0A4F4F9BD490A749D5437F821CF06DF1
Regulation of the General Law of Health in Matter of Transplants
http://www.diputados.gob.mx/LeyesBiblio/regley/Reg_LGS_MT.pdf
http://leaux.net/URLS/ConvertAPI Text Files/1BD7294BD0388D09B2FBDAC8136C861F.en.txt
Examining the file media/Synopses/1BD7294BD0388D09B2FBDAC8136C861F.html:
This file was generated: 2020-07-14 06:12:06
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 / Illegal Activity
Searching for indicator crime:
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p.(None): VII. The databases of the National Transplant Registry will be confidential, you can only have access to the
p.(None): according to their field of competence, authorized personnel of:
p.(None): a) CENATRA;
p.(None): b) COFEPRIS;
p.(None): c) Customs authorities;
p.(None): d) State Transplant Centers or State Transplant Councils;
p.(None): e) Institutional Coordinations, and
p.(None): f) Health Establishments that have authorization in terms of article 315 of the Law.
p.(None): Article 63. It is the responsibility of the Director of the Health Establishment to supervise that the person in charge
p.(None): sanitary update the information required in terms of article 338 of the Law.
p.(None): CENATRA must notify COFEPRIS of the breach of the content of this Chapter, so that said
p.(None): Authority proceed in terms of the applicable legal provisions.
p.(None): Article 64. Only Organs, Tissues or cells from deceased Donors may be transplanted, to
p.(None): patients enrolled in the National Transplant Registry at least forty-eight hours before the
p.(None): Donor's loss of life certification. The cases of Urgency of
p.(None): Transplant.
p.(None): SIXTH TITLE
p.(None): INTERVENTION OF THE PUBLIC MINISTRY AND THE JUDICIAL AUTHORITY IN THE DONATION OF ORGANS, FABRICS OR CELLS
p.(None): Single Chapter
p.(None): On the Intervention of the Public Ministry and the Judicial Authority in the Donation of Organs, Tissues or Cells
p.(None): Article 65. In cases where the loss of the Donor's life is related to the investigation of
p.(None): a crime, intervention will be given to the Public Prosecutor's Office, in order to rule on whether the
p.(None): Removal of the organs, tissues and cells of said donor interferes with their investigation.
p.(None): The intervention referred to in the previous paragraph, will be given to the judicial authority in cases where it
p.(None): Find out about the crime in question.
p.(None): The Removal of Organs, Tissues and cells that is performed without giving the intervention to the Public Ministry or the
p.(None): judicial authority, in terms of this article, will give rise to responsibilities
p.(None): administrative and criminal provisions set forth in the applicable legislation.
p.(None): 19 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 66. In the case of persons in whom the loss of life has been certified, whose
p.(None): identity unknown or unable to locate relatives, intervention will be given to the Ministry
p.(None): Public in order to state whether the events that caused the loss of life may constitute a crime and in
p.(None): affirmative case will be as provided in the previous article.
p.(None): In the event that a judicial authority is aware of the facts that caused the loss of the life of
p.(None): people whose identity is unknown or cannot locate their relatives, the intervention of
p.(None): The judicial authority will be carried out in the same terms established in the previous paragraph.
p.(None): Article 67. The determinations of the Public Ministry or of the competent judicial authority that are issued in
p.(None): terms of the provisions of articles 65 and 66 of this Regulation do not constitute an authorization for
p.(None): Carry out the extraction of organs, tissues and cells.
p.(None): The determinations referred to in the preceding paragraph shall be made known to the Hospital Coordinator for
p.(None): that, where appropriate, the latter take the necessary steps to meet the requirements that
p.(None): establish the Law, this Regulation and other applicable legal provisions for the Extraction of
p.(None): Organs, tissues and cells.
p.(None): SEVENTH TITLE
p.(None): NATIONAL SUBSYSTEM OF DONATION AND TRANSPLANTS
p.(None): Single Chapter
p.(None): From the National Donation and Transplant Subsystem
p.(None): Article 68. The National Donation and Transplant Subsystem aims to coordinate actions that facilitate the
p.(None): Transplantation to patients who require it, under the principles of confidentiality,
p.(None): absence of profit, altruism, feasibility, transparency, equity and efficiency, data must be protected
p.(None): personnel in terms of the applicable legal provisions.
...
Political / criminal
Searching for indicator criminal:
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p.(None): Authority proceed in terms of the applicable legal provisions.
p.(None): Article 64. Only Organs, Tissues or cells from deceased Donors may be transplanted, to
p.(None): patients enrolled in the National Transplant Registry at least forty-eight hours before the
p.(None): Donor's loss of life certification. The cases of Urgency of
p.(None): Transplant.
p.(None): SIXTH TITLE
p.(None): INTERVENTION OF THE PUBLIC MINISTRY AND THE JUDICIAL AUTHORITY IN THE DONATION OF ORGANS, FABRICS OR CELLS
p.(None): Single Chapter
p.(None): On the Intervention of the Public Ministry and the Judicial Authority in the Donation of Organs, Tissues or Cells
p.(None): Article 65. In cases where the loss of the Donor's life is related to the investigation of
p.(None): a crime, intervention will be given to the Public Prosecutor's Office, in order to rule on whether the
p.(None): Removal of the organs, tissues and cells of said donor interferes with their investigation.
p.(None): The intervention referred to in the previous paragraph, will be given to the judicial authority in cases where it
p.(None): Find out about the crime in question.
p.(None): The Removal of Organs, Tissues and cells that is performed without giving the intervention to the Public Ministry or the
p.(None): judicial authority, in terms of this article, will give rise to responsibilities
p.(None): administrative and criminal provisions set forth in the applicable legislation.
p.(None): 19 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 66. In the case of persons in whom the loss of life has been certified, whose
p.(None): identity unknown or unable to locate relatives, intervention will be given to the Ministry
p.(None): Public in order to state whether the events that caused the loss of life may constitute a crime and in
p.(None): affirmative case will be as provided in the previous article.
p.(None): In the event that a judicial authority is aware of the facts that caused the loss of the life of
p.(None): people whose identity is unknown or cannot locate their relatives, the intervention of
p.(None): The judicial authority will be carried out in the same terms established in the previous paragraph.
p.(None): Article 67. The determinations of the Public Ministry or of the competent judicial authority that are issued in
p.(None): terms of the provisions of articles 65 and 66 of this Regulation do not constitute an authorization for
p.(None): Carry out the extraction of organs, tissues and cells.
p.(None): The determinations referred to in the preceding paragraph shall be made known to the Hospital Coordinator for
p.(None): that, where appropriate, the latter take the necessary steps to meet the requirements that
p.(None): establish the Law, this Regulation and other applicable legal provisions for the Extraction of
p.(None): Organs, tissues and cells.
p.(None): SEVENTH TITLE
...
Political / political affiliation
Searching for indicator party:
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p.(None): Transplants must have the necessary equipment and conditions that guarantee the adequate transfer of
p.(None): the same, in terms of the applicable legal provisions.
p.(None): For no reason may the organs, tissues and cells be transported in the same vehicle
p.(None): Transplant and materials, equipment, substances or any other object that could contaminate, damage or confuse them.
p.(None): Article 78. The transfer referred to in this Chapter shall be made under the responsibility of the person who for that purpose
p.(None): designate the Internal Transplant Committee of the Health Facility to which the Body has been assigned,
p.(None): Tissue or cell, who must carry a document that identifies and accredits as responsible in
p.(None): Terms of this article. The Internal Transplant Committee before making the transfer, must notify the
p.(None): CENATRA of the person designated for this purpose.
p.(None): Article 79. In the Donor's file, the Health Establishment to which the
p.(None): Organs, tissues or cells; the date of the Procuration, as well as the name of the person responsible for the transfer to
p.(None): referred to in the previous article and the data that derive from the official identification it carries,
p.(None): including the folio number of it.
p.(None): TENTH TITLE
p.(None): PERMITS AND NOTICES
p.(None): Single Chapter
p.(None): Permits and Notices
p.(None): Article 80. Sanitary permit will be required, for admission or departure from the national territory, as the case may be,
p.(None): of Tissues, cells and their Components for Transplant purposes.
p.(None): Article 81. To obtain the sanitary permit for admission to the national territory of Tissues,
p.(None): Cells and their Components for Transplant purposes, the interested party must submit the request to COFEPRIS in the
p.(None): corresponding official format, to which the corresponding documentation will be attached, in accordance with the following:
p.(None): I. Document proving the operation of the Health Establishment issued by the authority
p.(None): health of the country of origin, and
p.(None): II. Sanitary license of the Establishment with specific turn for Transplant.
p.(None): Article 82. For the admission of tissues or cells to the national territory, the Health Establishment that seeks
p.(None): To receive the tissue or cell, you must justify before COFEPRIS and CENATRA the need for their internment, as well as
p.(None): the difficulty of obtaining it in the country.
p.(None): Article 83. To obtain the sanitary permit for the exit of the national territory of Tissues and cells, the
p.(None): interested party must submit an application in the corresponding official form to COFEPRIS, to which the
p.(None): following documentation:
p.(None): I. Copy of the sanitary authorization of the Health Establishment to make the Disposition of Organs,
p.(None): Tissues and cells;
p.(None): 22 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): II. Copy of the document proving the legal operation of the Health Establishment that you will receive
p.(None): Tissues and cells issued by the competent authority, for control purposes of the country of destination, and
p.(None): III. Letter of acceptance of the Health Establishment abroad.
p.(None): Article 84. Documents issued by the Health Establishment or the professional abroad
p.(None): they will be accompanied by their translation when they are written in a language other than Spanish, carried out by an expert
p.(None): translator.
p.(None): Article 85. COFEPRIS must be notified in the following cases:
p.(None): I. The withdrawal, temporary suspension and total or partial resumption of activities of the
p.(None): Health establishments that require health authorization for its operation, in terms of the Law
p.(None): and this Regulation;
p.(None): II. Appointment or removal of the health officer of the Health Establishments, and
p.(None): III. The others determined by the Law, these Regulations and other applicable legal provisions.
p.(None): TITLE ELEVENTH SURVEILLANCE
p.(None): Single Surveillance Chapter
...
Searching for indicator political:
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p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CURRENT TEXT
p.(None): New Regulation published in the Official Gazette of the Federation on March 26, 2014
p.(None): On the margin a seal with the National Shield, which says: United Mexican States.- Presidency of the
p.(None): Republic.
p.(None): ENRIQUE PEÑA NIETO, President of the United Mexican States, in exercise of the power conferred on me by the article
p.(None): 89, section I, of the Political Constitution of the United Mexican States, and based on articles 39 of the
p.(None): Organic Law of the Federal Public Administration and 3rd, section XXVI; 13, section A, section II; 17 Bis, paragraphs
p.(None): first and second, fractions II, IV, VIII and X; 202; 375, fraction VI; 313 to 342; 393 to 401 Bis 2; 462 and 462 Bis,
p.(None): second paragraph, of the General Health Law, I have been pleased to issue the following
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN THE FIELD OF TRANSPLANTS FIRST TITLE
p.(None): GENERAL DISPOSITION
p.(None): Single Chapter
p.(None): Of the General Provisions
p.(None): Article 1. The purpose of this Regulation is to regulate the disposition of organs, tissues and cells,
p.(None): with the exception of blood, blood components and progenitor or stem cells, which is performed for the purpose of
p.(None): transplants Its provisions are of public order, social interest and mandatory application throughout the
p.(None): National territory.
p.(None): Article 2. For the purposes of this Regulation, in addition to the definitions provided in article 314 of the Law,
p.(None): understand by:
p.(None): I. CENATRA: The National Transplant Center;
p.(None): II. State Transplant Centers or State Transplant Councils: The structures
p.(None): administrative or collegiate bodies established by the governments of federal entities or
p.(None): those already in charge of carrying out, in a coordinated manner with CENATRA, the functions
p.(None): linked to the matter of Disposition of Organs, Tissues and cells for Transplant purposes;
p.(None): III. COFEPRIS: The Federal Commission for Protection against Health Risks;
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): I. The medical or surgical specialty related to Transplants to be performed, independently of others
p.(None): health care activities they provide;
p.(None): 15 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): II. Clinical pathology laboratory;
p.(None): III. Pathological laboratory or access to one;
p.(None): IV. Blood bank or transfusion service, capable of providing blood units and Components
p.(None): Blood in the quantity and quality required for the type of transplant they perform;
p.(None): V. Recovery room;
p.(None): SAW. Intensive care unit;
p.(None): VII. Medical staff specialized in the type of transplants they perform, and other professional staff,
p.(None): technical and auxiliary health support with experience in Transplants;
p.(None): VIII. Medications, equipment and surgical medical instruments appropriate to the transplant they perform, and
p.(None): IX. The others indicated in this Regulation and other applicable legal provisions.
p.(None): Health Establishments that perform corneal transplantation exclusively, should only gather the
p.(None): requirements indicated in sections I, II, III, V, VII, VIII and IX, of this article.
p.(None): Article 52. To obtain the authorization referred to in article 315 of the Law, the
p.(None): Health establishments that carry out acts of Extraction, analysis, conservation, preparation and supply
p.(None): Organs, tissues and cells should have the following:
p.(None): I. A physical area with privacy and adequate environment to serve the family members of the potential Donor;
p.(None): II. Necessary equipment, as well as trained personnel for the certification of loss of life;
p.(None): III. A procedure that includes the registration of activities that include Extraction and
p.(None): Exchange of Organs, Tissues and cells, which allow the Traceability of said Organs, Tissues and
p.(None): cells;
p.(None): IV. Computer resources that guarantee electronic communication with CENATRA, and
p.(None): V. The others that indicate other applicable legal provisions.
p.(None): Article 53. The Secretariat may authorize, for therapeutic purposes, the installation of Organ Banks,
p.(None): Tissues and cells.
p.(None): For the purposes of the provisions of the preceding paragraph, an internal manual of
p.(None): procedures that contain the technical guidelines that must be observed in the analysis,
p.(None): conservation and preparation of Organs, Tissues and cells, in order to guarantee their viability and
p.(None): Traceability, as well as complying with infrastructure and equipment requirements, which are foreseen in
p.(None): applicable legal provisions.
p.(None): In the case of banks of Organs and cells, the Secretariat through general provisions published in
p.(None): The Official Gazette of the Federation will determine the functions that these and their health officials will have. These
p.(None): functions will be aimed at keeping the organs and cells in optimal conditions for the purpose of
p.(None): Transplants, their Traceability, as well as to monitor compliance with the applicable legal provisions.
p.(None): 16 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
...
p.(None): Organs, tissues and cells.
p.(None): SEVENTH TITLE
p.(None): NATIONAL SUBSYSTEM OF DONATION AND TRANSPLANTS
p.(None): Single Chapter
p.(None): From the National Donation and Transplant Subsystem
p.(None): Article 68. The National Donation and Transplant Subsystem aims to coordinate actions that facilitate the
p.(None): Transplantation to patients who require it, under the principles of confidentiality,
p.(None): absence of profit, altruism, feasibility, transparency, equity and efficiency, data must be protected
p.(None): personnel in terms of the applicable legal provisions.
p.(None): Article 69. The coordination of the National Donation and Transplant Subsystem is in charge of CENATRA.
p.(None): For the purposes of the preceding paragraph, CENATRA will have the following functions:
p.(None): I. Coordinate the donation and transplant activities of organs, tissues and cells of the
p.(None): members of the National Donation and Transplant Subsystem;
p.(None): II. Periodically evaluate the results achieved by the different members of the National Subsystem of
p.(None): Donation and Transplants, and
p.(None): III. To convene consensus to define the homologation of the criteria of integral medical attention in the matter of
p.(None): Transplants, as well as their diffusion.
p.(None): EIGHTH TITLE
p.(None): RECOGNITION OF THE MERIT AND ALTRUISM OF THE DONOR AND HIS FAMILIES
p.(None): Single Chapter
p.(None): From the Recognition to Merit and Altruism of the Donor and their Families
p.(None): Article 70. The Hospital Coordinator of the Health Establishment in which the donation was made will make
p.(None): record the merit and altruism of the Donor and his family, by means of a letter of
p.(None): 20 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): recognition, addressed to the family of the Donor, referring to the merit for having respected his will. In the
p.(None): Letter will not be specified Organs, Tissues or cells, reason for donation.
p.(None): Article 71. The CENATRA will annually hold a public ceremony of symbolic delivery of recognition
p.(None): to the merit and altruism of the Donor and his family.
p.(None): Likewise, CENATRA will promote that the State Transplant Centers or State Transplant Councils, in the
p.(None): framework of the National Donation and Transplant Subsystem, program annually, preferably during the month of
p.(None): September, the realization of a public ceremony of delivery of the recognition of merit and altruism of the Donor and
p.(None): of his family.
p.(None): NINTH TITLE
p.(None): THE TRANSPORTATION AND PACKING OF ORGANS, FABRICS AND CELLS
p.(None): Single Chapter
p.(None): Of the Transportation and Packaging of Organs, Tissues and Cells
p.(None): Article 72. The transfer of Organs, Tissues and cells of human beings for Transplant purposes, will be done in
p.(None): containers specifically designed for this, that allow its good handling, temperature and conservation in relation to
p.(None): with the type of Organ, Tissue or cell and ischemia time if necessary.
p.(None): Article 73. The containers referred to in the previous article must be identified by means of a document
p.(None): adhered that it will have the following data:
p.(None): I. The legend "ORGANS, FABRICS AND CELLS FOR TRANSPLANTATION";
p.(None): II. Type of Organ, Tissue or cell;
p.(None): III. Name of the Health Establishment where the Extraction was carried out;
p.(None): IV. Name of the Health Facility to be received by the Organ, Tissue or cell, and
p.(None): V. Name of the person responsible for the transfer.
p.(None): Article 74. The container must have a tight-fitting lid and appropriate measures according to the volume of the
p.(None): or the Organs, Tissues or cells to be transported.
p.(None): Article 75. The document must be accompanied by a document with the following information:
p.(None): I. Donor data, consisting of the initials of his name and the type of blood;
p.(None): II. Date and time of the Extraction, in order to determine the beginning of the period of cold ischemia;
p.(None): III. List of Organs, Tissues or cells that are in the container;
p.(None): IV. Destination Health Establishment and result of laboratory tests that rule out a risk
p.(None): sanitary, and
p.(None): V. Name of the person responsible for the transfer.
...
Health / Pregnant
Searching for indicator pregnant:
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p.(None): Health Establishment from which the Organ, Tissue or cell comes, informing the reasons for
p.(None): which it was not possible to perform this transplant, so that the Committee that has been informed determines
p.(None): a new Distribution of the Organ, Tissue or cell in question. Such determination must be notified.
p.(None): immediately to the National Transplant Registry.
p.(None): Article 19. The Health Establishment in which the Removal of the Organ, Tissue or
p.(None): cells must keep documentary evidence of the donation process, for at least five years counted
p.(None): from the Extraction.
p.(None): Chapter II
p.(None): Of Donor Transplants That Have Lost Life
p.(None): 6 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 20. For the Removal of Organs, Tissues and Cells of a Donor in which
p.(None): certified loss of life, in order to minimize the risks of adverse effects on the Recipient and not compromise
p.(None): The success of the Transplant must be verified by the corresponding medical evaluation that the
p.(None): Donor meets the following requirements:
p.(None): I. Have a useful physiological age for donation purposes at the time of loss of life;
p.(None): II. Not having presented malignancies with risk of metastasis, infections or other conditions
p.(None): that could affect the Recipient, and
p.(None): III. Not having suffered the deleterious effect of prolonged agony.
p.(None): Article 21. In the case of pregnant women in which the loss of life has been certified, preference will be given to
p.(None): the life of the product of conception before having Organs, Tissues or cells for Transplants.
p.(None): Article 22. For the realization of a Transplant of Organs, Tissues or cells from a Donor in which
p.(None): the loss of life has been certified, in foreign patients, it must comply with the
p.(None): following requirements:
p.(None): I. The Recipient must have a condition of stay in the national territory of resident
p.(None): temporary, temporary resident student or permanent resident and prove their uninterrupted stay in
p.(None): the country of at least six months prior to the transplant, except in cases of emergency
p.(None): diagnosed with fulminant hepatitis, properly documented, and
p.(None): II. The Recipient must have a favorable resolution from the Internal Transplant Committee of the
p.(None): Health Establishment where the Transplant will be performed, signed by all its members,
p.(None): previous medical, clinical and psychological evaluation. This resolution must state that it has been
p.(None): verified the absence of circumstances that could make presume acts of commerce or legal simulation
p.(None): whose objective is the onerous intermediation of Organs, Tissues and cells.
p.(None): The Secretariat may request the Health Establishment where the Transplant is to be performed, prior
p.(None): to that the same one is realized, the documentation that verifies the fulfillment of the indicated requirements.
p.(None): Article 23. Health professionals responsible for the extraction of organs, tissues or cells, should treat
p.(None): with care, respect and dignity to the Corpse, in order to preserve it and deliver it in the best conditions.
