0A4F4F9BD490A749D5437F821CF06DF1
Decree 18/1998 (XII 27) EüM on Implementing Act CLIV of 1997 on Health Care as Regards Transplantation and Storage of Organs and Tissues and Certain Histopathology Examinations
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / political affiliation
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p.000002: Page Usage Analysis of Wolters Kluwer Hungary Kft.
p.000002: (c) histopathological examination
p.000002: activities [Eütv.
p.000002: use of.
p.000002: its §];
p.000002: order personalized offers
p.000002: * search through the contact information you provided (if you have one
p.000002: (d) products derived from human tissues and cells intended for human applications.
p.000002: contact information eg. during registration)
p.000002: 1 / A. § * For the purposes of the Regulation
p.000002: page for full functionality with all the convenience features of the "Comfort
p.000002: cookie "setting. You can change your cookie settings at any time
p.000002: Donation 1: provision of organs for transplantation and tissues and cells for human use;
p.000002: browser (Firefox, Chrome, Safari, Internet Explorer, Microsoft Edge).
p.000002: The Wolters Kluwer
p.000002: Disposal 2: Hungary Kft
p.000002: the transposition of data management
p.000002: you can read about it here.
p.000002: permanent organ placement;
p.000002: 3. Distribution: transport and transfer of tissues and cells for human use;
p.000002: 4. human application: application of tissues and cells to or from the recipient's body or body;
p.000002: 5. "organization responsible for human use" means the organization of a healthcare provider or of an in-patient healthcare provider;
p.000002: a unit that uses human tissues and cells for transplantation;
p.000002: (6) 'processing' means any operation for the preparation, treatment, preservation and preservation of tissues and cells intended for human applications;
p.000002: packaging;
p.000002: 7. Authorized organization: as defined in section 1 / B. § 1, or the National Blood Supply Service (hereinafter: OVSZ)
p.000002: The exchange of organs participating in the Agreement is a Party to the Agreement on the European Economic Area
p.000002: specific quality and safety related to the exchange of organs to and from a Member State and third countries
p.000002: the performance of tasks;
p.000002: 8. * collection: the process by which tissues and cells are made available, that is, the removal of tissues and cells,
p.000002: they are then transported to the first tissue bank for storage;
p.000002: 9. 'procurement organization' means a healthcare provider that collects human tissues and cells without processing or storing them;
p.000002: 10. 'gametes' means all tissues and cells intended to be used for assisted reproduction;
p.000002: 1 1 quarantine: the physically or otherwise separated state of the removed tissues or cells for acceptance or rejection
p.000002: pending a decision to that effect;
p.000002: 12. Critical: any material activity, circumstance, or device that is involved in the collection, processing, preservation, storage of cells and tissues,
p.000002: may affect the quality and safety of cells and tissues by contact with them during transport and distribution;
p.000002: 1 3. quality management system: organizational structure for implementing quality management, defined responsibilities, procedures,
p.000002: a set of processes and resources that includes activities that directly or indirectly contribute to quality;
p.000002: 1 4. certification: the certification of the continuing compliance of a process, professional procedure, equipment or environment with:
p.000002: standards and quality requirements set out in standards; certification to evaluate the effectiveness of a particular system
p.000002: happening;
p.000002: 15. operational requirements: the steps of a specific process, including the materials and methods to be used and the expected end result;
p.000002: written information documents;
p.000002: 16. National Donor / Recipient Identification Number: means the identification code which has been assigned in accordance with Article 16 / D. (2) of the Act, the identifier established at Member State level
p.000002: assigned to a donor or recipient in accordance with the system;
p.000002: 1 7. traceability: identifying and identifying the location of a tissue, cell or organ from collection or donation to
p.000002: processing, examination and storage of organs or tissues for transplantation or for destruction or disposal
p.000002: during all steps of the process, including donor, recipient, tissue bank, and organ harvesting and transplantation
p.000002: identification of the healthcare provider; it also covers products and substances which come into contact with tissues, cells or organs
p.000002: it shall also be associated with the identification and identification of all relevant non-personally identifiable information;
p.000002: 1 8 partner donation: male and female donation of gametes that meet the requirements of human reproduction
p.000002: special procedures, and the availability and frozen storage of gametes and embryos
p.000002: 30/1998 on the detailed rules (VI. 24.) NM;
p.000002: 1 9 Preservation: The use of chemicals, modified environmental conditions, or other means to prevent or
p.000002: to delay the change in the biological or physical state of the cells, tissues and organs during processing;
p.000002: 20. Member State of destination: Member State to which the organ is intended for transplantation, which is party to the Agreement on the European Economic Area
p.000002: sent;
p.000002: 21. serious adverse event: examination, processing, storage and distribution of tissues and cells and from organ donation
p.000002: an unwanted, unexpected adverse event associated with any stage of the process leading to its implantation which is
p.000002: transmission of the disease, death of the patient or death, permanent impairment, disability or incapacity
p.000002: or requiring medical treatment, or leading to or prolonging them;
p.000002: in the case of special reproduction procedures, any false identification or exchange of gametes or embryos;
p.000002: 22. major complication: process of human application of tissues and cells and from organ donation to implantation
p.000002: any unwanted reaction in any stage of the donor or recipient body, including an infectious disease
p.000002: including death, life-threatening, permanent injury, disability or incapacitation
p.000002: results in or requires medical treatment or may lead to or prolong treatment;
p.000002: Professional code of practice 23: written procedure describing the steps of a process, including the materials and methods to be used, and the expected results
p.000002: instructions;
p.000002: (24) "Member State of origin" means a Member State in which an organ is transplanted into a Member State of the European Economic Area
p.000002: taken out;
p.000002: 25. organ procurement: the process by which donated organs become available;
p.000002: 26. * cell bank: a healthcare provider that performs screening of cell donors, processing, preserving, storing, and
p.000002: distributes cells to the transplanting health care provider;
...
p.000002: (3) * OVSZ maintains National Register of Organ Donation and Transplantation and living donors applying for organ donation
p.000002: A register is kept by the health care providers providing the care according to the procedure of the OVSZ.
p.000002: (4) In the case of an organ, the data necessary for traceability shall be kept by the OVSZ for 30 years after the donation. Retention of data
p.000002: it can also be done electronically.
p.000002: 16 / E. § * For organ harvesting, materials and equipment must be used that comply with the requirements of the Minister for Medical Devices
p.000002: and the applicable professional rules.
p.000002: 16 / F. § * The OVSZ
p.000002: (a) participate in the network of competent authorities and coordinate at national level the contribution to the activities of the network;
p.000002: (b) keep a record of the activities of transplantation centers, showing the total number of living and deceased donors and
p.000002: and contains the types and quantities of organs transplanted or otherwise disposed of,
p.000002: (c) prepare an annual report on the activities under point (b) and publish it on its website;
p.000002: d) ensure that in the case of organ exchange between Hungary and a Member State of the European Union, Article 9 / a. organs and organs according to Annex
p.000002: donor data to the Member State affected by the exchange of organs,
p.000002: e) * monitor organ transplant effectiveness and analyze the national situation of transplants.
p.000002: 16 / G. § * The National Chief Medical Officer shall keep records in accordance with the provisions of the legislation on the registration of health care providers.
p.000002: about transplant centers.
p.000002: Human organs intended for transplantation are party to the Agreement on the European Economic Area
p.000002: general rules of procedure for the exchange of information between Member States *
p.000002: 16 / Mon. § * (1) OVSZ shall be issued pursuant to Section 16 / I. Shall act in accordance with the provisions of paragraphs (2) and (3).
p.000002: 2. The data shall be in writing, by electronic means or by fax in the language agreed with the Member State of destination or, failing that, in English.
p.000002: shall be sent immediately after the availability of the data, including the date of transmission and
p.000002: the contact person responsible for the transfer. Following the transmission, it shall be ensured that the Member State of destination is the data
p.000002: confirm receipt.
p.000002: 3. When transferring data pursuant to paragraph 1, it shall be indicated, subject to compliance with data protection legislation, that personal data
p.000002: contains data.
p.000002: 4. In cases of urgency, data may be communicated orally, in particular in accordance with Article 16 / K. § report serious adverse events and events
p.000002: in case of. Following oral transmission, the procedure set out in paragraphs 2 and 3 shall apply.
p.000002: (5) The OVSZ shall provide a 24-hour reception for emergency data.
p.000002: 16 / I. § * (1) The OVSZ shall forward the information specified in Section 9 / a before the organ exchange takes place. Organ and donor data in accordance with Annex III
p.000002: workers to the competent authorities or authorized bodies in the Member State of destination.
p.000002: 2. If the transmission pursuant to paragraph 1 did not provide all the information required by Article 9 / a. to be provided in accordance with Annex
p.000002: data, the OVSZ shall ensure that the necessary data is transmitted as soon as it becomes available.
p.000002: (3) A 9 / a. of Annex 16 / B. (1) and (2) shall be determined and sent to the OVSZ
p.000002: data transfer.
p.000002: Organ traceability data *
p.000002: 16 / J. § * (1) OVSZ to ensure traceability of organs - Section 9 / a. In addition to the information contained in Annex I -
p.000002: In the case of a body originating in Hungary, forwarded by the competent authorities of the Member State of destination or its authorized organizations
p.000002: and the national donor identification number.
p.000002: 2. The data referred to in paragraph 1 relating to the definition of the organ shall be the anatomical description (organ name) of the organ,
p.000002: position, lateral position, and the whole organ, a part of it, and which lobes and segments of the organ
p.000002: it is.
p.000002: 3. In the case of a body arriving in Hungary, the OVSZ shall forward it to the competent authorities of the Member State of origin or to an authorized person
p.000002: your organization:
p.000002: (a) the national recipient identification number or, in the absence of an implant, the purpose of the organ,
p.000002: (b) the date of transposition,
p.000002: (c) the name and contact details of the transplantation center.
p.000002: 16 / Tues § * (1) If OVSZ becomes aware of a serious adverse event or complication that may be due to another
p.000002: It relates to a body received from a Member State which is party to a regional agreement, - Article 17 / C. § - without delay
p.000002: inform the competent authority or the authorized organization of the Member State of origin and of Annex 13 (A)
p.000002: send to them a preliminary report containing the information available.
p.000002: (2) If the OVSZ is informed of a serious adverse event or complication that may be related to a donor whose
p.000002: organs of the European Economic Area have been sent to another Member State party to the Agreement on the European Economic Area;
p.000002: The competent authority of the Member State of destination or its authorized organization shall provide a prior report containing the information referred to in paragraph
p.000002: for.
p.000002: 3. Where, following the submission of a prior report pursuant to paragraphs 1 and 2, a serious adverse event and
p.000002: Any additional information relating to this matter shall be communicated to the OVSZ without delay and forwarded to the bodies referred to in paragraphs 1 and 2.
p.000002: 4. Where a serious adverse event or complication is suspected to be related to a donor whose organs are other than those of the European Economic Area,
p.000002: Has also been sent to a Member State which is a party to a regional agreement, the OVSZ being the competent authority of the Member State of origin in accordance with paragraph 2.
p.000002: shall forward the competent authorities of all Member States of destination within three months of the forwarding of the prior report referred to in paragraph 1, or
p.000002: to its authorized organization, as specified in Annex 13 (B). For final report, destination
p.000002: the information sent by the competent authority or its authorized body in the Member States shall be used.
p.000002: 16 / L. § * In order to ensure interconnection between Member States that are parties to the Agreement on the European Economic Area, OVSZ shall send the
p.000002: Contact details of the European Commission (organization name, telephone number, e-mail address, fax number, postal address). If the data changes, please
p.000002: inform the European Commission.
p.000002: Histopathological examination
p.000002: § 17 Organ from living body - Histopathologic examination is not required for tissue removal in the following organs
p.000002: [EUT. Section 204 (2) (c)]:
p.000002: the tooth,
p.000002: (b) vitreous,
p.000002: (c) nails,
p.000002: (d) in the case of physiological birth, the placenta.
p.000002: Person in charge *
p.000002: 17 / A. § * (1) Within the tissue bank, the head of the tissue bank and the person responsible for the protection, registration and preservation of tissues
p.000002: a designated person (hereinafter referred to as "responsible person") shall be responsible.
p.000002: 2. The responsible person shall meet at least the following qualification criteria:
...
p.000002: forms. Healthcare providers under Section 14 shall provide information on the data required for the annual report in Annex 11 a
p.000002: by 30 April of the year following the reference year, inform the National Chief Medical Officer.
p.000002: 17 / C. § * (1) * Serious adverse event or serious complication to an organ known to the health care provider
p.000002: immediately inform OVSZ, which, with immediate notification to the Minister and the transplant centers,
p.000002: notifies the National Chief Medical Officer of the notification and investigation of the case. The OVSZ shall take the necessary measures without delay, including:
p.000002: if the consequences of a serious adverse event or serious incident could affect another Member State, the European Commission or the European Commission
p.000002: The competent authorities of the Member States of the Economic Area likely to be affected by a serious adverse event or serious complication shall:
p.000002: notification.
p.000002: 2. The formal requirements for the timely notification and treatment of serious adverse events and reactions in the organ shall be
p.000002: OVSZ issues an Operational Order which is published on its website.
p.000002: 17 / D. § * The National Chief Medical Officer, indicating the number and nature of serious adverse events and events
p.000002: keep a record.
p.000002: 17 / E. § * Compliance with the provisions of this Regulation shall also be examined in the course of professional supervision.
p.000002: 17 / F. § * The competent authorities shall be the Member States party to the Agreement on the European Economic Area or the European Commission
p.000002: they shall, on request, provide information on the results of the inspections and controls carried out in relation to the requirements of this Regulation.
p.000002: 17 / G. § * The National Chief Medical Officer shall carry out regular inspections of tissue processing and storage facilities and may inspect
p.000002: procedures and activities relating to the requirements of this Regulation and may be subject to inspection in the framework of this Regulation
p.000002: requirements.
p.000002: Single European Code *
p.000002: 17 / Mon. § * (1) The single European code shall apply to all tissues and cells distributed for human use. The tissues
p.000002: and, in the case of the placing on the market of cells and cells for other purposes, at least the accompanying documentation shall contain the donation identification character.
p.000002: 2. Paragraph 1 shall not apply
p.000002: (a) the donation of reproductive cells between partners,
p.000002: (b) tissues and cells delivered directly to the recipient for immediate transplantation;
p.000002: (c) in urgent cases, with the express authorization of the competent authority, for tissues and cells introduced into the European Union.
p.000002: 3. The following shall be exempted from the requirements of paragraph 1:
p.000002: (a) tissues and cells other than gametes intended for donation between partners, provided that they remain with the same healthcare provider,
...
p.000002: 3. In the case of tissue and cell fusion, the end product shall be assigned a new donation identification number. The individual donations
p.000002: the tissue bank which carries out the merger shall ensure its traceability.
p.000002: 17 / Tues § * (1) The National Chief Medical Officer shall assign a unique identification number to each authorized tissue bank. If the tissue bank is more different
p.000002: but has a single system for issuing unique donation numbers, then it can be considered as a tissue bank. If the
p.000002: tissue bank uses two or more systems to issue unique donation numbers, the number of systems used by a given site
p.000002: have a sufficient number of dedicated tissue bank codes.
p.000002: 2. The donation identification string assigned to tissues and cells already placed on the market shall not be altered unless
p.000002: needed to fix a coding error. In the event of a coding error, all patches must be properly documented.
p.000002: 3. § 37 and in the EU Tissue and Cellular Product Collection
p.000002: shall be applied at the latest before distribution for human consumption. The tissue and
p.000002: the label of your cell product shall indicate the appropriate batch number and the expiry date. In the case of tissues and cells in which
p.000002: no expiry date specified, the expiry date shall be 00000000 which shall be indicated at the latest before distribution for human consumption.
p.000002: 4. Prior to distribution of the product for human consumption, the labeling shall be indelibly and indelibly marked on the product.
p.000002: European code and should be included in the accompanying documentation. The tissue bank may entrust this task to a third party or parties, provided that:
p.000002: the third party ensures compliance with the provisions of this Regulation, in particular regarding the uniqueness of the single European code. If, due to the size of the label,
p.000002: the single European code cannot be included on the label, the code shall be included in the accompanying documentation, which shall be clearly
p.000002: affected tissues and cells.
p.000002: (5) The tissue bank and organizations responsible for human use shall keep at least 30 records as specified in Annex 14,
p.000002: for years.
p.000002: 17 / L. § * (1) The National Chief Medical Officer
p.000002: (a) examine, in its audit of the tissue bank, the application of the single European code;
p.000002: (b) ensure the validation of data on tissue banks in the Union Collection of Tissue Banks as set out in Annex 16;
p.000002: and update the collection within 10 business days at the latest, especially in the following cases:
p.000002: (ba) where a new tissue bank is authorized;
p.000002: (bb) in the event of changes in tissue bank information or misrepresentation of tissue banks in the Union collection;
p.000002: (bc) in the event of a change in the tissue bank authorization referred to in paragraph 2;
p.000002: (c) alert the competent authorities of another Member State if it detects incorrect information in relation to a Member
p.000002: or if it finds that the provisions of a European code are significant for the other Member State
p.000002: a case of non-compliance;
...
p.000002: apply.
p.000002: (2) Where the human tissues and cells to be imported are only processed products covered by other Union legislation
p.000002: for the purposes of this Chapter, the donation, collection and testing outside the European Union and from the donor to the
p.000002: to the recipient and from the recipient to the donor.
p.000002: 3. The provisions of this Chapter shall not apply
p.000002: a) 15 / C. § 1 for direct importation;
p.000002: (b) in cases of urgency, the importation of tissues and cells directly authorized by the national officer in charge.
p.000002: 17 / N. § * For the purposes of this Chapter
p.000002: 1. "single import" means the importation of any type of tissue and cell for single use to a specified known recipient;
p.000002: 2. "third country healthcare provider" means a tissue bank or healthcare provider established in a third country that:
p.000002: responsible for the export to the European Union of tissues and cells which it supplies to a tissue bank;
p.000002: 3. "Importing tissue bank" means a tissue bank established in the European Union and established with a healthcare provider in a third country.
p.000002: on the contracted importation into the European Union of knitted tissues and cells of human origin from third countries
p.000002: party to the agreement;
p.000002: 4. Urgent case: an unforeseeable situation where, in practice, there is no other option than urgent tissue and
p.000002: to import cells into the European Union for immediate use in a known recipient whose health is seriously compromised without such imports
p.000002: would be in danger.
p.000002: 17 / O. § * (1) The importation of tissues and cells from third countries shall be subject to an operating license issued by the
p.000002: may be carried out by an importing tissue bank holding an official certificate issued for that purpose.
p.000002: 2. When applying for an import authorization, the applicant importing tissue bank shall send to the national officer in charge of:
p.000002: Attach the information in Annex 17 and attach the documents in Annex 18 to the application. The nationwide
p.000002: The Chief Medical Officer shall verify the data transmitted and the existence of the requirements of this Regulation and shall authorize the application on the basis of
p.000002: and, where necessary, establish the conditions and restrictions for import and issue the
p.000002: (c) an official certificate in accordance with Annex II for authorized tissue establishment banks.
p.000002: (3) The importing tissue bank shall notify the National Chief Medical Officer of any material change in its import activities.
p.000002: for. The official officer shall amend the official certificate referred to in paragraph 2 upon notification.
p.000002: (4) A substantial change is the change in the type of tissues and cells to be imported, the quality and quality of the tissues and cells to be imported.
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Health / Cognitive Impairment
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p.000002: assigned to a donor or recipient in accordance with the system;
p.000002: 1 7. traceability: identifying and identifying the location of a tissue, cell or organ from collection or donation to
p.000002: processing, examination and storage of organs or tissues for transplantation or for destruction or disposal
p.000002: during all steps of the process, including donor, recipient, tissue bank, and organ harvesting and transplantation
p.000002: identification of the healthcare provider; it also covers products and substances which come into contact with tissues, cells or organs
p.000002: it shall also be associated with the identification and identification of all relevant non-personally identifiable information;
p.000002: 1 8 partner donation: male and female donation of gametes that meet the requirements of human reproduction
p.000002: special procedures, and the availability and frozen storage of gametes and embryos
p.000002: 30/1998 on the detailed rules (VI. 24.) NM;
p.000002: 1 9 Preservation: The use of chemicals, modified environmental conditions, or other means to prevent or
p.000002: to delay the change in the biological or physical state of the cells, tissues and organs during processing;
p.000002: 20. Member State of destination: Member State to which the organ is intended for transplantation, which is party to the Agreement on the European Economic Area
p.000002: sent;
p.000002: 21. serious adverse event: examination, processing, storage and distribution of tissues and cells and from organ donation
p.000002: an unwanted, unexpected adverse event associated with any stage of the process leading to its implantation which is
p.000002: transmission of the disease, death of the patient or death, permanent impairment, disability or incapacity
p.000002: or requiring medical treatment, or leading to or prolonging them;
p.000002: in the case of special reproduction procedures, any false identification or exchange of gametes or embryos;
p.000002: 22. major complication: process of human application of tissues and cells and from organ donation to implantation
p.000002: any unwanted reaction in any stage of the donor or recipient body, including an infectious disease
p.000002: including death, life-threatening, permanent injury, disability or incapacitation
p.000002: results in or requires medical treatment or may lead to or prolong treatment;
p.000002: Professional code of practice 23: written procedure describing the steps of a process, including the materials and methods to be used, and the expected results
p.000002: instructions;
p.000002: (24) "Member State of origin" means a Member State in which an organ is transplanted into a Member State of the European Economic Area
p.000002: taken out;
p.000002: 25. organ procurement: the process by which donated organs become available;
p.000002: 26. * cell bank: a healthcare provider that performs screening of cell donors, processing, preserving, storing, and
p.000002: distributes cells to the transplanting health care provider;
p.000002: 26a. * Tissue bank: a health care provider that performs screening of tissue donors, processing, preserving, storing,
p.000002: as well as distribution and transfer of tissues to the transplanting health care provider;
p.000002: 27. storage: storage of tissues and cells under controlled conditions until distribution;
p.000002: 28. * Donation Identification String: The first part of the Single European Code, which is the code for the tissue bank and the unique donation code.
