basic nomenclature), lot subset number (if
p.(None): applies) and expiry date.
p.(None): Article 53
p.(None): (1) The Bank shall appoint a responsible person who fulfills the following conditions:
p.(None): a) a medical college with a relevant specialization or another college where they are admitted
p.(None): knowledge in the field of medicine or biology with appropriate specializations in the field of human tissues and cells
p.(None): i
p.(None): b) at least two years of experience in the field of work with human tissues and cells.
p.(None): (2) The responsible person referred to in paragraph 1 of this Article shall:
p.(None): a) ensure that human tissues and cells intended for transplantation are treated, tested, preserved, isolated,
p.(None): warehouse or store and distribute in accordance with this Law,
p.(None): b) collects, analyzes and delivers information on serious adverse reactions and serious adverse events,
p.(None): The Coordination Center,
p.(None): v) performs tasks related to the evaluation and selection of providers in accordance with this Law;
p.(None): g) supervise and train the Bank's employees in the processing, testing, canning, isolation,
p.(None): the storage or storage and distribution of human tissues and cells,
p.(None): d) ensure the implementation of agreements between the Bank and third parties in accordance with this Law; and
p.(None): f) perform other tasks in accordance with this Law.
p.(None): Article 54
p.(None): Persons employed by the Bank engaged in processing, testing, canning, insulation,
p.(None): by storing or storing and distributing human tissues and cells, they must have appropriate education, with
p.(None): with additional transplant training.
p.(None): Article 55
p.(None): (1) The bank shall carry out laboratory testing of donated human tissues and cells and stem cells.
p.(None): (2) The Bank shall confirm and record the fact that the packaging of donated tissue and cells and stem cells is in accordance with
p.(None): donation process, into the same.
p.(None): (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.
p.(None): (4) The Bank shall keep records on the acceptance or rejection of human tissues and cells.
p.(None): (5) Human tissues and cells shall be kept in the Bank in isolation until all conditions for their incorporation have been fulfilled.
p.(None): Article 56
p.(None): (1) The bank shall have standard operating procedures for each process of human tissue and cell processing,
p.(None): which ensures their quality and safety.
p.(None): (2) The bank shall ensure that all human tissue and cell processing operations are performed in a controlled manner.
p.(None): conditions.
p.(None): (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
p.(None): operating procedures to ensure the quality and safety of human tissues and cells.
p.(None): (4) The standard operating procedures referred to in para. 1 and 2 of this Article refer to the processing of human tissues and
p.(None): cells, validation and control of equipment, space and work processes, as well as the handling of discarded human tissues
p.(None): and cells, to prevent contamination of other human tissues and cells, processing equipment, or employees
p.(None): faces.
p.(None): (5) The Minister shall prescribe in an ordinance the manner, procedure and conditions for the treatment of human tissues and
p.(None): cell.
p.(None): Article 57
p.(None): (1) The Bank shall be obliged to ensure that all procedures related to the storage or preservation of human tissues and
p.(None): cells shall be documented and performed in accordance with standard operating procedures.
p.(None): (2) The Bank shall ensure that all storage or safekeeping operations are carried out under controlled conditions.
p.(None): (3) The bank is obliged to apply all procedures of control of packaging and storage facilities in order to
p.(None): prevent phenomena that may adversely affect the functioning or integrity and quality of human tissues and
p.(None): cell.
p.(None): (4) The treated human tissues and cells shall not be distributed until the conditions prescribed by this Law are fulfilled.
p.(None): (5) In the event of termination of the Bank for any reason, it shall be stored
p.(None): transfer human tissues and cells to another Bank.
p.(None): (6) The Minister shall prescribe in an ordinance the manner, procedure and conditions of storage of human tissues and cells
p.(None): Article 58
p.(None): (1) The bank is obliged to ensure that the procedure for donating human tissues and cells and receiving them into the same
p.(None): mark appropriately, as well as appropriate documentation.
p.(None): (2) The bank shall provide appropriate packaging for human tissues and cells.
p.(None): (3) The Minister shall prescribe by an ordinance the conditions, manner and procedure for marking, documenting and packaging for
p.(None): human tissues and cells.
p.(None): Article 59
p.(None): (1) The bank shall ensure the quality and safety of human tissues and cells during distribution.
...