...
Health / hospitalized patients
Searching for indicator hospitalized:
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p.(None): National Transplant through the format established for this purpose by CENATRA, in order to activate a
p.(None): alert in the National Transplant Registry, to Health Establishments about the existence of a patient with
p.(None): Transplant Urgency status, so that they give priority to the Distribution and Assignment of the Organ in
p.(None): question to said patient.
p.(None): The validity of a notification about the existence of a patient with Transplant Urgency status
p.(None): it will be seventy-two hours counted from the receipt of the notification in the National Registry of
p.(None): Transplants, must be updated as many times as necessary, through the procedure indicated in this article.
p.(None): The documentation that supports the Emergency of Transplantation of a patient, must be protected by the Internal Committee of
p.(None): Transplants for a period of five years from the notification referred to in the second paragraph of this
p.(None): article and be available at any time in case the competent authorities require it. From
p.(None): If the Transplant is carried out, the protection of the information will be five years after its completion.
p.(None): Article 42. For cases of Transplant Urgency in the Assignment of the heart, the patient must present
p.(None): any of the following conditions, with no other treatment option:
p.(None): I. Patients with primary failure of the transplanted heart within the first forty-eight
p.(None): hours;
p.(None): II. Patients in cardiogenic shock and ventricular assistance;
p.(None): III. Patients in cardiogenic shock and with intra-aortic balloon counterpulsation;
p.(None): IV. Patients in cardiogenic shock who require vasoactive drugs and mechanical ventilation, or
p.(None): V. Patients hospitalized in functional class IV refractory to medical treatment.
p.(None): If there are several Heart Transplant Emergencies, the order of priority will be
p.(None): established in the previous sections.
p.(None): If there are two or more of the same degree of condition referred to in the first paragraph of this article,
p.(None): will assign by order of inscription in the National Transplant Registry.
p.(None): Article 43. For cases of Emergency Transplantation in the Assignment of the liver, the patient must be in
p.(None): any of the following situations:
p.(None): I. Fulminant or subfulminating hepatitis, and
p.(None): 14 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): II. Primary failure of the transplanted liver.
p.(None): If there are several liver transplant emergencies, the order of priority established will be followed.
p.(None): in the previous fractions.
p.(None): If there are two or more equal situations referred to in the first paragraph of this article, it will be assigned by
p.(None): order of registration in the National Transplant Registry.
p.(None): Article 44. The priority Assignment of a kidney will be in those cases in which there is no possibility of submitting to the
p.(None): patient to a dialytic treatment and his condition endangers his life.
p.(None): Transplant recipients who lose the function of the transplanted kidney within a month,
p.(None): they will retain their seniority in the database of the National Transplant Registry, once they are registered
p.(None): again.
...
Health / patients in emergency situations
Searching for indicator emergencies:
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p.(None): Transplant Urgency status, so that they give priority to the Distribution and Assignment of the Organ in
p.(None): question to said patient.
p.(None): The validity of a notification about the existence of a patient with Transplant Urgency status
p.(None): it will be seventy-two hours counted from the receipt of the notification in the National Registry of
p.(None): Transplants, must be updated as many times as necessary, through the procedure indicated in this article.
p.(None): The documentation that supports the Emergency of Transplantation of a patient, must be protected by the Internal Committee of
p.(None): Transplants for a period of five years from the notification referred to in the second paragraph of this
p.(None): article and be available at any time in case the competent authorities require it. From
p.(None): If the Transplant is carried out, the protection of the information will be five years after its completion.
p.(None): Article 42. For cases of Transplant Urgency in the Assignment of the heart, the patient must present
p.(None): any of the following conditions, with no other treatment option:
p.(None): I. Patients with primary failure of the transplanted heart within the first forty-eight
p.(None): hours;
p.(None): II. Patients in cardiogenic shock and ventricular assistance;
p.(None): III. Patients in cardiogenic shock and with intra-aortic balloon counterpulsation;
p.(None): IV. Patients in cardiogenic shock who require vasoactive drugs and mechanical ventilation, or
p.(None): V. Patients hospitalized in functional class IV refractory to medical treatment.
p.(None): If there are several Heart Transplant Emergencies, the order of priority will be
p.(None): established in the previous sections.
p.(None): If there are two or more of the same degree of condition referred to in the first paragraph of this article,
p.(None): will assign by order of inscription in the National Transplant Registry.
p.(None): Article 43. For cases of Emergency Transplantation in the Assignment of the liver, the patient must be in
p.(None): any of the following situations:
p.(None): I. Fulminant or subfulminating hepatitis, and
p.(None): 14 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): II. Primary failure of the transplanted liver.
p.(None): If there are several liver transplant emergencies, the order of priority established will be followed.
p.(None): in the previous fractions.
p.(None): If there are two or more equal situations referred to in the first paragraph of this article, it will be assigned by
p.(None): order of registration in the National Transplant Registry.
p.(None): Article 44. The priority Assignment of a kidney will be in those cases in which there is no possibility of submitting to the
p.(None): patient to a dialytic treatment and his condition endangers his life.
p.(None): Transplant recipients who lose the function of the transplanted kidney within a month,
p.(None): they will retain their seniority in the database of the National Transplant Registry, once they are registered
p.(None): again.
p.(None): Article 45. A cornea shall be assigned a priority, regardless of whether it comes from abroad, to the
p.(None): patient presenting corneal perforation or ulcer with imminent loss of the eyeball.
p.(None): Article 46. When in a Health Establishment a patient is identified who meets the
p.(None): characteristics indicated in articles 44 or 45 of these Regulations, the Internal Transplant Committee must
p.(None): Notify your Institutional Coordination, if you have it, CENATRA and your State Transplant Center or
p.(None): State Council of Transplants, so that this Transplant can be completed in the shortest possible time.
p.(None): Article 47. Cornea banks may only distribute them to those authorized Health Establishments
p.(None): for Corneal transplantation with those that have signed agreements for this purpose. The conclusion of these agreements is
p.(None): will inform CENATRA.
p.(None): Article 48. Health Institutions that import corneas may only use them for Transplantation
p.(None): in Receivers of their own Health Establishments.
p.(None): Article 49. The trade of Organs, Tissues or cells detached or sectioned by intervention is prohibited.
...
Health / stem cells
Searching for indicator stem cells:
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p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CURRENT TEXT
p.(None): New Regulation published in the Official Gazette of the Federation on March 26, 2014
p.(None): On the margin a seal with the National Shield, which says: United Mexican States.- Presidency of the
p.(None): Republic.
p.(None): ENRIQUE PEÑA NIETO, President of the United Mexican States, in exercise of the power conferred on me by the article
p.(None): 89, section I, of the Political Constitution of the United Mexican States, and based on articles 39 of the
p.(None): Organic Law of the Federal Public Administration and 3rd, section XXVI; 13, section A, section II; 17 Bis, paragraphs
p.(None): first and second, fractions II, IV, VIII and X; 202; 375, fraction VI; 313 to 342; 393 to 401 Bis 2; 462 and 462 Bis,
p.(None): second paragraph, of the General Health Law, I have been pleased to issue the following
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN THE FIELD OF TRANSPLANTS FIRST TITLE
p.(None): GENERAL DISPOSITION
p.(None): Single Chapter
p.(None): Of the General Provisions
p.(None): Article 1. The purpose of this Regulation is to regulate the disposition of organs, tissues and cells,
p.(None): with the exception of blood, blood components and progenitor or stem cells, which is performed for the purpose of
p.(None): transplants Its provisions are of public order, social interest and mandatory application throughout the
p.(None): National territory.
p.(None): Article 2. For the purposes of this Regulation, in addition to the definitions provided in article 314 of the Law,
p.(None): understand by:
p.(None): I. CENATRA: The National Transplant Center;
p.(None): II. State Transplant Centers or State Transplant Councils: The structures
p.(None): administrative or collegiate bodies established by the governments of federal entities or
p.(None): those already in charge of carrying out, in a coordinated manner with CENATRA, the functions
p.(None): linked to the matter of Disposition of Organs, Tissues and cells for Transplant purposes;
p.(None): III. COFEPRIS: The Federal Commission for Protection against Health Risks;
p.(None): IV. Internal Donation Coordination Committee: The Committee referred to in the second paragraph of Article 316
p.(None): of the law;
p.(None): V. Internal Transplant Committee: The Committee referred to in the third paragraph of article 316 of the Law;
p.(None): SAW. Compatibility: The degree of genetic similarity among individuals that is checked after carrying
p.(None): carry out studies corresponding to blood group, immunogenetic,
p.(None): 1 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): anthropometry or those necessary, attending to the Organ, Tissue or cell in question and the scientific progress; what
p.(None): prevent the risk of rejection of the Organ, Tissue or transplanted cells;
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): Article 47. Cornea banks may only distribute them to those authorized Health Establishments
p.(None): for Corneal transplantation with those that have signed agreements for this purpose. The conclusion of these agreements is
p.(None): will inform CENATRA.
p.(None): Article 48. Health Institutions that import corneas may only use them for Transplantation
p.(None): in Receivers of their own Health Establishments.
p.(None): Article 49. The trade of Organs, Tissues or cells detached or sectioned by intervention is prohibited.
p.(None): surgical, accident or wrongful act.
p.(None): FOURTH TITLE
p.(None): HEALTH ESTABLISHMENTS AND HEALTH RESPONSIBLE
p.(None): Single Chapter
p.(None): Of Health Establishments and Health Responsible
p.(None): Article 50. The Health Establishments in terms of article 315 of the Law may only carry out
p.(None): the acts expressly determined by the corresponding sanitary authorization, in the terms established by the Law,
p.(None): these Regulations and other applicable legal provisions.
p.(None): Article 51. To obtain the authorization referred to in article 315 of the Law, the
p.(None): Health establishments that perform acts of Organ, Tissue and Cell Transplants must have:
p.(None): I. The medical or surgical specialty related to Transplants to be performed, independently of others
p.(None): health care activities they provide;
p.(None): 15 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): II. Clinical pathology laboratory;
p.(None): III. Pathological laboratory or access to one;
p.(None): IV. Blood bank or transfusion service, capable of providing blood units and Components
p.(None): Blood in the quantity and quality required for the type of transplant they perform;
p.(None): V. Recovery room;
p.(None): SAW. Intensive care unit;
p.(None): VII. Medical staff specialized in the type of transplants they perform, and other professional staff,
p.(None): technical and auxiliary health support with experience in Transplants;
p.(None): VIII. Medications, equipment and surgical medical instruments appropriate to the transplant they perform, and
p.(None): IX. The others indicated in this Regulation and other applicable legal provisions.
p.(None): Health Establishments that perform corneal transplantation exclusively, should only gather the
p.(None): requirements indicated in sections I, II, III, V, VII, VIII and IX, of this article.
p.(None): Article 52. To obtain the authorization referred to in article 315 of the Law, the
p.(None): Health establishments that carry out acts of Extraction, analysis, conservation, preparation and supply
p.(None): Organs, tissues and cells should have the following:
p.(None): I. A physical area with privacy and adequate environment to serve the family members of the potential Donor;
p.(None): II. Necessary equipment, as well as trained personnel for the certification of loss of life;
p.(None): III. A procedure that includes the registration of activities that include Extraction and
p.(None): Exchange of Organs, Tissues and cells, which allow the Traceability of said Organs, Tissues and
p.(None): cells;
p.(None): IV. Computer resources that guarantee electronic communication with CENATRA, and
p.(None): V. The others that indicate other applicable legal provisions.
p.(None): Article 53. The Secretariat may authorize, for therapeutic purposes, the installation of Organ Banks,
p.(None): Tissues and cells.
...
p.(None): established in the Law, this Regulation, the internal manuals of procedures approved in each
p.(None): bank and other applicable legal provisions;
p.(None): II. Ensure that the quality of the fabrics meets the international standards established to ensure
p.(None): the optimal conditions of the transplant;
p.(None): 17 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): III. Implement and execute actions of Tissue Procurement that are under its protection, the
p.(None): which must be creditable;
p.(None): IV. Guarantee the Traceability of the Tissues, in accordance with the functions performed by the bank;
p.(None): V. Sign agreements with Health Establishments to promote the Distribution of Tissues for the purpose of
p.(None): Transplants;
p.(None): SAW. Maintain the optimal conditions for the transfer of the tissue that guarantee its viability for the transplant;
p.(None): VII. Supervise that the applicable legal provisions are complied with, and
p.(None): VIII. The others that determine the applicable legal provisions.
p.(None): FIFTH TITLE
p.(None): NATIONAL REGISTER OF TRANSPLANTS
p.(None): Single Chapter
p.(None): From the National Transplant Registry
p.(None): Article 61. The National Transplant Registry will operate under a computer system, which will be
p.(None): administered by CENATRA.
p.(None): Article 62. The integration, management and updating of the information of the National Registry of
p.(None): Transplants, in addition to meeting the provisions of the Federal Law on Transparency and Access to Public Information
p.(None): Government, will be subject to the following:
p.(None): I. Health officials should keep the surgeon's registry updated
p.(None): responsible for Extraction and Transplants and that of the Hospital Coordinators of your Establishment
p.(None): Health, informing high or low of these people;
p.(None): II. The health officer of the Health Establishment in which a Transplant will be performed,
p.(None): You must register the patient within forty-eight hours after the Internal Committee of
p.(None): Transplants grant your acceptance as a Candidate Recipient to receive a Transplant;
p.(None): III. Registration of a Candidate Recipient to receive the Transplant in the National Registry of
p.(None): Transplants, in terms of article 338, section V, of the Law, will be done only by the
p.(None): Public, social or private health establishment in which it is treated. In the cases of registration for
p.(None): receive more than one Organ, Tissue or cell, this will be done in the Health Establishment or Establishments in which it is attended,
p.(None): being able to generate more than one record per Recipient, but only one for each Organ, Tissue or cell in question;
p.(None): IV. Patients who transfer from one Health Facility to another, will retain their seniority
p.(None): in the National Transplant Registry;
p.(None): V. The health officer of the Health Establishment must keep the
p.(None): Information from Candidate Recipients to receive a Transplant, notifying the National Registry of
p.(None): Transplants any income or change;
p.(None): 18 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): SAW. The health officer of the Health Establishment must report a donation or
p.(None): of a Transplant, within the periods provided for in article 33, section XI, subsections b) and c), of this Regulation, and
p.(None): VII. The databases of the National Transplant Registry will be confidential, you can only have access to the
p.(None): according to their field of competence, authorized personnel of:
p.(None): a) CENATRA;
p.(None): b) COFEPRIS;
p.(None): c) Customs authorities;
p.(None): d) State Transplant Centers or State Transplant Councils;
p.(None): e) Institutional Coordinations, and
p.(None): f) Health Establishments that have authorization in terms of article 315 of the Law.
p.(None): Article 63. It is the responsibility of the Director of the Health Establishment to supervise that the person in charge
p.(None): sanitary update the information required in terms of article 338 of the Law.
p.(None): CENATRA must notify COFEPRIS of the breach of the content of this Chapter, so that said
p.(None): Authority proceed in terms of the applicable legal provisions.
p.(None): Article 64. Only Organs, Tissues or cells from deceased Donors may be transplanted, to
p.(None): patients enrolled in the National Transplant Registry at least forty-eight hours before the
p.(None): Donor's loss of life certification. The cases of Urgency of
p.(None): Transplant.
p.(None): SIXTH TITLE
p.(None): INTERVENTION OF THE PUBLIC MINISTRY AND THE JUDICIAL AUTHORITY IN THE DONATION OF ORGANS, FABRICS OR CELLS
p.(None): Single Chapter
p.(None): On the Intervention of the Public Ministry and the Judicial Authority in the Donation of Organs, Tissues or Cells
p.(None): Article 65. In cases where the loss of the Donor's life is related to the investigation of
p.(None): a crime, intervention will be given to the Public Prosecutor's Office, in order to rule on whether the
p.(None): Removal of the organs, tissues and cells of said donor interferes with their investigation.
...