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Health / Comatose
Searching for indicator coma:
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p.000002: .................................................. .................................................. ................................................
p.000002: .................................................. .................................................. ................................................
p.000002: .................................................. .................................................. ................................................
p.000002: Date: ................................................ ......................................
p.000002: .................................................. ...... ............................................. ............
p.000002: signature of donor (legal representative) signature of recipient (legal representative)
p.000002: .................................................. ......
p.000002: the doctor performing the intervention
p.000002: (Head of the medical team)
p.000002: Annex No 2 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000002: Determination of brain death
p.000002: Brain death can be caused by primary brain damage (direct damage to the brain) or secondary brain damage (indirect, hypoxic brain damage).
p.000002: Damage).
p.000002: Brain death, which is the complete and irreversible loss of brain function (including the brain stem) - primarily clinical trials
p.000002: and based on the course of the disease. Diagnosis of brain death can be confirmed by instrumental examinations. In case of primary brain damage
p.000002: CT skull must be performed.
p.000002: Determining brain death consists of three steps.
p.000002: 1. Clarification of exclusionary circumstances. Brain death is not detectable if any of the following is present:
p.000002: (a) coma caused by intoxication, medication;
p.000002: b) neuromuscular blockade;
p.000002: c) shock state;
p.000002: d) coma of metabolic or endocrine origin;
p.000002: (e) cooling (the rectal temperature at the time of test is below 35 ° C);
p.000002: (f) acute inflammatory nervous system disorders.
p.000002: 2. Demonstration of complete brain dysfunction: by establishing the presence of the clinical symptoms listed below.
p.000002: a) Deep coma. The presence of spinal reexects does not rule out the existence of brain death.
p.000002: (b) The following brainstem may not be replaced on any side:
p.000002: I. pupillare ex,
p.000002: II. corneare ex,
p.000002: III. trigemino-facial pain reaction,
p.000002: ARC. vestibulo ocularis re ex. Examination with caloric stimulation or so-called. baby eye symptom.
p.000002: Caloric stimulation can be achieved by the use of ice water or chlorine ethyl: 50 ml of ice water should be administered to the external canal in 30 seconds and chlorine ethyl in 5 seconds.
p.000002: injected. Physiologically, after one minute, slow and conjugated deviation of the eyelids to pacing can be examined. I miss
p.000002: re ex if the eye movement is not displayed. At least 15 minutes should elapse between pacing the two ear canals. Internal ear injury (eg, base fracture)
p.000002: If the ex is not inducible, the assay on this page cannot be evaluated, but it does not rule out brain death.
p.000002: To trigger the baby's eye symptom, the neck should be turned sideways with a sudden movement of the headrest raised 30 ° from the horizontal.
p.000002: Physiologically, the eyeballs move within the orbit. Missing re ex when bulbs follow passively within head orbit
p.000002: movement. (In case of cervical vertebral fracture or craniospinal lesion, or suspected of having a baby eye, no examination of the baby's eye may be performed.)
p.000002: V. coughing ex ex-pharyngeal, tracheal, bronchial stimulation with deep aspiration through the endotracheal tube.
p.000002: c) * Lack of spontaneous breathing and respiratory paralysis can be confirmed by apnea test. Apnea test: arterial pCO level
p.000002: 2
p.000002: physiological, should be set to 38-42 mmHg. After 10 minutes of normalization of pCO levels, 100% oxygen
p.000002: 2
...
p.000002: If technically possible, a test report shall be printed and recorded in the documentation.
p.000002: II. Tc99m perfusion scintigram with HMPAO: no intracranial isotope activity;
p.000002: III. quadriceps angiogenesis: angiograms lack cerebral palpation.
p.000002: If one or more of the above instrumental studies demonstrate irreversibility of the missing brain function, the treatment time indicated in (a)
p.000002: not necessary.
p.000002: Annex 3 to the Act No 18/1998. (XII. 27.) EüM Decree *
p.000002: Protocol for establishing brain death
p.000002: Serial number of the protocol
p.000002: Institution: ................................................ ........................... Department: ..................... .................................................. ..........
p.000002: Patient Name: ............................................... ........................... TAJ: ...................... .................................................. ................
p.000002: Place of birth: ............................................... ....................... Date of birth: ........................ ..................................................
p.000002: Diagnosis: ................................................. .................................................. ....................................
p.000002: Date of onset of unconsciousness: ........ year ....... month ....... day ........ hour ....... minutes
p.000002: Date of commencement of investigation: ........ year ....... month ....... day ........ hour ....... minutes
p.000002: Questions 1 and 2 above should be answered yes or no to the test
p.000002: 1. Foreclosure factors:
p.000002: Exclusions Factor 1 Test 2 Test 3 Test 3
p.000002: 1.1. Coma caused by poisoning, drug action can be ruled out
p.000002: 1.2. Neuromuscular blockade can be ruled out
p.000002: 1.3. Shock status can be ruled out
p.000002: 1.4. Metabolic or endocrine coma can be excluded
p.000002: 1.5. Cooling can be ruled out
p.000002: 1.6. Acute inflammatory nervous system disorders can be excluded
p.000002: 2. Demonstration of complete brain failure:
p.000002: Symptoms Test 1 Test 2 Test 3 Test 3
p.000002: 2.1. There is unconsciousness (coma)
p.000002: 2.2. The pupils are moderately broad / broad, the light reaction is mko.
p.000002: miss
p.000002: 2.3. Cornea-re ex mko. miss
p.000002: 2.4. A pain stimulator applied to the trigeminal nerve
p.000002: the reaction is mko. miss
p.000002: 2.5. Vestibulo-ocularis re ex mko. miss
p.000002: 2.6. Cough re ex missing
p.000002: 2.7. There is a lack of spontaneous breathing, paralysis of the respiratory center
p.000002: apnea test
p.000002: 3. Demonstration of irreversibility of complete brain failure:
p.000002: 3.1. Instrumental examinations:
p.000002: The name of the instrumental test is the Outcome of its Date
p.000002: 3.1.1.
p.000002: 3.1.2.
p.000002: 3.1.3.
p.000002: 3.1.4.
p.000002: 3.2. Observation time:
p.000002: Time of interrogation The person (s) conducting the interrogation
p.000002: year month day hour hour minute name
p.000002: 4. Confirmation of Brain Death:
p.000002: Based on the studies documented in this protocol, brain death was clearly established:
p.000002: ............. years .......... snow ....... days ......... hours ..... minutes
p.000002: Doctors who determine brain death:
p.000002: Tester 1: Name (in block letters): ........................................ .............................. medical seal:
p.000002: signature: ................................................ .................................................. ............
p.000002: Examiner 2: Name (in block letters): ........................................ .............................. medical seal:
p.000002: signature: ................................................ .................................................. .............
p.000002: Examiner 3: Name (in block letters): ........................................ .............................. medical seal:
p.000002: signature: ................................................ .................................................. ............
...
Health / Drug Usage
Searching for indicator drug:
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p.000002: If technically possible, a test report shall be printed and recorded in the documentation.
p.000002: II. Tc99m perfusion scintigram with HMPAO: no intracranial isotope activity;
p.000002: III. quadriceps angiogenesis: angiograms lack cerebral palpation.
p.000002: If one or more of the above instrumental studies demonstrate irreversibility of the missing brain function, the treatment time indicated in (a)
p.000002: not necessary.
p.000002: Annex 3 to the Act No 18/1998. (XII. 27.) EüM Decree *
p.000002: Protocol for establishing brain death
p.000002: Serial number of the protocol
p.000002: Institution: ................................................ ........................... Department: ..................... .................................................. ..........
p.000002: Patient Name: ............................................... ........................... TAJ: ...................... .................................................. ................
p.000002: Place of birth: ............................................... ....................... Date of birth: ........................ ..................................................
p.000002: Diagnosis: ................................................. .................................................. ....................................
p.000002: Date of onset of unconsciousness: ........ year ....... month ....... day ........ hour ....... minutes
p.000002: Date of commencement of investigation: ........ year ....... month ....... day ........ hour ....... minutes
p.000002: Questions 1 and 2 above should be answered yes or no to the test
p.000002: 1. Foreclosure factors:
p.000002: Exclusions Factor 1 Test 2 Test 3 Test 3
p.000002: 1.1. Coma caused by poisoning, drug action can be ruled out
p.000002: 1.2. Neuromuscular blockade can be ruled out
p.000002: 1.3. Shock status can be ruled out
p.000002: 1.4. Metabolic or endocrine coma can be excluded
p.000002: 1.5. Cooling can be ruled out
p.000002: 1.6. Acute inflammatory nervous system disorders can be excluded
p.000002: 2. Demonstration of complete brain failure:
p.000002: Symptoms Test 1 Test 2 Test 3 Test 3
p.000002: 2.1. There is unconsciousness (coma)
p.000002: 2.2. The pupils are moderately broad / broad, the light reaction is mko.
p.000002: miss
p.000002: 2.3. Cornea-re ex mko. miss
p.000002: 2.4. A pain stimulator applied to the trigeminal nerve
p.000002: the reaction is mko. miss
p.000002: 2.5. Vestibulo-ocularis re ex mko. miss
p.000002: 2.6. Cough re ex missing
p.000002: 2.7. There is a lack of spontaneous breathing, paralysis of the respiratory center
p.000002: apnea test
p.000002: 3. Demonstration of irreversibility of complete brain failure:
p.000002: 3.1. Instrumental examinations:
p.000002: The name of the instrumental test is the Outcome of its Date
p.000002: 3.1.1.
p.000002: 3.1.2.
p.000002: 3.1.3.
p.000002: 3.1.4.
p.000002: 3.2. Observation time:
p.000002: Time of interrogation The person (s) conducting the interrogation
p.000002: year month day hour hour minute name
p.000002: 4. Confirmation of Brain Death:
p.000002: Based on the studies documented in this protocol, brain death was clearly established:
p.000002: ............. years .......... snow ....... days ......... hours ..... minutes
p.000002: Doctors who determine brain death:
p.000002: Tester 1: Name (in block letters): ........................................ .............................. medical seal:
...
p.000002: professional bank.
p.000002: 1.5.2. The tissue bank must ensure that the received tissues and cells are quarantined as long as they and associated
p.000002: documentation is not verified or compliance is not otherwise verified. Responsible people need it
p.000002: Verify relevant donor / fundraising information and accept donation.
p.000002: 1.5.3. The tissue bank must have a professional code of conduct for each consignment of tissues and cells.
p.000002: These should include the technical requirements and other essentials required by the tissue bank to maintain acceptable quality.
p.000002: criteria. The tissue bank shall have a professional code of conduct with inadequate or incomplete test results
p.000002: the handling and isolation of consignments of such products, the risk of contamination of other processed, preserved or stored tissues and cells
p.000002: exclusion.
p.000002: 1.5.4. Data to be recorded in the tissue bank (except donors of reproductive cells intended for donation between spouses or life partners)
p.000002: must include:
p.000002: (a) the consent, including an indication of the purposes for which the tissues and cells may be used and the consent given;
p.000002: specific instructions for destruction of unused tissues and cells,
p.000002: (b) all necessary data on the donor's medical history and collection,
p.000002: (c) results of physical examination, laboratory and other examination,
p.000002: (d) for allogeneic donors, control of donor selection by the responsible person,
p.000002: (e) for cultures of cells intended for autologous use, documentation of the recipient's drug allergy.
p.000002: 1.5.5. * The tissue bank must have a professional code of practice for cell and tissue distribution and recall. Rules of procedure a
p.000002: it shall contain the necessary measures with regard to recall, the time limits for taking action, the procedure for taking responsibility for the measures and the
p.000002: rules for notifying the National Chief Medical Officer. Traceability of tissues and cells must be ensured by professional procedures. All
p.000002: identify a donor who may have contributed to the complication in the recipient,
p.000002: tissues and cells and the recipients and recipients of tissues and cells collected from the same donor must be notified if
p.000002: may be at risk. Measures to be taken in response to requests from health care providers for tissues and cells, and
p.000002: the distribution of tissues and cells to patients and healthcare providers shall be in accordance with professionally accessible procedures
p.000002: regulate. Treatment of returned products, including rules for returning products to inventory, in accordance with professional procedures
p.000002: to be determined.
p.000002: 1.5.6. * Critical processing procedures should be validated and should not result in tissue or cells becoming clinically ineffective or
p.000002: harmful to the recipient. Validation is based on your healthcare provider's own or other healthcare provider's information or other published information
p.000002: and, in the case of procedures already in place and in use, on the basis of their description and indicators. It must be ensured that
p.000002: a validated procedure can be performed by the tissue processing and storage unit. [Specifications especially for additives (eg solutions) and
...
p.000002: airborne. The effectiveness of these measures should be validated and verified. If the tissues or cells during processing are environmental
p.000002: are exposed without the need for a subsequent microbial inactivation procedure,
p.000002: air of particle number and microbial number in accordance with Annex 1 to the European GMP Code of Good Manufacturing Practice; and
p.000002: class A as defined in Directive 2003/94 / EC; in addition, the environment must adapt to the processing of the tissue or cell concerned, but
p.000002: for particle number and microbial count, at least class D as laid down in European guidelines for good manufacturing practice
p.000002: must meet.]
p.000002: Sterile instruments and devices must be used to collect tissues and cells. Tools and equipment must be of good quality
p.000002: they must be validated or certified for the purpose and must be maintained on a regular basis for the procurement of tissues and cells.
p.000002: Where reusable devices are to be used, validated cleaning and sterilization procedures for the removal of infectious agents
p.000002: should be introduced.
p.000002: 9 / a. Annex No. 18/1998. (XII. 27.) EüM Decree *
p.000002: The process of organ donation
p.000002: Determination of organ and donor data
p.000002: 1. Determination of organ and donor data
p.000002: 1.1. Minimum data set
p.000002: 1.1.1. The facility where the organ is removed and other general information necessary to identify the facility
p.000002: 1.1.2. Donor type
p.000002: 1.1.3. blood type
p.000002: 1.1.4. No
p.000002: 1.1.5. Cause of death
p.000002: 1.1.6. Date of death
p.000002: 1.1.7. Date of birth or estimated age
p.000002: 1.1.8. Body weight
p.000002: 1.1.9. Height
p.000002: 1.1.10. Past or current history of injecting drug use
p.000002: 1.1.11. History of past or present malignant neoplasia
p.000002: 1.1.12. Current history of other transmissible disease
p.000002: 1.1.13. HIV, HCV and HBV tests
p.000002: 1.1.14. Basic information for evaluating the functioning of the donated body
p.000002: 1.2. Additional data set
p.000002: 1.2.1. General Informations
p.000002: Contact details of the organ procurement establishment and the facility where the organ was harvested, from organs to donors
p.000002: recipients and vice versa for coordination, allocation and traceability.
p.000002: 1.2.2. Donor details
p.000002: Demographic and anthropometric data needed to ensure proper matching between the donor and the organ and the recipient.
p.000002: 1.2.3. The donor's medical history
p.000002: The medical history of the donor, in particular those conditions that may affect the suitability of the organ for transplantation and
p.000002: may carry the risk of transmission of disease.
p.000002: 1.2.4. Physical and clinical data
p.000002: To evaluate the potential donor's ziology and to identify diseases that have not been identified in the donor's medical history
p.000002: data from clinical trials that may affect the suitability of the organ for transplantation and may include
p.000002: risk of disease transmission.
p.000002: 1.2.5. Laboratory data
p.000002: To assess the functional characteristics of organs and to identify potentially transmissible diseases and the potential for organ donation
p.000002: data necessary to determine contraindications.
p.000002: 1.2.6. Imaging examinations
p.000002: Imaging tests to assess the anatomical status of organs for transplantation.
p.000002: 1.2.7. Therapy
...
Searching for indicator usage:
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p.000002: COOKIES NEEDED
p.000002: These cookies are primarily required for the proper functioning of the site. In addition, analytical measurements or site running
p.000002: I'll open it in the Jurisprudence
p.000002: ads.
p.000002: FUNCTIONAL COOKIES
p.000002: These cookies allow us to show you ads that are relevant to your interests.
p.000002: COMFORTABLE COOKIE-K
p.000002: 18/1998. (XII. 27.) EüM decree
p.000002: Recommended setting. These cookies provide an opportunity for you to analyze your use of the site for personalized content and
p.000002: or send you ads, or use our analytics to improve our services.
p.000002: CLIV of 1997 on Health Act on Organ and Tissue Transplantation and Storage; and
p.000002: implementing certain provisions of its histopathological examination
p.000002: Rescue
p.000002: CLIV of 1997 on Health (5), Article 204 (2) (c) of the Act
p.000002: On the basis of the authorization contained in Section 247 (2) (q), I hereby order:
p.000002: * This option enables:
p.000002: Article 1 The scope of this Decree shall be covered
p.000002: Secure login, remember login details
p.000002: a) * human tissues and cells intended for human application [Eütv. 3 / A. § (a) and (b)], donate, remove, investigate,
p.000002: Memorizing the process of tasks and transactions
p.000002: Web analytics measurements for statistical purposes
p.000002: processing, Reminder
p.000002: preservation, storage and distribution, except as an autologous graft used in the same surgical procedure
p.000002: send items from your cart
p.000002: Show ads on the page
p.000002: tissues and cells;
p.000002: Showing ads that are relevant to your interests (remarketing) a
p.000002: (b) transplantation of organs or tissues
p.000002: website (e.g., community related
p.000002: pages) to healthcare providers, providers, or users,
p.000002: Page Usage Analysis in order to customize your content
p.000002: including Eutv
p.000002: 211 (1) website
p.000002: make and record a statement of opposition under paragraph;
p.000002: Page Usage Analysis of Wolters Kluwer Hungary Kft.
p.000002: (c) histopathological examination
p.000002: activities [Eütv.
p.000002: use of.
p.000002: its §];
p.000002: order personalized offers
p.000002: * search through the contact information you provided (if you have one
p.000002: (d) products derived from human tissues and cells intended for human applications.
p.000002: contact information eg. during registration)
p.000002: 1 / A. § * For the purposes of the Regulation
p.000002: page for full functionality with all the convenience features of the "Comfort
p.000002: cookie "setting. You can change your cookie settings at any time
p.000002: Donation 1: provision of organs for transplantation and tissues and cells for human use;
p.000002: browser (Firefox, Chrome, Safari, Internet Explorer, Microsoft Edge).
p.000002: The Wolters Kluwer
p.000002: Disposal 2: Hungary Kft
p.000002: the transposition of data management
p.000002: you can read about it here.
p.000002: permanent organ placement;
p.000002: 3. Distribution: transport and transfer of tissues and cells for human use;
p.000002: 4. human application: application of tissues and cells to or from the recipient's body or body;
p.000002: 5. "organization responsible for human use" means the organization of a healthcare provider or of an in-patient healthcare provider;
p.000002: a unit that uses human tissues and cells for transplantation;
p.000002: (6) 'processing' means any operation for the preparation, treatment, preservation and preservation of tissues and cells intended for human applications;
p.000002: packaging;
p.000002: 7. Authorized organization: as defined in section 1 / B. § 1, or the National Blood Supply Service (hereinafter: OVSZ)
p.000002: The exchange of organs participating in the Agreement is a Party to the Agreement on the European Economic Area
...
Health / HIV/AIDS
Searching for indicator HIV:
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p.000002: if any of the following criteria are met:
p.000002: 1. Tissue removal from the dead
p.000002: 1.1. General exclusion criteria
p.000002: 1.1.1. The cause of death is unknown unless dissection following tissue removal reveals the cause of death and the general
p.000002: none of the exclusion criteria are met.
p.000002: 1.1.2. Disease of unknown origin in the medical history.
p.000002: 1.1.3. * Malignant disease except fully healed in situ carcinoma. In the case of Cornea transplantation, the donor is not a malicious cause
p.000002: with the exception of haematological cancers, retinoblastoma and anterior malignant neoplasm.
p.000002: 1.1.4. Transmissible spongiform encephalopathies (TSEs; eg Creutzfeld-Jakob disease, variant Creutzfeld-Jakob disease):
p.000002: at risk of developing TSE; who have had a corneal or dura mater transplant and who have
p.000002: received medicines made from human pituitary gland. Additional precautions should be taken in case of a new variant of Creutzfeld-Jakob disease
p.000002: to do.
p.000002: 1.1.5. Generalized infection at the time of donation, including bacterial disease, general viral, fungal or parasitic
p.000002: infections or significant local infection of the tissues and cells to be donated. It is a donor with bacterial blood poisoning
p.000002: in the case of risk assessment, the eyeball may be removed for transplantation, provided that the cornea is stored in tissue culture
p.000002: in order to detect any bacterial contamination of the tissue prior to implantation.
p.000002: 1.1.6. * History, clinical or laboratory evidence of HIV infection, acute or chronic hepatitis B (except with proven immune status)
p.000002: individuals), the risk of transmission of hepatitis C and HTLV-I / II, or the presence of risk factors for these infections.
p.000002: 1.1.7. A chronic, generalized autoimmune disease history that may have adversely affected the quality of the tissue to be removed.
p.000002: 1.1.8. Signs that donor blood test results will be inadequate due to:
p.000002: a) incidence of blood thinning, Annex 8, paragraph 2.3. if no pre-transfusion sample is available
p.000002: available, or
p.000002: (b) treatment with immunosuppressive agents.
p.000002: 1.1.9. Based on the risk assessment, the presence of any other risk factor for transmissible diseases, taking into account the
p.000002: and exposure history and local incidence of infectious diseases.
p.000002: 1.1.10. The donor body exhibits physical lesions that justify the exclusion of the donor, especially with regard to transmissible diseases.
p.000002: risk.
p.000002: 1.1.11. Poisoning (eg cyanide, lead, mercury, gold).
p.000002: 1.1.12. Vaccination with a live virus diluted history.
p.000002: 1.1.13. According to medical history, he was the recipient of deceased organ and tissue transplantation.
p.000002: 1.2. Additional exclusion criteria for a minor donor
p.000002: An HIV-positive mother's child should not be listed as a donor.
p.000002: 2. Tissue removal from a living person
p.000002: 2.1. Autologous use (removal and application of cells or tissues in the same person)
p.000002: If the removed tissues and cells are to be stored or cultured, the same biological tests as for allogeneic living donors are required.
p.000002: minimum tests should be applied. A positive test result does not necessarily prevent the tissues or cells from either
p.000002: any product made therefrom shall be stored, processed or replanted if a separate storage facility is available
p.000002: to ensure that there is no cross-contamination with other tissues, contamination with contaminants or exchange
p.000002: the risk.
p.000002: 2.2. Allogeneic use (removing cells or tissues from one person and using them in another person)
p.000002: 2.2.1. Allogeneic donors should be selected based on their health and medical history: a questionnaire completed by the donor,
p.000002: professional qualifications and experience relevant to the personal conditions of the legislation on minimum professional conditions for services
p.000002: on the basis of a medical history recorded by a person with the courtesy of 2.2.2. . This assessment must include a significant one
p.000002: including factors that can help identify and screen out individuals who are endowed with a health risk to others
p.000002: This may pose a risk, for example, to the possibility of transmitting disease or a health risk to yourself. The collection process is
...
p.000002: or if crystalloids were injected within one hour prior to death.
p.000002: Tissue and cell processing and storage units may receive tissues and donations from donors with a plasma dilution of more than 50%.
p.000002: cells if the assay methods used have been validated for such plasma or a pre-transfusion sample is available.
p.000002: 2.4. In the case of tissue removal from the dead, blood samples must be taken immediately prior to death; such a pattern
p.000002: in the absence of blood, blood samples must be collected as early as possible after death, but not later than 24 hours after death.