Social / gender
Searching for indicator gender:
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p.(None): including the materials and methods used, as well as the expected outcome,
p.(None): r) validation is the production of documented evidence that, with a high degree of certainty, provides assurances that
p.(None): a particular process, standard operating procedures, equipment, or environment consistently delivers a product that satisfies
p.(None): predefined specifications and quality features, with the process being validated to evaluate
p.(None): the performance of the system in terms of its effectiveness for the intended purpose,
p.(None): s) traceability is the ability to identify donors and recipients of human tissues and cells and locate them at each stage of
p.(None): donation to implantation, or rejection of human tissues and cells that are implanted, as well as the ability to locate all
p.(None): relevant data relating to products and materials that come in contact with human tissues and cells,
p.(None): t) a family member is a spouse or spouse, relatives in a straight line, regardless of the degree of kinship,
p.(None): in a sloping line to the second degree of kinship, adopter, adopter and guardian i
p.(None): Ć) promotion of transplantation is the continuous provision of information to citizens on opportunities and conditions
p.(None): for donation of human tissues and cells, so that citizens for life decide to become donors, or how
p.(None): to introduce to their family members and legal representatives their desire to be human tissue and cell donors,
p.(None): as well as providing the necessary information to healthcare professionals.
p.(None): Article 4
p.(None): The grammatical terminology of using masculine or feminine gender in the text of the law implies the inclusion of both
p.(None): Stork.
p.(None): II TRANSPLANTATION PRINCIPLES
p.(None): Article 5
p.(None): The principle of transplantation availability is achieved in such a way as to provide equal opportunity for transplantation
p.(None): transplantation to all recipients for whom this is the only treatment, with due regard for medical justification and in accordance with
p.(None): medical standards.
p.(None): Article 6
p.(None): The principle of medical justification for transplantation is achieved if it is the most appropriate treatment, in accordance with
p.(None): 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
p.(None): if all have been done previously
p.(None): medical tests that can predict the safety of the donor and the recipient, as well as the success
p.(None): interventions.
p.(None): Article 7
p.(None): The safety principle is achieved by performing the transplant procedure in accordance with a professional one
p.(None): medical science standards, standardized operating procedures, and ethical principles.
p.(None): Article 8
p.(None): The principle of non - discrimination is achieved by prohibiting all forms of discrimination when performing actions on
p.(None): the basis of this law and regulations made thereunder.
p.(None): Article 9
p.(None): The principle of protection of the identity, interests and dignity of the donor and recipient is established in the transplant process, in the manner
p.(None): which ensures and guarantees their respect
p.(None): III ORGANIZATION OF PROFESSIONAL MEDICAL OPERATIONS IN THE FIELD OF TRANSPLANTATION
p.(None): Article 10
...
Social / parents
Searching for indicator parent:
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p.(None): uptake of human tissues and cells.
p.(None): Article 39
p.(None): (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
p.(None): on the basis of written and given written consent for the life of the donor and with the consent of the family.
p.(None): (2) The written consent referred to in paragraph 1 of this Article shall be given before the authorized person of the Coordination
p.(None): 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
p.(None): institution of the third level, appointed by the director.
p.(None): (3) On the basis of written and given written consent, the Coordination Center or health institution referred to in paragraph
p.(None): 2 of this Article, issues to the potential donor a donor card in which the consent is recorded.
p.(None): Article 40
p.(None): Written statement on non-donation of human tissues and cells to an adult capable of reasoning gives to the elect
p.(None): doctor of medicine at the primary level of health care, which must be recorded in the medical record and immediately
p.(None): submits to the Coordination Center.
p.(None): Article 41
p.(None): Taking human tissues and cells from a deceased minor donor and adult donor may be
p.(None): only if both the parent or his legal representative or guardian gives written consent.
p.(None): Article 42
p.(None): (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
p.(None): there is consent from the Ethics Committee.
p.(None): (2) A doctor of medicine, a specialist in gynecology and obstetrics who performed a termination of pregnancy, may not participate in
p.(None): implantation of human tissues and cells resulting from termination of pregnancy, or in any way related to and
p.(None): interested in transplantation.
p.(None): Article 43
p.(None): 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
p.(None): and which has not given written consent under this law, human tissues and cells may be taken for the sake of
p.(None): implantation to another person for the purpose of treatment, only with the written consent of a family member.
p.(None): Article 44
p.(None): An authorized healthcare professional can begin the process of taking human tissues and cells from a deceased person if:
p.(None): a) have at his disposal evidence of the written consent of the deceased person, or a donor card,
...
p.(None): VIII PENALTY PROVISIONS
p.(None): Article 63
p.(None): Whoever, contrary to this law, performs transplantation and taking of human tissues and cells, shall be punished according to the Criminal Code
p.(None): Law of the Republika Srpska (Official Gazette of the Republika Srpska, Nos. 49/03, 108/04, 37/06 and 70/06).