Social / Age
Searching for indicator age:
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p.(None): V. Coordinate the National Donation and Transplant Subsystem;
p.(None): SAW. Coordinate the Distribution and Assignment of Organs, Tissues and Donor Cells with loss of life to
p.(None): Transplant, and
p.(None): VII. Operate the National Transplant Registry.
p.(None): Article 5. In any donation or transplant of Organs, Tissues and cells obtained from Donors who had lost the
p.(None): life, the health officials of the Health Establishments and the participating health personnel must
p.(None): keep the identity between the Donor and the Receiver anonymous.
p.(None): SECOND TITLE
p.(None): THE DONATION FOR TRANSPLANTATION PURPOSES
p.(None): Chapter I
p.(None): Consent for Donation for Transplant Purposes
p.(None): Article 6. Under no circumstances may organs, tissues and cells be available for transplant purposes, in
p.(None): against the will of the Donor.
p.(None): Article 7. The donation of the whole of a single Organ, essential for the conservation of life, may only
p.(None): be done once declared the loss of the life of the Donor.
p.(None): The eyes and corneal tissue may only be removed for Donor Transplantation purposes that have lost their lives, or
p.(None): by surgical act by medical indication.
p.(None): Article 8. CENATRA will announce, through publication that is made in the Official Gazette of the Federation, the
p.(None): official format that will be used to express the express consent to donate Organs, Tissues and
p.(None): cells after death for them to be used in transplants, in terms of the second paragraph
p.(None): of article 329 of the Law.
p.(None): The format referred to in the previous paragraph will contain at least the full name
p.(None): of his grantor, his age, sex, nationality, marital status, occupation, personal references, and the indication of
p.(None): document with which you have identified, as well as if it is a broad or limited donation.
p.(None): Article 9. The document in which the Donor expresses his consent for the living donation of his Organs,
p.(None): Tissues and cells for Transplant purposes, must be obtained by the Internal Transplant Committee and at least
p.(None): contain:
p.(None): I. Name of the Donor;
p.(None): II. Donor Address;
p.(None): 3 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): III. Donor Age;
p.(None): IV. Donor sex;
p.(None): V. Marital status of the Donor;
p.(None): SAW. Donor occupation;
p.(None): VII. Name and address of spouse, concubine or concubine, if the Donor has;
p.(None): VIII. Name and address of the parents and in the absence of them, of any of their closest relatives, when the
p.(None): Donor is single;
p.(None): IX. The indication that by his own will and free of charge, he consents to the donation of the
p.(None): Organ, Tissue or cell in question, expressing that this donation will be understood as made between living, which must
p.(None): be in accordance with the applicable legal provisions;
p.(None): X. Name of the Recipient of the Organ, Tissue or cell;
p.(None): XI The indication of having received information to your satisfaction about the risks of the operation
p.(None): and the consequences of the extraction of the organ, tissue or cell;
p.(None): XII. Name, signature and address of the witnesses in the case of a private document;
p.(None): XIII Place and date the document is issued;
p.(None): XIV Signature or fingerprint of the Donor;
p.(None): XV. The indication of whether the donation is made in favor of any particular person or institution. In this case, it
p.(None): You must mention the name or company name or business name of that person or institution, and
p.(None): XVI. The other circumstances of manner, place and time that the donor considers pertinent, as well as
p.(None): any other that conditions the donation.
p.(None): In the case of donation between people in which there is no kind of relationship, it must be exhibited
p.(None): in addition, the express consent granted before a notary public, in terms of the provisions of article 333,
p.(None): Section VI, subsection b), of the Law.
p.(None): Article 10. The document stating the consent granted by the persons referred to in the
p.(None): First paragraph of article 324 of the Law, will be collected by the Hospital Coordinator, once
p.(None): certify the loss of life.
p.(None): The document stating the consent referred to in the preceding paragraph must contain, when
p.(None): less, the following:
p.(None): I. Name of the grantor and date of birth;
p.(None): II. Address of the grantor;
p.(None): III. Name and general information of the Donor, including date of birth, address and
p.(None): nationality;
p.(None): 4 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): IV. Relationship of the grantor with the Donor that legitimizes him to give his consent;
p.(None): V. The statement that he was informed about the donation in question, which was given
p.(None): opportunity to ask questions and that they were answered satisfactorily;
p.(None): SAW. The statement that being of legal age and in full use of his mental faculties,
p.(None): freely authorizes the total or partial donation of the Donor's body, free of charge, to be used for purposes
p.(None): of transplant;
p.(None): VII. Place and date the document is issued, and
p.(None): VIII. Signature or fingerprint of the grantor and that of two witnesses.
p.(None): Article 11. The public or private document by which the person expresses his express refusal to be a Donor, to whom
p.(None): refers to the second paragraph of article 324 of the Law, it will be written in free format, which must contain
p.(None): the signature of the person who expresses said refusal or his fingerprint in case of not being able to sign.
p.(None): Notwithstanding the foregoing, the Donor may express his refusal using the format that for this purpose, give
p.(None): know the CENATRA, through publication that is made in the Official Gazette of the Federation, which
p.(None): It must contain at least the full name of its grantor, his age, sex, nationality, marital status, occupation
p.(None): and the identification of the document with which it has been identified.
p.(None): Chapter II
p.(None): From the Hospital Coordinator
p.(None): Article 12. The Hospital Coordinator, in addition to what is indicated in the Law, will be responsible for:
p.(None): I. Verify that the Corpses of which Organs, Tissues or cells were disposed for Transplant purposes,
p.(None): delivered to their relatives or to the competent authority, with the least possible delay;
p.(None): II. Participate in the elaboration of work programs and projects, as well as manuals of
p.(None): medical, technical and administrative procedures related to the activities of Procurement of Organs, Tissues and
p.(None): cells that the Health Establishment carries out, as well as monitoring their observance;
p.(None): III. Participate in the training and evaluation of the performance of the personnel in charge and, where appropriate, assist in
p.(None): teaching and research activities in the field of transplants;
p.(None): IV. Promote and disseminate strategies and actions that encourage voluntary and altruistic donation to
p.(None): inside the Health Establishment in which they work, and
p.(None): V. The others that indicate other applicable legal provisions.
p.(None): Article 13. The Hospital Coordinator shall perform his duties in coordination with CENATRA, with
p.(None): State Transplant Centers or State Transplant Councils and, where appropriate, with the Coordinations
p.(None): Respective institutions.
p.(None): Article 14. Training of the Hospital Coordinator, referred to in article 316 Bis of the Law, as well as
p.(None): the issuance of the certificate evidencing said training will be in charge of the
...
p.(None): Transplant, this must be granted by those who exercise parental rights, the guardian or the legal representative, according to
p.(None): correspond.
p.(None): Article 18. If for any circumstance in the Health Establishment to which a
p.(None): Organ, tissue or cell to be transplanted, the transplant could not be performed, you must notify it in a manner
p.(None): Immediate in writing to the Internal Donation Coordination Committee or the Internal Transplant Committee of the
p.(None): Health Establishment from which the Organ, Tissue or cell comes, informing the reasons for
p.(None): which it was not possible to perform this transplant, so that the Committee that has been informed determines
p.(None): a new Distribution of the Organ, Tissue or cell in question. Such determination must be notified.
p.(None): immediately to the National Transplant Registry.
p.(None): Article 19. The Health Establishment in which the Removal of the Organ, Tissue or
p.(None): cells must keep documentary evidence of the donation process, for at least five years counted
p.(None): from the Extraction.
p.(None): Chapter II
p.(None): Of Donor Transplants That Have Lost Life
p.(None): 6 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 20. For the Removal of Organs, Tissues and Cells of a Donor in which
p.(None): certified loss of life, in order to minimize the risks of adverse effects on the Recipient and not compromise
p.(None): The success of the Transplant must be verified by the corresponding medical evaluation that the
p.(None): Donor meets the following requirements:
p.(None): I. Have a useful physiological age for donation purposes at the time of loss of life;
p.(None): II. Not having presented malignancies with risk of metastasis, infections or other conditions
p.(None): that could affect the Recipient, and
p.(None): III. Not having suffered the deleterious effect of prolonged agony.
p.(None): Article 21. In the case of pregnant women in which the loss of life has been certified, preference will be given to
p.(None): the life of the product of conception before having Organs, Tissues or cells for Transplants.
p.(None): Article 22. For the realization of a Transplant of Organs, Tissues or cells from a Donor in which
p.(None): the loss of life has been certified, in foreign patients, it must comply with the
p.(None): following requirements:
p.(None): I. The Recipient must have a condition of stay in the national territory of resident
p.(None): temporary, temporary resident student or permanent resident and prove their uninterrupted stay in
p.(None): the country of at least six months prior to the transplant, except in cases of emergency
p.(None): diagnosed with fulminant hepatitis, properly documented, and
p.(None): II. The Recipient must have a favorable resolution from the Internal Transplant Committee of the
p.(None): Health Establishment where the Transplant will be performed, signed by all its members,
p.(None): previous medical, clinical and psychological evaluation. This resolution must state that it has been
p.(None): verified the absence of circumstances that could make presume acts of commerce or legal simulation
p.(None): whose objective is the onerous intermediation of Organs, Tissues and cells.
p.(None): The Secretariat may request the Health Establishment where the Transplant is to be performed, prior
p.(None): to that the same one is realized, the documentation that verifies the fulfillment of the indicated requirements.
p.(None): Article 23. Health professionals responsible for the extraction of organs, tissues or cells, should treat
p.(None): with care, respect and dignity to the Corpse, in order to preserve it and deliver it in the best conditions.
p.(None): Article 24. The Corpse shall be delivered to the next of kin or to the competent authority as the case may be, at the conclusion of the
p.(None): Removal of Organs, Tissues or cells, for the above, hospital procedures should be expedited
p.(None): corresponding.
p.(None): Chapter III
p.(None): Of Transplants Between Live
p.(None): Article 25. In cases of Transplant with Living Donors, once the Internal Committee of
p.(None): Transplants have favorably evaluated both the Donor and the Candidate Recipient, must be
p.(None): Provide, prior to the transplant, the information corresponding to the National Registry of
p.(None): Transplants, through your computer system.
p.(None): 7 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): If after having provided the information referred to in the previous paragraph, the
p.(None): Transplant, the Candidate Recipient will retain the age of its registration in the National Transplant Registry.
p.(None): In cases where the Donor is not related to the patient, the Internal Transplant Committee
p.(None): of the Health Establishment where the Transplant is to be performed, must issue the resolution
p.(None): favorable to do it, prior to the registration of the Candidate Receiver in the National Registry of
p.(None): Transplants This resolution will be signed by all the members of the Internal Transplant Committee of the
p.(None): Health Establishment, when the Donor or Receiver are of foreign nationality.
p.(None): Article 26. The resolution referred to in article 333, section VI, subsection a), of the Law, must contain the
p.(None): next:
p.(None): I. The clinical summary of the case, including medical, clinical and psychological evaluation studies of the Recipient;
p.(None): II. The medical, clinical and psychological evaluation of the Donor, and
p.(None): III. The result of the investigation carried out by the Internal Transplant Committee, which should be considered by the
p.(None): result of the medical, clinical and psychological evaluations performed on the Donor and the Recipient, with the
p.(None): purpose of discarding possible conduct of legal simulation, trade or coercion whose purpose is the
p.(None): Onerous intermediation of Organs, Tissues and cells, stating that the absence of said
p.(None): behaviors
p.(None): For this purpose, the Internal Transplant Committee must add the documents that allow it
p.(None): check the absence of profit motive and coercion facts. These documents must
p.(None): be integrated into the clinical record
p.(None): Article 27. To perform transplants between living, when the Recipient, the Donor or both, are
...
p.(None): Health Establishment where the donation took place, and
p.(None): IV. To any Health Establishment of a National Health Institution.
p.(None): In the cases referred to in sections III and IV of this article, the Internal Committee
p.(None): Coordination for Donation or Transplant, as appropriate, will attempt to deliver
p.(None): Organs, tissues and cells generated in your Health Establishment, to Health Establishments of
p.(None): Health Institutions of its own sector, that is, if the Health Establishment is public, it will look for a
p.(None): Health Establishment of a Public Sector Health Institution, and if private, to a Health Establishment
p.(None): of a private sector Health Institution.
p.(None): Article 39. Internal Transplant Committees may, in exceptional and duly justified cases,
p.(None): previous opinion of CENATRA, establish distribution schemes that allow to allocate organs, tissues and
p.(None): cells to a Health Establishment that does not belong to your Health Institution, with the approval of the
p.(None): Institutional coordination to which it belongs, where appropriate.
p.(None): The reasons that justify the establishment of exceptional distribution schemes referred to in the paragraph
p.(None): above, they may be circumstances that make it more appropriate and feasible to consider a
p.(None): Health Establishment that does not belong to your Health Institution.
p.(None): 13 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 40. For the Distribution and Assignment of Organs, Tissues and Donor Cells that have lost their lives
p.(None): under 18 years of age, called pediatric, in case there is no Transplant Urgency,
p.(None): give preference to recipients who are under 18 years of age.
p.(None): Article 41. The notification of a Transplant Urgency by a Health Establishment implies the Distribution and
p.(None): Nationally preferred allocation of an Organ, Tissue or cell to the patient who has been qualified in such
p.(None): condition.
p.(None): The determination of a Transplant Urgency corresponds to the Internal Transplant Committee of the Establishment of
p.(None): Health in which the transplant will be performed. The Transplant Urgency must be notified to the Registry
p.(None): National Transplant through the format established for this purpose by CENATRA, in order to activate a
p.(None): alert in the National Transplant Registry, to Health Establishments about the existence of a patient with
p.(None): Transplant Urgency status, so that they give priority to the Distribution and Assignment of the Organ in
p.(None): question to said patient.
p.(None): The validity of a notification about the existence of a patient with Transplant Urgency status
p.(None): it will be seventy-two hours counted from the receipt of the notification in the National Registry of
p.(None): Transplants, must be updated as many times as necessary, through the procedure indicated in this article.
p.(None): The documentation that supports the Emergency of Transplantation of a patient, must be protected by the Internal Committee of
p.(None): Transplants for a period of five years from the notification referred to in the second paragraph of this
p.(None): article and be available at any time in case the competent authorities require it. From
p.(None): If the Transplant is carried out, the protection of the information will be five years after its completion.
p.(None): Article 42. For cases of Transplant Urgency in the Assignment of the heart, the patient must present
...
Social / Linguistic Proficiency
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p.(None): result of the medical, clinical and psychological evaluations performed on the Donor and the Recipient, with the
p.(None): purpose of discarding possible conduct of legal simulation, trade or coercion whose purpose is the
p.(None): Onerous intermediation of Organs, Tissues and cells, stating that the absence of said
p.(None): behaviors
p.(None): For this purpose, the Internal Transplant Committee must add the documents that allow it
p.(None): check the absence of profit motive and coercion facts. These documents must
p.(None): be integrated into the clinical record
p.(None): Article 27. To perform transplants between living, when the Recipient, the Donor or both, are
p.(None): foreigners, in addition to complying with the provisions of article 333 of the Law, will be as follows:
p.(None): I. In cases where there is no relationship between the Donor and the Receiver:
p.(None): a) They must prove their condition of regular stay in the country, in the terms of the provisions
p.(None): applicable migration, with a verifiable permanence in national territory, of at least six months
p.(None): prior to the transplant, and
p.(None): b) The Recipient must have a clinical record of at least six months in the Establishment of
p.(None): Health in which said transplant will be performed;
p.(None): II. In cases where there is a relationship between the Donor and the Receiver:
p.(None): a) It must be added to the original clinical file or certified copy of the documentation that proves the relationship
p.(None): kinship, duly apostilled or, where appropriate, legalized in terms of legal provisions
p.(None): applicable. If the documentation exhibited is written in a language other than Spanish, it must be accompanied by
p.(None): the translation performed by a translator expert, and
p.(None): b) The Internal Transplant Committee must draw up an act signed by all its members, in which it is done
p.(None): state that there are no circumstances that make a simulation presume
p.(None): 8 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Legal or trade of Organs, Tissues and cells, or, made of coercion towards the Donor.
p.(None): In order to draw up the minutes referred to in the previous paragraph, the
p.(None): Medical, clinical and psychological evaluations of the Recipient and the Donor.
p.(None): The Health Establishment in which the Transplant is to be performed must register the Candidate Recipient of the
p.(None): Organ, Tissue or cell in the National Transplant Registry at least fifteen business days in advance,
p.(None): if it is a Transplant between relatives by consanguinity, civil or affinity until the fourth grade, and in the
p.(None): other cases, at least six months prior to the transplant.
p.(None): Article 28. In the cases provided for in articles 26, section III and 27, section II, subparagraph b), of this Regulation,
p.(None): COFEPRIS and CENATRA, when they deem it necessary, may request any other element of
p.(None): conviction that allows to prove the legality of the realization of the Transplant.
p.(None): Chapter IV
p.(None): Of the Internal Committees of Coordination for Donation and Transplants
p.(None): Article 29. The Internal Donation Coordination Committees, as well as the Internal Transplant Committees,
...
p.(None): I. Document proving the operation of the Health Establishment issued by the authority
p.(None): health of the country of origin, and
p.(None): II. Sanitary license of the Establishment with specific turn for Transplant.
p.(None): Article 82. For the admission of tissues or cells to the national territory, the Health Establishment that seeks
p.(None): To receive the tissue or cell, you must justify before COFEPRIS and CENATRA the need for their internment, as well as
p.(None): the difficulty of obtaining it in the country.
p.(None): Article 83. To obtain the sanitary permit for the exit of the national territory of Tissues and cells, the
p.(None): interested party must submit an application in the corresponding official form to COFEPRIS, to which the
p.(None): following documentation:
p.(None): I. Copy of the sanitary authorization of the Health Establishment to make the Disposition of Organs,
p.(None): Tissues and cells;
p.(None): 22 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): II. Copy of the document proving the legal operation of the Health Establishment that you will receive
p.(None): Tissues and cells issued by the competent authority, for control purposes of the country of destination, and
p.(None): III. Letter of acceptance of the Health Establishment abroad.
p.(None): Article 84. Documents issued by the Health Establishment or the professional abroad
p.(None): they will be accompanied by their translation when they are written in a language other than Spanish, carried out by an expert
p.(None): translator.
p.(None): Article 85. COFEPRIS must be notified in the following cases:
p.(None): I. The withdrawal, temporary suspension and total or partial resumption of activities of the
p.(None): Health establishments that require health authorization for its operation, in terms of the Law
p.(None): and this Regulation;
p.(None): II. Appointment or removal of the health officer of the Health Establishments, and
p.(None): III. The others determined by the Law, these Regulations and other applicable legal provisions.
p.(None): TITLE ELEVENTH SURVEILLANCE
p.(None): Single Surveillance Chapter
p.(None): Article 86. The Ministry of Health is responsible for monitoring compliance with these Regulations and others.
p.(None): applicable legal provisions, which will be carried out in accordance with the Seventh Title of the Law.
p.(None): Article 87. During the health verification visit and when the health authority deems it
p.(None): necessary, the procedures required to verify that the Organs, tissues, cells,
p.(None): Donors and recipients meet the sanitary conditions and requirements established by the Law, these Regulations and others
p.(None): applicable legal provisions. In case of finding any irregularity, deficiency or anomaly, the authority
p.(None): The company may order the necessary actions to identify the origin of the failures or problems.
p.(None): The minutes that are drawn up for this purpose will be made in accordance with the provisions of article 401, section III, of the Law
p.(None): and other applicable legal provisions.
...
Social / Marital Status
Searching for indicator marital status:
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p.(None): Transplant, and
p.(None): VII. Operate the National Transplant Registry.
p.(None): Article 5. In any donation or transplant of Organs, Tissues and cells obtained from Donors who had lost the
p.(None): life, the health officials of the Health Establishments and the participating health personnel must
p.(None): keep the identity between the Donor and the Receiver anonymous.
p.(None): SECOND TITLE
p.(None): THE DONATION FOR TRANSPLANTATION PURPOSES
p.(None): Chapter I
p.(None): Consent for Donation for Transplant Purposes
p.(None): Article 6. Under no circumstances may organs, tissues and cells be available for transplant purposes, in
p.(None): against the will of the Donor.
p.(None): Article 7. The donation of the whole of a single Organ, essential for the conservation of life, may only
p.(None): be done once declared the loss of the life of the Donor.
p.(None): The eyes and corneal tissue may only be removed for Donor Transplantation purposes that have lost their lives, or
p.(None): by surgical act by medical indication.
p.(None): Article 8. CENATRA will announce, through publication that is made in the Official Gazette of the Federation, the
p.(None): official format that will be used to express the express consent to donate Organs, Tissues and
p.(None): cells after death for them to be used in transplants, in terms of the second paragraph
p.(None): of article 329 of the Law.
p.(None): The format referred to in the previous paragraph will contain at least the full name
p.(None): of his grantor, his age, sex, nationality, marital status, occupation, personal references, and the indication of
p.(None): document with which you have identified, as well as if it is a broad or limited donation.
p.(None): Article 9. The document in which the Donor expresses his consent for the living donation of his Organs,
p.(None): Tissues and cells for Transplant purposes, must be obtained by the Internal Transplant Committee and at least
p.(None): contain:
p.(None): I. Name of the Donor;
p.(None): II. Donor Address;
p.(None): 3 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): III. Donor Age;
p.(None): IV. Donor sex;
p.(None): V. Marital status of the Donor;
p.(None): SAW. Donor occupation;
p.(None): VII. Name and address of spouse, concubine or concubine, if the Donor has;
p.(None): VIII. Name and address of the parents and in the absence of them, of any of their closest relatives, when the
p.(None): Donor is single;
p.(None): IX. The indication that by his own will and free of charge, he consents to the donation of the
p.(None): Organ, Tissue or cell in question, expressing that this donation will be understood as made between living, which must
p.(None): be in accordance with the applicable legal provisions;
p.(None): X. Name of the Recipient of the Organ, Tissue or cell;
p.(None): XI The indication of having received information to your satisfaction about the risks of the operation
p.(None): and the consequences of the extraction of the organ, tissue or cell;
p.(None): XII. Name, signature and address of the witnesses in the case of a private document;
p.(None): XIII Place and date the document is issued;
p.(None): XIV Signature or fingerprint of the Donor;
p.(None): XV. The indication of whether the donation is made in favor of any particular person or institution. In this case, it
p.(None): You must mention the name or company name or business name of that person or institution, and
p.(None): XVI. The other circumstances of manner, place and time that the donor considers pertinent, as well as
p.(None): any other that conditions the donation.
p.(None): In the case of donation between people in which there is no kind of relationship, it must be exhibited
p.(None): in addition, the express consent granted before a notary public, in terms of the provisions of article 333,
...
p.(None): nationality;
p.(None): 4 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): IV. Relationship of the grantor with the Donor that legitimizes him to give his consent;
p.(None): V. The statement that he was informed about the donation in question, which was given
p.(None): opportunity to ask questions and that they were answered satisfactorily;
p.(None): SAW. The statement that being of legal age and in full use of his mental faculties,
p.(None): freely authorizes the total or partial donation of the Donor's body, free of charge, to be used for purposes
p.(None): of transplant;
p.(None): VII. Place and date the document is issued, and
p.(None): VIII. Signature or fingerprint of the grantor and that of two witnesses.
p.(None): Article 11. The public or private document by which the person expresses his express refusal to be a Donor, to whom
p.(None): refers to the second paragraph of article 324 of the Law, it will be written in free format, which must contain
p.(None): the signature of the person who expresses said refusal or his fingerprint in case of not being able to sign.
p.(None): Notwithstanding the foregoing, the Donor may express his refusal using the format that for this purpose, give
p.(None): know the CENATRA, through publication that is made in the Official Gazette of the Federation, which
p.(None): It must contain at least the full name of its grantor, his age, sex, nationality, marital status, occupation
p.(None): and the identification of the document with which it has been identified.
p.(None): Chapter II
p.(None): From the Hospital Coordinator
p.(None): Article 12. The Hospital Coordinator, in addition to what is indicated in the Law, will be responsible for:
p.(None): I. Verify that the Corpses of which Organs, Tissues or cells were disposed for Transplant purposes,
p.(None): delivered to their relatives or to the competent authority, with the least possible delay;
p.(None): II. Participate in the elaboration of work programs and projects, as well as manuals of
p.(None): medical, technical and administrative procedures related to the activities of Procurement of Organs, Tissues and
p.(None): cells that the Health Establishment carries out, as well as monitoring their observance;
p.(None): III. Participate in the training and evaluation of the performance of the personnel in charge and, where appropriate, assist in
p.(None): teaching and research activities in the field of transplants;
p.(None): IV. Promote and disseminate strategies and actions that encourage voluntary and altruistic donation to
p.(None): inside the Health Establishment in which they work, and
p.(None): V. The others that indicate other applicable legal provisions.
p.(None): Article 13. The Hospital Coordinator shall perform his duties in coordination with CENATRA, with
p.(None): State Transplant Centers or State Transplant Councils and, where appropriate, with the Coordinations
p.(None): Respective institutions.
p.(None): Article 14. Training of the Hospital Coordinator, referred to in article 316 Bis of the Law, as well as
p.(None): the issuance of the certificate evidencing said training will be in charge of the
p.(None): 5 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
...