p.000002: 2.5. Sampling
p.000002: 2.5.1. For live tissue removal (for practical reasons, the use of allogeneic bone marrow cell donors and peripheral blood haematopo
p.000002: blood donors) should be collected at the time of donation, if this is not possible, within 7 days of donation (
p.000002: hereafter referred to as the Donation Model).
p.000002: 2.5.2. * If the tissues and cells of allogeneic living donors can be stored for extended periods of time, repeat sampling and
p.000002: testing shall be performed except for tissues (including amniotic membranes) which are stored at -70 ° C. During this re-examination
p.000002: the sample at the time of donation may be taken up to 30 days prior to donation and up to 7 days after donation.
p.000002: 2.5.3. If the tissues and cells of allogeneic living donors cannot be stored for a long period of time and repeat sampling is therefore not possible, the procedure described in 2.5.1.
p.000002: shall be followed.
p.000002: 2.6. If in the case of live donation the donor (other than bone marrow stem cells and peripheral blood haematopoietic stem cell donors) 2.5.1. subsection
p.000002: Nucleic Acid Multiplication (NAT) Supplemental Nucleic Acid Multiple Assay for HIV, HBV and HCV
p.000002: repeat blood test is not required. Re-testing may be omitted even if the procedure is validated for inactivated viruses
p.000002: steps.
p.000002: 2.7. In the case of bone marrow and peripheral blood haematopoietic progenitors, blood samples should be collected within 30 days prior to donation.
p.000002: testing.
p.000002: 2.8. In the case of a newborn donor, biological tests may also be carried out on the donor's mother to avoid medically examining the infant.
p.000002: unreasonable procedures.
p.000002: Annex No. 9 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000002: Donation and collection of tissues (cells)
p.000002: Reception of tissues (cells) in the tissue processing and storage unit
p.000002: 1. Donation and collection procedures
p.000002: 1.1. Collection of tissues and cells
p.000002: 1.1.1. Collection should be done according to the nature of the donor and the tissues and cells donated. The removal must be done by:
p.000002: it shall comply with the relevant professional rules.
p.000002: 1.1.2. During collection, care should be taken to ensure that the properties of the tissues / cells required for the final clinical use are not compromised and
p.000002: the risk of microbial contamination should be minimized, especially if tissues and cells cannot subsequently be
p.000002: sterilized.
p.000002: 1.1.3. * Minimum professional conditions to be met in the case of removal from the deceased
p.000002: equipment, facilities and premises complying with the minimum conditions laid down in Decree. From a deceased person
p.000002: in case of donation the body should be kept in a confined area. Use sterile sheets to create the sterile separate used for this purpose
...
p.000002: air of particle number and microbial number in accordance with Annex 1 to the European GMP Code of Good Manufacturing Practice; and
p.000002: class A as defined in Directive 2003/94 / EC; in addition, the environment must adapt to the processing of the tissue or cell concerned, but
p.000002: for particle number and microbial count, at least class D as laid down in European guidelines for good manufacturing practice
p.000002: must meet.]
p.000002: Sterile instruments and devices must be used to collect tissues and cells. Tools and equipment must be of good quality
p.000002: they must be validated or certified for the purpose and must be maintained on a regular basis for the procurement of tissues and cells.
p.000002: Where reusable devices are to be used, validated cleaning and sterilization procedures for the removal of infectious agents
p.000002: should be introduced.
p.000002: 9 / a. Annex No. 18/1998. (XII. 27.) EüM Decree *
p.000002: The process of organ donation
p.000002: Determination of organ and donor data
p.000002: 1. Determination of organ and donor data
p.000002: 1.1. Minimum data set
p.000002: 1.1.1. The facility where the organ is removed and other general information necessary to identify the facility
p.000002: 1.1.2. Donor type
p.000002: 1.1.3. blood type
p.000002: 1.1.4. No
p.000002: 1.1.5. Cause of death
p.000002: 1.1.6. Date of death
p.000002: 1.1.7. Date of birth or estimated age
p.000002: 1.1.8. Body weight
p.000002: 1.1.9. Height
p.000002: 1.1.10. Past or current history of injecting drug use
p.000002: 1.1.11. History of past or present malignant neoplasia
p.000002: 1.1.12. Current history of other transmissible disease
p.000002: 1.1.13. HIV, HCV and HBV tests
p.000002: 1.1.14. Basic information for evaluating the functioning of the donated body
p.000002: 1.2. Additional data set
p.000002: 1.2.1. General Informations
p.000002: Contact details of the organ procurement establishment and the facility where the organ was harvested, from organs to donors
p.000002: recipients and vice versa for coordination, allocation and traceability.
p.000002: 1.2.2. Donor details
p.000002: Demographic and anthropometric data needed to ensure proper matching between the donor and the organ and the recipient.
p.000002: 1.2.3. The donor's medical history
p.000002: The medical history of the donor, in particular those conditions that may affect the suitability of the organ for transplantation and
p.000002: may carry the risk of transmission of disease.
p.000002: 1.2.4. Physical and clinical data
p.000002: To evaluate the potential donor's ziology and to identify diseases that have not been identified in the donor's medical history
p.000002: data from clinical trials that may affect the suitability of the organ for transplantation and may include
p.000002: risk of disease transmission.
p.000002: 1.2.5. Laboratory data
p.000002: To assess the functional characteristics of organs and to identify potentially transmissible diseases and the potential for organ donation
p.000002: data necessary to determine contraindications.
p.000002: 1.2.6. Imaging examinations
p.000002: Imaging tests to assess the anatomical status of organs for transplantation.
p.000002: 1.2.7. Therapy
p.000002: Donor treatments relevant to the assessment of organ function and organ fitness, in particular:
p.000002: antibiotic therapy, inotropic support or transfusion therapy.
p.000002: 2. Container labeling
...
p.000002: quality and safety of Tissue and Cellular Fault Equipment Failure Human Failure Other
p.000002: occurred (specify)
p.000002: serious adverse event due to error:
p.000002: Collection
p.000002: test
p.000002: Transport
p.000002: Processing
p.000002: Storage
p.000002: dispersion
p.000002: Materials
p.000002: Other (specify)
p.000002: B. Conclusions of the investigation into serious adverse events
p.000002: Tissue bank name, operating license number
p.000002: Union code for tissue bank
p.000002: Application ID
p.000002: Confirmation date (year / month / day)
p.000002: Date of serious adverse event (year / month / day)
p.000002: Analyzing the root cause (details)
p.000002: Corrective actions taken (details)
p.000002: Annex No 11 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000002: Forms to be used for the annual report
p.000002: A. Standard form for the annual report on serious adverse events
p.000002: Reporting country
p.000002: Reporting period (year) January 1 - December 31
p.000002: Number of serious complications (s) per tissue and cell type
p.000002: (or type of product that comes into contact with tissues and cells)
p.000002: Tissue / Cell (or Tissue Serious Complication (s))
p.000002: and product in contact with cells, total (if
p.000002: type of data available)
p.000001: 1
p.000002: 2
p.000003: 3
p.000004: 4
p.000004: ...
p.000004: Altogether
p.000004: Total number of tissues and cells distributed (including tissue and cell types for which no serious
p.000004: complications)
p.000004: Number of recipients affected (total number of recipients):
p.000004: Nature of serious complications reported Total number of serious complications (s) reported
p.000004: Transmitted bacterial infection
p.000004: Transmitted viral infection HBV
p.000004: HCV
p.000004: HIV 1/2
p.000004: Other (specify)
p.000004: Transmitted parasitic infection is malaria
p.000004: Other (specify)
p.000004: Transmitted malignant diseases
p.000004: Transmission of other diseases
p.000004: Other serious complications (specify)
p.000004: B. Standard form for the annual report on serious adverse events
p.000004: Reporting country
p.000004: Reporting period (year) January 1 - December 31
p.000004: Total number of tissues and cells processed
p.000004: For the quality and safety of tissues and cells,
p.000004: Details of any discrepancy that occurs
p.000004: total number of serious adverse events
p.000004: Tissue and cell failure Equipment failure Human omission Other
p.000004: (specify) (specify) (specify) (specify)
p.000004: Collection
p.000004: test
p.000004: Transport
p.000004: Processing
p.000004: Storage
p.000004: Distribution
p.000004: Materials
p.000004: Other (specify)
p.000004: Annex 12 to the Act No 18/1998. (XII. 27.) EüM Decree *
p.000004: Tissue Bank Annual Report
p.000004: Tissue and Cell Bank 15 / E. § The annual report pursuant to § 1 shall include:
p.000004: 1. Tissue bank activities
p.000004: 1.1. Number of tissue donors
p.000004: 1.2. Number of tissues donated (number of individual donations)
p.000004: 1.3. Number (units) of tissue from the eye (cornea) *
p.000004: 1.4. Skin (epithelial cell)
p.000004: 1.4.1. Skin (epithelial cell) (number of units) *
p.000004: 1.4.2. Skin (epithelial cell) cm 2 *
p.000004: 1.5. Number of heart valves (units) *
p.000004: 1.6. Number of blood vessels (units) *
p.000004: 1.7. Knitting and support fabric
p.000004: 1.7.1. Total or partial bones (units) *
p.000004: 1.7.2. Number of tendons / ligaments (units) *
p.000004: 1.7.3. Number of cartilage (units) *
p.000004: 1.7.4. Number of bone fillers (units) *
p.000004: 1.7.5. Number of other connective and support tissues (units) (eg, intervertebral disc, auditory bone, etc.) *
...
Health / Intoxication
Searching for indicator intoxication:
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p.000002: .................................................. .................................................. ................................................
p.000002: .................................................. .................................................. ................................................
p.000002: .................................................. .................................................. ................................................
p.000002: Date: ................................................ ......................................
p.000002: .................................................. ...... ............................................. ............
p.000002: signature of donor (legal representative) signature of recipient (legal representative)
p.000002: .................................................. ......
p.000002: the doctor performing the intervention
p.000002: (Head of the medical team)
p.000002: Annex No 2 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000002: Determination of brain death
p.000002: Brain death can be caused by primary brain damage (direct damage to the brain) or secondary brain damage (indirect, hypoxic brain damage).
p.000002: Damage).
p.000002: Brain death, which is the complete and irreversible loss of brain function (including the brain stem) - primarily clinical trials
p.000002: and based on the course of the disease. Diagnosis of brain death can be confirmed by instrumental examinations. In case of primary brain damage
p.000002: CT skull must be performed.
p.000002: Determining brain death consists of three steps.
p.000002: 1. Clarification of exclusionary circumstances. Brain death is not detectable if any of the following is present:
p.000002: (a) coma caused by intoxication, medication;
p.000002: b) neuromuscular blockade;
p.000002: c) shock state;
p.000002: d) coma of metabolic or endocrine origin;
p.000002: (e) cooling (the rectal temperature at the time of test is below 35 ° C);
p.000002: (f) acute inflammatory nervous system disorders.
p.000002: 2. Demonstration of complete brain dysfunction: by establishing the presence of the clinical symptoms listed below.
p.000002: a) Deep coma. The presence of spinal reexects does not rule out the existence of brain death.
p.000002: (b) The following brainstem may not be replaced on any side:
p.000002: I. pupillare ex,
p.000002: II. corneare ex,
p.000002: III. trigemino-facial pain reaction,
p.000002: ARC. vestibulo ocularis re ex. Examination with caloric stimulation or so-called. baby eye symptom.
p.000002: Caloric stimulation can be achieved by the use of ice water or chlorine ethyl: 50 ml of ice water should be administered to the external canal in 30 seconds and chlorine ethyl in 5 seconds.
p.000002: injected. Physiologically, after one minute, slow and conjugated deviation of the eyelids to pacing can be examined. I miss
p.000002: re ex if the eye movement is not displayed. At least 15 minutes should elapse between pacing the two ear canals. Internal ear injury (eg, base fracture)
p.000002: If the ex is not inducible, the assay on this page cannot be evaluated, but it does not rule out brain death.
p.000002: To trigger the baby's eye symptom, the neck should be turned sideways with a sudden movement of the headrest raised 30 ° from the horizontal.
p.000002: Physiologically, the eyeballs move within the orbit. Missing re ex when bulbs follow passively within head orbit
...
Health / Mentally Disabled
Searching for indicator disability:
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p.000002: assigned to a donor or recipient in accordance with the system;
p.000002: 1 7. traceability: identifying and identifying the location of a tissue, cell or organ from collection or donation to
p.000002: processing, examination and storage of organs or tissues for transplantation or for destruction or disposal
p.000002: during all steps of the process, including donor, recipient, tissue bank, and organ harvesting and transplantation
p.000002: identification of the healthcare provider; it also covers products and substances which come into contact with tissues, cells or organs
p.000002: it shall also be associated with the identification and identification of all relevant non-personally identifiable information;
p.000002: 1 8 partner donation: male and female donation of gametes that meet the requirements of human reproduction
p.000002: special procedures, and the availability and frozen storage of gametes and embryos
p.000002: 30/1998 on the detailed rules (VI. 24.) NM;
p.000002: 1 9 Preservation: The use of chemicals, modified environmental conditions, or other means to prevent or
p.000002: to delay the change in the biological or physical state of the cells, tissues and organs during processing;
p.000002: 20. Member State of destination: Member State to which the organ is intended for transplantation, which is party to the Agreement on the European Economic Area
p.000002: sent;
p.000002: 21. serious adverse event: examination, processing, storage and distribution of tissues and cells and from organ donation
p.000002: an unwanted, unexpected adverse event associated with any stage of the process leading to its implantation which is
p.000002: transmission of the disease, death of the patient or death, permanent impairment, disability or incapacity
p.000002: or requiring medical treatment, or leading to or prolonging them;
p.000002: in the case of special reproduction procedures, any false identification or exchange of gametes or embryos;
p.000002: 22. major complication: process of human application of tissues and cells and from organ donation to implantation
p.000002: any unwanted reaction in any stage of the donor or recipient body, including an infectious disease
p.000002: including death, life-threatening, permanent injury, disability or incapacitation
p.000002: results in or requires medical treatment or may lead to or prolong treatment;
p.000002: Professional code of practice 23: written procedure describing the steps of a process, including the materials and methods to be used, and the expected results
p.000002: instructions;
p.000002: (24) "Member State of origin" means a Member State in which an organ is transplanted into a Member State of the European Economic Area
p.000002: taken out;
p.000002: 25. organ procurement: the process by which donated organs become available;
p.000002: 26. * cell bank: a healthcare provider that performs screening of cell donors, processing, preserving, storing, and
p.000002: distributes cells to the transplanting health care provider;
p.000002: 26a. * Tissue bank: a health care provider that performs screening of tissue donors, processing, preserving, storing,
p.000002: as well as distribution and transfer of tissues to the transplanting health care provider;
p.000002: 27. storage: storage of tissues and cells under controlled conditions until distribution;
p.000002: 28. * Donation Identification String: The first part of the Single European Code, which is the code for the tissue bank and the unique donation code.
p.000002: consists of numbers;
p.000002: 29. * Number of Items: A number that distinguishes and uniquely identifies with the same unique donation number and the same
p.000002: tissues and cells with a product code from the same tissue bank as set out in Annex 15;
p.000002: 30. * unique donation number: the unique number assigned to a specific donation of tissues and cells in that Member State
p.000002: in accordance with the applicable system for assigning numbers as set out in Annex 15;
p.000002: 31. * fusion: the physical contact of tissues and cells from more than one collection from the same donor or from two or more donors; or
...
Health / Motherhood/Family
Searching for indicator family:
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p.000002: (g) the donor identification number.
p.000002: (3) * Donor name must not be on the label. The donor identification number is used to identify the donor. Tissue or cell removal
p.000002: health care provider for tissue and cell donors, legislation on the management of health data, and no
p.000002: The Commission shall keep records as specified in Annex.
p.000002: (4) * For the transport of tissue or cells, see Annex 9, paragraph 1.4. shall be complied with.
p.000002: Requirements for the collection of human tissues and cells *
p.000002: 16 / A. § * (1) * The procurement of human tissues and cells shall be carried out in accordance with the provisions of paragraphs 2 to 9. In paragraphs 2 to 9
p.000002: shall not apply in the case of specific human reproduction procedures where the gametes are concerned
p.000002: is used without storage (direct use).
p.000002: (2) The collection of human tissues and cells in accordance with the personal conditions of the legislation on minimum standards of professional health services
p.000002: it may be carried out by a person with the appropriate specialist qualifications and experience.
p.000002: 3. The written agreement between the tissue bank or procurement organization and the health care provider selecting the donor shall include:
p.000002: procedures to ensure the proper application of the selection criteria in Annex 7.
p.000002: (4) * The written agreement between the tissue bank and the procurement organization shall specify the tissues, cells and
p.000002: the nature of the test samples and the procedures to be followed during collection.
p.000002: (5) The health care provider shall establish a professional procedure
p.000002: (a) the identity of the donor,
p.000002: (b) with the consent of the donor or the donor's family,
p.000002: (c) assessing the donor selection criteria in Annex 7; and
p.000002: d) evaluating the donor's tests in accordance with Annex 8
p.000002: to verify compliance with applicable rules.
p.000002: (6) The rules of procedure for the donation and procurement of tissues and cells and the rules governing admission to the tissue bank
p.000002: of Annex 9, paragraph 1.1. and 1.5. .
p.000002: (7) The health care provider shall establish a professional code of practice with respect to the provisions of Annex 9 in which the tissue, cells,
p.000002: and the collection, packaging, labeling and transport of tissue and cell samples. The rules of procedure shall be such that:
p.000002: includes the steps of the process processes of the tissue, cell or their samples into the tissue bank,
p.000002: until you arrive at your health care provider.
p.000002: (8) A health care provider who is licensed to carry out this activity, including healthcare, is listed in Annex 9.
p.000002: It is intended to minimize the potential for bacterial or other contamination of tissues and cells.
p.000002: (9) Tissue and cell harvesting shall be carried out using the means, collectors and equipment referred to in Annex 9, which:
p.000002: they comply with the requirements of the in vitro medical device legislation and the applicable professional rules.
p.000002: Quality and safety requirements for organ harvesting *
p.000002: 16 / B. § * (1) Prior to transplantation, the details of the donated organ and the donor are specified in Section 9 / a. to be determined according to Annex.
p.000002: (2) When determining donor data, to assess the suitability of the donor for organ donation
p.000002: the necessary data must be collected to carry out an appropriate risk assessment, minimize the risks to the recipient and
p.000002: optimization.
...
p.000004: and of its cellular activities, including export activities.
p.000004: That documentation shall also include contact details of the competent authority or authorities of the third country. In countries where it is not
p.000004: If such documentation is available, other documentation, such as audit reports from a third country healthcare provider, must be provided.
p.000004: Annex No. 18 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000004: Imported by a tissue bank intending to import tissues and cells from third countries is national
p.000004: Requirements for documentation to be provided to the Chief Medical Officer to accompany the application
p.000004: A. Documentation relating to the importing tissue bank
p.000004: 1. The job description of the responsible person and the relevant qualifications and training information as defined in this Regulation.
p.000004: 2. Copy of the label on the primary packaging and the label used on the repackaging, as well as a document on the outer packaging
p.000004: and from the container.
p.000004: 3. In relation to the import activities of a tissue bank, including the application of the Single European Code,
p.000004: receiving and storing cells at the importing tissue bank, treating serious complications and adverse events, recalling
p.000004: management and donor-to-recipient traceability - relevant operational standards procedures relevant, up-to-date
p.000004: list of variations.
p.000004: B. Documentation relating to the third country healthcare provider
p.000004: 1. Detailed information on the criteria used to identify and evaluate the donor, information on the donor and his / her family
p.000004: how they obtained the donor's or their family's consent, and whether the donation was voluntary and unpaid.
p.000004: 2. Detailed information on the test center or centers used by the third country healthcare provider
p.000004: .
p.000004: 3. Detailed information on the techniques used in tissue and cell processing, including critical processing techniques
p.000004: Validation.
p.000004: 4. Detailed information on the quality control of each activity performed by the third country healthcare provider; and
p.000004: equipment, materials and criteria used for environmental inspections.
p.000004: 5. Detailed information on the conditions under which tissues and cells are made available by a healthcare provider in a third country.
p.000004: 6. Details of all subcontractors used by the third country healthcare provider, including name, address and
p.000004: activity performed.
p.000004: 7. Recent inquiries by the competent authority of the third country concerning the third country healthcare provider
p.000004: summary, including date, type and main conclusions of the study.
p.000004: 8. Recent investigation of a third country healthcare provider by or on behalf of the importing tissue bank
p.000004: Summary.
p.000004: 9. Any relevant national or international accreditation.
p.000004: Annex No 19 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: Details of the official certificate to be issued by the National Chief Medical Officer to the importing tissue bank a
p.000004: for imports of cells and tissues from third countries
p.000004: Official Certificate for the Importing Tissue Bank
p.000004: 1. Data on the Importing Tissue Establishment (ITE)
p.000004: 1.1. The name of the tissue bank
p.000004: 1.2. Code according to the EU Collection of Tissue Banks
...
Health / Physically Disabled
Searching for indicator physically:
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p.000002: browser (Firefox, Chrome, Safari, Internet Explorer, Microsoft Edge).
p.000002: The Wolters Kluwer
p.000002: Disposal 2: Hungary Kft
p.000002: the transposition of data management
p.000002: you can read about it here.
p.000002: permanent organ placement;
p.000002: 3. Distribution: transport and transfer of tissues and cells for human use;
p.000002: 4. human application: application of tissues and cells to or from the recipient's body or body;
p.000002: 5. "organization responsible for human use" means the organization of a healthcare provider or of an in-patient healthcare provider;
p.000002: a unit that uses human tissues and cells for transplantation;
p.000002: (6) 'processing' means any operation for the preparation, treatment, preservation and preservation of tissues and cells intended for human applications;
p.000002: packaging;
p.000002: 7. Authorized organization: as defined in section 1 / B. § 1, or the National Blood Supply Service (hereinafter: OVSZ)
p.000002: The exchange of organs participating in the Agreement is a Party to the Agreement on the European Economic Area
p.000002: specific quality and safety related to the exchange of organs to and from a Member State and third countries
p.000002: the performance of tasks;
p.000002: 8. * collection: the process by which tissues and cells are made available, that is, the removal of tissues and cells,
p.000002: they are then transported to the first tissue bank for storage;
p.000002: 9. 'procurement organization' means a healthcare provider that collects human tissues and cells without processing or storing them;
p.000002: 10. 'gametes' means all tissues and cells intended to be used for assisted reproduction;
p.000002: 1 1 quarantine: the physically or otherwise separated state of the removed tissues or cells for acceptance or rejection
p.000002: pending a decision to that effect;
p.000002: 12. Critical: any material activity, circumstance, or device that is involved in the collection, processing, preservation, storage of cells and tissues,
p.000002: may affect the quality and safety of cells and tissues by contact with them during transport and distribution;
p.000002: 1 3. quality management system: organizational structure for implementing quality management, defined responsibilities, procedures,
p.000002: a set of processes and resources that includes activities that directly or indirectly contribute to quality;
p.000002: 1 4. certification: the certification of the continuing compliance of a process, professional procedure, equipment or environment with:
p.000002: standards and quality requirements set out in standards; certification to evaluate the effectiveness of a particular system
p.000002: happening;
p.000002: 15. operational requirements: the steps of a specific process, including the materials and methods to be used and the expected end result;
p.000002: written information documents;
p.000002: 16. National Donor / Recipient Identification Number: means the identification code which has been assigned in accordance with Article 16 / D. (2) of the Act, the identifier established at Member State level
p.000002: assigned to a donor or recipient in accordance with the system;
p.000002: 1 7. traceability: identifying and identifying the location of a tissue, cell or organ from collection or donation to
p.000002: processing, examination and storage of organs or tissues for transplantation or for destruction or disposal
p.000002: during all steps of the process, including donor, recipient, tissue bank, and organ harvesting and transplantation
...