p.(None): Article 64
p.(None): (1) A fine from 20,000 KM to 100,000 KM shall be imposed on a health institution for a misdemeanor if:
p.(None): a) does not determine the brain death of the person from whom the human tissues and cells were taken (Article 35),
p.(None): b) does not detect brain death in a person in deep coma who has no spontaneous breathing and has clearly demonstrated
p.(None): a cause capable of explaining this condition (Article 36) i
p.(None): 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
p.(None): The Coordination Center or if it does not preserve it or record it properly in the documentation (Article 40).
p.(None): (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.
p.(None): health institutions.
p.(None): Article 65
p.(None): (1) A fine of KM 5,000 to KM 10,000 shall be imposed on a doctor of medicine who has:
p.(None): a) place the recipient on the waiting list in the opposite order of urgency according to clinical indications and provisions
p.(None): of this Law (Article 17),
p.(None): b) perform the transplant without the consent of the recipient or his parent or guardian when the recipient
p.(None): a minor or a person without legal capacity (Article 25),
p.(None): v) transplant or perform a transplant, and there is no finding by a medical doctor that they will
p.(None): to improve the recipient's health from such treatment (Article 27) and
p.(None): 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
p.(None): transplantation risk (Article 33).
p.(None): Article 66
p.(None): (1) A legal person dealing with public shall be fined from 10,000 KM to 50,000 KM.
p.(None): informing or transmitting news that advertises the offer or need for human tissues and cells (Article
p.(None): 20).
p.(None): (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
p.(None): KM 2,000 to KM 10,000, which deals with public information or news transmission, which announces an offer or
p.(None): the need for human tissues and cells (Article 20).
p.(None): XI TRANSITIONAL AND FINAL PROVISIONS
p.(None): Article 67
p.(None): The Minister shall, within one year from the day this Law enters into force, issue ordinances on:
p.(None): a) the conditions of the premises, personnel and equipment, as well as the verification procedure for the health care institution that performs it
p.(None): transplantation or human tissue and cell collection (Article 10),
p.(None): b) the manner and procedure of work of the transplant coordinator (Article 14); v) the manner and procedure of keeping the Unified Register
p.(None): donors (Article 14), g) the manner and procedure of compiling and maintaining the Checklist (Article 17),
...
Searching for indicator parents:
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p.(None): (2) Information about the donor cannot be communicated to the recipient, and information about the recipient cannot be communicated to family members
p.(None): of the deceased donor.
p.(None): (3) In order to protect personal data and prevent unauthorized use, certain personal data must be provided
p.(None): replace with the identification code that the sender or recipient receives when registering and entering data into
p.(None): a unique database, maintained at the Coordination Center.
p.(None): (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.
p.(None): Article 23
p.(None): Information on the donor and the recipient, ie all medical and other documentation on transplantation and mediation in
p.(None): transplantation is kept for 30 years in a healthcare facility that has taken or implanted human tissues and
p.(None): cells and shall be destroyed within one year from the expiry of the said period.
p.(None): Article 24
p.(None): (1) The healthcare provider involved in the transplant procedure must complete all tests and procedures necessary for success
p.(None): procedure.
p.(None): (2) The Minister shall prescribe by an ordinance the criteria for testing donors for transmissible diseases
p.(None): by transplantation.
p.(None): Article 25
p.(None): (1) The implantation of human tissues and cells may be performed only with the written consent of the recipient, or both
p.(None): parents or guardians, if the recipient is a minor or a person deprived of legal capacity.
p.(None): (2) The consent referred to in paragraph 1 of this Article must be an expression of free will arising after a complete explanation of
p.(None): the nature and purpose of this treatment, the likelihood of its success, its consequences and risk, as well as others
p.(None): treatment options
p.(None): Article 26
p.(None): The recipient and the living donor of human tissues and cells must be provided with appropriate medical attention
p.(None): monitoring of post-transplant health, in accordance with the standards of the medical profession.
p.(None): V TAKING HUMAN TISSUES AND CELLS FROM A LIVE GIVER
p.(None): Article 27
p.(None): The taking of human tissues and cells from a living donor is done unless there are adequate human ones
p.(None): 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
p.(None): the condition of the recipient, applying such treatment.
p.(None): Article 28
p.(None): (1) In the process of taking human tissues and cells from a living donor, his consent must be obtained in writing, which
p.(None): is an expression of free will.
p.(None): (2) The written consent of the donor referred to in paragraph 1 of this Article shall refer to the planned medical one
p.(None): intervention, that is, taking certain human tissues and cells.
p.(None): (3) A living donor may require that the transplantation of human tissues and cells be performed to a specific recipient.