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p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CURRENT TEXT
p.(None): New Regulation published in the Official Gazette of the Federation on March 26, 2014
p.(None): On the margin a seal with the National Shield, which says: United Mexican States.- Presidency of the
p.(None): Republic.
p.(None): ENRIQUE PEÑA NIETO, President of the United Mexican States, in exercise of the power conferred on me by the article
p.(None): 89, section I, of the Political Constitution of the United Mexican States, and based on articles 39 of the
p.(None): Organic Law of the Federal Public Administration and 3rd, section XXVI; 13, section A, section II; 17 Bis, paragraphs
p.(None): first and second, fractions II, IV, VIII and X; 202; 375, fraction VI; 313 to 342; 393 to 401 Bis 2; 462 and 462 Bis,
p.(None): second paragraph, of the General Health Law, I have been pleased to issue the following
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN THE FIELD OF TRANSPLANTS FIRST TITLE
p.(None): GENERAL DISPOSITION
p.(None): Single Chapter
p.(None): Of the General Provisions
p.(None): Article 1. The purpose of this Regulation is to regulate the disposition of organs, tissues and cells,
p.(None): with the exception of blood, blood components and progenitor or stem cells, which is performed for the purpose of
p.(None): transplants Its provisions are of public order, social interest and mandatory application throughout the
p.(None): National territory.
p.(None): Article 2. For the purposes of this Regulation, in addition to the definitions provided in article 314 of the Law,
p.(None): understand by:
p.(None): I. CENATRA: The National Transplant Center;
p.(None): II. State Transplant Centers or State Transplant Councils: The structures
p.(None): administrative or collegiate bodies established by the governments of federal entities or
p.(None): those already in charge of carrying out, in a coordinated manner with CENATRA, the functions
p.(None): linked to the matter of Disposition of Organs, Tissues and cells for Transplant purposes;
p.(None): III. COFEPRIS: The Federal Commission for Protection against Health Risks;
p.(None): IV. Internal Donation Coordination Committee: The Committee referred to in the second paragraph of Article 316
p.(None): of the law;
p.(None): V. Internal Transplant Committee: The Committee referred to in the third paragraph of article 316 of the Law;
p.(None): SAW. Compatibility: The degree of genetic similarity among individuals that is checked after carrying
p.(None): carry out studies corresponding to blood group, immunogenetic,
p.(None): 1 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
...
p.(None): cells, both in life and after the loss of it, for transplant purposes;
p.(None): 2 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): III. Encourage the development of study and research programs related to Organ Disposition,
p.(None): Tissues and cells, in regards to Transplants;
p.(None): IV. Inform and guide the population about the donation of Organs, Tissues and cells for Transplant purposes, as well
p.(None): as, to promote the participation of the media in the dissemination of information related to the actions that
p.(None): involve activities in favor of the culture of donation of organs, tissues and cells;
p.(None): V. Coordinate the National Donation and Transplant Subsystem;
p.(None): SAW. Coordinate the Distribution and Assignment of Organs, Tissues and Donor Cells with loss of life to
p.(None): Transplant, and
p.(None): VII. Operate the National Transplant Registry.
p.(None): Article 5. In any donation or transplant of Organs, Tissues and cells obtained from Donors who had lost the
p.(None): life, the health officials of the Health Establishments and the participating health personnel must
p.(None): keep the identity between the Donor and the Receiver anonymous.
p.(None): SECOND TITLE
p.(None): THE DONATION FOR TRANSPLANTATION PURPOSES
p.(None): Chapter I
p.(None): Consent for Donation for Transplant Purposes
p.(None): Article 6. Under no circumstances may organs, tissues and cells be available for transplant purposes, in
p.(None): against the will of the Donor.
p.(None): Article 7. The donation of the whole of a single Organ, essential for the conservation of life, may only
p.(None): be done once declared the loss of the life of the Donor.
p.(None): The eyes and corneal tissue may only be removed for Donor Transplantation purposes that have lost their lives, or
p.(None): by surgical act by medical indication.
p.(None): Article 8. CENATRA will announce, through publication that is made in the Official Gazette of the Federation, the
p.(None): official format that will be used to express the express consent to donate Organs, Tissues and
p.(None): cells after death for them to be used in transplants, in terms of the second paragraph
p.(None): of article 329 of the Law.
p.(None): The format referred to in the previous paragraph will contain at least the full name
p.(None): of his grantor, his age, sex, nationality, marital status, occupation, personal references, and the indication of
p.(None): document with which you have identified, as well as if it is a broad or limited donation.
p.(None): Article 9. The document in which the Donor expresses his consent for the living donation of his Organs,
p.(None): Tissues and cells for Transplant purposes, must be obtained by the Internal Transplant Committee and at least
p.(None): contain:
p.(None): I. Name of the Donor;
p.(None): II. Donor Address;
p.(None): 3 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): III. Donor Age;
p.(None): IV. Donor sex;
p.(None): V. Marital status of the Donor;
p.(None): SAW. Donor occupation;
p.(None): VII. Name and address of spouse, concubine or concubine, if the Donor has;
p.(None): VIII. Name and address of the parents and in the absence of them, of any of their closest relatives, when the
p.(None): Donor is single;
p.(None): IX. The indication that by his own will and free of charge, he consents to the donation of the
p.(None): Organ, Tissue or cell in question, expressing that this donation will be understood as made between living, which must
p.(None): be in accordance with the applicable legal provisions;
p.(None): X. Name of the Recipient of the Organ, Tissue or cell;
p.(None): XI The indication of having received information to your satisfaction about the risks of the operation
p.(None): and the consequences of the extraction of the organ, tissue or cell;
p.(None): XII. Name, signature and address of the witnesses in the case of a private document;
p.(None): XIII Place and date the document is issued;
p.(None): XIV Signature or fingerprint of the Donor;
p.(None): XV. The indication of whether the donation is made in favor of any particular person or institution. In this case, it
p.(None): You must mention the name or company name or business name of that person or institution, and
p.(None): XVI. The other circumstances of manner, place and time that the donor considers pertinent, as well as
p.(None): any other that conditions the donation.
p.(None): In the case of donation between people in which there is no kind of relationship, it must be exhibited
p.(None): in addition, the express consent granted before a notary public, in terms of the provisions of article 333,
p.(None): Section VI, subsection b), of the Law.
p.(None): Article 10. The document stating the consent granted by the persons referred to in the
p.(None): First paragraph of article 324 of the Law, will be collected by the Hospital Coordinator, once
p.(None): certify the loss of life.
p.(None): The document stating the consent referred to in the preceding paragraph must contain, when
...
p.(None): IV. Promote and disseminate strategies and actions that encourage voluntary and altruistic donation to
p.(None): inside the Health Establishment in which they work, and
p.(None): V. The others that indicate other applicable legal provisions.
p.(None): Article 13. The Hospital Coordinator shall perform his duties in coordination with CENATRA, with
p.(None): State Transplant Centers or State Transplant Councils and, where appropriate, with the Coordinations
p.(None): Respective institutions.
p.(None): Article 14. Training of the Hospital Coordinator, referred to in article 316 Bis of the Law, as well as
p.(None): the issuance of the certificate evidencing said training will be in charge of the
p.(None): 5 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): CENATRA, for which it may benefit from academic institutions, in terms of the agreements that for this purpose are
p.(None): celebrate.
p.(None): Article 15. In addition to the training referred to in article 316 Bis of the Law, the Hospital Coordinator
p.(None): you must prove every five years, before the members of your Internal Donation Coordination Committee, or the
p.(None): Internal Committee of Transplants of the Health Establishment in which they work, which has the knowledge
p.(None): updated to perform its function. Said accreditation must be notified to CENATRA.
p.(None): THIRD TITLE THE TRANSPLANTS
p.(None): Chapter I Common Provisions
p.(None): Article 16. When this Regulation refers to Tissue Transplantation, it may be Tissue Transplant.
p.(None): simple or compound, understood as a Simple Tissue Transplant, one that is made of a single Tissue, and of
p.(None): Composite tissue, that Transplant that is performed of different musculoskeletal tissues, using or not
p.(None): vascular anastomosis, among which are those of limbs and face.
p.(None): Article 17. A person will be considered a candidate to receive a Transplant when:
p.(None): I. Have a condition that can be treated effectively through an Organ Transplant,
p.(None): Tissue or cell;
p.(None): II. Do not present other diseases that could put at risk the success of the Transplant;
p.(None): III. Have a physical and mental condition that allows us to assume that it will tolerate the Transplant and its evolution, and
p.(None): IV. Grant your informed consent in accordance with the applicable legal provisions.
p.(None): In the case of minors or the patient's inability to grant their consent for the performance of the
p.(None): Transplant, this must be granted by those who exercise parental rights, the guardian or the legal representative, according to
p.(None): correspond.
p.(None): Article 18. If for any circumstance in the Health Establishment to which a
p.(None): Organ, tissue or cell to be transplanted, the transplant could not be performed, you must notify it in a manner
p.(None): Immediate in writing to the Internal Donation Coordination Committee or the Internal Transplant Committee of the
p.(None): Health Establishment from which the Organ, Tissue or cell comes, informing the reasons for
p.(None): which it was not possible to perform this transplant, so that the Committee that has been informed determines
p.(None): a new Distribution of the Organ, Tissue or cell in question. Such determination must be notified.
p.(None): immediately to the National Transplant Registry.
...
p.(None): order of registration in the National Transplant Registry.
p.(None): Article 44. The priority Assignment of a kidney will be in those cases in which there is no possibility of submitting to the
p.(None): patient to a dialytic treatment and his condition endangers his life.
p.(None): Transplant recipients who lose the function of the transplanted kidney within a month,
p.(None): they will retain their seniority in the database of the National Transplant Registry, once they are registered
p.(None): again.
p.(None): Article 45. A cornea shall be assigned a priority, regardless of whether it comes from abroad, to the
p.(None): patient presenting corneal perforation or ulcer with imminent loss of the eyeball.
p.(None): Article 46. When in a Health Establishment a patient is identified who meets the
p.(None): characteristics indicated in articles 44 or 45 of these Regulations, the Internal Transplant Committee must
p.(None): Notify your Institutional Coordination, if you have it, CENATRA and your State Transplant Center or
p.(None): State Council of Transplants, so that this Transplant can be completed in the shortest possible time.
p.(None): Article 47. Cornea banks may only distribute them to those authorized Health Establishments
p.(None): for Corneal transplantation with those that have signed agreements for this purpose. The conclusion of these agreements is
p.(None): will inform CENATRA.
p.(None): Article 48. Health Institutions that import corneas may only use them for Transplantation
p.(None): in Receivers of their own Health Establishments.
p.(None): Article 49. The trade of Organs, Tissues or cells detached or sectioned by intervention is prohibited.
p.(None): surgical, accident or wrongful act.
p.(None): FOURTH TITLE
p.(None): HEALTH ESTABLISHMENTS AND HEALTH RESPONSIBLE
p.(None): Single Chapter
p.(None): Of Health Establishments and Health Responsible
p.(None): Article 50. The Health Establishments in terms of article 315 of the Law may only carry out
p.(None): the acts expressly determined by the corresponding sanitary authorization, in the terms established by the Law,
p.(None): these Regulations and other applicable legal provisions.
p.(None): Article 51. To obtain the authorization referred to in article 315 of the Law, the
p.(None): Health establishments that perform acts of Organ, Tissue and Cell Transplants must have:
p.(None): I. The medical or surgical specialty related to Transplants to be performed, independently of others
p.(None): health care activities they provide;
p.(None): 15 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): II. Clinical pathology laboratory;
p.(None): III. Pathological laboratory or access to one;
p.(None): IV. Blood bank or transfusion service, capable of providing blood units and Components
p.(None): Blood in the quantity and quality required for the type of transplant they perform;
p.(None): V. Recovery room;
p.(None): SAW. Intensive care unit;
p.(None): VII. Medical staff specialized in the type of transplants they perform, and other professional staff,
p.(None): technical and auxiliary health support with experience in Transplants;
p.(None): VIII. Medications, equipment and surgical medical instruments appropriate to the transplant they perform, and
p.(None): IX. The others indicated in this Regulation and other applicable legal provisions.
p.(None): Health Establishments that perform corneal transplantation exclusively, should only gather the
...
p.(None): authorized, and
p.(None): II. Maintain the Fabric in optimum condition until its processing or Final Destination, or,
p.(None): Send it to another Health Facility.
p.(None): Article 60. Those responsible for Tissue Banks will have the following functions:
p.(None): I. Ensure that the preservation and storage of tissues is carried out in accordance with the
p.(None): established in the Law, this Regulation, the internal manuals of procedures approved in each
p.(None): bank and other applicable legal provisions;
p.(None): II. Ensure that the quality of the fabrics meets the international standards established to ensure
p.(None): the optimal conditions of the transplant;
p.(None): 17 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): III. Implement and execute actions of Tissue Procurement that are under its protection, the
p.(None): which must be creditable;
p.(None): IV. Guarantee the Traceability of the Tissues, in accordance with the functions performed by the bank;
p.(None): V. Sign agreements with Health Establishments to promote the Distribution of Tissues for the purpose of
p.(None): Transplants;
p.(None): SAW. Maintain the optimal conditions for the transfer of the tissue that guarantee its viability for the transplant;
p.(None): VII. Supervise that the applicable legal provisions are complied with, and
p.(None): VIII. The others that determine the applicable legal provisions.
p.(None): FIFTH TITLE
p.(None): NATIONAL REGISTER OF TRANSPLANTS
p.(None): Single Chapter
p.(None): From the National Transplant Registry
p.(None): Article 61. The National Transplant Registry will operate under a computer system, which will be
p.(None): administered by CENATRA.
p.(None): Article 62. The integration, management and updating of the information of the National Registry of
p.(None): Transplants, in addition to meeting the provisions of the Federal Law on Transparency and Access to Public Information
p.(None): Government, will be subject to the following:
p.(None): I. Health officials should keep the surgeon's registry updated
p.(None): responsible for Extraction and Transplants and that of the Hospital Coordinators of your Establishment
p.(None): Health, informing high or low of these people;
p.(None): II. The health officer of the Health Establishment in which a Transplant will be performed,
p.(None): You must register the patient within forty-eight hours after the Internal Committee of
p.(None): Transplants grant your acceptance as a Candidate Recipient to receive a Transplant;
p.(None): III. Registration of a Candidate Recipient to receive the Transplant in the National Registry of
p.(None): Transplants, in terms of article 338, section V, of the Law, will be done only by the
p.(None): Public, social or private health establishment in which it is treated. In the cases of registration for
p.(None): receive more than one Organ, Tissue or cell, this will be done in the Health Establishment or Establishments in which it is attended,
p.(None): being able to generate more than one record per Recipient, but only one for each Organ, Tissue or cell in question;
p.(None): IV. Patients who transfer from one Health Facility to another, will retain their seniority
p.(None): in the National Transplant Registry;
...