Health / breastfeeding
Searching for indicator breastfeeding:
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p.000002: professional qualifications and experience relevant to the personal conditions of the legislation on minimum professional conditions for services
p.000002: on the basis of a medical history recorded by a person with the courtesy of 2.2.2. . This assessment must include a significant one
p.000002: including factors that can help identify and screen out individuals who are endowed with a health risk to others
p.000002: This may pose a risk, for example, to the possibility of transmitting disease or a health risk to yourself. The collection process is
p.000002: in the case of donation, not endanger the health of the donor. This is the condition when donating umbilical cord blood or amniotic membrane
p.000002: applies to both mother and baby.
p.000002: 2.2.2. Criteria for selection of allogeneic donor for tissue establishment and, in the case of direct use, for transplantation
p.000002: is determined and documented by the attending physician, the specific tissues or cells to be donated, and the medical history and medical history of the donor
p.000002: and behavioral history together with the results of clinical and laboratory tests to confirm the donor's health
p.000002: based on his earnings.
p.000002: 2.2.3. The exclusion criteria for tissue removal from the dead shall also apply to the removal from the body. The
p.000002: Depending on the nature of the tissue or cell being donated, additional specific exclusion criteria may be applied, such as:
p.000002: (a) pregnancy (excluding donors of umbilical cord blood cells and amniotic donors and blood progenitor cells between siblings),
p.000002: (b) breastfeeding,
p.000002: (c) in the case of hematopoietic stem cells, the possibility of transmitting hereditary factors
p.000002: fact.
p.000002: Annex No 8 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000002: Laboratory tests for tissue and cell donors (except donors of reproductive cells)
p.000002: 1. * In a ministerial decree on epidemiological measures required to prevent infectious diseases and epidemics at the donor
p.000002: specific tests must be carried out.
p.000002: 1.2. * If the medical history of the donor and the characteristics of the tissue or cells to be donated so warrant, further investigations should be performed. Need
p.000002: for example, RhD, HLA, malaria, CMV, Toxoplasma, EBV, Trypanosoma cruzi. HTLV-I antibody testing should be performed
p.000002: donors who live in or come from an area with a high prevalence or sexual
p.000002: partners or parents come from such an area.
p.000002: 1.3. In the case of autologous donors, the requirements of Annex 7, paragraph 2.1. shall apply.
p.000002: 1.4. * If the tests described in point 1 have not been performed until the umbilical cord stem / mesenchymal stem cell has been removed
p.000002: the tissue bank must ensure that the umbilical cord blood stem cell / mesenchymal stem cell is quarantined for the screening result
p.000002: complete understanding.
p.000002: 2. When determining the biological property (marker), the following general requirements must be met
p.000002: 2.1. The tests shall be carried out in an immuno-laboratory as defined in the legislation on the minimum standards of professional health services
p.000002: must be done.
p.000002: 2.2. Biological tests should be performed on donor blood serum or plasma and should not be performed on other body fluids or secretions -
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.000002: for medical reasons - cannot be performed, but according to specialist advice, two organ transplants can be done by exchanging donor and recipient pairs,
p.000002: submitted jointly to the Ethics Committee for Specialist Advice and Transplant Health Care -
p.000002: At their joint request and with the approval of the Ethics Committee, the two organs may be transplanted.
p.000002: 2. The joint application referred to in paragraph 1 shall contain
p.000002: (a) the contents of Annex 1 for the two donors and the two recipients,
p.000002: (b) a joint declaration by the two donors
p.000002: (ba) that offerings are made without consideration, without compulsion, threat, deception, and
p.000002: bb) taking note that the provisions of the § 209 (4), the other simultaneous organ removal and
p.000002: organ transplantation may take place in the absence of medical advice to that effect,
p.000002: (c) a declaration by both donors and two recipients that they Information on the contents of subsections (4) and (5) of Section 209 has been received and
p.000002: they took note.
p.000002: 3. The health care provider referred to in paragraph 1 shall, where practicable,
p.000002: you can do organ transplants at the same time.
p.000002: § 5 Invasive testing in the context of a donor investigation may only be performed after the decision of the hospital ethics committee.
p.000002: 5 / A. § * Cell or tissue extraction of living donors for the procurement of umbilical cord blood for transplantation of haemopoietic stem cells
p.000002: rules apply.
p.000002: Organ, tissue removal from the dead
p.000002: § 6 Removal of organs and tissues from a dead person for transplantation into another person's body may commence if
p.000002: a) * a health worker designated by the head of the donor institution (hereinafter referred to as a designated health worker) -
p.000002: - ensure that the deceased person has not made a statement to the contrary, and
p.000002: (b) the cause of death has been established by medical examination in accordance with professional rules, or the cause of brain death has been established in
p.000002: established by the three - member Medical Committee, hereinafter referred to as "the Committee", and
p.000002: (c) the organ, tissue removal physician has determined that the organ, tissue to be removed, the examinations carried out and the deceased
p.000002: is available for transplantation from a professional standpoint.
p.000002: Article 7 (1) Until the establishment of brain death, the care of the patient, including resuscitation, shall be carried out with the utmost care and in accordance with professional rules and regulations.
p.000002: should be performed using all available options.
p.000002: (2) The members of the Committee shall complete and sign the minutes set out in Annex 3 when establishing the brain death. The record of the deceased
p.000002: health records.
p.000002: Section 8 (1) The designated health care professional shall verify by examining the medical records and records of the deceased that the patient
p.000002: has made a protest statement in his life. You will make a note of this in your health documentation.
p.000002: (2) * If a statement of opposition is sent to the treating physician within the time available to remove the organ tissue, the attending physician must
p.000002: hand over immediately to a designated health professional.
...
p.000002: on the basis of a medical history recorded by a person with the courtesy of 2.2.2. . This assessment must include a significant one
p.000002: including factors that can help identify and screen out individuals who are endowed with a health risk to others
p.000002: This may pose a risk, for example, to the possibility of transmitting disease or a health risk to yourself. The collection process is
p.000002: in the case of donation, not endanger the health of the donor. This is the condition when donating umbilical cord blood or amniotic membrane
p.000002: applies to both mother and baby.
p.000002: 2.2.2. Criteria for selection of allogeneic donor for tissue establishment and, in the case of direct use, for transplantation
p.000002: is determined and documented by the attending physician, the specific tissues or cells to be donated, and the medical history and medical history of the donor
p.000002: and behavioral history together with the results of clinical and laboratory tests to confirm the donor's health
p.000002: based on his earnings.
p.000002: 2.2.3. The exclusion criteria for tissue removal from the dead shall also apply to the removal from the body. The
p.000002: Depending on the nature of the tissue or cell being donated, additional specific exclusion criteria may be applied, such as:
p.000002: (a) pregnancy (excluding donors of umbilical cord blood cells and amniotic donors and blood progenitor cells between siblings),
p.000002: (b) breastfeeding,
p.000002: (c) in the case of hematopoietic stem cells, the possibility of transmitting hereditary factors
p.000002: fact.
p.000002: Annex No 8 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000002: Laboratory tests for tissue and cell donors (except donors of reproductive cells)
p.000002: 1. * In a ministerial decree on epidemiological measures required to prevent infectious diseases and epidemics at the donor
p.000002: specific tests must be carried out.
p.000002: 1.2. * If the medical history of the donor and the characteristics of the tissue or cells to be donated so warrant, further investigations should be performed. Need
p.000002: for example, RhD, HLA, malaria, CMV, Toxoplasma, EBV, Trypanosoma cruzi. HTLV-I antibody testing should be performed
p.000002: donors who live in or come from an area with a high prevalence or sexual
p.000002: partners or parents come from such an area.
p.000002: 1.3. In the case of autologous donors, the requirements of Annex 7, paragraph 2.1. shall apply.
p.000002: 1.4. * If the tests described in point 1 have not been performed until the umbilical cord stem / mesenchymal stem cell has been removed
p.000002: the tissue bank must ensure that the umbilical cord blood stem cell / mesenchymal stem cell is quarantined for the screening result
p.000002: complete understanding.
p.000002: 2. When determining the biological property (marker), the following general requirements must be met
p.000002: 2.1. The tests shall be carried out in an immuno-laboratory as defined in the legislation on the minimum standards of professional health services
p.000002: must be done.
p.000002: 2.2. Biological tests should be performed on donor blood serum or plasma and should not be performed on other body fluids or secretions -
p.000002: such as aqueous or glassy body fluids - unless a study using a validated test for such fluids is clinically
...
p.000002: They were injected within 48 hours, or if crystalloids were injected within one hour before the blood sample was taken, or
p.000002: (b) post mortem (post mortem) blood, blood components and / or colloids prior to death 48
p.000002: or if crystalloids were injected within one hour prior to death.
p.000002: Tissue and cell processing and storage units may receive tissues and donations from donors with a plasma dilution of more than 50%.
p.000002: cells if the assay methods used have been validated for such plasma or a pre-transfusion sample is available.
p.000002: 2.4. In the case of tissue removal from the dead, blood samples must be taken immediately prior to death; such a pattern
p.000002: in the absence of blood, blood samples must be collected as early as possible after death, but not later than 24 hours after death.
p.000002: 2.5. Sampling
p.000002: 2.5.1. For live tissue removal (for practical reasons, the use of allogeneic bone marrow cell donors and peripheral blood haematopo
p.000002: blood donors) should be collected at the time of donation, if this is not possible, within 7 days of donation (
p.000002: hereafter referred to as the Donation Model).
p.000002: 2.5.2. * If the tissues and cells of allogeneic living donors can be stored for extended periods of time, repeat sampling and
p.000002: testing shall be performed except for tissues (including amniotic membranes) which are stored at -70 ° C. During this re-examination
p.000002: the sample at the time of donation may be taken up to 30 days prior to donation and up to 7 days after donation.
p.000002: 2.5.3. If the tissues and cells of allogeneic living donors cannot be stored for a long period of time and repeat sampling is therefore not possible, the procedure described in 2.5.1.
p.000002: shall be followed.
p.000002: 2.6. If in the case of live donation the donor (other than bone marrow stem cells and peripheral blood haematopoietic stem cell donors) 2.5.1. subsection
p.000002: Nucleic Acid Multiplication (NAT) Supplemental Nucleic Acid Multiple Assay for HIV, HBV and HCV
p.000002: repeat blood test is not required. Re-testing may be omitted even if the procedure is validated for inactivated viruses
p.000002: steps.
p.000002: 2.7. In the case of bone marrow and peripheral blood haematopoietic progenitors, blood samples should be collected within 30 days prior to donation.
p.000002: testing.
p.000002: 2.8. In the case of a newborn donor, biological tests may also be carried out on the donor's mother to avoid medically examining the infant.
p.000002: unreasonable procedures.
p.000002: Annex No. 9 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000002: Donation and collection of tissues (cells)
p.000002: Reception of tissues (cells) in the tissue processing and storage unit
p.000002: 1. Donation and collection procedures
p.000002: 1.1. Collection of tissues and cells
p.000002: 1.1.1. Collection should be done according to the nature of the donor and the tissues and cells donated. The removal must be done by:
p.000002: it shall comply with the relevant professional rules.
p.000002: 1.1.2. During collection, care should be taken to ensure that the properties of the tissues / cells required for the final clinical use are not compromised and
p.000002: the risk of microbial contamination should be minimized, especially if tissues and cells cannot subsequently be
p.000002: sterilized.
p.000002: 1.1.3. * Minimum professional conditions to be met in the case of removal from the deceased
p.000002: equipment, facilities and premises complying with the minimum conditions laid down in Decree. From a deceased person
...
Social / Access to Social Goods
Searching for indicator access:
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p.000002: 4. On arrival of the removed organs in the recipient establishment, it shall be documented that the organ, including the
p.000002: conditions, packaging, labeling, related documentation and samples - meet the requirements of this Regulation and
p.000002: minimum conditions and legal provisions on rescue.
p.000002: 5. The host institution shall have in place rules of procedure for the control of the organs received. The rules of procedure must be out
p.000002: it should also cover the verification of technical requirements and other conditions which are essential to the prevailing professional rules.
p.000002: Before transplantation, the transplantation center shall verify that:
p.000002: (a) the organ and donor data have been determined and recorded,
p.000002: (b) conditions for the preservation and transport of the organs transported are fulfilled.
p.000002: (7) Organ removal procedures for organs removed for transplantation but not implanted and sent for histological examination
p.000002: The health care provider should have a professional procedure to ensure the traceability of the organs. OVSZ maintains a register of
p.000002: histological results of organs removed and not transplanted for transplantation purposes.
p.000002: 16 / D. § * (1) In order to protect donors and recipients, all organs distributed and transplanted shall be monitored in accordance with this Regulation.
p.000002: as required.
p.000002: (2) The OVSZ shall provide a unique identifier for each donation and for each donation and associated organs and recipients,
p.000002: and in accordance with the legal requirements for the protection of the recipient's health and personal information. The system should provide it
p.000002: should prevent unauthorized access to, and unauthorized access to, such data
p.000002: Any use of data.
p.000002: (3) * OVSZ maintains National Register of Organ Donation and Transplantation and living donors applying for organ donation
p.000002: A register is kept by the health care providers providing the care according to the procedure of the OVSZ.
p.000002: (4) In the case of an organ, the data necessary for traceability shall be kept by the OVSZ for 30 years after the donation. Retention of data
p.000002: it can also be done electronically.
p.000002: 16 / E. § * For organ harvesting, materials and equipment must be used that comply with the requirements of the Minister for Medical Devices
p.000002: and the applicable professional rules.
p.000002: 16 / F. § * The OVSZ
p.000002: (a) participate in the network of competent authorities and coordinate at national level the contribution to the activities of the network;
p.000002: (b) keep a record of the activities of transplantation centers, showing the total number of living and deceased donors and
p.000002: and contains the types and quantities of organs transplanted or otherwise disposed of,
p.000002: (c) prepare an annual report on the activities under point (b) and publish it on its website;
p.000002: d) ensure that in the case of organ exchange between Hungary and a Member State of the European Union, Article 9 / a. organs and organs according to Annex
p.000002: donor data to the Member State affected by the exchange of organs,
p.000002: e) * monitor organ transplant effectiveness and analyze the national situation of transplants.
p.000002: 16 / G. § * The National Chief Medical Officer shall keep records in accordance with the provisions of the legislation on the registration of health care providers.
p.000002: about transplant centers.
...
Social / Age
Searching for indicator age:
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p.000002: 2
p.000002: oxygen saturation. Subsequently, the patient was weaned from the ventilator via a catheter inserted into the intratracheal tube 6
p.000002: liters / minute with a flow of 100% oxygen should be observed for spontaneous respiratory movement. Meanwhile, follow up with re-examination
p.000002: arterial blood pCO levels should be monitored. If there is no respiratory movement at an arterial pCO of more than 60 mmHg, the respiratory center is proven
p.000002: 2 2
p.000002: ingerelhetetlensége. In the case of a history of hypercapnia, the pre-test pCO level is the baseline value. If the pCO level before the test
p.000002: 2 2
p.000002: respiratory movement does not occur with an arterial pCO value increased by 20 mmHg, the respiratory center is considered proven
p.000002: 2
p.000002: ingerelhetetlensége.
p.000002: 3. Demonstration of the irreversibility of missing brain function. This is either solely by observing the clinical symptoms and course of the disease, or clinical
p.000002: in addition to symptoms, additional instrumental examinations.
p.000002: Until the irreversibility of the missing brain function is demonstrated, every effort should be made to
p.000002: to keep it alive.
p.000002: (a) The determination of brain death is primarily based on clinical symptoms. If we rely only on clinical symptoms and course, it is
p.000002: after the onset of symptoms suggestive of brain dysfunction, the following observation period is required:
p.000002: I. 12 hours for primary brain damage in adults and children and 72 hours for secondary brain damage in children and adolescents;
p.000002: II. from five weeks to three years in both cases 24 hours;
p.000002: III. for newborns up to five weeks of age in both cases 72 hours.
p.000002: The attending physician will determine whether the patient has primary or secondary brain damage based on the patient's disease factors and course and whether
p.000002: properly determine the required waiting time. The decision shall be recorded in the documentation. Signs of brain death are recorded by the treating physician every 4 hours and
p.000002: documented.
p.000002: The Committee shall be convened at the end of the observation period.
p.000002: During the observation period, all symptoms indicating a complete loss of brain function should be present.
p.000002: b) Irreversibility of the missing brain function can be demonstrated by the following instrumental results in addition to clinical symptoms (
p.000002: you can choose from the methods listed below):
p.000002: I. Transcranial Doppler (TCD) Test: Use as a conclusive test in the diagnosis of brain death only if
p.000002: with the same gain, the same ultrasound probe, irradiation angle and test depths, flow could have been detected earlier
p.000002: intracranial vessels. The study is only conclusive if two times after the onset of clinical symptoms of brain death
p.000002: repeated testing of the pendulum flow (systole and diastole of the same amplitude), systolic abortion peaks (spike),
p.000002: or if no flow can be detected. There must be at least 30 minutes between the two tests and the two test results must be confirmed unanimously
p.000002: need to stop blood flow. If no flow can be detected at the first examination, then the brain death will prevail
p.000002: whether there was any detectable flow in the TCD before the onset of symptoms. If you have failed before the symptoms of brain death
p.000002: flow measurement in intracranial vessels, the TCD test should not be used as a confirmatory test. Both TCD examinations are written findings
...
p.000002: in case of donation the body should be kept in a confined area. Use sterile sheets to create the sterile separate used for this purpose
p.000002: place. Collecting staff should dress according to the type of collection. This includes laundry, as well as sterile clothing, sterile
p.000002: wearing gloves, surgical mask and protective mask.
p.000002: 1.1.4. In the case of removal from the dead, the place, time of collection and the time between death and removal shall be recorded.
p.000002: documentation to check if the tissues / cells are suitable for transplantation.
p.000002: 1.1.5. In the case of live tissue removal, the donor's medical records must be documented and examined at the time of collection
p.000002: any adverse event that may have resulted in a living donor's health damage, and the cause of the event
p.000002: tested.
p.000002: 1.1.6. Hygiene conditions in accordance with special legislation should be respected to minimize the risk of contamination of tissues or cells
p.000002: to reduce it.
p.000002: 1.1.7. * Prior to commencement of collection, the donor's medical records must certify and record that Section 12 (1) (a)
p.000002: and a statement of how and by whom the donor's identity was identified.
p.000002: 1.2. donor Documentation
p.000002: 1.2.1. The following information on the donor must be recorded:
p.000002: (a) the identity of the donor (given name, surname, date of birth; if the donation involves a mother and child, both the mother's name and,
p.000002: date of birth, both the child's date of birth and, if known, his name);
p.000002: (b) age, sex, medical history and life-history data necessary to identify the reasons for exclusion;
p.000002: (c) the result of the examination of the body, where applicable;
p.000002: (d) the blood thinning formula, where applicable;
p.000002: (e) clinical data, results of laboratory tests and other tests carried out;
p.000002: (f) if an autopsy has been carried out, the result must be recorded (in the case of tissues and cells which cannot be stored for
p.000002: preliminary oral report of autopsy to be recorded);
p.000002: (g) for donors of peripheral blood haematopoietic progenitor cells, the donor's suitability for the selected recipient shall be documented.
p.000002: 1.2.2. The collection organization shall draw up a collection report which shall be submitted to the tissue bank. This report shall at least:
p.000002: included:
p.000002: (a) the identity, name and address of the tissue establishment receiving the cells / tissues;
p.000002: (b) the identity of the donor (including the method of identifying the donor and the person performing it);
p.000002: (c) a description and identification of the tissues and cells which have been removed (including test samples);
p.000002: (d) the medical seal and signature of the person responsible for the collection phase;
p.000002: (e) the date, time (where relevant, start and end) and location of collection, and the professional procedures used, including any adventitious events;
p.000002: events; where applicable, the environmental conditions of the collection point (description of the site where collection took place);
p.000002: (f) in the case of removal from the dead, the conditions under which the body was stored: chilling (or lack thereof), commencing chilling and
p.000002: date of completion;
p.000002: (g) identification / batch number of reagents and delivery solutions used;
...
p.000002: to minimize the risk of infection (including cross-donation) - specific quality and purity
p.000002: airborne. The effectiveness of these measures should be validated and verified. If the tissues or cells during processing are environmental
p.000002: are exposed without the need for a subsequent microbial inactivation procedure,
p.000002: air of particle number and microbial number in accordance with Annex 1 to the European GMP Code of Good Manufacturing Practice; and
p.000002: class A as defined in Directive 2003/94 / EC; in addition, the environment must adapt to the processing of the tissue or cell concerned, but
p.000002: for particle number and microbial count, at least class D as laid down in European guidelines for good manufacturing practice
p.000002: must meet.]
p.000002: Sterile instruments and devices must be used to collect tissues and cells. Tools and equipment must be of good quality
p.000002: they must be validated or certified for the purpose and must be maintained on a regular basis for the procurement of tissues and cells.
p.000002: Where reusable devices are to be used, validated cleaning and sterilization procedures for the removal of infectious agents
p.000002: should be introduced.
p.000002: 9 / a. Annex No. 18/1998. (XII. 27.) EüM Decree *
p.000002: The process of organ donation
p.000002: Determination of organ and donor data
p.000002: 1. Determination of organ and donor data
p.000002: 1.1. Minimum data set
p.000002: 1.1.1. The facility where the organ is removed and other general information necessary to identify the facility
p.000002: 1.1.2. Donor type
p.000002: 1.1.3. blood type
p.000002: 1.1.4. No
p.000002: 1.1.5. Cause of death
p.000002: 1.1.6. Date of death
p.000002: 1.1.7. Date of birth or estimated age
p.000002: 1.1.8. Body weight
p.000002: 1.1.9. Height
p.000002: 1.1.10. Past or current history of injecting drug use
p.000002: 1.1.11. History of past or present malignant neoplasia
p.000002: 1.1.12. Current history of other transmissible disease
p.000002: 1.1.13. HIV, HCV and HBV tests
p.000002: 1.1.14. Basic information for evaluating the functioning of the donated body
p.000002: 1.2. Additional data set
p.000002: 1.2.1. General Informations
p.000002: Contact details of the organ procurement establishment and the facility where the organ was harvested, from organs to donors
p.000002: recipients and vice versa for coordination, allocation and traceability.