p.(None): (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
p.(None): in accordance with the law.
p.(None): (5) The health institution referred to in paragraph 4 of this Article shall submit a copy of the written consent to the Coordination
p.(None): center.
p.(None): Article 29
p.(None): (1) The taking of human tissues and cells cannot be carried out by a living juvenile or adult donor who
p.(None): is devoid of legal capacity.
p.(None): (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
p.(None): transplant, take and store stem cells, with the written consent of the parents.
p.(None): (3) The Minister shall prescribe in an ordinance the manner and procedure for taking blood from the umbilical cord of an infant for separation
p.(None): stem cells, and the conditions of storage or storage and distribution of stem cells.
p.(None): Article 30
p.(None): (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
p.(None): with the second degree of kinship.
p.(None): (2) By way of derogation from paragraph 1 of this Article, a living donor may be a spouse or extramarital partner,
p.(None): adopter, adopter and guardian.
p.(None): Article 31
p.(None): (1) The taking of human tissues and cells from a living donor requires the approval of the Ethics Committee established in
p.(None): the health institution where the transplantation is performed, in accordance with the law.
p.(None): (2) The Ethics Committee shall approve on the basis of an insight into the medical records of the living donor or recipient of human
p.(None): tissues and cells after obtaining the written consent of the living donor as well as the written consent of the recipient
p.(None): human tissues and cells, which are given in accordance with this law.
p.(None): Article 32
p.(None): (1) Prior to taking human tissues and cells from a living donor, a medical doctor who performs human taking
p.(None): tissues and cells must perform appropriate medical tests to assess the health risks of the living donor and
p.(None): take action to reduce it.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): the health institution where the transplantation is performed, in accordance with the law.
p.(None): (2) The Ethics Committee shall approve on the basis of an insight into the medical records of the living donor or recipient of human
p.(None): tissues and cells after obtaining the written consent of the living donor as well as the written consent of the recipient
p.(None): human tissues and cells, which are given in accordance with this law.
p.(None): Article 32
p.(None): (1) Prior to taking human tissues and cells from a living donor, a medical doctor who performs human taking
p.(None): tissues and cells must perform appropriate medical tests to assess the health risks of the living donor and
p.(None): take action to reduce it.
p.(None): (2) The effects of taking human tissues and cells on the health of a living donor must not be disproportionate to the
p.(None): the expected improvement in the recipient's health.
p.(None): Article 33
p.(None): (1) A doctor of medicine who performs the taking of human tissues and cells is obliged to instruct the living donor of the purpose
p.(None): and the need to take it, as well as the possible consequences and risk of transplantation.
p.(None): (2) The lesson referred to in paragraph 1 of this Article shall not be suggestive or in any way affect the decision.
p.(None): a living donor, giving consent to take human tissues and cells.
p.(None): (3) A living donor of human tissues and cells has the right to an expert opinion from a healthcare professional with
p.(None): the required experience in the field of transplantation, which does not participate in the uptake or implantation of human tissues and cells.
p.(None): Article 34
p.(None): (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
p.(None): tissues and cells.
p.(None): (2) The consent shall be withdrawn in writing and a copy thereof shall be submitted to the Coordination
p.(None): center.
p.(None): VI TAKING HUMAN TISSUES AND CELLS FROM THE DEAD GIVER
p.(None): Article 35
p.(None): The removal of human tissues and cells from a deceased donor may be performed after, based on medical criteria,
p.(None): in the manner and according to the procedure prescribed by this Law, the brain death of the same was determined.
p.(None): Article 36
p.(None): (1) The intensive care unit of the third- and fourth-level hospitals must determine brain death
p.(None): in a person in deep coma who does not have spontaneous breathing, and there is a clearly proven cause that can explain this condition.
p.(None): (2) The institution referred to in paragraph 1 of this Article must immediately report suspected brain death to the Coordination Center.
p.(None): Article 37
p.(None): (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
p.(None): medicine, appointed by the director of the health care facility.
p.(None): (2) A record on the determined brain death shall be drawn up and signed by all members of the commission
p.(None): medical record and kept in accordance with applicable regulations.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| coma | Comatose |
| criminal | criminal |
| disability | Mentally Disabled |
| education | education |
| employees | employees |
| family | Motherhood/Family |
| fetuses | Fetus/Neonate |
| gender | gender |
| infant | Infant |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| parents | parents |
| party | political affiliation |
| physically | Physically Disabled |
| single | Marital Status |
| socialXwelfare | Access to Social Goods |
| stem cells | stem cells |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| parent | ['parents'] |
| parents | ['parent'] |
Trigger Words
capacity
consent
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input