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): SAW. The health officer of the Health Establishment must report a donation or
p.(None): of a Transplant, within the periods provided for in article 33, section XI, subsections b) and c), of this Regulation, and
p.(None): VII. The databases of the National Transplant Registry will be confidential, you can only have access to the
p.(None): according to their field of competence, authorized personnel of:
p.(None): a) CENATRA;
p.(None): b) COFEPRIS;
p.(None): c) Customs authorities;
p.(None): d) State Transplant Centers or State Transplant Councils;
p.(None): e) Institutional Coordinations, and
p.(None): f) Health Establishments that have authorization in terms of article 315 of the Law.
p.(None): Article 63. It is the responsibility of the Director of the Health Establishment to supervise that the person in charge
p.(None): sanitary update the information required in terms of article 338 of the Law.
p.(None): CENATRA must notify COFEPRIS of the breach of the content of this Chapter, so that said
p.(None): Authority proceed in terms of the applicable legal provisions.
p.(None): Article 64. Only Organs, Tissues or cells from deceased Donors may be transplanted, to
p.(None): patients enrolled in the National Transplant Registry at least forty-eight hours before the
p.(None): Donor's loss of life certification. The cases of Urgency of
p.(None): Transplant.
p.(None): SIXTH TITLE
p.(None): INTERVENTION OF THE PUBLIC MINISTRY AND THE JUDICIAL AUTHORITY IN THE DONATION OF ORGANS, FABRICS OR CELLS
p.(None): Single Chapter
p.(None): On the Intervention of the Public Ministry and the Judicial Authority in the Donation of Organs, Tissues or Cells
p.(None): Article 65. In cases where the loss of the Donor's life is related to the investigation of
p.(None): a crime, intervention will be given to the Public Prosecutor's Office, in order to rule on whether the
p.(None): Removal of the organs, tissues and cells of said donor interferes with their investigation.
p.(None): The intervention referred to in the previous paragraph, will be given to the judicial authority in cases where it
p.(None): Find out about the crime in question.
p.(None): The Removal of Organs, Tissues and cells that is performed without giving the intervention to the Public Ministry or the
p.(None): judicial authority, in terms of this article, will give rise to responsibilities
p.(None): administrative and criminal provisions set forth in the applicable legislation.
p.(None): 19 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 66. In the case of persons in whom the loss of life has been certified, whose
p.(None): identity unknown or unable to locate relatives, intervention will be given to the Ministry
p.(None): Public in order to state whether the events that caused the loss of life may constitute a crime and in
p.(None): affirmative case will be as provided in the previous article.
p.(None): In the event that a judicial authority is aware of the facts that caused the loss of the life of
p.(None): people whose identity is unknown or cannot locate their relatives, the intervention of
p.(None): The judicial authority will be carried out in the same terms established in the previous paragraph.
p.(None): Article 67. The determinations of the Public Ministry or of the competent judicial authority that are issued in
p.(None): terms of the provisions of articles 65 and 66 of this Regulation do not constitute an authorization for
p.(None): Carry out the extraction of organs, tissues and cells.
p.(None): The determinations referred to in the preceding paragraph shall be made known to the Hospital Coordinator for
p.(None): that, where appropriate, the latter take the necessary steps to meet the requirements that
p.(None): establish the Law, this Regulation and other applicable legal provisions for the Extraction of
p.(None): Organs, tissues and cells.
p.(None): SEVENTH TITLE
p.(None): NATIONAL SUBSYSTEM OF DONATION AND TRANSPLANTS
p.(None): Single Chapter
p.(None): From the National Donation and Transplant Subsystem
p.(None): Article 68. The National Donation and Transplant Subsystem aims to coordinate actions that facilitate the
p.(None): Transplantation to patients who require it, under the principles of confidentiality,
p.(None): absence of profit, altruism, feasibility, transparency, equity and efficiency, data must be protected
p.(None): personnel in terms of the applicable legal provisions.
p.(None): Article 69. The coordination of the National Donation and Transplant Subsystem is in charge of CENATRA.
p.(None): For the purposes of the preceding paragraph, CENATRA will have the following functions:
p.(None): I. Coordinate the donation and transplant activities of organs, tissues and cells of the
p.(None): members of the National Donation and Transplant Subsystem;
p.(None): II. Periodically evaluate the results achieved by the different members of the National Subsystem of
p.(None): Donation and Transplants, and
p.(None): III. To convene consensus to define the homologation of the criteria of integral medical attention in the matter of
p.(None): Transplants, as well as their diffusion.
p.(None): EIGHTH TITLE
p.(None): RECOGNITION OF THE MERIT AND ALTRUISM OF THE DONOR AND HIS FAMILIES
p.(None): Single Chapter
p.(None): From the Recognition to Merit and Altruism of the Donor and their Families
p.(None): Article 70. The Hospital Coordinator of the Health Establishment in which the donation was made will make
p.(None): record the merit and altruism of the Donor and his family, by means of a letter of
p.(None): 20 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): recognition, addressed to the family of the Donor, referring to the merit for having respected his will. In the
p.(None): Letter will not be specified Organs, Tissues or cells, reason for donation.
p.(None): Article 71. The CENATRA will annually hold a public ceremony of symbolic delivery of recognition
p.(None): to the merit and altruism of the Donor and his family.
p.(None): Likewise, CENATRA will promote that the State Transplant Centers or State Transplant Councils, in the
p.(None): framework of the National Donation and Transplant Subsystem, program annually, preferably during the month of
p.(None): September, the realization of a public ceremony of delivery of the recognition of merit and altruism of the Donor and
p.(None): of his family.
p.(None): NINTH TITLE
p.(None): THE TRANSPORTATION AND PACKING OF ORGANS, FABRICS AND CELLS
p.(None): Single Chapter
p.(None): Of the Transportation and Packaging of Organs, Tissues and Cells
p.(None): Article 72. The transfer of Organs, Tissues and cells of human beings for Transplant purposes, will be done in
p.(None): containers specifically designed for this, that allow its good handling, temperature and conservation in relation to
p.(None): with the type of Organ, Tissue or cell and ischemia time if necessary.
p.(None): Article 73. The containers referred to in the previous article must be identified by means of a document
p.(None): adhered that it will have the following data:
p.(None): I. The legend "ORGANS, FABRICS AND CELLS FOR TRANSPLANTATION";
p.(None): II. Type of Organ, Tissue or cell;
p.(None): III. Name of the Health Establishment where the Extraction was carried out;
p.(None): IV. Name of the Health Facility to be received by the Organ, Tissue or cell, and
p.(None): V. Name of the person responsible for the transfer.
p.(None): Article 74. The container must have a tight-fitting lid and appropriate measures according to the volume of the
p.(None): or the Organs, Tissues or cells to be transported.
p.(None): Article 75. The document must be accompanied by a document with the following information:
p.(None): I. Donor data, consisting of the initials of his name and the type of blood;
p.(None): II. Date and time of the Extraction, in order to determine the beginning of the period of cold ischemia;
p.(None): III. List of Organs, Tissues or cells that are in the container;
p.(None): IV. Destination Health Establishment and result of laboratory tests that rule out a risk
p.(None): sanitary, and
p.(None): V. Name of the person responsible for the transfer.
p.(None): Article 76. For the management and conservation of the Organs, Tissues or cells to be transplanted, they must be used,
...
p.(None): 21 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Preservation thereof, in terms of the applicable legal provisions and through the techniques
p.(None): internationally accepted.
p.(None): Article 77. Vehicles dedicated to the transport of Organs, Tissues and cells of human beings for the purpose of
p.(None): Transplants must have the necessary equipment and conditions that guarantee the adequate transfer of
p.(None): the same, in terms of the applicable legal provisions.
p.(None): For no reason may the organs, tissues and cells be transported in the same vehicle
p.(None): Transplant and materials, equipment, substances or any other object that could contaminate, damage or confuse them.
p.(None): Article 78. The transfer referred to in this Chapter shall be made under the responsibility of the person who for that purpose
p.(None): designate the Internal Transplant Committee of the Health Facility to which the Body has been assigned,
p.(None): Tissue or cell, who must carry a document that identifies and accredits as responsible in
p.(None): Terms of this article. The Internal Transplant Committee before making the transfer, must notify the
p.(None): CENATRA of the person designated for this purpose.
p.(None): Article 79. In the Donor's file, the Health Establishment to which the
p.(None): Organs, tissues or cells; the date of the Procuration, as well as the name of the person responsible for the transfer to
p.(None): referred to in the previous article and the data that derive from the official identification it carries,
p.(None): including the folio number of it.
p.(None): TENTH TITLE
p.(None): PERMITS AND NOTICES
p.(None): Single Chapter
p.(None): Permits and Notices
p.(None): Article 80. Sanitary permit will be required, for admission or departure from the national territory, as the case may be,
p.(None): of Tissues, cells and their Components for Transplant purposes.
p.(None): Article 81. To obtain the sanitary permit for admission to the national territory of Tissues,
p.(None): Cells and their Components for Transplant purposes, the interested party must submit the request to COFEPRIS in the
p.(None): corresponding official format, to which the corresponding documentation will be attached, in accordance with the following:
p.(None): I. Document proving the operation of the Health Establishment issued by the authority
p.(None): health of the country of origin, and
p.(None): II. Sanitary license of the Establishment with specific turn for Transplant.
p.(None): Article 82. For the admission of tissues or cells to the national territory, the Health Establishment that seeks
p.(None): To receive the tissue or cell, you must justify before COFEPRIS and CENATRA the need for their internment, as well as
p.(None): the difficulty of obtaining it in the country.
p.(None): Article 83. To obtain the sanitary permit for the exit of the national territory of Tissues and cells, the
p.(None): interested party must submit an application in the corresponding official form to COFEPRIS, to which the
p.(None): following documentation:
p.(None): I. Copy of the sanitary authorization of the Health Establishment to make the Disposition of Organs,
p.(None): Tissues and cells;
p.(None): 22 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): II. Copy of the document proving the legal operation of the Health Establishment that you will receive
p.(None): Tissues and cells issued by the competent authority, for control purposes of the country of destination, and
p.(None): III. Letter of acceptance of the Health Establishment abroad.
p.(None): Article 84. Documents issued by the Health Establishment or the professional abroad
p.(None): they will be accompanied by their translation when they are written in a language other than Spanish, carried out by an expert
p.(None): translator.
p.(None): Article 85. COFEPRIS must be notified in the following cases:
p.(None): I. The withdrawal, temporary suspension and total or partial resumption of activities of the
p.(None): Health establishments that require health authorization for its operation, in terms of the Law
p.(None): and this Regulation;
p.(None): II. Appointment or removal of the health officer of the Health Establishments, and
p.(None): III. The others determined by the Law, these Regulations and other applicable legal provisions.
p.(None): TITLE ELEVENTH SURVEILLANCE
p.(None): Single Surveillance Chapter
p.(None): Article 86. The Ministry of Health is responsible for monitoring compliance with these Regulations and others.
p.(None): applicable legal provisions, which will be carried out in accordance with the Seventh Title of the Law.
p.(None): Article 87. During the health verification visit and when the health authority deems it
p.(None): necessary, the procedures required to verify that the Organs, tissues, cells,
p.(None): Donors and recipients meet the sanitary conditions and requirements established by the Law, these Regulations and others
p.(None): applicable legal provisions. In case of finding any irregularity, deficiency or anomaly, the authority
p.(None): The company may order the necessary actions to identify the origin of the failures or problems.
p.(None): The minutes that are drawn up for this purpose will be made in accordance with the provisions of article 401, section III, of the Law
p.(None): and other applicable legal provisions.
p.(None): Article 88. The health authority may, at any time, determine the cases in which the Bodies,
p.(None): Tissues and their Components and cells do not meet the requirements and optimal conditions for their use, in the
p.(None): terms established by these Regulations and in the other applicable legal provisions.
p.(None): Article 89. In the exercise of its powers, the health authority may request the support of the
p.(None): personnel from the technical areas of the Secretariat that are considered necessary.
p.(None): TRANSITORY
p.(None): FIRST. This Regulation shall enter into force on the day following its publication in the Official Gazette of the
p.(None): Federation.
p.(None): 23 of 24
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p.(None): Transplant, and
p.(None): VII. Operate the National Transplant Registry.
p.(None): Article 5. In any donation or transplant of Organs, Tissues and cells obtained from Donors who had lost the
p.(None): life, the health officials of the Health Establishments and the participating health personnel must
p.(None): keep the identity between the Donor and the Receiver anonymous.
p.(None): SECOND TITLE
p.(None): THE DONATION FOR TRANSPLANTATION PURPOSES
p.(None): Chapter I
p.(None): Consent for Donation for Transplant Purposes
p.(None): Article 6. Under no circumstances may organs, tissues and cells be available for transplant purposes, in
p.(None): against the will of the Donor.
p.(None): Article 7. The donation of the whole of a single Organ, essential for the conservation of life, may only
p.(None): be done once declared the loss of the life of the Donor.
p.(None): The eyes and corneal tissue may only be removed for Donor Transplantation purposes that have lost their lives, or
p.(None): by surgical act by medical indication.
p.(None): Article 8. CENATRA will announce, through publication that is made in the Official Gazette of the Federation, the
p.(None): official format that will be used to express the express consent to donate Organs, Tissues and
p.(None): cells after death for them to be used in transplants, in terms of the second paragraph
p.(None): of article 329 of the Law.
p.(None): The format referred to in the previous paragraph will contain at least the full name
p.(None): of his grantor, his age, sex, nationality, marital status, occupation, personal references, and the indication of
p.(None): document with which you have identified, as well as if it is a broad or limited donation.
p.(None): Article 9. The document in which the Donor expresses his consent for the living donation of his Organs,
p.(None): Tissues and cells for Transplant purposes, must be obtained by the Internal Transplant Committee and at least
p.(None): contain:
p.(None): I. Name of the Donor;
p.(None): II. Donor Address;
p.(None): 3 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): III. Donor Age;
p.(None): IV. Donor sex;
p.(None): V. Marital status of the Donor;
p.(None): SAW. Donor occupation;
p.(None): VII. Name and address of spouse, concubine or concubine, if the Donor has;
p.(None): VIII. Name and address of the parents and in the absence of them, of any of their closest relatives, when the
p.(None): Donor is single;
p.(None): IX. The indication that by his own will and free of charge, he consents to the donation of the
p.(None): Organ, Tissue or cell in question, expressing that this donation will be understood as made between living, which must
p.(None): be in accordance with the applicable legal provisions;
p.(None): X. Name of the Recipient of the Organ, Tissue or cell;
p.(None): XI The indication of having received information to your satisfaction about the risks of the operation
p.(None): and the consequences of the extraction of the organ, tissue or cell;
p.(None): XII. Name, signature and address of the witnesses in the case of a private document;
p.(None): XIII Place and date the document is issued;
p.(None): XIV Signature or fingerprint of the Donor;
p.(None): XV. The indication of whether the donation is made in favor of any particular person or institution. In this case, it
p.(None): You must mention the name or company name or business name of that person or institution, and
p.(None): XVI. The other circumstances of manner, place and time that the donor considers pertinent, as well as
p.(None): any other that conditions the donation.
p.(None): In the case of donation between people in which there is no kind of relationship, it must be exhibited
p.(None): in addition, the express consent granted before a notary public, in terms of the provisions of article 333,
p.(None): Section VI, subsection b), of the Law.
...
p.(None): nationality;
p.(None): 4 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): IV. Relationship of the grantor with the Donor that legitimizes him to give his consent;
p.(None): V. The statement that he was informed about the donation in question, which was given
p.(None): opportunity to ask questions and that they were answered satisfactorily;
p.(None): SAW. The statement that being of legal age and in full use of his mental faculties,
p.(None): freely authorizes the total or partial donation of the Donor's body, free of charge, to be used for purposes
p.(None): of transplant;
p.(None): VII. Place and date the document is issued, and
p.(None): VIII. Signature or fingerprint of the grantor and that of two witnesses.
p.(None): Article 11. The public or private document by which the person expresses his express refusal to be a Donor, to whom
p.(None): refers to the second paragraph of article 324 of the Law, it will be written in free format, which must contain
p.(None): the signature of the person who expresses said refusal or his fingerprint in case of not being able to sign.
p.(None): Notwithstanding the foregoing, the Donor may express his refusal using the format that for this purpose, give
p.(None): know the CENATRA, through publication that is made in the Official Gazette of the Federation, which
p.(None): It must contain at least the full name of its grantor, his age, sex, nationality, marital status, occupation
p.(None): and the identification of the document with which it has been identified.
p.(None): Chapter II
p.(None): From the Hospital Coordinator
p.(None): Article 12. The Hospital Coordinator, in addition to what is indicated in the Law, will be responsible for:
p.(None): I. Verify that the Corpses of which Organs, Tissues or cells were disposed for Transplant purposes,
p.(None): delivered to their relatives or to the competent authority, with the least possible delay;
p.(None): II. Participate in the elaboration of work programs and projects, as well as manuals of
p.(None): medical, technical and administrative procedures related to the activities of Procurement of Organs, Tissues and
p.(None): cells that the Health Establishment carries out, as well as monitoring their observance;
p.(None): III. Participate in the training and evaluation of the performance of the personnel in charge and, where appropriate, assist in
p.(None): teaching and research activities in the field of transplants;
p.(None): IV. Promote and disseminate strategies and actions that encourage voluntary and altruistic donation to
p.(None): inside the Health Establishment in which they work, and
p.(None): V. The others that indicate other applicable legal provisions.
p.(None): Article 13. The Hospital Coordinator shall perform his duties in coordination with CENATRA, with
p.(None): State Transplant Centers or State Transplant Councils and, where appropriate, with the Coordinations
p.(None): Respective institutions.
p.(None): Article 14. Training of the Hospital Coordinator, referred to in article 316 Bis of the Law, as well as
p.(None): the issuance of the certificate evidencing said training will be in charge of the
p.(None): 5 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
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p.(None): other cases, at least six months prior to the transplant.
p.(None): Article 28. In the cases provided for in articles 26, section III and 27, section II, subparagraph b), of this Regulation,
p.(None): COFEPRIS and CENATRA, when they deem it necessary, may request any other element of
p.(None): conviction that allows to prove the legality of the realization of the Transplant.
p.(None): Chapter IV
p.(None): Of the Internal Committees of Coordination for Donation and Transplants
p.(None): Article 29. The Internal Donation Coordination Committees, as well as the Internal Transplant Committees,
p.(None): must be installed under the responsibility of the directors or holders of the Establishments
p.(None): Health, by signing an act, which must stipulate their respective characteristics,
p.(None): operation and operation, as well as the people who integrate them, in accordance with the provisions of the Law, the
p.(None): this Regulation and other applicable legal provisions.
p.(None): Article 30. The Internal Donation Coordination Committees shall be composed of:
p.(None): I. The Director General or his equivalent of the Health Establishment, and in his absence, his
p.(None): Immediately inferior that has a high level of medical, academic and professional knowledge, who
p.(None): will preside;
p.(None): II. A representative of the Hospital Bioethics Committee of the Health Establishment;
p.(None): III. A representative of the legal area of the Health Establishment, in case of having said area or of the
p.(None): Institution to which it belongs;
p.(None): IV. The chief of emergency of the Health Establishment;
p.(None): V. The head of intensive care of the Health Establishment if it exists;
p.(None): SAW. The health officer of the Health Establishment, in cases where this function is not performed
p.(None): by any of the persons indicated in the preceding fractions, and
p.(None): VII. The other members that the Health Establishment determines for its proper functioning,
p.(None): which will have training and knowledge in the area of Disposition of Organs, Tissues and
p.(None): cells.
p.(None): The Hospital Health Coordinator will serve as Technical Secretary of the Internal Committee of
p.(None): Donation Coordination.
p.(None): 9 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): The sessions of the Internal Donation Coordination Committee will be considered valid with the
p.(None): assistance of the majority of its members and their decisions will be taken by majority.
p.(None): The President of the Internal Donation Coordination Committee will have a quality vote in case of a tie.
p.(None): Article 31. The Internal Donation Coordination Committees, in addition to those provided by the Law, shall have the
p.(None): following functions:
p.(None): I. Prepare the minutes corresponding to each session that takes place, which once signed by the
p.(None): Members will be incorporated into the corresponding minutes book. Both the minutes and the book must be kept by a
p.(None): minimum of five years. In the case of the minutes book, the five years will be counted from the date of the last
p.(None): recorded record
p.(None): In the minutes referred to in the preceding paragraph, the following shall be recorded, among other aspects:
p.(None): a) The changes of members that have been presented in the Internal Coordination Committees
p.(None): for Donation and Hospital Coordinators, and
p.(None): b) The provisions of Organs, Tissues and cells made in the Health Establishment to which they belong,
p.(None): specifying the Medical, legal and scientific Criteria and arguments that were taken into account for its Distribution;
p.(None): II. Establish the Distribution of Organs, Tissues and cells to other Health Establishments, in accordance with
p.(None): the procedures established by CENATRA, and
p.(None): III. Assist with the health officer in providing the National Transplant Registry, within
p.(None): of the forty-eight hours after the event, the information of your Health Establishment related to:
p.(None): a) Transplant surgeons responsible for Extraction, as well as Hospital Coordinators, and
p.(None): b) Section III of article 338 of the Law.
p.(None): Article 32. The Internal Transplant Committees shall consist of:
p.(None): I. The Director General or his equivalent of the Health Establishment, and in his absence, his
p.(None): Immediately inferior that has a high level of medical, academic and professional knowledge, who
p.(None): will preside;
p.(None): II. The psychiatrist or psychologist of the Health Establishment, in case of having said professional;
p.(None): III. A representative of the legal area of the Health Establishment, in case of having said area or of the
p.(None): Institution to which it belongs;
p.(None): IV. A representative of each Transplant Program of the health services involved in the Transplant of
p.(None): concerned
p.(None): V. A representative of the Hospital Bioethics Committee of the Health Establishment;
p.(None): SAW. A representative of the Research Ethics Committee;
p.(None): 10 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): VII. The health officer of the Health Establishment, in cases where this function is not performed
p.(None): by any of the persons indicated in the preceding fractions, and
p.(None): VIII. The other members that the Health Establishment determines for its proper functioning,
p.(None): which will have training and knowledge in the area of Disposition of Organs, Tissues and
p.(None): cells.