p.000002: 1.2.2. Donor details
p.000002: Demographic and anthropometric data needed to ensure proper matching between the donor and the organ and the recipient.
p.000002: 1.2.3. The donor's medical history
p.000002: The medical history of the donor, in particular those conditions that may affect the suitability of the organ for transplantation and
p.000002: may carry the risk of transmission of disease.
p.000002: 1.2.4. Physical and clinical data
p.000002: To evaluate the potential donor's ziology and to identify diseases that have not been identified in the donor's medical history
p.000002: data from clinical trials that may affect the suitability of the organ for transplantation and may include
p.000002: risk of disease transmission.
p.000002: 1.2.5. Laboratory data
p.000002: To assess the functional characteristics of organs and to identify potentially transmissible diseases and the potential for organ donation
p.000002: data necessary to determine contraindications.
p.000002: 1.2.6. Imaging examinations
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Social / Child
Searching for indicator child:
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p.000002: 1.1.6. * History, clinical or laboratory evidence of HIV infection, acute or chronic hepatitis B (except with proven immune status)
p.000002: individuals), the risk of transmission of hepatitis C and HTLV-I / II, or the presence of risk factors for these infections.
p.000002: 1.1.7. A chronic, generalized autoimmune disease history that may have adversely affected the quality of the tissue to be removed.
p.000002: 1.1.8. Signs that donor blood test results will be inadequate due to:
p.000002: a) incidence of blood thinning, Annex 8, paragraph 2.3. if no pre-transfusion sample is available
p.000002: available, or
p.000002: (b) treatment with immunosuppressive agents.
p.000002: 1.1.9. Based on the risk assessment, the presence of any other risk factor for transmissible diseases, taking into account the
p.000002: and exposure history and local incidence of infectious diseases.
p.000002: 1.1.10. The donor body exhibits physical lesions that justify the exclusion of the donor, especially with regard to transmissible diseases.
p.000002: risk.
p.000002: 1.1.11. Poisoning (eg cyanide, lead, mercury, gold).
p.000002: 1.1.12. Vaccination with a live virus diluted history.
p.000002: 1.1.13. According to medical history, he was the recipient of deceased organ and tissue transplantation.
p.000002: 1.2. Additional exclusion criteria for a minor donor
p.000002: An HIV-positive mother's child should not be listed as a donor.
p.000002: 2. Tissue removal from a living person
p.000002: 2.1. Autologous use (removal and application of cells or tissues in the same person)
p.000002: If the removed tissues and cells are to be stored or cultured, the same biological tests as for allogeneic living donors are required.
p.000002: minimum tests should be applied. A positive test result does not necessarily prevent the tissues or cells from either
p.000002: any product made therefrom shall be stored, processed or replanted if a separate storage facility is available
p.000002: to ensure that there is no cross-contamination with other tissues, contamination with contaminants or exchange
p.000002: the risk.
p.000002: 2.2. Allogeneic use (removing cells or tissues from one person and using them in another person)
p.000002: 2.2.1. Allogeneic donors should be selected based on their health and medical history: a questionnaire completed by the donor,
p.000002: professional qualifications and experience relevant to the personal conditions of the legislation on minimum professional conditions for services
p.000002: on the basis of a medical history recorded by a person with the courtesy of 2.2.2. . This assessment must include a significant one
p.000002: including factors that can help identify and screen out individuals who are endowed with a health risk to others
p.000002: This may pose a risk, for example, to the possibility of transmitting disease or a health risk to yourself. The collection process is
p.000002: in the case of donation, not endanger the health of the donor. This is the condition when donating umbilical cord blood or amniotic membrane
p.000002: applies to both mother and baby.
...
p.000002: sterilized.
p.000002: 1.1.3. * Minimum professional conditions to be met in the case of removal from the deceased
p.000002: equipment, facilities and premises complying with the minimum conditions laid down in Decree. From a deceased person
p.000002: in case of donation the body should be kept in a confined area. Use sterile sheets to create the sterile separate used for this purpose
p.000002: place. Collecting staff should dress according to the type of collection. This includes laundry, as well as sterile clothing, sterile
p.000002: wearing gloves, surgical mask and protective mask.
p.000002: 1.1.4. In the case of removal from the dead, the place, time of collection and the time between death and removal shall be recorded.
p.000002: documentation to check if the tissues / cells are suitable for transplantation.
p.000002: 1.1.5. In the case of live tissue removal, the donor's medical records must be documented and examined at the time of collection
p.000002: any adverse event that may have resulted in a living donor's health damage, and the cause of the event
p.000002: tested.
p.000002: 1.1.6. Hygiene conditions in accordance with special legislation should be respected to minimize the risk of contamination of tissues or cells
p.000002: to reduce it.
p.000002: 1.1.7. * Prior to commencement of collection, the donor's medical records must certify and record that Section 12 (1) (a)
p.000002: and a statement of how and by whom the donor's identity was identified.
p.000002: 1.2. donor Documentation
p.000002: 1.2.1. The following information on the donor must be recorded:
p.000002: (a) the identity of the donor (given name, surname, date of birth; if the donation involves a mother and child, both the mother's name and,
p.000002: date of birth, both the child's date of birth and, if known, his name);
p.000002: (b) age, sex, medical history and life-history data necessary to identify the reasons for exclusion;
p.000002: (c) the result of the examination of the body, where applicable;
p.000002: (d) the blood thinning formula, where applicable;
p.000002: (e) clinical data, results of laboratory tests and other tests carried out;
p.000002: (f) if an autopsy has been carried out, the result must be recorded (in the case of tissues and cells which cannot be stored for
p.000002: preliminary oral report of autopsy to be recorded);
p.000002: (g) for donors of peripheral blood haematopoietic progenitor cells, the donor's suitability for the selected recipient shall be documented.
p.000002: 1.2.2. The collection organization shall draw up a collection report which shall be submitted to the tissue bank. This report shall at least:
p.000002: included:
p.000002: (a) the identity, name and address of the tissue establishment receiving the cells / tissues;
p.000002: (b) the identity of the donor (including the method of identifying the donor and the person performing it);
p.000002: (c) a description and identification of the tissues and cells which have been removed (including test samples);
p.000002: (d) the medical seal and signature of the person responsible for the collection phase;
p.000002: (e) the date, time (where relevant, start and end) and location of collection, and the professional procedures used, including any adventitious events;
p.000002: events; where applicable, the environmental conditions of the collection point (description of the site where collection took place);
p.000002: (f) in the case of removal from the dead, the conditions under which the body was stored: chilling (or lack thereof), commencing chilling and
p.000002: date of completion;
...
p.000004: 4. Contact transplant center contact information: telephone number, e-mail address, and fax number
p.000004: 5. Date and time of filing (year / month / day / hour / minute)
p.000004: 6. Member State of origin
p.000004: 7. National donor identification number
p.000004: 8. Designation of Member State (s) of destination (if known)
p.000004: 9. National Recipient Identification Number (s)
p.000004: 10. Date and time of commencement of serious adverse event or event (year / month / day / hour / minute)
p.000004: 11. Date and time of detection of major adverse event or event (year / month / day / hour / minute)
p.000004: 12. Description of the serious adverse event or event
p.000004: 13. Immediate measures taken / proposed
p.000004: B) Final Report on Serious Adverse Events or Complications
p.000004: 1. Designation of the notifying Member State
p.000004: 2. Report reference number: country (ISO code) / national number
p.000004: 3. Contact details of the notifying authority: telephone number, e-mail address and fax number
p.000004: 4. Date and time of notification (year / month / day / hour / minute)
p.000004: 5. Identification number (s) of preliminary report (s)
p.000004: 6. Description of the case
p.000004: 7. Member States concerned
p.000004: 8. Result of the investigation and final conclusion
p.000004: 9. Preventive and remedial measures taken
p.000004: 10. Conclusion / Follow-up (if necessary)
p.000004: Annex No 14 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: Minimum data to be retained
p.000004: A. FOR FABRIC BANKS
p.000004: (1) Identity of the donor (given name, surname, date of birth, if the donation involves a mother and child, both the mother's name and
p.000004: date of birth and date of birth of the child and, if known, name, nationality, ID number)
p.000004: 2. Identification of the donation, which shall include at least the following information:
p.000004: - Identification (name, address) or tissue bank (name, address) of the collection healthcare provider
p.000004: - Unique donation number
p.000004: - Date of collection
p.000004: - The place of collection
p.000004: - Type of donation (eg tissue of one or more cell types, autologous or allogeneic, living or deceased donor)
p.000004: 3. The product identifier, which shall include at least the following information:
p.000004: - Identification of the tissue bank (name, address)
p.000004: - Tissue / cell / product type (basic nomenclature)
p.000004: - Number of item groups (in case of merger)
p.000004: - Number of sublots
p.000004: - Expiration date (year / month / day)
p.000004: Tissue / cell status (ie quarantined, usable, etc.)
p.000004: - Description and origin of the products, the processing steps used, the contact with and the quality of the tissues and cells, and
p.000004: substances and additives affecting safety
p.000004: - Identification of the establishment issuing the final label
p.000004: (4) Single European code
p.000004: 5. Identity of the human use, which shall include at least the following information:
p.000004: - Date of distribution / destruction
p.000004: - Identity of the doctor or end user / provider
p.000004: B. FOR THE HUMAN CONSUMPTION ORGANIZATION (1) Union code for tissue establishment
p.000004: (2) Identifier of the physician or end user / facility
p.000004: (3) Type of tissues and cells
p.000004: (4) Product ID
p.000004: (5) Identity of the recipient
p.000004: (6) Date of use
p.000004: (7) Single European code
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Searching for indicator children:
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p.000002: c) * Lack of spontaneous breathing and respiratory paralysis can be confirmed by apnea test. Apnea test: arterial pCO level
p.000002: 2
p.000002: physiological, should be set to 38-42 mmHg. After 10 minutes of normalization of pCO levels, 100% oxygen
p.000002: 2
p.000002: oxygen saturation. Subsequently, the patient was weaned from the ventilator via a catheter inserted into the intratracheal tube 6
p.000002: liters / minute with a flow of 100% oxygen should be observed for spontaneous respiratory movement. Meanwhile, follow up with re-examination
p.000002: arterial blood pCO levels should be monitored. If there is no respiratory movement at an arterial pCO of more than 60 mmHg, the respiratory center is proven
p.000002: 2 2
p.000002: ingerelhetetlensége. In the case of a history of hypercapnia, the pre-test pCO level is the baseline value. If the pCO level before the test
p.000002: 2 2
p.000002: respiratory movement does not occur with an arterial pCO value increased by 20 mmHg, the respiratory center is considered proven
p.000002: 2
p.000002: ingerelhetetlensége.
p.000002: 3. Demonstration of the irreversibility of missing brain function. This is either solely by observing the clinical symptoms and course of the disease, or clinical
p.000002: in addition to symptoms, additional instrumental examinations.
p.000002: Until the irreversibility of the missing brain function is demonstrated, every effort should be made to
p.000002: to keep it alive.
p.000002: (a) The determination of brain death is primarily based on clinical symptoms. If we rely only on clinical symptoms and course, it is
p.000002: after the onset of symptoms suggestive of brain dysfunction, the following observation period is required:
p.000002: I. 12 hours for primary brain damage in adults and children and 72 hours for secondary brain damage in children and adolescents;
p.000002: II. from five weeks to three years in both cases 24 hours;
p.000002: III. for newborns up to five weeks of age in both cases 72 hours.
p.000002: The attending physician will determine whether the patient has primary or secondary brain damage based on the patient's disease factors and course and whether
p.000002: properly determine the required waiting time. The decision shall be recorded in the documentation. Signs of brain death are recorded by the treating physician every 4 hours and
p.000002: documented.
p.000002: The Committee shall be convened at the end of the observation period.
p.000002: During the observation period, all symptoms indicating a complete loss of brain function should be present.
p.000002: b) Irreversibility of the missing brain function can be demonstrated by the following instrumental results in addition to clinical symptoms (
p.000002: you can choose from the methods listed below):
p.000002: I. Transcranial Doppler (TCD) Test: Use as a conclusive test in the diagnosis of brain death only if
p.000002: with the same gain, the same ultrasound probe, irradiation angle and test depths, flow could have been detected earlier
p.000002: intracranial vessels. The study is only conclusive if two times after the onset of clinical symptoms of brain death
p.000002: repeated testing of the pendulum flow (systole and diastole of the same amplitude), systolic abortion peaks (spike),
p.000002: or if no flow can be detected. There must be at least 30 minutes between the two tests and the two test results must be confirmed unanimously
p.000002: need to stop blood flow. If no flow can be detected at the first examination, then the brain death will prevail
p.000002: whether there was any detectable flow in the TCD before the onset of symptoms. If you have failed before the symptoms of brain death
...
p.000002: 1.6. Gottsegen György National Institute of Cardiology Budapest (pediatric heart and congenital heart disease - GUCH Disease; Grown-Up
p.000002: Congenital Heart Disease - heart in patients over 18 years).
p.000002: 1.7. * Semmelweis University, Faculty of Medicine, Department of Chest Surgery (lung).
p.000002: 2. Health service providers authorized to remove organs from a deceased person in respect of that organ
p.000002: 2.1. University of Debrecen Medical and Health Sciences Center Institute of Surgery No. 1 Debrecen (kidney).
p.000002: 2.2. * Department of Surgery, Faculty of Medicine, University of Pécs, Pécs (kidney; pancreas).
p.000002: 2.3. * Department of Transplantation and Surgery, Faculty of Medicine, Semmelweis University, Budapest (lung; kidney; pancreas; liver).
p.000002: 2.4. Semmelweis University Department of Vascular and Cardiac Surgery Budapest (heart).
p.000002: 2.5. University of Szeged, Szent-Györgyi Albert Clinical Center, Department of Surgery Szeged (kidney).
p.000002: 2.6. National Koranyi TBC and Pulmonology Institute Budapest (lung).
p.000002: 2.7. Gottsegen György National Institute of Cardiology Budapest (pediatric heart and heart).
p.000002: 2.8. * Semmelweis University, Faculty of Medicine, Department of Chest Surgery (lung).
p.000002: Annex No 6 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000002: A) * Authorized tissue transplant providers
p.000002: Bone marrow (includes all haemopoietic stem cell forms)
p.000002: Allogeneic bone marrow transplantation over 18 years:
p.000002: a) United St Stephen's and St Ladislaus's Hospital - Clinic,
p.000002: b) University of Debrecen Clinical Center,
p.000002: Allogeneic bone marrow transplantation at 18 years:
p.000002: a) United St Stephen's and St Ladislaus's Hospital - Clinic,
p.000002: b) BAZ County Hospital and University Teaching Hospital Children's Health Center Miskolc,
p.000002: Autologous bone marrow transplantation over 18 years:
p.000002: a) United St Stephen's and St Ladislaus's Hospital - Clinic,
p.000002: b) University of Pécs, Faculty of Medicine, Pécs,
p.000002: c) University of Debrecen Clinical Center,
p.000002: d) Albert Szent-Györgyi Clinical Center of the University of Szeged, Szeged,
p.000002: Autologous bone marrow transplantation over 18 years:
p.000002: a) United St Stephen's and St Ladislaus's Hospital - Clinic,
p.000002: b) BAZ County Hospital and University Teaching Hospital Children's Health Center Miskolc,
p.000002: Cornea
p.000002: a) University of Pécs, Faculty of Medicine, Pécs,
p.000002: b) Albert Szent-Györgyi Albert Clinical Center, University of Szeged, Szeged,
p.000002: c) University of Debrecen Medical and Health Sciences Center in Debrecen,
p.000002: d) Semmelweis University Faculty of Medicine Budapest,
p.000002: e) Bajcsy-Zsilinszky Hospital and Clinic Budapest,
p.000002: f) Markusovszky University Teaching Hospital Szombathely,
p.000002: g) * Péterfy Sándor Street Hospital, Budapest.
p.000002: Knitting and support fabric
p.000002: 60/2003 on the minimum professional conditions for the provision of health services (X. 20.) ESzCsM decree general
p.000002: Surgery, Pediatric Surgery, Orthopedics and Traumatology, Neurosurgery, Ear Nose Surgery, Surgery (Neck Surgery), Oral Surgery and Oral Surgery,
p.000002: health care providers licensed to operate in plastic surgery.
p.000002: (B) Health care providers authorized to remove tissue for transplantation from a living person
p.000002: Bone marrow (includes all haemopoietic stem cell forms)
p.000002: a) * United St Stephen's and St Ladislaus's Hospital - Clinic,
p.000002: b) BAZ County Hospital and University Teaching Hospital Children's Health Center Miskolc,
p.000002: c) Faculty of Medicine, University of Pécs, Pécs,
p.000002: d) University of Debrecen Medical and Health Sciences Center in Debrecen,
p.000002: e) Albert Szent-Györgyi Albert Clinical Center, University of Szeged II. Belklinika Szeged.
p.000002: Knitting and support fabric
p.000002: 60/2003 on the minimum professional conditions for the provision of health services (X. 20.) ESzCsM decree general
p.000002: health care providers licensed to operate in surgery, pediatric surgery, orthopedics and traumatology.
p.000002: Annex No. 7 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000002: Selection criteria for tissue (cell) donors (excluding donors of reproductive cells)
p.000002: Donor selection criteria are based on an analysis of the risks associated with the use of individual cells / tissues. Signs of these risks
p.000002: health examination, medical history review, life examination, biological examination, post mortem examination
p.000002: (in the case of tissue removal from the dead) and any other suitable test. Donors should be excluded from donation,
p.000002: if any of the following criteria are met:
p.000002: 1. Tissue removal from the dead
p.000002: 1.1. General exclusion criteria
p.000002: 1.1.1. The cause of death is unknown unless dissection following tissue removal reveals the cause of death and the general
p.000002: none of the exclusion criteria are met.
p.000002: 1.1.2. Disease of unknown origin in the medical history.
p.000002: 1.1.3. * Malignant disease except fully healed in situ carcinoma. In the case of Cornea transplantation, the donor is not a malicious cause
p.000002: with the exception of haematological cancers, retinoblastoma and anterior malignant neoplasm.
p.000002: 1.1.4. Transmissible spongiform encephalopathies (TSEs; eg Creutzfeld-Jakob disease, variant Creutzfeld-Jakob disease):
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Social / Infant
Searching for indicator infant:
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p.000002: 2.5. Sampling
p.000002: 2.5.1. For live tissue removal (for practical reasons, the use of allogeneic bone marrow cell donors and peripheral blood haematopo
p.000002: blood donors) should be collected at the time of donation, if this is not possible, within 7 days of donation (
p.000002: hereafter referred to as the Donation Model).
p.000002: 2.5.2. * If the tissues and cells of allogeneic living donors can be stored for extended periods of time, repeat sampling and
p.000002: testing shall be performed except for tissues (including amniotic membranes) which are stored at -70 ° C. During this re-examination
p.000002: the sample at the time of donation may be taken up to 30 days prior to donation and up to 7 days after donation.
p.000002: 2.5.3. If the tissues and cells of allogeneic living donors cannot be stored for a long period of time and repeat sampling is therefore not possible, the procedure described in 2.5.1.
p.000002: shall be followed.
p.000002: 2.6. If in the case of live donation the donor (other than bone marrow stem cells and peripheral blood haematopoietic stem cell donors) 2.5.1. subsection
p.000002: Nucleic Acid Multiplication (NAT) Supplemental Nucleic Acid Multiple Assay for HIV, HBV and HCV
p.000002: repeat blood test is not required. Re-testing may be omitted even if the procedure is validated for inactivated viruses
p.000002: steps.
p.000002: 2.7. In the case of bone marrow and peripheral blood haematopoietic progenitors, blood samples should be collected within 30 days prior to donation.
p.000002: testing.
p.000002: 2.8. In the case of a newborn donor, biological tests may also be carried out on the donor's mother to avoid medically examining the infant.
p.000002: unreasonable procedures.
p.000002: Annex No. 9 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000002: Donation and collection of tissues (cells)
p.000002: Reception of tissues (cells) in the tissue processing and storage unit
p.000002: 1. Donation and collection procedures
p.000002: 1.1. Collection of tissues and cells
p.000002: 1.1.1. Collection should be done according to the nature of the donor and the tissues and cells donated. The removal must be done by:
p.000002: it shall comply with the relevant professional rules.
p.000002: 1.1.2. During collection, care should be taken to ensure that the properties of the tissues / cells required for the final clinical use are not compromised and
p.000002: the risk of microbial contamination should be minimized, especially if tissues and cells cannot subsequently be
p.000002: sterilized.
p.000002: 1.1.3. * Minimum professional conditions to be met in the case of removal from the deceased
p.000002: equipment, facilities and premises complying with the minimum conditions laid down in Decree. From a deceased person
p.000002: in case of donation the body should be kept in a confined area. Use sterile sheets to create the sterile separate used for this purpose
p.000002: place. Collecting staff should dress according to the type of collection. This includes laundry, as well as sterile clothing, sterile
p.000002: wearing gloves, surgical mask and protective mask.
p.000002: 1.1.4. In the case of removal from the dead, the place, time of collection and the time between death and removal shall be recorded.
p.000002: documentation to check if the tissues / cells are suitable for transplantation.
p.000002: 1.1.5. In the case of live tissue removal, the donor's medical records must be documented and examined at the time of collection
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.000002: 16 / E. § * For organ harvesting, materials and equipment must be used that comply with the requirements of the Minister for Medical Devices
p.000002: and the applicable professional rules.
p.000002: 16 / F. § * The OVSZ
p.000002: (a) participate in the network of competent authorities and coordinate at national level the contribution to the activities of the network;
p.000002: (b) keep a record of the activities of transplantation centers, showing the total number of living and deceased donors and
p.000002: and contains the types and quantities of organs transplanted or otherwise disposed of,
p.000002: (c) prepare an annual report on the activities under point (b) and publish it on its website;
p.000002: d) ensure that in the case of organ exchange between Hungary and a Member State of the European Union, Article 9 / a. organs and organs according to Annex
p.000002: donor data to the Member State affected by the exchange of organs,
p.000002: e) * monitor organ transplant effectiveness and analyze the national situation of transplants.
p.000002: 16 / G. § * The National Chief Medical Officer shall keep records in accordance with the provisions of the legislation on the registration of health care providers.
p.000002: about transplant centers.
p.000002: Human organs intended for transplantation are party to the Agreement on the European Economic Area
p.000002: general rules of procedure for the exchange of information between Member States *
p.000002: 16 / Mon. § * (1) OVSZ shall be issued pursuant to Section 16 / I. Shall act in accordance with the provisions of paragraphs (2) and (3).
p.000002: 2. The data shall be in writing, by electronic means or by fax in the language agreed with the Member State of destination or, failing that, in English.
p.000002: shall be sent immediately after the availability of the data, including the date of transmission and
p.000002: the contact person responsible for the transfer. Following the transmission, it shall be ensured that the Member State of destination is the data
p.000002: confirm receipt.
p.000002: 3. When transferring data pursuant to paragraph 1, it shall be indicated, subject to compliance with data protection legislation, that personal data
p.000002: contains data.
p.000002: 4. In cases of urgency, data may be communicated orally, in particular in accordance with Article 16 / K. § report serious adverse events and events
p.000002: in case of. Following oral transmission, the procedure set out in paragraphs 2 and 3 shall apply.
p.000002: (5) The OVSZ shall provide a 24-hour reception for emergency data.
p.000002: 16 / I. § * (1) The OVSZ shall forward the information specified in Section 9 / a before the organ exchange takes place. Organ and donor data in accordance with Annex III
p.000002: workers to the competent authorities or authorized bodies in the Member State of destination.
p.000002: 2. If the transmission pursuant to paragraph 1 did not provide all the information required by Article 9 / a. to be provided in accordance with Annex
p.000002: data, the OVSZ shall ensure that the necessary data is transmitted as soon as it becomes available.
p.000002: (3) A 9 / a. of Annex 16 / B. (1) and (2) shall be determined and sent to the OVSZ
p.000002: data transfer.
p.000002: Organ traceability data *
p.000002: 16 / J. § * (1) OVSZ to ensure traceability of organs - Section 9 / a. In addition to the information contained in Annex I -
...