p.(None): The Hospital Health Coordinator will serve as Technical Secretary of the Internal Committee of
p.(None): Transplants
p.(None): The sessions of the Internal Transplant Committee will be considered valid with the assistance of the majority of
p.(None): its members, except in cases where matters related to the selection of Donor and Recipient are discussed
p.(None): for Transplants in persons of foreign nationality, in which case the participation of
p.(None): all of its members. The decisions of the Internal Transplant Committee will be taken by majority.
p.(None): The President of the Internal Transplant Committee will have a quality vote in case of a tie.
p.(None): Article 33. Internal Transplant Committees, in addition to those provided by Law, shall have the functions
p.(None): following:
p.(None): I. Carry out the selection of Donors and Recipients for Transplantation, with the exception of cases in which the
p.(None): Donation of Organs, Tissues or cells is made between people who have a relationship by consanguinity,
p.(None): civil or affinity, in which case said Committee will evaluate the feasibility and feasibility of carrying out the
p.(None): Transplant;
p.(None): II. Supervise that the Transplants that are carried out in the Health Establishment, in addition to complying with
p.(None): the principles referred to in article 327 of the Law, are carried out with maximum security,
p.(None): in accordance with the principles of medical ethics and in accordance with the requirements established by the Law and
p.(None): this regulation;
p.(None): III. Supervise the performance of the Hospital Coordinator, as well as the surgical team and the various
p.(None): health professionals participating in the Transplant;
p.(None): IV. Select the Histocompatibility laboratory to be used for tests related to
p.(None): Transplants;
p.(None): V. Evaluate, where appropriate, the attention of the resolutions or recommendations issued by the Hospital Committees of
p.(None): Bioethics, Research and Research Ethics;
p.(None): SAW. Establish the Assignment of Organs, Tissues and cells, as well as the Distribution of them to others
p.(None): Health Establishments, in accordance with the procedures established by CENATRA;
p.(None): VII. Establish procedures for the conservation of Organs, Tissues and cells;
p.(None): VIII. Approve or reject the realization of the Transplant, previous opinion of the availability of the
p.(None): human resources, materials and supplies necessary for its realization;
p.(None): IX. Evaluate the results of the Transplant Programs that the Health Establishment has;
p.(None): 11 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): X. Dictaminate, as the case may be, the publications that may derive from the work programs or
p.(None): of research of the Health Establishment within the area of Transplants;
p.(None): XI Assist with the health officer in providing the National Transplant Registry with information on
p.(None): Your Health Establishment relating to:
p.(None): a) Section II of Article 338 of the Law, within forty-eight hours after designation;
p.(None): b) Section III of article 338 of the Law, within forty-eight hours after the event;
p.(None): c) Section IV of Article 338 of the Law, within seventy-two hours after the event, and
p.(None): d) Section V of article 338 of the Law, within forty-eight hours after the resolution of the
p.(None): Internal Transplant Committee;
p.(None): XII. Prepare the minutes corresponding to each session that takes place, which once signed by the
p.(None): Members will be integrated into the corresponding minutes book. Both the minutes and the book must
p.(None): Keep for a minimum of five years. In the case of the minutes book, the five years will be computed from the
p.(None): date of the last recorded act.
p.(None): In the minutes referred to in the preceding paragraph, the following shall be recorded, among other aspects:
p.(None): a) The changes of members that have been presented in the Internal Transplant Committees,
p.(None): of Hospital Coordinators, as well as of the surgeons responsible for the Extraction and Transplants of Organs,
p.(None): Tissues and cells;
p.(None): b) Cases of acceptance of Candidate Receptors and rejection of patients to be Receptors of
p.(None): Organs, tissues and cells for transplantation, as well as living donors;
p.(None): c) The provisions of Organs, Tissues and cells made in the Health Establishment to which they belong,
p.(None): specifying the Medical, legal and scientific Criteria and arguments that were taken into account for its Distribution,
p.(None): Y
p.(None): d) Transplants performed in the Health Establishment to which they belong, specifying
p.(None): Medical, legal, scientific and ethical Criteria and arguments that were taken into account for their
p.(None): Assignment, and
p.(None): XIII The others that establish the applicable legal provisions.
p.(None): Article 34. Internal Transplant Committees must have a quality management system of
p.(None): Transplant Programs, defined, where appropriate, in coordination with their respective Coordinations
p.(None): Institutional, which should be sent to CENATRA and the State Transplant Centers or
p.(None): State Transplant Councils, which may formulate the recommendations they deem pertinent.
p.(None): Article 35. The health officer referred to in article 338 of the Law shall provide CENATRA with the
p.(None): information regarding the integration of the Internal Transplant Committee and the Internal Coordination Committee for the
p.(None): Donation, if the latter exists, as well as the changes of its members or, where appropriate, the
p.(None): dissolution of the Committee.
p.(None): 12 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Chapter V
p.(None): On the Distribution and Assignment of Organs, Tissues and Cells for Transplant Purposes
p.(None): Article 36. The Internal Committees of Coordination for Donation, and Transplants of
p.(None): Health Establishments, as appropriate, will be responsible for carrying out the Distribution and
p.(None): Assignment of Organs, Tissues and cells, in accordance with the provisions of articles 316 and 339 of the Law, based on
p.(None): the criteria and requirements set forth in said system, this Regulation, and other legal provisions
p.(None): applicable.
p.(None): Likewise, the Committees referred to in the preceding paragraph shall establish an internal Distribution procedure for
p.(None): each type of Organ, Tissue and cell contemplated in its Transplant Programs, which must be in accordance with the
p.(None): procedures established by CENATRA.
p.(None): The internal procedure referred to in the preceding paragraph must be approved by the Director
p.(None): General, or its equivalent, of the Health Establishment and by the Institutional Coordination, of having the latter.
p.(None): This procedure will be sent to CENATRA for its information, which may formulate the recommendations it deems
p.(None): relevant.
...
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): III. Implement and execute actions of Tissue Procurement that are under its protection, the
p.(None): which must be creditable;
p.(None): IV. Guarantee the Traceability of the Tissues, in accordance with the functions performed by the bank;
p.(None): V. Sign agreements with Health Establishments to promote the Distribution of Tissues for the purpose of
p.(None): Transplants;
p.(None): SAW. Maintain the optimal conditions for the transfer of the tissue that guarantee its viability for the transplant;
p.(None): VII. Supervise that the applicable legal provisions are complied with, and
p.(None): VIII. The others that determine the applicable legal provisions.
p.(None): FIFTH TITLE
p.(None): NATIONAL REGISTER OF TRANSPLANTS
p.(None): Single Chapter
p.(None): From the National Transplant Registry
p.(None): Article 61. The National Transplant Registry will operate under a computer system, which will be
p.(None): administered by CENATRA.
p.(None): Article 62. The integration, management and updating of the information of the National Registry of
p.(None): Transplants, in addition to meeting the provisions of the Federal Law on Transparency and Access to Public Information
p.(None): Government, will be subject to the following:
p.(None): I. Health officials should keep the surgeon's registry updated
p.(None): responsible for Extraction and Transplants and that of the Hospital Coordinators of your Establishment
p.(None): Health, informing high or low of these people;
p.(None): II. The health officer of the Health Establishment in which a Transplant will be performed,
p.(None): You must register the patient within forty-eight hours after the Internal Committee of
p.(None): Transplants grant your acceptance as a Candidate Recipient to receive a Transplant;
p.(None): III. Registration of a Candidate Recipient to receive the Transplant in the National Registry of
p.(None): Transplants, in terms of article 338, section V, of the Law, will be done only by the
p.(None): Public, social or private health establishment in which it is treated. In the cases of registration for
p.(None): receive more than one Organ, Tissue or cell, this will be done in the Health Establishment or Establishments in which it is attended,
p.(None): being able to generate more than one record per Recipient, but only one for each Organ, Tissue or cell in question;
p.(None): IV. Patients who transfer from one Health Facility to another, will retain their seniority
p.(None): in the National Transplant Registry;
p.(None): V. The health officer of the Health Establishment must keep the
p.(None): Information from Candidate Recipients to receive a Transplant, notifying the National Registry of
p.(None): Transplants any income or change;
p.(None): 18 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): SAW. The health officer of the Health Establishment must report a donation or
p.(None): of a Transplant, within the periods provided for in article 33, section XI, subsections b) and c), of this Regulation, and
p.(None): VII. The databases of the National Transplant Registry will be confidential, you can only have access to the
p.(None): according to their field of competence, authorized personnel of:
p.(None): a) CENATRA;
p.(None): b) COFEPRIS;
p.(None): c) Customs authorities;
p.(None): d) State Transplant Centers or State Transplant Councils;
p.(None): e) Institutional Coordinations, and
p.(None): f) Health Establishments that have authorization in terms of article 315 of the Law.
p.(None): Article 63. It is the responsibility of the Director of the Health Establishment to supervise that the person in charge
p.(None): sanitary update the information required in terms of article 338 of the Law.
p.(None): CENATRA must notify COFEPRIS of the breach of the content of this Chapter, so that said
p.(None): Authority proceed in terms of the applicable legal provisions.
p.(None): Article 64. Only Organs, Tissues or cells from deceased Donors may be transplanted, to
p.(None): patients enrolled in the National Transplant Registry at least forty-eight hours before the
p.(None): Donor's loss of life certification. The cases of Urgency of
p.(None): Transplant.
p.(None): SIXTH TITLE
p.(None): INTERVENTION OF THE PUBLIC MINISTRY AND THE JUDICIAL AUTHORITY IN THE DONATION OF ORGANS, FABRICS OR CELLS
p.(None): Single Chapter
p.(None): On the Intervention of the Public Ministry and the Judicial Authority in the Donation of Organs, Tissues or Cells
...
p.(None): the difficulty of obtaining it in the country.
p.(None): Article 83. To obtain the sanitary permit for the exit of the national territory of Tissues and cells, the
p.(None): interested party must submit an application in the corresponding official form to COFEPRIS, to which the
p.(None): following documentation:
p.(None): I. Copy of the sanitary authorization of the Health Establishment to make the Disposition of Organs,
p.(None): Tissues and cells;
p.(None): 22 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): II. Copy of the document proving the legal operation of the Health Establishment that you will receive
p.(None): Tissues and cells issued by the competent authority, for control purposes of the country of destination, and
p.(None): III. Letter of acceptance of the Health Establishment abroad.
p.(None): Article 84. Documents issued by the Health Establishment or the professional abroad
p.(None): they will be accompanied by their translation when they are written in a language other than Spanish, carried out by an expert
p.(None): translator.
p.(None): Article 85. COFEPRIS must be notified in the following cases:
p.(None): I. The withdrawal, temporary suspension and total or partial resumption of activities of the
p.(None): Health establishments that require health authorization for its operation, in terms of the Law
p.(None): and this Regulation;
p.(None): II. Appointment or removal of the health officer of the Health Establishments, and
p.(None): III. The others determined by the Law, these Regulations and other applicable legal provisions.
p.(None): TITLE ELEVENTH SURVEILLANCE
p.(None): Single Surveillance Chapter
p.(None): Article 86. The Ministry of Health is responsible for monitoring compliance with these Regulations and others.
p.(None): applicable legal provisions, which will be carried out in accordance with the Seventh Title of the Law.
p.(None): Article 87. During the health verification visit and when the health authority deems it
p.(None): necessary, the procedures required to verify that the Organs, tissues, cells,
p.(None): Donors and recipients meet the sanitary conditions and requirements established by the Law, these Regulations and others
p.(None): applicable legal provisions. In case of finding any irregularity, deficiency or anomaly, the authority
p.(None): The company may order the necessary actions to identify the origin of the failures or problems.
p.(None): The minutes that are drawn up for this purpose will be made in accordance with the provisions of article 401, section III, of the Law
p.(None): and other applicable legal provisions.
p.(None): Article 88. The health authority may, at any time, determine the cases in which the Bodies,
p.(None): Tissues and their Components and cells do not meet the requirements and optimal conditions for their use, in the
p.(None): terms established by these Regulations and in the other applicable legal provisions.
p.(None): Article 89. In the exercise of its powers, the health authority may request the support of the
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p.(None): from the Extraction.
p.(None): Chapter II
p.(None): Of Donor Transplants That Have Lost Life
p.(None): 6 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 20. For the Removal of Organs, Tissues and Cells of a Donor in which
p.(None): certified loss of life, in order to minimize the risks of adverse effects on the Recipient and not compromise
p.(None): The success of the Transplant must be verified by the corresponding medical evaluation that the
p.(None): Donor meets the following requirements:
p.(None): I. Have a useful physiological age for donation purposes at the time of loss of life;
p.(None): II. Not having presented malignancies with risk of metastasis, infections or other conditions
p.(None): that could affect the Recipient, and
p.(None): III. Not having suffered the deleterious effect of prolonged agony.
p.(None): Article 21. In the case of pregnant women in which the loss of life has been certified, preference will be given to
p.(None): the life of the product of conception before having Organs, Tissues or cells for Transplants.
p.(None): Article 22. For the realization of a Transplant of Organs, Tissues or cells from a Donor in which
p.(None): the loss of life has been certified, in foreign patients, it must comply with the
p.(None): following requirements:
p.(None): I. The Recipient must have a condition of stay in the national territory of resident
p.(None): temporary, temporary resident student or permanent resident and prove their uninterrupted stay in
p.(None): the country of at least six months prior to the transplant, except in cases of emergency
p.(None): diagnosed with fulminant hepatitis, properly documented, and
p.(None): II. The Recipient must have a favorable resolution from the Internal Transplant Committee of the
p.(None): Health Establishment where the Transplant will be performed, signed by all its members,
p.(None): previous medical, clinical and psychological evaluation. This resolution must state that it has been
p.(None): verified the absence of circumstances that could make presume acts of commerce or legal simulation
p.(None): whose objective is the onerous intermediation of Organs, Tissues and cells.
p.(None): The Secretariat may request the Health Establishment where the Transplant is to be performed, prior
p.(None): to that the same one is realized, the documentation that verifies the fulfillment of the indicated requirements.
p.(None): Article 23. Health professionals responsible for the extraction of organs, tissues or cells, should treat
p.(None): with care, respect and dignity to the Corpse, in order to preserve it and deliver it in the best conditions.
p.(None): Article 24. The Corpse shall be delivered to the next of kin or to the competent authority as the case may be, at the conclusion of the
p.(None): Removal of Organs, Tissues or cells, for the above, hospital procedures should be expedited
p.(None): corresponding.
p.(None): Chapter III
p.(None): Of Transplants Between Live
p.(None): Article 25. In cases of Transplant with Living Donors, once the Internal Committee of
p.(None): Transplants have favorably evaluated both the Donor and the Candidate Recipient, must be
...
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p.(None): Health Establishment from which the Organ, Tissue or cell comes, informing the reasons for
p.(None): which it was not possible to perform this transplant, so that the Committee that has been informed determines
p.(None): a new Distribution of the Organ, Tissue or cell in question. Such determination must be notified.
p.(None): immediately to the National Transplant Registry.
p.(None): Article 19. The Health Establishment in which the Removal of the Organ, Tissue or
p.(None): cells must keep documentary evidence of the donation process, for at least five years counted
p.(None): from the Extraction.
p.(None): Chapter II
p.(None): Of Donor Transplants That Have Lost Life
p.(None): 6 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 20. For the Removal of Organs, Tissues and Cells of a Donor in which
p.(None): certified loss of life, in order to minimize the risks of adverse effects on the Recipient and not compromise
p.(None): The success of the Transplant must be verified by the corresponding medical evaluation that the
p.(None): Donor meets the following requirements:
p.(None): I. Have a useful physiological age for donation purposes at the time of loss of life;
p.(None): II. Not having presented malignancies with risk of metastasis, infections or other conditions
p.(None): that could affect the Recipient, and
p.(None): III. Not having suffered the deleterious effect of prolonged agony.
p.(None): Article 21. In the case of pregnant women in which the loss of life has been certified, preference will be given to
p.(None): the life of the product of conception before having Organs, Tissues or cells for Transplants.
p.(None): Article 22. For the realization of a Transplant of Organs, Tissues or cells from a Donor in which
p.(None): the loss of life has been certified, in foreign patients, it must comply with the
p.(None): following requirements:
p.(None): I. The Recipient must have a condition of stay in the national territory of resident
p.(None): temporary, temporary resident student or permanent resident and prove their uninterrupted stay in
p.(None): the country of at least six months prior to the transplant, except in cases of emergency
p.(None): diagnosed with fulminant hepatitis, properly documented, and
p.(None): II. The Recipient must have a favorable resolution from the Internal Transplant Committee of the
p.(None): Health Establishment where the Transplant will be performed, signed by all its members,
p.(None): previous medical, clinical and psychological evaluation. This resolution must state that it has been
p.(None): verified the absence of circumstances that could make presume acts of commerce or legal simulation
p.(None): whose objective is the onerous intermediation of Organs, Tissues and cells.
p.(None): The Secretariat may request the Health Establishment where the Transplant is to be performed, prior
p.(None): to that the same one is realized, the documentation that verifies the fulfillment of the indicated requirements.
p.(None): Article 23. Health professionals responsible for the extraction of organs, tissues or cells, should treat
p.(None): with care, respect and dignity to the Corpse, in order to preserve it and deliver it in the best conditions.
...
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p.(None): Traceability, as well as complying with infrastructure and equipment requirements, which are foreseen in
p.(None): applicable legal provisions.
p.(None): In the case of banks of Organs and cells, the Secretariat through general provisions published in
p.(None): The Official Gazette of the Federation will determine the functions that these and their health officials will have. These
p.(None): functions will be aimed at keeping the organs and cells in optimal conditions for the purpose of
p.(None): Transplants, their Traceability, as well as to monitor compliance with the applicable legal provisions.
p.(None): 16 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 54. The supply and reception of Organs, Tissues and cells for therapeutic purposes, may only
p.(None): be carried out between Health Establishments that have the specific authorization of the Secretariat,
p.(None): to carry out the Extraction, conservation, supply or Transplants of the type of Organ, Tissue or cell of which
p.(None): try.
p.(None): Article 55. The person responsible for the extraction of organs and composite tissues must be a medical professional and have
p.(None): with a specialty or postgraduate degree, in accordance with the Transplant Program for which the Health Facility
p.(None): It is authorized.
p.(None): The removal of simple tissue or cells may be performed by trained medical or technical personnel.
p.(None): Article 56. The person responsible for each Organ, Tissue and Cell Transplant Program must be professional
p.(None): doctor, with title legally issued and registered by the competent educational authorities, and be
p.(None): designated by the Internal Transplant Committee, giving notice to CENATRA. Such designation must be established in
p.(None): the corresponding record.
p.(None): Article 57. Banks of Organs, Tissues and cells must function in coordination with one or more
p.(None): Health establishments authorized for the purposes of this Regulation.
p.(None): Article 58. Tissue Banks may be:
p.(None): I. Cornea;
p.(None): II. Bone;
p.(None): III. Skeletal muscle;
p.(None): IV. Skin;
p.(None): V. Cardiovascular;
p.(None): SAW. Of amnion, and
p.(None): VII. The others authorized by the Secretariat, according to advances in science and technology in this area.
p.(None): Article 59. Tissue Banks will have the following functions:
p.(None): I. Receive the tissues sent for temporary protection of the Health Establishments
p.(None): authorized, and
p.(None): II. Maintain the Fabric in optimum condition until its processing or Final Destination, or,
p.(None): Send it to another Health Facility.
p.(None): Article 60. Those responsible for Tissue Banks will have the following functions:
p.(None): I. Ensure that the preservation and storage of tissues is carried out in accordance with the
p.(None): established in the Law, this Regulation, the internal manuals of procedures approved in each
p.(None): bank and other applicable legal provisions;
p.(None): II. Ensure that the quality of the fabrics meets the international standards established to ensure
p.(None): the optimal conditions of the transplant;
p.(None): 17 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
...
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Searching for indicator parents:
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p.(None): official format that will be used to express the express consent to donate Organs, Tissues and
p.(None): cells after death for them to be used in transplants, in terms of the second paragraph
p.(None): of article 329 of the Law.
p.(None): The format referred to in the previous paragraph will contain at least the full name
p.(None): of his grantor, his age, sex, nationality, marital status, occupation, personal references, and the indication of
p.(None): document with which you have identified, as well as if it is a broad or limited donation.
p.(None): Article 9. The document in which the Donor expresses his consent for the living donation of his Organs,
p.(None): Tissues and cells for Transplant purposes, must be obtained by the Internal Transplant Committee and at least
p.(None): contain:
p.(None): I. Name of the Donor;
p.(None): II. Donor Address;
p.(None): 3 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): III. Donor Age;
p.(None): IV. Donor sex;
p.(None): V. Marital status of the Donor;
p.(None): SAW. Donor occupation;
p.(None): VII. Name and address of spouse, concubine or concubine, if the Donor has;
p.(None): VIII. Name and address of the parents and in the absence of them, of any of their closest relatives, when the
p.(None): Donor is single;
p.(None): IX. The indication that by his own will and free of charge, he consents to the donation of the
p.(None): Organ, Tissue or cell in question, expressing that this donation will be understood as made between living, which must
p.(None): be in accordance with the applicable legal provisions;
p.(None): X. Name of the Recipient of the Organ, Tissue or cell;
p.(None): XI The indication of having received information to your satisfaction about the risks of the operation
p.(None): and the consequences of the extraction of the organ, tissue or cell;
p.(None): XII. Name, signature and address of the witnesses in the case of a private document;
p.(None): XIII Place and date the document is issued;
p.(None): XIV Signature or fingerprint of the Donor;
p.(None): XV. The indication of whether the donation is made in favor of any particular person or institution. In this case, it
p.(None): You must mention the name or company name or business name of that person or institution, and
p.(None): XVI. The other circumstances of manner, place and time that the donor considers pertinent, as well as
p.(None): any other that conditions the donation.
p.(None): In the case of donation between people in which there is no kind of relationship, it must be exhibited
p.(None): in addition, the express consent granted before a notary public, in terms of the provisions of article 333,
p.(None): Section VI, subsection b), of the Law.
p.(None): Article 10. The document stating the consent granted by the persons referred to in the
p.(None): First paragraph of article 324 of the Law, will be collected by the Hospital Coordinator, once
p.(None): certify the loss of life.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): Article 33. Internal Transplant Committees, in addition to those provided by Law, shall have the functions
p.(None): following:
p.(None): I. Carry out the selection of Donors and Recipients for Transplantation, with the exception of cases in which the
p.(None): Donation of Organs, Tissues or cells is made between people who have a relationship by consanguinity,
p.(None): civil or affinity, in which case said Committee will evaluate the feasibility and feasibility of carrying out the
p.(None): Transplant;
p.(None): II. Supervise that the Transplants that are carried out in the Health Establishment, in addition to complying with
p.(None): the principles referred to in article 327 of the Law, are carried out with maximum security,
p.(None): in accordance with the principles of medical ethics and in accordance with the requirements established by the Law and
p.(None): this regulation;
p.(None): III. Supervise the performance of the Hospital Coordinator, as well as the surgical team and the various
p.(None): health professionals participating in the Transplant;
p.(None): IV. Select the Histocompatibility laboratory to be used for tests related to
p.(None): Transplants;
p.(None): V. Evaluate, where appropriate, the attention of the resolutions or recommendations issued by the Hospital Committees of
p.(None): Bioethics, Research and Research Ethics;
p.(None): SAW. Establish the Assignment of Organs, Tissues and cells, as well as the Distribution of them to others
p.(None): Health Establishments, in accordance with the procedures established by CENATRA;
p.(None): VII. Establish procedures for the conservation of Organs, Tissues and cells;
p.(None): VIII. Approve or reject the realization of the Transplant, previous opinion of the availability of the
p.(None): human resources, materials and supplies necessary for its realization;
p.(None): IX. Evaluate the results of the Transplant Programs that the Health Establishment has;
p.(None): 11 of 24
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p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): X. Dictaminate, as the case may be, the publications that may derive from the work programs or
p.(None): of research of the Health Establishment within the area of Transplants;
p.(None): XI Assist with the health officer in providing the National Transplant Registry with information on
p.(None): Your Health Establishment relating to:
p.(None): a) Section II of Article 338 of the Law, within forty-eight hours after designation;
p.(None): b) Section III of article 338 of the Law, within forty-eight hours after the event;
p.(None): c) Section IV of Article 338 of the Law, within seventy-two hours after the event, and
p.(None): d) Section V of article 338 of the Law, within forty-eight hours after the resolution of the
p.(None): Internal Transplant Committee;
p.(None): XII. Prepare the minutes corresponding to each session that takes place, which once signed by the
p.(None): Members will be integrated into the corresponding minutes book. Both the minutes and the book must
p.(None): Keep for a minimum of five years. In the case of the minutes book, the five years will be computed from the
p.(None): date of the last recorded act.
p.(None): In the minutes referred to in the preceding paragraph, the following shall be recorded, among other aspects:
p.(None): a) The changes of members that have been presented in the Internal Transplant Committees,
...
p.(None): relevant.
p.(None): Article 37. The Internal Committees for the Coordination of Donation and Transplants may not delegate
p.(None): its faculty for the Distribution and Assignment of Organs, Tissues and cells, so this faculty does not
p.(None): It may be exercised by only one person.
p.(None): Article 38. Distribution by Health Establishment, if there is no Emergency of
p.(None): Transplant, will be done taking into account the following order:
p.(None): I. To the Health Establishment where the donation takes place, provided it is authorized to make
p.(None): Transplants of the type of Organ, Tissue or cell in question;
p.(None): II. To the Health Institution to which the Health Establishment belongs, for which it will be assisted
p.(None): of its Institutional Coordinations, where appropriate, for said Distribution;
p.(None): III. To any Health Establishment of the federative entity in which the
p.(None): Health Establishment where the donation took place, and
p.(None): IV. To any Health Establishment of a National Health Institution.
p.(None): In the cases referred to in sections III and IV of this article, the Internal Committee
p.(None): Coordination for Donation or Transplant, as appropriate, will attempt to deliver
p.(None): Organs, tissues and cells generated in your Health Establishment, to Health Establishments of
p.(None): Health Institutions of its own sector, that is, if the Health Establishment is public, it will look for a
p.(None): Health Establishment of a Public Sector Health Institution, and if private, to a Health Establishment
p.(None): of a private sector Health Institution.
p.(None): Article 39. Internal Transplant Committees may, in exceptional and duly justified cases,
p.(None): previous opinion of CENATRA, establish distribution schemes that allow to allocate organs, tissues and
p.(None): cells to a Health Establishment that does not belong to your Health Institution, with the approval of the
p.(None): Institutional coordination to which it belongs, where appropriate.
p.(None): The reasons that justify the establishment of exceptional distribution schemes referred to in the paragraph
p.(None): above, they may be circumstances that make it more appropriate and feasible to consider a
p.(None): Health Establishment that does not belong to your Health Institution.
p.(None): 13 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 40. For the Distribution and Assignment of Organs, Tissues and Donor Cells that have lost their lives
p.(None): under 18 years of age, called pediatric, in case there is no Transplant Urgency,
p.(None): give preference to recipients who are under 18 years of age.
p.(None): Article 41. The notification of a Transplant Urgency by a Health Establishment implies the Distribution and
p.(None): Nationally preferred allocation of an Organ, Tissue or cell to the patient who has been qualified in such
p.(None): condition.
p.(None): The determination of a Transplant Urgency corresponds to the Internal Transplant Committee of the Establishment of
p.(None): Health in which the transplant will be performed. The Transplant Urgency must be notified to the Registry
p.(None): National Transplant through the format established for this purpose by CENATRA, in order to activate a
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 20. For the Removal of Organs, Tissues and Cells of a Donor in which
p.(None): certified loss of life, in order to minimize the risks of adverse effects on the Recipient and not compromise
p.(None): The success of the Transplant must be verified by the corresponding medical evaluation that the
p.(None): Donor meets the following requirements:
p.(None): I. Have a useful physiological age for donation purposes at the time of loss of life;
p.(None): II. Not having presented malignancies with risk of metastasis, infections or other conditions
p.(None): that could affect the Recipient, and
p.(None): III. Not having suffered the deleterious effect of prolonged agony.
p.(None): Article 21. In the case of pregnant women in which the loss of life has been certified, preference will be given to
p.(None): the life of the product of conception before having Organs, Tissues or cells for Transplants.
p.(None): Article 22. For the realization of a Transplant of Organs, Tissues or cells from a Donor in which
p.(None): the loss of life has been certified, in foreign patients, it must comply with the
p.(None): following requirements:
p.(None): I. The Recipient must have a condition of stay in the national territory of resident
p.(None): temporary, temporary resident student or permanent resident and prove their uninterrupted stay in
p.(None): the country of at least six months prior to the transplant, except in cases of emergency
p.(None): diagnosed with fulminant hepatitis, properly documented, and
p.(None): II. The Recipient must have a favorable resolution from the Internal Transplant Committee of the
p.(None): Health Establishment where the Transplant will be performed, signed by all its members,
p.(None): previous medical, clinical and psychological evaluation. This resolution must state that it has been
p.(None): verified the absence of circumstances that could make presume acts of commerce or legal simulation
p.(None): whose objective is the onerous intermediation of Organs, Tissues and cells.
p.(None): The Secretariat may request the Health Establishment where the Transplant is to be performed, prior
p.(None): to that the same one is realized, the documentation that verifies the fulfillment of the indicated requirements.
p.(None): Article 23. Health professionals responsible for the extraction of organs, tissues or cells, should treat
p.(None): with care, respect and dignity to the Corpse, in order to preserve it and deliver it in the best conditions.
p.(None): Article 24. The Corpse shall be delivered to the next of kin or to the competent authority as the case may be, at the conclusion of the
p.(None): Removal of Organs, Tissues or cells, for the above, hospital procedures should be expedited
p.(None): corresponding.
p.(None): Chapter III
p.(None): Of Transplants Between Live
p.(None): Article 25. In cases of Transplant with Living Donors, once the Internal Committee of
p.(None): Transplants have favorably evaluated both the Donor and the Candidate Recipient, must be
p.(None): Provide, prior to the transplant, the information corresponding to the National Registry of
p.(None): Transplants, through your computer system.
p.(None): 7 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
...
p.(None): Organ, Tissue or cell in the National Transplant Registry at least fifteen business days in advance,
p.(None): if it is a Transplant between relatives by consanguinity, civil or affinity until the fourth grade, and in the
p.(None): other cases, at least six months prior to the transplant.
p.(None): Article 28. In the cases provided for in articles 26, section III and 27, section II, subparagraph b), of this Regulation,
p.(None): COFEPRIS and CENATRA, when they deem it necessary, may request any other element of
p.(None): conviction that allows to prove the legality of the realization of the Transplant.
p.(None): Chapter IV
p.(None): Of the Internal Committees of Coordination for Donation and Transplants
p.(None): Article 29. The Internal Donation Coordination Committees, as well as the Internal Transplant Committees,
p.(None): must be installed under the responsibility of the directors or holders of the Establishments
p.(None): Health, by signing an act, which must stipulate their respective characteristics,
p.(None): operation and operation, as well as the people who integrate them, in accordance with the provisions of the Law, the
p.(None): this Regulation and other applicable legal provisions.
p.(None): Article 30. The Internal Donation Coordination Committees shall be composed of:
p.(None): I. The Director General or his equivalent of the Health Establishment, and in his absence, his
p.(None): Immediately inferior that has a high level of medical, academic and professional knowledge, who
p.(None): will preside;
p.(None): II. A representative of the Hospital Bioethics Committee of the Health Establishment;
p.(None): III. A representative of the legal area of the Health Establishment, in case of having said area or of the
p.(None): Institution to which it belongs;
p.(None): IV. The chief of emergency of the Health Establishment;
p.(None): V. The head of intensive care of the Health Establishment if it exists;
p.(None): SAW. The health officer of the Health Establishment, in cases where this function is not performed
p.(None): by any of the persons indicated in the preceding fractions, and
p.(None): VII. The other members that the Health Establishment determines for its proper functioning,
p.(None): which will have training and knowledge in the area of Disposition of Organs, Tissues and
p.(None): cells.
p.(None): The Hospital Health Coordinator will serve as Technical Secretary of the Internal Committee of
p.(None): Donation Coordination.
p.(None): 9 of 24
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p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): The sessions of the Internal Donation Coordination Committee will be considered valid with the
p.(None): assistance of the majority of its members and their decisions will be taken by majority.
p.(None): The President of the Internal Donation Coordination Committee will have a quality vote in case of a tie.
p.(None): Article 31. The Internal Donation Coordination Committees, in addition to those provided by the Law, shall have the
p.(None): following functions:
p.(None): I. Prepare the minutes corresponding to each session that takes place, which once signed by the
p.(None): Members will be incorporated into the corresponding minutes book. Both the minutes and the book must be kept by a
p.(None): minimum of five years. In the case of the minutes book, the five years will be counted from the date of the last
p.(None): recorded record
...
p.(None): 12 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Chapter V
p.(None): On the Distribution and Assignment of Organs, Tissues and Cells for Transplant Purposes
p.(None): Article 36. The Internal Committees of Coordination for Donation, and Transplants of
p.(None): Health Establishments, as appropriate, will be responsible for carrying out the Distribution and
p.(None): Assignment of Organs, Tissues and cells, in accordance with the provisions of articles 316 and 339 of the Law, based on
p.(None): the criteria and requirements set forth in said system, this Regulation, and other legal provisions
p.(None): applicable.
p.(None): Likewise, the Committees referred to in the preceding paragraph shall establish an internal Distribution procedure for
p.(None): each type of Organ, Tissue and cell contemplated in its Transplant Programs, which must be in accordance with the
p.(None): procedures established by CENATRA.
p.(None): The internal procedure referred to in the preceding paragraph must be approved by the Director
p.(None): General, or its equivalent, of the Health Establishment and by the Institutional Coordination, of having the latter.
p.(None): This procedure will be sent to CENATRA for its information, which may formulate the recommendations it deems
p.(None): relevant.
p.(None): Article 37. The Internal Committees for the Coordination of Donation and Transplants may not delegate
p.(None): its faculty for the Distribution and Assignment of Organs, Tissues and cells, so this faculty does not
p.(None): It may be exercised by only one person.
p.(None): Article 38. Distribution by Health Establishment, if there is no Emergency of
p.(None): Transplant, will be done taking into account the following order:
p.(None): I. To the Health Establishment where the donation takes place, provided it is authorized to make
p.(None): Transplants of the type of Organ, Tissue or cell in question;
p.(None): II. To the Health Institution to which the Health Establishment belongs, for which it will be assisted
p.(None): of its Institutional Coordinations, where appropriate, for said Distribution;
p.(None): III. To any Health Establishment of the federative entity in which the
p.(None): Health Establishment where the donation took place, and
p.(None): IV. To any Health Establishment of a National Health Institution.
p.(None): In the cases referred to in sections III and IV of this article, the Internal Committee
p.(None): Coordination for Donation or Transplant, as appropriate, will attempt to deliver
p.(None): Organs, tissues and cells generated in your Health Establishment, to Health Establishments of
p.(None): Health Institutions of its own sector, that is, if the Health Establishment is public, it will look for a
p.(None): Health Establishment of a Public Sector Health Institution, and if private, to a Health Establishment
p.(None): of a private sector Health Institution.
p.(None): Article 39. Internal Transplant Committees may, in exceptional and duly justified cases,
p.(None): previous opinion of CENATRA, establish distribution schemes that allow to allocate organs, tissues and
p.(None): cells to a Health Establishment that does not belong to your Health Institution, with the approval of the
p.(None): Institutional coordination to which it belongs, where appropriate.
p.(None): The reasons that justify the establishment of exceptional distribution schemes referred to in the paragraph
p.(None): above, they may be circumstances that make it more appropriate and feasible to consider a
...
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 40. For the Distribution and Assignment of Organs, Tissues and Donor Cells that have lost their lives
p.(None): under 18 years of age, called pediatric, in case there is no Transplant Urgency,
p.(None): give preference to recipients who are under 18 years of age.
p.(None): Article 41. The notification of a Transplant Urgency by a Health Establishment implies the Distribution and
p.(None): Nationally preferred allocation of an Organ, Tissue or cell to the patient who has been qualified in such
p.(None): condition.
p.(None): The determination of a Transplant Urgency corresponds to the Internal Transplant Committee of the Establishment of
p.(None): Health in which the transplant will be performed. The Transplant Urgency must be notified to the Registry
p.(None): National Transplant through the format established for this purpose by CENATRA, in order to activate a
p.(None): alert in the National Transplant Registry, to Health Establishments about the existence of a patient with
p.(None): Transplant Urgency status, so that they give priority to the Distribution and Assignment of the Organ in
p.(None): question to said patient.
p.(None): The validity of a notification about the existence of a patient with Transplant Urgency status
p.(None): it will be seventy-two hours counted from the receipt of the notification in the National Registry of
p.(None): Transplants, must be updated as many times as necessary, through the procedure indicated in this article.
p.(None): The documentation that supports the Emergency of Transplantation of a patient, must be protected by the Internal Committee of
p.(None): Transplants for a period of five years from the notification referred to in the second paragraph of this
p.(None): article and be available at any time in case the competent authorities require it. From
p.(None): If the Transplant is carried out, the protection of the information will be five years after its completion.
p.(None): Article 42. For cases of Transplant Urgency in the Assignment of the heart, the patient must present
p.(None): any of the following conditions, with no other treatment option:
p.(None): I. Patients with primary failure of the transplanted heart within the first forty-eight
p.(None): hours;
p.(None): II. Patients in cardiogenic shock and ventricular assistance;
p.(None): III. Patients in cardiogenic shock and with intra-aortic balloon counterpulsation;
p.(None): IV. Patients in cardiogenic shock who require vasoactive drugs and mechanical ventilation, or
p.(None): V. Patients hospitalized in functional class IV refractory to medical treatment.
p.(None): If there are several Heart Transplant Emergencies, the order of priority will be
p.(None): established in the previous sections.
p.(None): If there are two or more of the same degree of condition referred to in the first paragraph of this article,
p.(None): will assign by order of inscription in the National Transplant Registry.
p.(None): Article 43. For cases of Emergency Transplantation in the Assignment of the liver, the patient must be in
p.(None): any of the following situations:
p.(None): I. Fulminant or subfulminating hepatitis, and
p.(None): 14 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): II. Primary failure of the transplanted liver.
p.(None): If there are several liver transplant emergencies, the order of priority established will be followed.
p.(None): in the previous fractions.
p.(None): If there are two or more equal situations referred to in the first paragraph of this article, it will be assigned by
p.(None): order of registration in the National Transplant Registry.
p.(None): Article 44. The priority Assignment of a kidney will be in those cases in which there is no possibility of submitting to the
p.(None): patient to a dialytic treatment and his condition endangers his life.
p.(None): Transplant recipients who lose the function of the transplanted kidney within a month,
p.(None): they will retain their seniority in the database of the National Transplant Registry, once they are registered
p.(None): again.
p.(None): Article 45. A cornea shall be assigned a priority, regardless of whether it comes from abroad, to the
p.(None): patient presenting corneal perforation or ulcer with imminent loss of the eyeball.