Social / Marital Status
Searching for indicator single:
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p.000002: or requiring medical treatment, or leading to or prolonging them;
p.000002: in the case of special reproduction procedures, any false identification or exchange of gametes or embryos;
p.000002: 22. major complication: process of human application of tissues and cells and from organ donation to implantation
p.000002: any unwanted reaction in any stage of the donor or recipient body, including an infectious disease
p.000002: including death, life-threatening, permanent injury, disability or incapacitation
p.000002: results in or requires medical treatment or may lead to or prolong treatment;
p.000002: Professional code of practice 23: written procedure describing the steps of a process, including the materials and methods to be used, and the expected results
p.000002: instructions;
p.000002: (24) "Member State of origin" means a Member State in which an organ is transplanted into a Member State of the European Economic Area
p.000002: taken out;
p.000002: 25. organ procurement: the process by which donated organs become available;
p.000002: 26. * cell bank: a healthcare provider that performs screening of cell donors, processing, preserving, storing, and
p.000002: distributes cells to the transplanting health care provider;
p.000002: 26a. * Tissue bank: a health care provider that performs screening of tissue donors, processing, preserving, storing,
p.000002: as well as distribution and transfer of tissues to the transplanting health care provider;
p.000002: 27. storage: storage of tissues and cells under controlled conditions until distribution;
p.000002: 28. * Donation Identification String: The first part of the Single European Code, which is the code for the tissue bank and the unique donation code.
p.000002: consists of numbers;
p.000002: 29. * Number of Items: A number that distinguishes and uniquely identifies with the same unique donation number and the same
p.000002: tissues and cells with a product code from the same tissue bank as set out in Annex 15;
p.000002: 30. * unique donation number: the unique number assigned to a specific donation of tissues and cells in that Member State
p.000002: in accordance with the applicable system for assigning numbers as set out in Annex 15;
p.000002: 31. * fusion: the physical contact of tissues and cells from more than one collection from the same donor or from two or more donors; or
p.000002: mixing in a single container;
p.000002: 32. * single European code: the unique identifier for tissues and cells distributed in the European Union, containing
p.000002: the donation identification string and the product identification string as set out in Annex 15;
p.000002: 33. * EUTC: The product code system developed by the European Union for tissues and cells and found in the European Union.
p.000002: records all types of tissues and cells and the corresponding product codes;
p.000002: 34. * placed on the market: cellular and tissue products distributed or transmitted for human use whether or not they are returned
p.000002: to the original tissue bank;
p.000002: 35. * Expiry date: The date until which the tissues and cells can be used;
p.000002: 36. * Tissue Bank Union Code: The unique identifier of the Tissue Bank, which is the ISO country code and the Tissue Bank is the T
p.000002: consists of a specific number in its collection;
p.000002: 37. * EU Collection of Tissue and Cellular Products: Tissue and Cell Types circulating in the European Union and permitted coding
p.000002: a collection of product codes corresponding to the systems (EUTC, ISBT128 and Eurocode);
p.000002: 38. * Union collection of tissue banks: all accredited, designated, authorized or authorized by the competent authority of Member States
p.000002: a collection of tissue banks containing information in accordance with Annex 15;
p.000002: 39. * product identifier string: the second part of the uniform European code comprising the product code, the number of sublots and the expiry date;
...
p.000002: if the consequences of a serious adverse event or serious incident could affect another Member State, the European Commission or the European Commission
p.000002: The competent authorities of the Member States of the Economic Area likely to be affected by a serious adverse event or serious complication shall:
p.000002: notification.
p.000002: 2. The formal requirements for the timely notification and treatment of serious adverse events and reactions in the organ shall be
p.000002: OVSZ issues an Operational Order which is published on its website.
p.000002: 17 / D. § * The National Chief Medical Officer, indicating the number and nature of serious adverse events and events
p.000002: keep a record.
p.000002: 17 / E. § * Compliance with the provisions of this Regulation shall also be examined in the course of professional supervision.
p.000002: 17 / F. § * The competent authorities shall be the Member States party to the Agreement on the European Economic Area or the European Commission
p.000002: they shall, on request, provide information on the results of the inspections and controls carried out in relation to the requirements of this Regulation.
p.000002: 17 / G. § * The National Chief Medical Officer shall carry out regular inspections of tissue processing and storage facilities and may inspect
p.000002: procedures and activities relating to the requirements of this Regulation and may be subject to inspection in the framework of this Regulation
p.000002: requirements.
p.000002: Single European Code *
p.000002: 17 / Mon. § * (1) The single European code shall apply to all tissues and cells distributed for human use. The tissues
p.000002: and, in the case of the placing on the market of cells and cells for other purposes, at least the accompanying documentation shall contain the donation identification character.
p.000002: 2. Paragraph 1 shall not apply
p.000002: (a) the donation of reproductive cells between partners,
p.000002: (b) tissues and cells delivered directly to the recipient for immediate transplantation;
p.000002: (c) in urgent cases, with the express authorization of the competent authority, for tissues and cells introduced into the European Union.
p.000002: 3. The following shall be exempted from the requirements of paragraph 1:
p.000002: (a) tissues and cells other than gametes intended for donation between partners, provided that they remain with the same healthcare provider,
p.000002: (b) tissues and cells imported into the European Union, provided that they remain with the same healthcare provider from import to use;
p.000002: provided that the healthcare provider is accredited, designated, authorized or licensed for import activities
p.000002: tissue bank.
p.000002: 4. For the purposes of paragraph 3, the same healthcare provider shall be considered to be a healthcare provider where the collection of human
p.000002: all steps in the process leading up to the use under the responsibility of the same person, same quality assurance and
p.000002: traceability system and where at least one authorized tissue processing and storage unit is located in the same location,
p.000002: and an organization responsible for human use.
p.000002: 5. The specifications for the structure of the uniform European code referred to in paragraph 1 are set out in Annex 15.
p.000002: (6) The Common European Code should be legible and preceded by the abbreviation "SEC". The single European code
p.000002: use of another label or traceability system is permitted.
p.000002: (7) The European Uniform Code should be indicated either by the donation identifier and the product identifier or by a single identifier.
p.000002: spaces, or two consecutive rows.
p.000002: 17 / I. § * The application of the single European code shall not preclude the application of additional codes in accordance with national requirements
p.000002: They are.
p.000002: Requirements for the application of the single European code *
p.000002: 17 / J. § * (1) The Tissue Bank, including the Tissue Bank of Import, shall provide the following with respect to the application of the Single European Code:
p.000002: conditions:
p.000002: (a) at the latest before distribution for human use, assign a single European code to all tissues and cells which:
p.000002: in the case of such a code;
p.000002: (b) the tissue and cell donation assigns an identification string after collection, or
p.000002: on arrival at a service provider or on importation from a healthcare provider in a third country;
p.000002: (c) notify the national officer in the following cases:
p.000002: (ca) where the information contained in the Union collection of tissue banks needs to be updated or corrected;
p.000002: (cb) when the Union collection of tissue and cell products needs to be updated;
p.000002: (cc) if the tissue bank establishes that a single European code has been obtained for tissues and cells from another Union tissue bank;
p.000002: does not meet the requirements of this Chapter.
p.000002: 2. The donation identification string referred to in paragraph 1 (b) shall consist of the following elements:
p.000002: (a) the Union Tissue Bank code, according to the Union Tissue Bank Collection,
p.000002: (b) the unique donation number issued by the tissue bank, unless it is a worldwide unique donation number.
p.000002: 3. In the case of tissue and cell fusion, the end product shall be assigned a new donation identification number. The individual donations
p.000002: the tissue bank which carries out the merger shall ensure its traceability.
p.000002: 17 / Tues § * (1) The National Chief Medical Officer shall assign a unique identification number to each authorized tissue bank. If the tissue bank is more different
p.000002: but has a single system for issuing unique donation numbers, then it can be considered as a tissue bank. If the
p.000002: tissue bank uses two or more systems to issue unique donation numbers, the number of systems used by a given site
p.000002: have a sufficient number of dedicated tissue bank codes.
p.000002: 2. The donation identification string assigned to tissues and cells already placed on the market shall not be altered unless
p.000002: needed to fix a coding error. In the event of a coding error, all patches must be properly documented.
p.000002: 3. § 37 and in the EU Tissue and Cellular Product Collection
p.000002: shall be applied at the latest before distribution for human consumption. The tissue and
p.000002: the label of your cell product shall indicate the appropriate batch number and the expiry date. In the case of tissues and cells in which
p.000002: no expiry date specified, the expiry date shall be 00000000 which shall be indicated at the latest before distribution for human consumption.
p.000002: 4. Prior to distribution of the product for human consumption, the labeling shall be indelibly and indelibly marked on the product.
p.000002: European code and should be included in the accompanying documentation. The tissue bank may entrust this task to a third party or parties, provided that:
p.000002: the third party ensures compliance with the provisions of this Regulation, in particular regarding the uniqueness of the single European code. If, due to the size of the label,
p.000002: the single European code cannot be included on the label, the code shall be included in the accompanying documentation, which shall be clearly
p.000002: affected tissues and cells.
p.000002: (5) The tissue bank and organizations responsible for human use shall keep at least 30 records as specified in Annex 14,
p.000002: for years.
p.000002: 17 / L. § * (1) The National Chief Medical Officer
p.000002: (a) examine, in its audit of the tissue bank, the application of the single European code;
p.000002: (b) ensure the validation of data on tissue banks in the Union Collection of Tissue Banks as set out in Annex 16;
p.000002: and update the collection within 10 business days at the latest, especially in the following cases:
p.000002: (ba) where a new tissue bank is authorized;
p.000002: (bb) in the event of changes in tissue bank information or misrepresentation of tissue banks in the Union collection;
p.000002: (bc) in the event of a change in the tissue bank authorization referred to in paragraph 2;
p.000002: (c) alert the competent authorities of another Member State if it detects incorrect information in relation to a Member
p.000002: or if it finds that the provisions of a European code are significant for the other Member State
p.000002: a case of non-compliance;
p.000002: (d) advise the European Commission and the competent authorities of other Member States of any collection of EU code numbers for tissues and cells;
p.000002: need to be updated.
p.000002: 2. In the Union Collection of Tissue Banks, the national officer in charge of carrying out the activities referred to in paragraph 1 (b) (bc) shall:
p.000002: leads the change:
p.000002: (a) an authorization for a new type of tissue or cell,
p.000002: (b) a permit for a new prescribed activity,
p.000002: (c) a condition or exception to any permit;
p.000002: (d) suspension of operation in relation to a particular activity or type of tissue or cell,
p.000002: (e) withdrawal of the tissue bank authorization,
p.000002: (f) situations where a tissue bank voluntarily ceases the activity or activities covered by the authorization.
p.000002: Provisions applicable to imports into the European Union of human tissues and cells *
p.000002: 17 / M. § * (1) The rules of this Decree shall apply to human tissues and cells intended for human
p.000002: the importation into the European Union of products derived from tissues and cells shall be subject to the derogations provided for in this Chapter.
p.000002: apply.
p.000002: (2) Where the human tissues and cells to be imported are only processed products covered by other Union legislation
p.000002: for the purposes of this Chapter, the donation, collection and testing outside the European Union and from the donor to the
p.000002: to the recipient and from the recipient to the donor.
p.000002: 3. The provisions of this Chapter shall not apply
p.000002: a) 15 / C. § 1 for direct importation;
p.000002: (b) in cases of urgency, the importation of tissues and cells directly authorized by the national officer in charge.
p.000002: 17 / N. § * For the purposes of this Chapter
p.000002: 1. "single import" means the importation of any type of tissue and cell for single use to a specified known recipient;
p.000002: 2. "third country healthcare provider" means a tissue bank or healthcare provider established in a third country that:
p.000002: responsible for the export to the European Union of tissues and cells which it supplies to a tissue bank;
p.000002: 3. "Importing tissue bank" means a tissue bank established in the European Union and established with a healthcare provider in a third country.
p.000002: on the contracted importation into the European Union of knitted tissues and cells of human origin from third countries
p.000002: party to the agreement;
p.000002: 4. Urgent case: an unforeseeable situation where, in practice, there is no other option than urgent tissue and
p.000002: to import cells into the European Union for immediate use in a known recipient whose health is seriously compromised without such imports
p.000002: would be in danger.
p.000002: 17 / O. § * (1) The importation of tissues and cells from third countries shall be subject to an operating license issued by the
p.000002: may be carried out by an importing tissue bank holding an official certificate issued for that purpose.
p.000002: 2. When applying for an import authorization, the applicant importing tissue bank shall send to the national officer in charge of:
p.000002: Attach the information in Annex 17 and attach the documents in Annex 18 to the application. The nationwide
p.000002: The Chief Medical Officer shall verify the data transmitted and the existence of the requirements of this Regulation and shall authorize the application on the basis of
p.000002: and, where necessary, establish the conditions and restrictions for import and issue the
p.000002: (c) an official certificate in accordance with Annex II for authorized tissue establishment banks.
p.000002: (3) The importing tissue bank shall notify the National Chief Medical Officer of any material change in its import activities.
p.000002: for. The official officer shall amend the official certificate referred to in paragraph 2 upon notification.
p.000002: (4) A substantial change is the change in the type of tissues and cells to be imported, the quality and quality of the tissues and cells to be imported.
p.000002: a change in the safety of a third country activity or a third country healthcare provider.
p.000002: 5. Single tissues or cells originating from a third country healthcare provider shall not be considered as a substantial change
p.000002: Imports not covered by an existing official certificate of the importing tissue bank but subject to an official certificate
p.000002: for imports of tissues or cells of the same type from another healthcare provider in the same third country.
p.000002: 17 / Fri. § * (1) In the case of an import tissue bank, the National Chief Medical Officer 17 / G. The interval between inspections pursuant to Article 2 shall not exceed two years.
p.000002: (2) * At the reasoned request of another Member State or the European Commission, the National Chief Medical Officer shall provide information to the importing tissue banks.
p.000002: the results of inspections and controls in relation to.
p.000002: (3) * At the reasoned request of the Member State of distribution of the imported tissues and cells, the Chief Medical Officer shall examine whether
p.000002: control of the activity of the importing tissue bank and of the healthcare provider in the third country.
p.000002: 4. If an on-the-spot inspection is carried out pursuant to a request under paragraph 3, the national officer in charge shall be competent for the requesting Member State.
p.000002: the competent authority of the requesting Member State referred to in paragraph 3, in agreement with its competent authority. The
p.000002: in the event of refusal of inspection, the national officer in charge shall give reasons for his decision in the requesting Member State referred to in paragraph 3.
p.000002: direction.
p.000002: 17 / Q. § * The documentation according to Annex 17 F and Annex 19 need not be attached for single import.
p.000002: One-time import must ensure that the imported tissues and cells are tracked from donor to recipient and from recipient to donor
p.000002: and that the imported tissues and cells are used only at the intended recipient.
p.000002: 17 / R. § * (1) The importing tissue bank shall promptly notify the National Chief Medical Officer of any suspected or
p.000002: an event or complication of which you are aware of a third country health care provider that may affect
p.000002: quality and safety of imported tissues and cells. The notification shall contain the information specified in Annex 10.
p.000002: 2. In addition to paragraph 1, the importing tissue bank shall promptly notify the National Chief Medical Officer if it becomes aware that:
p.000002: a healthcare provider in a third country
p.000002: (a) the authorization to export the tissues and cells has been withdrawn or suspended; or
p.000002: (b) the competent authority of the Member State of establishment has taken a decision which is essential for the quality and safety of the tissues and cells imported.
p.000002: 17 / S. § * (1) In the case of the donation, procurement, testing, processing, preservation of tissues and cells to be imported into the European Union,
p.000002: any storage and distribution activities are carried out outside the European Union by the importing tissue bank
p.000002: have a written agreement with the health care provider in the third country.
p.000002: 2. A written agreement between the importing tissue bank and the healthcare provider in the third country shall specify what is to be fulfilled
p.000002: quality and safety requirements to ensure that the tissues and cells to be imported comply with this Regulation
p.000002: quality and safety standards equivalent to those laid down. The written agreement shall include at least clause 20
p.000002: The information listed in Annex II.
p.000002: 17 / T. § * (1) The importing tissue bank shall keep a record of its activities, including in the case of a single import, the
p.000002: type, amount, origin and destination of tissues and cells.
p.000002: (2) The data referred to in paragraph (1) shall also be included in the annual report in accordance with Annex 12.
p.000002: (3) A 17 / O. Section 15 / D. Shall also be indicated in the register.
p.000002: Transitional and final provisions
p.000002: Article 18 (1) This Decree, with the exception of paragraph (2), shall enter into force on 1 January 1999 and shall at the same time repeal
p.000002: Act II of 1972 18/1972 on the implementation of the provisions of Act IV of 1975 on the removal and transplantation of organs and tissues (XI. 4.) EüM,
p.000002: 3/1988, as amended. (II. 17.) SZEM decree.
p.000002: (2) * of Decree 44/2016 amending this ministerial decree on health and health insurance. (XII. 28.) EMMI
p.000002: 17 / H. And Annex 15 to the Common European Code a
p.000002: Mode. It shall not apply to tissues and cells already in storage on the date of entry into force of this Directive, provided that such tissues and cells are
p.000002: Mode. shall be placed on the market within the European Union within five years of the date of its entry into force and shall be fully traceable to this Regulation.
p.000002: otherwise insured.
p.000002: (3) * For tissues and cells which have a long storage life and only after the expiry of the five-year period referred to in paragraph 2
p.000002: and which are not eligible for the uniform European code because they are stored under refrigeration,
p.000002: tissue banks shall apply procedures for labeled products in accordance with Section 16.
p.000002: (4) * This Regulation is intended to comply with the following acts of the Union:
...
p.000004: 6. Description of the case
p.000004: 7. Member States concerned
p.000004: 8. Result of the investigation and final conclusion
p.000004: 9. Preventive and remedial measures taken
p.000004: 10. Conclusion / Follow-up (if necessary)
p.000004: Annex No 14 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: Minimum data to be retained
p.000004: A. FOR FABRIC BANKS
p.000004: (1) Identity of the donor (given name, surname, date of birth, if the donation involves a mother and child, both the mother's name and
p.000004: date of birth and date of birth of the child and, if known, name, nationality, ID number)
p.000004: 2. Identification of the donation, which shall include at least the following information:
p.000004: - Identification (name, address) or tissue bank (name, address) of the collection healthcare provider
p.000004: - Unique donation number
p.000004: - Date of collection
p.000004: - The place of collection
p.000004: - Type of donation (eg tissue of one or more cell types, autologous or allogeneic, living or deceased donor)
p.000004: 3. The product identifier, which shall include at least the following information:
p.000004: - Identification of the tissue bank (name, address)
p.000004: - Tissue / cell / product type (basic nomenclature)
p.000004: - Number of item groups (in case of merger)
p.000004: - Number of sublots
p.000004: - Expiration date (year / month / day)
p.000004: Tissue / cell status (ie quarantined, usable, etc.)
p.000004: - Description and origin of the products, the processing steps used, the contact with and the quality of the tissues and cells, and
p.000004: substances and additives affecting safety
p.000004: - Identification of the establishment issuing the final label
p.000004: (4) Single European code
p.000004: 5. Identity of the human use, which shall include at least the following information:
p.000004: - Date of distribution / destruction
p.000004: - Identity of the doctor or end user / provider
p.000004: B. FOR THE HUMAN CONSUMPTION ORGANIZATION (1) Union code for tissue establishment
p.000004: (2) Identifier of the physician or end user / facility
p.000004: (3) Type of tissues and cells
p.000004: (4) Product ID
p.000004: (5) Identity of the recipient
p.000004: (6) Date of use
p.000004: (7) Single European code
p.000004: Annex No 15 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: STRUCTURE OF THE SINGLE EUROPEAN CODE
p.000004: GIVING IDENTIFICATION CHARACTER PRODUCT IDENTIFICATION CHARACTERISTICS
p.000004: FEDERAL BANK CODE SPECIFIC DONATION PRODUCT CODE TERMS EXPIRY DATE
p.000004: NUMBER * NUMBER (year / month / day)
p.000004: ISO country code The tissue bank Product code Product number
p.000004: number system
p.000004: identification
p.000004: 2 alphabetic 6 alpha-13 alpha-1 alpha-bet 7 alpha-3 alpha-8 numeric characters
p.000004: Character Numeric Numeric Character Numeric Character Numeric
p.000004: character character
p.000004: * If the tissue bank is not compatible with the Uniform European Code, Section 1 / A shall apply. § 37, is unique
p.000004: To assign a donation number, the tissue bank assigns a unique donation number, which is the date of collection of the tissue and cell (year / month / day -
p.000004: eight numeric characters), plus the donor's serial number, followed by zeros up to 13 characters.
p.000004: Annex 16 to the Act No 18/1998. (XII. 27.) EüM Decree *
p.000004: DATA TO BE RECORDED IN THE UNION COLLECTION OF BANKING BANKS
p.000004: A. Tissue Bank Information
p.000004: 1. Name of the tissue bank
p.000004: 2. The national or EU code of the tissue bank
p.000004: 3. Name of the organization within which the tissue bank is located
p.000004: 4. Address of the tissue bank
p.000004: 5. Available contact information: working email address, telephone and fax number
p.000004: B. Tissue Bank Authorization Information
p.000004: 1. Competent Authorizing Authority (s)
p.000004: 2. Name of the competent authority (ies) responsible for the management of the Union collection of tissue banks
p.000004: 3. Name of the authorization holder
...
p.000004: The content of the application to be submitted by a tissue bank seeking authorization for import activities
p.000004: requirements
p.000004: When applying for import licenses for import activities, the applicant shall provide the importing tissue bank with the most up-to-date information.
p.000004: information or documentation for Section F, unless you are a tissue bank or an import tissue bank
p.000004: has already submitted, as part of its previous application for authorization:
p.000004: A. General Information on the Importing Tissue Establishment (ITE)
p.000004: 1. Name of the tissue bank
p.000004: 2. Address of the seat of the tissue bank
p.000004: 3. Address of the tissue bank (if different)
p.000004: 4. Name of the department
p.000004: 5. Address of the department's headquarters
p.000004: 6. Departmental postal address (if different)
p.000004: 7. Tissue Bank Applicant Status: It must be stated that the first application for a Tissue Bank operating license or, where applicable,
p.000004: This is a request for amendment. If the applicant is already an authorized tissue establishment (TE), the tissue banks must be provided
p.000004: Union collection code.
p.000004: 8. Name of place of importation (if not the name of the tissue bank or the applicant unit)
p.000004: 9. Visiting address of the betting site
p.000004: 10. Address of destination (if different)
p.000004: B. The Tissue Bank
p.000004: 1. Head of department
p.000004: 2. Phone number
p.000004: 3. Email address
p.000004: 4. Name of the responsible person
p.000004: 5. Phone number
p.000004: 6. Email address
p.000004: 7. Website address of the importing tissue bank
p.000004: C. Tissues and cells to be imported
p.000004: 1. List of types of tissues and cells to be imported, including single import of any type of tissues and cells.
p.000004: 2. Product names of all types of tissues and cells to be imported (where applicable in accordance with the EU Common List).
p.000004: 3. Trade names of all types of tissues and cells to be imported (if not the product name).
p.000004: 4. The name of the third country healthcare provider for all types of tissues and cells to be imported.
p.000004: D. Location of activities
p.000004: 1. List of activities for the purpose of donation, collection, testing, processing, preservation or storage
p.000004: prior to import by a third country healthcare provider, broken down by type of tissue or cell.
p.000004: 2. List of activities for the purpose of donation, collection, testing, processing, preservation or storage
p.000004: prior to importation by a third country healthcare provider by subcontractor, by type of tissue or cell
p.000004: breakdown.
p.000004: 3. List of activities carried out by the tissue bank after importation, broken down by type of tissue or cell.
p.000004: 4. The name of the third countries in which the activities take place prior to import, broken down by type of tissue or cell.
p.000004: E. Information concerning the third country healthcare provider
p.000004: 1. Name (company name) of the third country service partner (s)
p.000004: 2. Name of the contact person
p.000004: 3. Visiting address
p.000004: 4. Postal address (if different)
p.000004: 5. Telephone number including the international country code
p.000004: 6. Emergency telephone number (if different)
p.000004: 7. Email
p.000004: F. Documentation to accompany the application
p.000004: 1. Copy of the written contract with the third country healthcare provider.
p.000004: 2. Detailed description of the path of the imported tissues and cells from collection to arrival at the importing tissue bank.
p.000004: 3. Copy of the export license of the third country healthcare provider or, if no such specific certificate has been issued
p.000004: certified by the competent authority (ies) of the third country concerned,
p.000004: and of its cellular activities, including export activities.
p.000004: That documentation shall also include contact details of the competent authority or authorities of the third country. In countries where it is not
p.000004: If such documentation is available, other documentation, such as audit reports from a third country healthcare provider, must be provided.
p.000004: Annex No. 18 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000004: Imported by a tissue bank intending to import tissues and cells from third countries is national
p.000004: Requirements for documentation to be provided to the Chief Medical Officer to accompany the application
p.000004: A. Documentation relating to the importing tissue bank
p.000004: 1. The job description of the responsible person and the relevant qualifications and training information as defined in this Regulation.
p.000004: 2. Copy of the label on the primary packaging and the label used on the repackaging, as well as a document on the outer packaging
p.000004: and from the container.
p.000004: 3. In relation to the import activities of a tissue bank, including the application of the Single European Code,
p.000004: receiving and storing cells at the importing tissue bank, treating serious complications and adverse events, recalling
p.000004: management and donor-to-recipient traceability - relevant operational standards procedures relevant, up-to-date
p.000004: list of variations.
p.000004: B. Documentation relating to the third country healthcare provider
p.000004: 1. Detailed information on the criteria used to identify and evaluate the donor, information on the donor and his / her family
p.000004: how they obtained the donor's or their family's consent, and whether the donation was voluntary and unpaid.
p.000004: 2. Detailed information on the test center or centers used by the third country healthcare provider
p.000004: .
p.000004: 3. Detailed information on the techniques used in tissue and cell processing, including critical processing techniques
p.000004: Validation.
p.000004: 4. Detailed information on the quality control of each activity performed by the third country healthcare provider; and
p.000004: equipment, materials and criteria used for environmental inspections.
p.000004: 5. Detailed information on the conditions under which tissues and cells are made available by a healthcare provider in a third country.
p.000004: 6. Details of all subcontractors used by the third country healthcare provider, including name, address and
p.000004: activity performed.
p.000004: 7. Recent inquiries by the competent authority of the third country concerning the third country healthcare provider
p.000004: summary, including date, type and main conclusions of the study.
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p.000004: E. Information concerning the third country healthcare provider
p.000004: 1. Name (company name) of the third country service partner (s)
p.000004: 2. Name of the contact person
p.000004: 3. Visiting address
p.000004: 4. Postal address (if different)
p.000004: 5. Telephone number including the international country code
p.000004: 6. Emergency telephone number (if different)
p.000004: 7. Email
p.000004: F. Documentation to accompany the application
p.000004: 1. Copy of the written contract with the third country healthcare provider.
p.000004: 2. Detailed description of the path of the imported tissues and cells from collection to arrival at the importing tissue bank.
p.000004: 3. Copy of the export license of the third country healthcare provider or, if no such specific certificate has been issued
p.000004: certified by the competent authority (ies) of the third country concerned,
p.000004: and of its cellular activities, including export activities.
p.000004: That documentation shall also include contact details of the competent authority or authorities of the third country. In countries where it is not
p.000004: If such documentation is available, other documentation, such as audit reports from a third country healthcare provider, must be provided.
p.000004: Annex No. 18 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000004: Imported by a tissue bank intending to import tissues and cells from third countries is national
p.000004: Requirements for documentation to be provided to the Chief Medical Officer to accompany the application
p.000004: A. Documentation relating to the importing tissue bank
p.000004: 1. The job description of the responsible person and the relevant qualifications and training information as defined in this Regulation.
p.000004: 2. Copy of the label on the primary packaging and the label used on the repackaging, as well as a document on the outer packaging
p.000004: and from the container.
p.000004: 3. In relation to the import activities of a tissue bank, including the application of the Single European Code,
p.000004: receiving and storing cells at the importing tissue bank, treating serious complications and adverse events, recalling
p.000004: management and donor-to-recipient traceability - relevant operational standards procedures relevant, up-to-date
p.000004: list of variations.
p.000004: B. Documentation relating to the third country healthcare provider
p.000004: 1. Detailed information on the criteria used to identify and evaluate the donor, information on the donor and his / her family
p.000004: how they obtained the donor's or their family's consent, and whether the donation was voluntary and unpaid.
p.000004: 2. Detailed information on the test center or centers used by the third country healthcare provider
p.000004: .
p.000004: 3. Detailed information on the techniques used in tissue and cell processing, including critical processing techniques
p.000004: Validation.
p.000004: 4. Detailed information on the quality control of each activity performed by the third country healthcare provider; and
p.000004: equipment, materials and criteria used for environmental inspections.
p.000004: 5. Detailed information on the conditions under which tissues and cells are made available by a healthcare provider in a third country.
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p.000002: to the original tissue bank;
p.000002: 35. * Expiry date: The date until which the tissues and cells can be used;
p.000002: 36. * Tissue Bank Union Code: The unique identifier of the Tissue Bank, which is the ISO country code and the Tissue Bank is the T
p.000002: consists of a specific number in its collection;
p.000002: 37. * EU Collection of Tissue and Cellular Products: Tissue and Cell Types circulating in the European Union and permitted coding
p.000002: a collection of product codes corresponding to the systems (EUTC, ISBT128 and Eurocode);
p.000002: 38. * Union collection of tissue banks: all accredited, designated, authorized or authorized by the competent authority of Member States
p.000002: a collection of tissue banks containing information in accordance with Annex 15;
p.000002: 39. * product identifier string: the second part of the uniform European code comprising the product code, the number of sublots and the expiry date;
p.000002: 40. * Product code: identifier that identifies the specific type of tissue and cell that identifies the coding system used by the tissue bank.
p.000002: product code system identifier ("E" for EUTC, "A" for ISBT128, "B" for Eurocode) and the relevant coding system or tissue and
p.000002: The EU collection of cellular products shall consist of the number of tissues and cells of the product type.
p.000002: 1 / B. § * As the competent authority in relation to organ transplantation in this Regulation and in organ transplantation as a health service
p.000002: the National Chief Medical Officer, the OVSZ and the Minister for Health (hereinafter:
p.000002: Minister).
p.000002: 1 / C. § * When donating, collecting, testing, processing, storing and distributing human tissues, cells - if personal data
p.000002: protection legislation - make sure that the donor and recipient as well as their families are not
p.000002: each other's person.
p.000002: Organ, tissue removal from a living person
p.000002: Section 2 (1) Organ transplantation and tissue transplantation shall be governed by the provisions of Art. In the case defined in Article 206 (3), he is employed by that health care provider
p.000002: hospital ethics committee (hereinafter: ethics committee) where organ, tissue transplantation is performed.
p.000002: (2) Tissue transplantation shall be subject to In the case specified in Section 206 (5), the Ethics Committee of that healthcare provider
p.000002: where the tissue removal is performed.
p.000002: 3. The Ethics Committee shall not be a member of the Ethics Committee for the consideration of the matter set out in paragraphs 1 to 2,
p.000002: (a) involved in the removal or implantation of organs, tissue,
p.000002: (b) who carries out the treatment of the recipient,
p.000002: (c) over which the doctor, directly or indirectly, directly involved in the removal or implantation of the organ, tissue
p.000002: exercise.
p.000002: 4. In the cases referred to in paragraphs 1 to 2, the procedure of the Ethics Committee, with the exception of paragraph 5, shall be at the joint request of the donor and the recipient.
...
p.000002: eligible.
p.000002: (3) Removal of tissue from the dead, transplantation and storage of such tissue pending processing by a healthcare provider
p.000002: department and tissue bank.
p.000002: 4. The processing and post-processing of tissue removed for transplantation shall be carried out only in a tissue bank.
p.000002: (5) In the case of paragraphs (1) to (4), the healthcare provider shall comply with the person and
p.000002: conditions. *
p.000002: Article 15 * (1) * Organ donors shall be subjected to serological tests in accordance with separate legislation.
p.000002: (2) The reasons for the exclusion of organ donation from an organ donor shall be determined by the medical rules of the state of the art.
p.000002: (3) The eligibility of tissue and cell donors, with the exception of donors of special procedures for human reproduction, is subject to:
p.000002: of Annex 7.
p.000002: (4) Tissue, cell donors, with the exception of donors of special procedures for human reproduction, shall be tested in accordance with Annex 8.
p.000002: must be done.
p.000002: 15 / A. Section * For the purposes of § 243 (7), approval of an exchange of organs with third countries requires that organs: a
p.000002: (a) be traceable from donor to recipient and from recipient to donor and meet the quality and
p.000002: security requirements. The approval of an exchange of organs with third countries is based on the declaration of the third country.
p.000002: 15 / B. § * Tissues and cells may only be imported from third countries where requirements equivalent to those in this Regulation are in place.
p.000002: The documents required to verify this - in accordance with the Acting pursuant to Section 243 (7), it shall be procured by the National Chief Medical Officer.
p.000002: 15 / C. § * For hematopoietic stem cell transplantation from tissue bank directly to transplant provider
p.000002: can be delivered if the healthcare provider is licensed for transplantation.
p.000002: 15 / D. § * The National Chief Physician shall publish a register of tissue and cell banks on its website. The register contains health information
p.000002: of the data in the legislation on the registration of providers, the name of the healthcare provider, the address of the provider and
p.000002: information on the establishment where the healthcare is provided and the authorized healthcare professions; and
p.000002: activities.
p.000002: 15 / E. § * (1) The Tissue and Cell Bank shall keep records of the collection, testing, preservation, processing, storage and distribution, or otherwise
p.000002: on the type and quantity of tissues and cells used and the origin and destination of the tissues and cells intended for human applications
p.000002: place.
p.000002: (2) * According to the records referred to in paragraph (1), the Tissue and Cell Bank, by 31 January each year - the items in Annex 12
p.000002: - send a report on the activities of the previous year to the National Chief Medical Officer. The report will be published on the website of the National Chief Medical Officer.
p.000002: Provisions for the storage of tissues and cells *
p.000002: Section 16 (1) * Tissue may be stored only in tissue bank, cell only in cell bank. On packaging containing tissues and cells, storage and storage shall be carried out
p.000002: a processing label shall be used. During storage of the tissue and the cell until processed, the label is as follows
p.000002: included:
p.000002: (a) the date of removal,
p.000002: (b) the name and address of the health care provider carrying out the removal and storage,
p.000002: (c) the name of the type of tissue or cell,
p.000002: (d) the donor identification number,
p.000002: (e) warning of potential risks to health,
p.000002: (f) in the case of donation for personal purposes, a reference to the fact.
p.000002: 2. During storage after processing, the following particulars shall appear on the label:
p.000002: (a) the name of the tissue or cell type,
p.000002: (b) the name and address of the tissue bank carrying out the processing,
p.000002: (c) the expiry date,
p.000002: (d) the recommended method of storage,
p.000002: (e) the sterilization method used,
p.000002: (f) the amount or dimensions of the tissue, the possible reference to chemical residues; and
p.000002: (g) the donor identification number.
p.000002: (3) * Donor name must not be on the label. The donor identification number is used to identify the donor. Tissue or cell removal
p.000002: health care provider for tissue and cell donors, legislation on the management of health data, and no
p.000002: The Commission shall keep records as specified in Annex.
p.000002: (4) * For the transport of tissue or cells, see Annex 9, paragraph 1.4. shall be complied with.
p.000002: Requirements for the collection of human tissues and cells *
p.000002: 16 / A. § * (1) * The procurement of human tissues and cells shall be carried out in accordance with the provisions of paragraphs 2 to 9. In paragraphs 2 to 9
...
p.000002: should prevent unauthorized access to, and unauthorized access to, such data
p.000002: Any use of data.
p.000002: (3) * OVSZ maintains National Register of Organ Donation and Transplantation and living donors applying for organ donation
p.000002: A register is kept by the health care providers providing the care according to the procedure of the OVSZ.
p.000002: (4) In the case of an organ, the data necessary for traceability shall be kept by the OVSZ for 30 years after the donation. Retention of data
p.000002: it can also be done electronically.
p.000002: 16 / E. § * For organ harvesting, materials and equipment must be used that comply with the requirements of the Minister for Medical Devices
p.000002: and the applicable professional rules.
p.000002: 16 / F. § * The OVSZ
p.000002: (a) participate in the network of competent authorities and coordinate at national level the contribution to the activities of the network;
p.000002: (b) keep a record of the activities of transplantation centers, showing the total number of living and deceased donors and
p.000002: and contains the types and quantities of organs transplanted or otherwise disposed of,
p.000002: (c) prepare an annual report on the activities under point (b) and publish it on its website;
p.000002: d) ensure that in the case of organ exchange between Hungary and a Member State of the European Union, Article 9 / a. organs and organs according to Annex
p.000002: donor data to the Member State affected by the exchange of organs,
p.000002: e) * monitor organ transplant effectiveness and analyze the national situation of transplants.
p.000002: 16 / G. § * The National Chief Medical Officer shall keep records in accordance with the provisions of the legislation on the registration of health care providers.
p.000002: about transplant centers.
p.000002: Human organs intended for transplantation are party to the Agreement on the European Economic Area
p.000002: general rules of procedure for the exchange of information between Member States *
p.000002: 16 / Mon. § * (1) OVSZ shall be issued pursuant to Section 16 / I. Shall act in accordance with the provisions of paragraphs (2) and (3).
p.000002: 2. The data shall be in writing, by electronic means or by fax in the language agreed with the Member State of destination or, failing that, in English.
p.000002: shall be sent immediately after the availability of the data, including the date of transmission and
p.000002: the contact person responsible for the transfer. Following the transmission, it shall be ensured that the Member State of destination is the data
p.000002: confirm receipt.
p.000002: 3. When transferring data pursuant to paragraph 1, it shall be indicated, subject to compliance with data protection legislation, that personal data
p.000002: contains data.
p.000002: 4. In cases of urgency, data may be communicated orally, in particular in accordance with Article 16 / K. § report serious adverse events and events
p.000002: in case of. Following oral transmission, the procedure set out in paragraphs 2 and 3 shall apply.
p.000002: (5) The OVSZ shall provide a 24-hour reception for emergency data.
p.000002: 16 / I. § * (1) The OVSZ shall forward the information specified in Section 9 / a before the organ exchange takes place. Organ and donor data in accordance with Annex III
...
p.000002: inform the European Commission.
p.000002: Histopathological examination
p.000002: § 17 Organ from living body - Histopathologic examination is not required for tissue removal in the following organs
p.000002: [EUT. Section 204 (2) (c)]:
p.000002: the tooth,
p.000002: (b) vitreous,
p.000002: (c) nails,
p.000002: (d) in the case of physiological birth, the placenta.
p.000002: Person in charge *
p.000002: 17 / A. § * (1) Within the tissue bank, the head of the tissue bank and the person responsible for the protection, registration and preservation of tissues
p.000002: a designated person (hereinafter referred to as "responsible person") shall be responsible.
p.000002: 2. The responsible person shall meet at least the following qualification criteria:
p.000002: (a) advanced vocational education or training in the field of medicine or biological sciences; and
p.000002: (b) at least two years' professional experience in the field referred to in point (a).
p.000002: (3) Responsible person
p.000002: (a) enforce the legal requirements for the collection, storage, processing and distribution of human tissues for human use;
p.000002: regulations and institutional rules;
p.000002: (b) regularly inform the tissue bank manager of the activities of the tissue bank;
p.000002: (c) initiates, in the event of malfunctioning, the restoration of legitimate or professional operations by the head of the tissue bank
p.000002: taking the necessary measures;
p.000002: d) * if, in its opinion, suspension of the activity of stored tissue would be warranted,
p.000002: inform the National Chief Medical Officer directly, giving notice, to take the necessary measures;
p.000002: (e) inform, upon request, the authorities responsible for overseeing the operation of the tissue bank for operational review purposes
p.000002: essential data and the initiative under point (c);
p.000002: f) provide for the provisions of § 3, 6-8. §, a 12 §, a 15 / A. And the requirements of Section 16 at the tissue bank;
p.000002: g) * approve donor evaluation based on exclusion criteria in Annex 7.
p.000002: (4) * The tissue bank shall inform the National Chief Medical Officer of the name of the responsible person referred to in paragraph 1 within the specific area for which it is responsible.
p.000002: with institutional responsibilities.
p.000002: Reporting of serious adverse events and events *
p.000002: 17 / B. § * (1) * The health care provider shall promptly notify the National Chief Medical Officer for examination, processing,
p.000002: all relevant information relating to the storage and distribution of data and any serious adverse event, including that which:
p.000002: can affect the quality and safety of tissues for human use. The National Chief Medical Officer shall notify them in Section 14
p.000002: specific healthcare providers and the Minister.
p.000002: (2) * The health care provider referred to in Section 14 shall promptly notify the National Chief Medical Officer of any serious complication
p.000002: which have been detected during or after the implantation or removal of tissue and which are of inadequate quality for human tissue
p.000002: can be traced back.
p.000002: (3) * Upon notification pursuant to paragraphs 1 and 2, the National Chief Medical Officer shall immediately take the necessary measures, including
p.000002: - if the consequences of a serious adverse event or serious incident could affect another Member State, the European Commission or the European Commission
p.000002: The competent authorities of the Member States of the Economic Area likely to be affected by a serious adverse event or serious complication shall:
p.000002: notification.
p.000002: 3a. * Except as provided in paragraph 3, the National Chief Medical Officer shall commence an investigation and take the necessary measures if
p.000002: Upon reasoned request by a competent authority of a Member State of the European Economic Area.
p.000002: (4) Notifications under paragraphs (1) and (2) shall be made on the form set out in Annex 10.
p.000002: (5) * By 30 June of the year following the reference year, the National Chief Medical Officer shall submit to the Commission of the European Union an annual report in accordance with Annex 11.
p.000002: forms. Healthcare providers under Section 14 shall provide information on the data required for the annual report in Annex 11 a
p.000002: by 30 April of the year following the reference year, inform the National Chief Medical Officer.
p.000002: 17 / C. § * (1) * Serious adverse event or serious complication to an organ known to the health care provider
p.000002: immediately inform OVSZ, which, with immediate notification to the Minister and the transplant centers,
p.000002: notifies the National Chief Medical Officer of the notification and investigation of the case. The OVSZ shall take the necessary measures without delay, including:
p.000002: if the consequences of a serious adverse event or serious incident could affect another Member State, the European Commission or the European Commission
p.000002: The competent authorities of the Member States of the Economic Area likely to be affected by a serious adverse event or serious complication shall:
p.000002: notification.
p.000002: 2. The formal requirements for the timely notification and treatment of serious adverse events and reactions in the organ shall be
p.000002: OVSZ issues an Operational Order which is published on its website.
p.000002: 17 / D. § * The National Chief Medical Officer, indicating the number and nature of serious adverse events and events
p.000002: keep a record.
p.000002: 17 / E. § * Compliance with the provisions of this Regulation shall also be examined in the course of professional supervision.
p.000002: 17 / F. § * The competent authorities shall be the Member States party to the Agreement on the European Economic Area or the European Commission
p.000002: they shall, on request, provide information on the results of the inspections and controls carried out in relation to the requirements of this Regulation.
p.000002: 17 / G. § * The National Chief Medical Officer shall carry out regular inspections of tissue processing and storage facilities and may inspect
p.000002: procedures and activities relating to the requirements of this Regulation and may be subject to inspection in the framework of this Regulation
p.000002: requirements.