p.(None): Article 46. When in a Health Establishment a patient is identified who meets the
p.(None): characteristics indicated in articles 44 or 45 of these Regulations, the Internal Transplant Committee must
p.(None): Notify your Institutional Coordination, if you have it, CENATRA and your State Transplant Center or
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): opportunity to ask questions and that they were answered satisfactorily;
p.(None): SAW. The statement that being of legal age and in full use of his mental faculties,
p.(None): freely authorizes the total or partial donation of the Donor's body, free of charge, to be used for purposes
p.(None): of transplant;
p.(None): VII. Place and date the document is issued, and
p.(None): VIII. Signature or fingerprint of the grantor and that of two witnesses.
p.(None): Article 11. The public or private document by which the person expresses his express refusal to be a Donor, to whom
p.(None): refers to the second paragraph of article 324 of the Law, it will be written in free format, which must contain
p.(None): the signature of the person who expresses said refusal or his fingerprint in case of not being able to sign.
p.(None): Notwithstanding the foregoing, the Donor may express his refusal using the format that for this purpose, give
p.(None): know the CENATRA, through publication that is made in the Official Gazette of the Federation, which
p.(None): It must contain at least the full name of its grantor, his age, sex, nationality, marital status, occupation
p.(None): and the identification of the document with which it has been identified.
p.(None): Chapter II
p.(None): From the Hospital Coordinator
p.(None): Article 12. The Hospital Coordinator, in addition to what is indicated in the Law, will be responsible for:
p.(None): I. Verify that the Corpses of which Organs, Tissues or cells were disposed for Transplant purposes,
p.(None): delivered to their relatives or to the competent authority, with the least possible delay;
p.(None): II. Participate in the elaboration of work programs and projects, as well as manuals of
p.(None): medical, technical and administrative procedures related to the activities of Procurement of Organs, Tissues and
p.(None): cells that the Health Establishment carries out, as well as monitoring their observance;
p.(None): III. Participate in the training and evaluation of the performance of the personnel in charge and, where appropriate, assist in
p.(None): teaching and research activities in the field of transplants;
p.(None): IV. Promote and disseminate strategies and actions that encourage voluntary and altruistic donation to
p.(None): inside the Health Establishment in which they work, and
p.(None): V. The others that indicate other applicable legal provisions.
p.(None): Article 13. The Hospital Coordinator shall perform his duties in coordination with CENATRA, with
p.(None): State Transplant Centers or State Transplant Councils and, where appropriate, with the Coordinations
p.(None): Respective institutions.
p.(None): Article 14. Training of the Hospital Coordinator, referred to in article 316 Bis of the Law, as well as
p.(None): the issuance of the certificate evidencing said training will be in charge of the
p.(None): 5 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): CENATRA, for which it may benefit from academic institutions, in terms of the agreements that for this purpose are
p.(None): celebrate.
p.(None): Article 15. In addition to the training referred to in article 316 Bis of the Law, the Hospital Coordinator
p.(None): you must prove every five years, before the members of your Internal Donation Coordination Committee, or the
...
p.(None): Article 22. For the realization of a Transplant of Organs, Tissues or cells from a Donor in which
p.(None): the loss of life has been certified, in foreign patients, it must comply with the
p.(None): following requirements:
p.(None): I. The Recipient must have a condition of stay in the national territory of resident
p.(None): temporary, temporary resident student or permanent resident and prove their uninterrupted stay in
p.(None): the country of at least six months prior to the transplant, except in cases of emergency
p.(None): diagnosed with fulminant hepatitis, properly documented, and
p.(None): II. The Recipient must have a favorable resolution from the Internal Transplant Committee of the
p.(None): Health Establishment where the Transplant will be performed, signed by all its members,
p.(None): previous medical, clinical and psychological evaluation. This resolution must state that it has been
p.(None): verified the absence of circumstances that could make presume acts of commerce or legal simulation
p.(None): whose objective is the onerous intermediation of Organs, Tissues and cells.
p.(None): The Secretariat may request the Health Establishment where the Transplant is to be performed, prior
p.(None): to that the same one is realized, the documentation that verifies the fulfillment of the indicated requirements.
p.(None): Article 23. Health professionals responsible for the extraction of organs, tissues or cells, should treat
p.(None): with care, respect and dignity to the Corpse, in order to preserve it and deliver it in the best conditions.
p.(None): Article 24. The Corpse shall be delivered to the next of kin or to the competent authority as the case may be, at the conclusion of the
p.(None): Removal of Organs, Tissues or cells, for the above, hospital procedures should be expedited
p.(None): corresponding.
p.(None): Chapter III
p.(None): Of Transplants Between Live
p.(None): Article 25. In cases of Transplant with Living Donors, once the Internal Committee of
p.(None): Transplants have favorably evaluated both the Donor and the Candidate Recipient, must be
p.(None): Provide, prior to the transplant, the information corresponding to the National Registry of
p.(None): Transplants, through your computer system.
p.(None): 7 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): If after having provided the information referred to in the previous paragraph, the
p.(None): Transplant, the Candidate Recipient will retain the age of its registration in the National Transplant Registry.
p.(None): In cases where the Donor is not related to the patient, the Internal Transplant Committee
p.(None): of the Health Establishment where the Transplant is to be performed, must issue the resolution
p.(None): favorable to do it, prior to the registration of the Candidate Receiver in the National Registry of
p.(None): Transplants This resolution will be signed by all the members of the Internal Transplant Committee of the
p.(None): Health Establishment, when the Donor or Receiver are of foreign nationality.
p.(None): Article 26. The resolution referred to in article 333, section VI, subsection a), of the Law, must contain the
p.(None): next:
p.(None): I. The clinical summary of the case, including medical, clinical and psychological evaluation studies of the Recipient;
...
p.(None): IV. Patients who transfer from one Health Facility to another, will retain their seniority
p.(None): in the National Transplant Registry;
p.(None): V. The health officer of the Health Establishment must keep the
p.(None): Information from Candidate Recipients to receive a Transplant, notifying the National Registry of
p.(None): Transplants any income or change;
p.(None): 18 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): SAW. The health officer of the Health Establishment must report a donation or
p.(None): of a Transplant, within the periods provided for in article 33, section XI, subsections b) and c), of this Regulation, and
p.(None): VII. The databases of the National Transplant Registry will be confidential, you can only have access to the
p.(None): according to their field of competence, authorized personnel of:
p.(None): a) CENATRA;
p.(None): b) COFEPRIS;
p.(None): c) Customs authorities;
p.(None): d) State Transplant Centers or State Transplant Councils;
p.(None): e) Institutional Coordinations, and
p.(None): f) Health Establishments that have authorization in terms of article 315 of the Law.
p.(None): Article 63. It is the responsibility of the Director of the Health Establishment to supervise that the person in charge
p.(None): sanitary update the information required in terms of article 338 of the Law.
p.(None): CENATRA must notify COFEPRIS of the breach of the content of this Chapter, so that said
p.(None): Authority proceed in terms of the applicable legal provisions.
p.(None): Article 64. Only Organs, Tissues or cells from deceased Donors may be transplanted, to
p.(None): patients enrolled in the National Transplant Registry at least forty-eight hours before the
p.(None): Donor's loss of life certification. The cases of Urgency of
p.(None): Transplant.
p.(None): SIXTH TITLE
p.(None): INTERVENTION OF THE PUBLIC MINISTRY AND THE JUDICIAL AUTHORITY IN THE DONATION OF ORGANS, FABRICS OR CELLS
p.(None): Single Chapter
p.(None): On the Intervention of the Public Ministry and the Judicial Authority in the Donation of Organs, Tissues or Cells
p.(None): Article 65. In cases where the loss of the Donor's life is related to the investigation of
p.(None): a crime, intervention will be given to the Public Prosecutor's Office, in order to rule on whether the
p.(None): Removal of the organs, tissues and cells of said donor interferes with their investigation.
p.(None): The intervention referred to in the previous paragraph, will be given to the judicial authority in cases where it
p.(None): Find out about the crime in question.
p.(None): The Removal of Organs, Tissues and cells that is performed without giving the intervention to the Public Ministry or the
p.(None): judicial authority, in terms of this article, will give rise to responsibilities
p.(None): administrative and criminal provisions set forth in the applicable legislation.
p.(None): 19 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): Article 66. In the case of persons in whom the loss of life has been certified, whose
p.(None): identity unknown or unable to locate relatives, intervention will be given to the Ministry
p.(None): Public in order to state whether the events that caused the loss of life may constitute a crime and in
p.(None): affirmative case will be as provided in the previous article.
p.(None): In the event that a judicial authority is aware of the facts that caused the loss of the life of
p.(None): people whose identity is unknown or cannot locate their relatives, the intervention of
p.(None): The judicial authority will be carried out in the same terms established in the previous paragraph.
p.(None): Article 67. The determinations of the Public Ministry or of the competent judicial authority that are issued in
p.(None): terms of the provisions of articles 65 and 66 of this Regulation do not constitute an authorization for
p.(None): Carry out the extraction of organs, tissues and cells.
p.(None): The determinations referred to in the preceding paragraph shall be made known to the Hospital Coordinator for
p.(None): that, where appropriate, the latter take the necessary steps to meet the requirements that
p.(None): establish the Law, this Regulation and other applicable legal provisions for the Extraction of
p.(None): Organs, tissues and cells.
p.(None): SEVENTH TITLE
p.(None): NATIONAL SUBSYSTEM OF DONATION AND TRANSPLANTS
p.(None): Single Chapter
p.(None): From the National Donation and Transplant Subsystem
p.(None): Article 68. The National Donation and Transplant Subsystem aims to coordinate actions that facilitate the
p.(None): Transplantation to patients who require it, under the principles of confidentiality,
p.(None): absence of profit, altruism, feasibility, transparency, equity and efficiency, data must be protected
p.(None): personnel in terms of the applicable legal provisions.
p.(None): Article 69. The coordination of the National Donation and Transplant Subsystem is in charge of CENATRA.
p.(None): For the purposes of the preceding paragraph, CENATRA will have the following functions:
p.(None): I. Coordinate the donation and transplant activities of organs, tissues and cells of the
p.(None): members of the National Donation and Transplant Subsystem;
p.(None): II. Periodically evaluate the results achieved by the different members of the National Subsystem of
p.(None): Donation and Transplants, and
p.(None): III. To convene consensus to define the homologation of the criteria of integral medical attention in the matter of
p.(None): Transplants, as well as their diffusion.
p.(None): EIGHTH TITLE
...
p.(None): Article 78. The transfer referred to in this Chapter shall be made under the responsibility of the person who for that purpose
p.(None): designate the Internal Transplant Committee of the Health Facility to which the Body has been assigned,
p.(None): Tissue or cell, who must carry a document that identifies and accredits as responsible in
p.(None): Terms of this article. The Internal Transplant Committee before making the transfer, must notify the
p.(None): CENATRA of the person designated for this purpose.
p.(None): Article 79. In the Donor's file, the Health Establishment to which the
p.(None): Organs, tissues or cells; the date of the Procuration, as well as the name of the person responsible for the transfer to
p.(None): referred to in the previous article and the data that derive from the official identification it carries,
p.(None): including the folio number of it.
p.(None): TENTH TITLE
p.(None): PERMITS AND NOTICES
p.(None): Single Chapter
p.(None): Permits and Notices
p.(None): Article 80. Sanitary permit will be required, for admission or departure from the national territory, as the case may be,
p.(None): of Tissues, cells and their Components for Transplant purposes.
p.(None): Article 81. To obtain the sanitary permit for admission to the national territory of Tissues,
p.(None): Cells and their Components for Transplant purposes, the interested party must submit the request to COFEPRIS in the
p.(None): corresponding official format, to which the corresponding documentation will be attached, in accordance with the following:
p.(None): I. Document proving the operation of the Health Establishment issued by the authority
p.(None): health of the country of origin, and
p.(None): II. Sanitary license of the Establishment with specific turn for Transplant.
p.(None): Article 82. For the admission of tissues or cells to the national territory, the Health Establishment that seeks
p.(None): To receive the tissue or cell, you must justify before COFEPRIS and CENATRA the need for their internment, as well as
p.(None): the difficulty of obtaining it in the country.
p.(None): Article 83. To obtain the sanitary permit for the exit of the national territory of Tissues and cells, the
p.(None): interested party must submit an application in the corresponding official form to COFEPRIS, to which the
p.(None): following documentation:
p.(None): I. Copy of the sanitary authorization of the Health Establishment to make the Disposition of Organs,
p.(None): Tissues and cells;
p.(None): 22 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): II. Copy of the document proving the legal operation of the Health Establishment that you will receive
p.(None): Tissues and cells issued by the competent authority, for control purposes of the country of destination, and
p.(None): III. Letter of acceptance of the Health Establishment abroad.
p.(None): Article 84. Documents issued by the Health Establishment or the professional abroad
p.(None): they will be accompanied by their translation when they are written in a language other than Spanish, carried out by an expert
p.(None): translator.
p.(None): Article 85. COFEPRIS must be notified in the following cases:
p.(None): I. The withdrawal, temporary suspension and total or partial resumption of activities of the
p.(None): Health establishments that require health authorization for its operation, in terms of the Law
p.(None): and this Regulation;
p.(None): II. Appointment or removal of the health officer of the Health Establishments, and
p.(None): III. The others determined by the Law, these Regulations and other applicable legal provisions.
p.(None): TITLE ELEVENTH SURVEILLANCE
p.(None): Single Surveillance Chapter
p.(None): Article 86. The Ministry of Health is responsible for monitoring compliance with these Regulations and others.
p.(None): applicable legal provisions, which will be carried out in accordance with the Seventh Title of the Law.
p.(None): Article 87. During the health verification visit and when the health authority deems it
p.(None): necessary, the procedures required to verify that the Organs, tissues, cells,
p.(None): Donors and recipients meet the sanitary conditions and requirements established by the Law, these Regulations and others
p.(None): applicable legal provisions. In case of finding any irregularity, deficiency or anomaly, the authority
p.(None): The company may order the necessary actions to identify the origin of the failures or problems.
p.(None): The minutes that are drawn up for this purpose will be made in accordance with the provisions of article 401, section III, of the Law
p.(None): and other applicable legal provisions.
p.(None): Article 88. The health authority may, at any time, determine the cases in which the Bodies,
p.(None): Tissues and their Components and cells do not meet the requirements and optimal conditions for their use, in the
p.(None): terms established by these Regulations and in the other applicable legal provisions.
p.(None): Article 89. In the exercise of its powers, the health authority may request the support of the
p.(None): personnel from the technical areas of the Secretariat that are considered necessary.
p.(None): TRANSITORY
p.(None): FIRST. This Regulation shall enter into force on the day following its publication in the Official Gazette of the
p.(None): Federation.
p.(None): 23 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): SECOND. The provisions of the Regulations of the General Health Law on Health Control of the
p.(None): Disposition of Organs, Tissues and Dead Bodies of Human Beings, which refer to the donation, disposition and
p.(None): transplantation of organs, tissues and cells, other than blood and its components, progenitor cells
p.(None): hematopoietic or trunk, as well as those provisions that oppose this Regulation.
p.(None): Consequently, Sections Third and Fourth of Chapter III remain in force; Chapter IV, and Chapter
p.(None): V of the Regulations of the General Health Law on Health Control of Organ Disposal,
p.(None): Tissues and Corpses of Human Beings, as well as the other provisions of the same order, that are necessary
p.(None): for the application of said Sections and Chapters mentioned above.
p.(None): THIRD. The Agreement is abrogated by which the guidelines for the allocation and distribution of
p.(None): organs and tissues of corpses of human beings for transplantation, published in the Official Gazette of the Federation on 23
p.(None): April 2009
p.(None): ROOM. The Agreement delegated to the Head of the Federal Commission for the Protection against Protection is repealed
...
Orphaned Trigger Words
p.(None): prevent the risk of rejection of the Organ, Tissue or transplanted cells;
p.(None): VII. Hospital Coordinator: To the Hospital Organ and Tissue Donor Coordinator for Transplants to which
p.(None): section XX of article 314 of the Law refers;
p.(None): VIII. Medical Criteria: The clinical, laboratory and cabinet elements, defined by the Committees
p.(None): Transplant Interns, which allow selecting candidates to receive an Organ, Tissue or cell;
p.(None): IX. Health Establishments: The clinical or hospital units that perform acts of
p.(None): Extraction, analysis, conservation, preparation, supply and transplantation of Organs, Tissues and cells;
p.(None): X. Removal of Organs, Tissues or cells: The surgical act through which one or several are obtained
p.(None): Organs, tissues or cells of a living or deceased donor for subsequent transplantation into one or more recipients;
p.(None): XI Histocompatibility: The similarity between two or more tissues at the level of their genetic characteristics
p.(None): and immunological;
p.(None): XII. Law: The General Health Law;
p.(None): XIII Transplant Opportunity: The set of conditions of time, mode and place that allow a
p.(None): Transplant;
p.(None): XIV Transplant Program: The set of services authorized to a Health Facility for
p.(None): provide comprehensively to patients who require a Transplant of an Organ, Tissue or
p.(None): cell, coordinated by the Internal Transplant Committee;
p.(None): XV. Candidate Recipient: The patient who has been accepted by the Internal Transplant Committee to be a Recipient of
p.(None): an Organ, Tissue or cell and that has been registered in the National Transplant Registry, until before it
p.(None): perform the transplant;
p.(None): XVI. Secretariat: The Ministry of Health, and
p.(None): XVII Transplant Urgency or Code 0: The imminent risk of death of a patient, that due to his condition of
p.(None): gravity, its only life alternative is Organ Transplantation.
p.(None): Article 3. The interpretation for administrative purposes of this Regulation corresponds to the
p.(None): Secretary.
p.(None): Article 4. It corresponds to the Secretariat through CENATRA:
p.(None): I. Establish programs and campaigns aimed at disseminating among health officials and health professionals.
p.(None): health, sanitary requirements that must be met in the Provision of Organs, Tissues and cells for purposes
p.(None): of transplants;
p.(None): II. Encourage in coordination with the dependencies and entities of the Federal Public Administration and
p.(None): the governments of the federal entities, actions to promote the donation of Organs, Tissues and
p.(None): cells, both in life and after the loss of it, for transplant purposes;
p.(None): 2 of 24
p.(None): REGULATIONS OF THE GENERAL LAW OF HEALTH IN TRANSPLANTATION
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Regulation DOF 03-26-2014
p.(None): III. Encourage the development of study and research programs related to Organ Disposition,
p.(None): Tissues and cells, in regards to Transplants;
p.(None): IV. Inform and guide the population about the donation of Organs, Tissues and cells for Transplant purposes, as well
p.(None): as, to promote the participation of the media in the dissemination of information related to the actions that
p.(None): involve activities in favor of the culture of donation of organs, tissues and cells;
p.(None): V. Coordinate the National Donation and Transplant Subsystem;
p.(None): SAW. Coordinate the Distribution and Assignment of Organs, Tissues and Donor Cells with loss of life to
p.(None): Transplant, and
p.(None): VII. Operate the National Transplant Registry.
...
Appendix
Indicator List
Indicator | Vulnerability |
access | Access to Social Goods |
age | Age |
authority | Relationship to Authority |
crime | Illegal Activity |
criminal | criminal |
educational | education |
emergencies | patients in emergency situations |
emergency | Public Emergency |
family | Motherhood/Family |
hospitalized | hospitalized patients |
language | Linguistic Proficiency |
marital status | Marital Status |
occupation | Occupation |
officer | Police Officer |
opinion | philosophical differences/differences of opinion |
parents | parents |
party | political affiliation |
political | political affiliation |
pregnant | Pregnant |
single | Marital Status |
stem cells | stem cells |
student | Student |
women | Women |
Indicator Peers (Indicators in Same Vulnerability)
Indicator | Peers |
marital status | ['single'] |
party | ['political'] |
political | ['party'] |
single | ['maritalXstatus'] |
Trigger Words
coercion
consent
ethics
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input