p.000002: Single European Code *
p.000002: 17 / Mon. § * (1) The single European code shall apply to all tissues and cells distributed for human use. The tissues
p.000002: and, in the case of the placing on the market of cells and cells for other purposes, at least the accompanying documentation shall contain the donation identification character.
p.000002: 2. Paragraph 1 shall not apply
p.000002: (a) the donation of reproductive cells between partners,
p.000002: (b) tissues and cells delivered directly to the recipient for immediate transplantation;
p.000002: (c) in urgent cases, with the express authorization of the competent authority, for tissues and cells introduced into the European Union.
p.000002: 3. The following shall be exempted from the requirements of paragraph 1:
p.000002: (a) tissues and cells other than gametes intended for donation between partners, provided that they remain with the same healthcare provider,
p.000002: (b) tissues and cells imported into the European Union, provided that they remain with the same healthcare provider from import to use;
p.000002: provided that the healthcare provider is accredited, designated, authorized or licensed for import activities
p.000002: tissue bank.
p.000002: 4. For the purposes of paragraph 3, the same healthcare provider shall be considered to be a healthcare provider where the collection of human
...
p.000002: traceability system and where at least one authorized tissue processing and storage unit is located in the same location,
p.000002: and an organization responsible for human use.
p.000002: 5. The specifications for the structure of the uniform European code referred to in paragraph 1 are set out in Annex 15.
p.000002: (6) The Common European Code should be legible and preceded by the abbreviation "SEC". The single European code
p.000002: use of another label or traceability system is permitted.
p.000002: (7) The European Uniform Code should be indicated either by the donation identifier and the product identifier or by a single identifier.
p.000002: spaces, or two consecutive rows.
p.000002: 17 / I. § * The application of the single European code shall not preclude the application of additional codes in accordance with national requirements
p.000002: They are.
p.000002: Requirements for the application of the single European code *
p.000002: 17 / J. § * (1) The Tissue Bank, including the Tissue Bank of Import, shall provide the following with respect to the application of the Single European Code:
p.000002: conditions:
p.000002: (a) at the latest before distribution for human use, assign a single European code to all tissues and cells which:
p.000002: in the case of such a code;
p.000002: (b) the tissue and cell donation assigns an identification string after collection, or
p.000002: on arrival at a service provider or on importation from a healthcare provider in a third country;
p.000002: (c) notify the national officer in the following cases:
p.000002: (ca) where the information contained in the Union collection of tissue banks needs to be updated or corrected;
p.000002: (cb) when the Union collection of tissue and cell products needs to be updated;
p.000002: (cc) if the tissue bank establishes that a single European code has been obtained for tissues and cells from another Union tissue bank;
p.000002: does not meet the requirements of this Chapter.
p.000002: 2. The donation identification string referred to in paragraph 1 (b) shall consist of the following elements:
p.000002: (a) the Union Tissue Bank code, according to the Union Tissue Bank Collection,
p.000002: (b) the unique donation number issued by the tissue bank, unless it is a worldwide unique donation number.
p.000002: 3. In the case of tissue and cell fusion, the end product shall be assigned a new donation identification number. The individual donations
p.000002: the tissue bank which carries out the merger shall ensure its traceability.
p.000002: 17 / Tues § * (1) The National Chief Medical Officer shall assign a unique identification number to each authorized tissue bank. If the tissue bank is more different
p.000002: but has a single system for issuing unique donation numbers, then it can be considered as a tissue bank. If the
p.000002: tissue bank uses two or more systems to issue unique donation numbers, the number of systems used by a given site
p.000002: have a sufficient number of dedicated tissue bank codes.
p.000002: 2. The donation identification string assigned to tissues and cells already placed on the market shall not be altered unless
p.000002: needed to fix a coding error. In the event of a coding error, all patches must be properly documented.
p.000002: 3. § 37 and in the EU Tissue and Cellular Product Collection
p.000002: shall be applied at the latest before distribution for human consumption. The tissue and
p.000002: the label of your cell product shall indicate the appropriate batch number and the expiry date. In the case of tissues and cells in which
p.000002: no expiry date specified, the expiry date shall be 00000000 which shall be indicated at the latest before distribution for human consumption.
p.000002: 4. Prior to distribution of the product for human consumption, the labeling shall be indelibly and indelibly marked on the product.
p.000002: European code and should be included in the accompanying documentation. The tissue bank may entrust this task to a third party or parties, provided that:
p.000002: the third party ensures compliance with the provisions of this Regulation, in particular regarding the uniqueness of the single European code. If, due to the size of the label,
p.000002: the single European code cannot be included on the label, the code shall be included in the accompanying documentation, which shall be clearly
p.000002: affected tissues and cells.
p.000002: (5) The tissue bank and organizations responsible for human use shall keep at least 30 records as specified in Annex 14,
p.000002: for years.
p.000002: 17 / L. § * (1) The National Chief Medical Officer
p.000002: (a) examine, in its audit of the tissue bank, the application of the single European code;
p.000002: (b) ensure the validation of data on tissue banks in the Union Collection of Tissue Banks as set out in Annex 16;
p.000002: and update the collection within 10 business days at the latest, especially in the following cases:
p.000002: (ba) where a new tissue bank is authorized;
p.000002: (bb) in the event of changes in tissue bank information or misrepresentation of tissue banks in the Union collection;
p.000002: (bc) in the event of a change in the tissue bank authorization referred to in paragraph 2;
p.000002: (c) alert the competent authorities of another Member State if it detects incorrect information in relation to a Member
p.000002: or if it finds that the provisions of a European code are significant for the other Member State
p.000002: a case of non-compliance;
p.000002: (d) advise the European Commission and the competent authorities of other Member States of any collection of EU code numbers for tissues and cells;
p.000002: need to be updated.
p.000002: 2. In the Union Collection of Tissue Banks, the national officer in charge of carrying out the activities referred to in paragraph 1 (b) (bc) shall:
p.000002: leads the change:
p.000002: (a) an authorization for a new type of tissue or cell,
p.000002: (b) a permit for a new prescribed activity,
p.000002: (c) a condition or exception to any permit;
p.000002: (d) suspension of operation in relation to a particular activity or type of tissue or cell,
p.000002: (e) withdrawal of the tissue bank authorization,
p.000002: (f) situations where a tissue bank voluntarily ceases the activity or activities covered by the authorization.
p.000002: Provisions applicable to imports into the European Union of human tissues and cells *
p.000002: 17 / M. § * (1) The rules of this Decree shall apply to human tissues and cells intended for human
p.000002: the importation into the European Union of products derived from tissues and cells shall be subject to the derogations provided for in this Chapter.
p.000002: apply.
p.000002: (2) Where the human tissues and cells to be imported are only processed products covered by other Union legislation
p.000002: for the purposes of this Chapter, the donation, collection and testing outside the European Union and from the donor to the
p.000002: to the recipient and from the recipient to the donor.
p.000002: 3. The provisions of this Chapter shall not apply
p.000002: a) 15 / C. § 1 for direct importation;
p.000002: (b) in cases of urgency, the importation of tissues and cells directly authorized by the national officer in charge.
p.000002: 17 / N. § * For the purposes of this Chapter
p.000002: 1. "single import" means the importation of any type of tissue and cell for single use to a specified known recipient;
p.000002: 2. "third country healthcare provider" means a tissue bank or healthcare provider established in a third country that:
p.000002: responsible for the export to the European Union of tissues and cells which it supplies to a tissue bank;
p.000002: 3. "Importing tissue bank" means a tissue bank established in the European Union and established with a healthcare provider in a third country.
p.000002: on the contracted importation into the European Union of knitted tissues and cells of human origin from third countries
p.000002: party to the agreement;
p.000002: 4. Urgent case: an unforeseeable situation where, in practice, there is no other option than urgent tissue and
p.000002: to import cells into the European Union for immediate use in a known recipient whose health is seriously compromised without such imports
p.000002: would be in danger.
p.000002: 17 / O. § * (1) The importation of tissues and cells from third countries shall be subject to an operating license issued by the
p.000002: may be carried out by an importing tissue bank holding an official certificate issued for that purpose.
p.000002: 2. When applying for an import authorization, the applicant importing tissue bank shall send to the national officer in charge of:
p.000002: Attach the information in Annex 17 and attach the documents in Annex 18 to the application. The nationwide
p.000002: The Chief Medical Officer shall verify the data transmitted and the existence of the requirements of this Regulation and shall authorize the application on the basis of
p.000002: and, where necessary, establish the conditions and restrictions for import and issue the
p.000002: (c) an official certificate in accordance with Annex II for authorized tissue establishment banks.
p.000002: (3) The importing tissue bank shall notify the National Chief Medical Officer of any material change in its import activities.
p.000002: for. The official officer shall amend the official certificate referred to in paragraph 2 upon notification.
p.000002: (4) A substantial change is the change in the type of tissues and cells to be imported, the quality and quality of the tissues and cells to be imported.
p.000002: a change in the safety of a third country activity or a third country healthcare provider.
p.000002: 5. Single tissues or cells originating from a third country healthcare provider shall not be considered as a substantial change
p.000002: Imports not covered by an existing official certificate of the importing tissue bank but subject to an official certificate
p.000002: for imports of tissues or cells of the same type from another healthcare provider in the same third country.
p.000002: 17 / Fri. § * (1) In the case of an import tissue bank, the National Chief Medical Officer 17 / G. The interval between inspections pursuant to Article 2 shall not exceed two years.
p.000002: (2) * At the reasoned request of another Member State or the European Commission, the National Chief Medical Officer shall provide information to the importing tissue banks.
p.000002: the results of inspections and controls in relation to.
p.000002: (3) * At the reasoned request of the Member State of distribution of the imported tissues and cells, the Chief Medical Officer shall examine whether
p.000002: control of the activity of the importing tissue bank and of the healthcare provider in the third country.
p.000002: 4. If an on-the-spot inspection is carried out pursuant to a request under paragraph 3, the national officer in charge shall be competent for the requesting Member State.
p.000002: the competent authority of the requesting Member State referred to in paragraph 3, in agreement with its competent authority. The
p.000002: in the event of refusal of inspection, the national officer in charge shall give reasons for his decision in the requesting Member State referred to in paragraph 3.
p.000002: direction.
p.000002: 17 / Q. § * The documentation according to Annex 17 F and Annex 19 need not be attached for single import.
p.000002: One-time import must ensure that the imported tissues and cells are tracked from donor to recipient and from recipient to donor
p.000002: and that the imported tissues and cells are used only at the intended recipient.
p.000002: 17 / R. § * (1) The importing tissue bank shall promptly notify the National Chief Medical Officer of any suspected or
p.000002: an event or complication of which you are aware of a third country health care provider that may affect
p.000002: quality and safety of imported tissues and cells. The notification shall contain the information specified in Annex 10.
p.000002: 2. In addition to paragraph 1, the importing tissue bank shall promptly notify the National Chief Medical Officer if it becomes aware that:
p.000002: a healthcare provider in a third country
p.000002: (a) the authorization to export the tissues and cells has been withdrawn or suspended; or
p.000002: (b) the competent authority of the Member State of establishment has taken a decision which is essential for the quality and safety of the tissues and cells imported.
p.000002: 17 / S. § * (1) In the case of the donation, procurement, testing, processing, preservation of tissues and cells to be imported into the European Union,
p.000002: any storage and distribution activities are carried out outside the European Union by the importing tissue bank
p.000002: have a written agreement with the health care provider in the third country.
p.000002: 2. A written agreement between the importing tissue bank and the healthcare provider in the third country shall specify what is to be fulfilled
p.000002: quality and safety requirements to ensure that the tissues and cells to be imported comply with this Regulation
p.000002: quality and safety standards equivalent to those laid down. The written agreement shall include at least clause 20
p.000002: The information listed in Annex II.
p.000002: 17 / T. § * (1) The importing tissue bank shall keep a record of its activities, including in the case of a single import, the
p.000002: type, amount, origin and destination of tissues and cells.
p.000002: (2) The data referred to in paragraph (1) shall also be included in the annual report in accordance with Annex 12.
p.000002: (3) A 17 / O. Section 15 / D. Shall also be indicated in the register.
p.000002: Transitional and final provisions
...
p.000002: These should include the technical requirements and other essentials required by the tissue bank to maintain acceptable quality.
p.000002: criteria. The tissue bank shall have a professional code of conduct with inadequate or incomplete test results
p.000002: the handling and isolation of consignments of such products, the risk of contamination of other processed, preserved or stored tissues and cells
p.000002: exclusion.
p.000002: 1.5.4. Data to be recorded in the tissue bank (except donors of reproductive cells intended for donation between spouses or life partners)
p.000002: must include:
p.000002: (a) the consent, including an indication of the purposes for which the tissues and cells may be used and the consent given;
p.000002: specific instructions for destruction of unused tissues and cells,
p.000002: (b) all necessary data on the donor's medical history and collection,
p.000002: (c) results of physical examination, laboratory and other examination,
p.000002: (d) for allogeneic donors, control of donor selection by the responsible person,
p.000002: (e) for cultures of cells intended for autologous use, documentation of the recipient's drug allergy.
p.000002: 1.5.5. * The tissue bank must have a professional code of practice for cell and tissue distribution and recall. Rules of procedure a
p.000002: it shall contain the necessary measures with regard to recall, the time limits for taking action, the procedure for taking responsibility for the measures and the
p.000002: rules for notifying the National Chief Medical Officer. Traceability of tissues and cells must be ensured by professional procedures. All
p.000002: identify a donor who may have contributed to the complication in the recipient,
p.000002: tissues and cells and the recipients and recipients of tissues and cells collected from the same donor must be notified if
p.000002: may be at risk. Measures to be taken in response to requests from health care providers for tissues and cells, and
p.000002: the distribution of tissues and cells to patients and healthcare providers shall be in accordance with professionally accessible procedures
p.000002: regulate. Treatment of returned products, including rules for returning products to inventory, in accordance with professional procedures
p.000002: to be determined.
p.000002: 1.5.6. * Critical processing procedures should be validated and should not result in tissue or cells becoming clinically ineffective or
p.000002: harmful to the recipient. Validation is based on your healthcare provider's own or other healthcare provider's information or other published information
p.000002: and, in the case of procedures already in place and in use, on the basis of their description and indicators. It must be ensured that
p.000002: a validated procedure can be performed by the tissue processing and storage unit. [Specifications especially for additives (eg solutions) and
p.000002: for packaging materials. Critical reagents and materials must meet documented specifications and
p.000002: where appropriate, the requirements of the Medical Devices Regulation and the In vitro Diagnostic Medical Devices Regulation.]
p.000002: Procedures shall be established in accordance with the rules of procedure and, in all cases, shall be governed by the rules of procedure set out in this Annex
...
p.000004: 4. The name of the third countries in which the activities take place prior to import, broken down by type of tissue or cell.
p.000004: E. Information concerning the third country healthcare provider
p.000004: 1. Name (company name) of the third country service partner (s)
p.000004: 2. Name of the contact person
p.000004: 3. Visiting address
p.000004: 4. Postal address (if different)
p.000004: 5. Telephone number including the international country code
p.000004: 6. Emergency telephone number (if different)
p.000004: 7. Email
p.000004: F. Documentation to accompany the application
p.000004: 1. Copy of the written contract with the third country healthcare provider.
p.000004: 2. Detailed description of the path of the imported tissues and cells from collection to arrival at the importing tissue bank.
p.000004: 3. Copy of the export license of the third country healthcare provider or, if no such specific certificate has been issued
p.000004: certified by the competent authority (ies) of the third country concerned,
p.000004: and of its cellular activities, including export activities.
p.000004: That documentation shall also include contact details of the competent authority or authorities of the third country. In countries where it is not
p.000004: If such documentation is available, other documentation, such as audit reports from a third country healthcare provider, must be provided.
p.000004: Annex No. 18 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000004: Imported by a tissue bank intending to import tissues and cells from third countries is national
p.000004: Requirements for documentation to be provided to the Chief Medical Officer to accompany the application
p.000004: A. Documentation relating to the importing tissue bank
p.000004: 1. The job description of the responsible person and the relevant qualifications and training information as defined in this Regulation.
p.000004: 2. Copy of the label on the primary packaging and the label used on the repackaging, as well as a document on the outer packaging
p.000004: and from the container.
p.000004: 3. In relation to the import activities of a tissue bank, including the application of the Single European Code,
p.000004: receiving and storing cells at the importing tissue bank, treating serious complications and adverse events, recalling
p.000004: management and donor-to-recipient traceability - relevant operational standards procedures relevant, up-to-date
p.000004: list of variations.
p.000004: B. Documentation relating to the third country healthcare provider
p.000004: 1. Detailed information on the criteria used to identify and evaluate the donor, information on the donor and his / her family
p.000004: how they obtained the donor's or their family's consent, and whether the donation was voluntary and unpaid.
p.000004: 2. Detailed information on the test center or centers used by the third country healthcare provider
p.000004: .
p.000004: 3. Detailed information on the techniques used in tissue and cell processing, including critical processing techniques
p.000004: Validation.
p.000004: 4. Detailed information on the quality control of each activity performed by the third country healthcare provider; and
p.000004: equipment, materials and criteria used for environmental inspections.
p.000004: 5. Detailed information on the conditions under which tissues and cells are made available by a healthcare provider in a third country.
p.000004: 6. Details of all subcontractors used by the third country healthcare provider, including name, address and
p.000004: activity performed.
p.000004: 7. Recent inquiries by the competent authority of the third country concerning the third country healthcare provider
p.000004: summary, including date, type and main conclusions of the study.
p.000004: 8. Recent investigation of a third country healthcare provider by or on behalf of the importing tissue bank
p.000004: Summary.
p.000004: 9. Any relevant national or international accreditation.
p.000004: Annex No 19 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: Details of the official certificate to be issued by the National Chief Medical Officer to the importing tissue bank a
p.000004: for imports of cells and tissues from third countries
p.000004: Official Certificate for the Importing Tissue Bank
p.000004: 1. Data on the Importing Tissue Establishment (ITE)
p.000004: 1.1. The name of the tissue bank
p.000004: 1.2. Code according to the EU Collection of Tissue Banks
p.000004: 1.3. Tissue bank address and postal address (if different)
p.000004: 1.4. Place of importation (if not the above address)
p.000004: 1.5 Tissue bank telephone number (optional)
p.000004: 1.6. Tissue bank email (optional)
p.000004: 1.7. The web address of the tissue bank
p.000004: 2. Scope of the activity
p.000004: 2.1. Type of tissues and cells Activities in third countries Imports
p.000004: (specify the status M given
p.000004: tissue processing and storage F suspended
p.000004: units EU V withdrawn
p.000004: collection
p.000004: listed Tissue and Ado- Collection Test-Up-Storage
p.000004: cell categories mammal guarding work
p.000004: using the need
p.000004: additional lines
p.000004: addition)
p.000004: - a third country healthcare provider
p.000004: - subcontracting to a third country healthcare provider
p.000004: 2.2. One-off imports
p.000004: 2.3. Product name (s) of imported tissues and cells
p.000004: 2.4. Conditions or explanatory notes on imports
p.000004: 2.5. Designation of third country (ies) of collection (a)
p.000004: for each import of tissues and cells)
p.000004: 2.6. Identification of third country (ies) where other activities are carried out
p.000004: takes place (if different)
p.000004: 2.7. Name and country of the third country healthcare provider
p.000004: (for each import of tissues and cells
p.000004: on)
p.000004: 2.8. Designation of EU Member States which:
p.000004: serve as a destination for imported tissues and cells for distribution
p.000004: (if known)
p.000004: 3. The competent authority (MA) responsible for issuing the official certificate is the national officer in charge
p.000004: 3.1. The tissue bank operating license number
p.000004: 3.2.Legal basis for the authorization
p.000004: 3.3. Expiry of the license
p.000004: 3.4. Tissue Bank Operating License Release Date Date Modified
p.000004: 3.5. Certificate of Authorization Issued to the Importing Tissue Bank Date Issued Date Modified
p.000004: 3.6. Additional notes
p.000004: 3.7. The name of the IH
p.000004: 3.8. Name of the IH official
p.000004: 3.9. Signature of the IH official
p.000004: 3:11. Stamp of the IH
p.000004: Annex No 20 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: Written agreement between the importing tissue bank and the healthcare provider in the third country
p.000004: content requirements
p.000004: Except in the case of one-off imports, a written agreement between the importing tissue bank and a health care provider in a third country
p.000004: shall contain at least the following provisions.
p.000004: 1. Detailed information on the importing tissue bank's procedures for quality and safety as defined in this Regulation
p.000004: ensuring compliance, as well as detailed information on the mutually agreed role and responsibilities of the imported
p.000004: ensuring that tissues and cells are of equivalent quality and safety.
p.000004: 2. Provision to ensure that the third country healthcare provider makes available to the importing tissue bank the information referred to in Article 18.
p.000004: The information set out in point B of Annex I to this Regulation.
p.000004: 3. Provision to ensure that the third country healthcare provider informs the importing tissue bank of such tissue bank
p.000004: of suspected or actual serious adverse events or events that could affect the
p.000004: or the quality and safety of the tissues and cells to be imported.
p.000004: 4. Provision to ensure that the third country healthcare provider informs the importing tissue bank about its activities
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p.000002: preliminary oral report of autopsy to be recorded);
p.000002: (g) for donors of peripheral blood haematopoietic progenitor cells, the donor's suitability for the selected recipient shall be documented.
p.000002: 1.2.2. The collection organization shall draw up a collection report which shall be submitted to the tissue bank. This report shall at least:
p.000002: included:
p.000002: (a) the identity, name and address of the tissue establishment receiving the cells / tissues;
p.000002: (b) the identity of the donor (including the method of identifying the donor and the person performing it);
p.000002: (c) a description and identification of the tissues and cells which have been removed (including test samples);
p.000002: (d) the medical seal and signature of the person responsible for the collection phase;
p.000002: (e) the date, time (where relevant, start and end) and location of collection, and the professional procedures used, including any adventitious events;
p.000002: events; where applicable, the environmental conditions of the collection point (description of the site where collection took place);
p.000002: (f) in the case of removal from the dead, the conditions under which the body was stored: chilling (or lack thereof), commencing chilling and
p.000002: date of completion;
p.000002: (g) identification / batch number of reagents and delivery solutions used;
p.000002: (h) * type of donation (eg tissue of one or more cell types, autologous or allogeneic donor, living donor or deceased);
p.000002: i) * Identification of the human use, including the date of distribution or disposal and the healthcare provider
p.000002: ID.
p.000002: Where possible, the report should include the date and time of death.
p.000002: In the case of semen collected at home, the collection report shall state this fact and shall only include:
p.000002: (a) the name and address of the tissue / tissue establishment receiving the cells / tissues;
p.000002: (b) the donor identifier.
p.000002: If possible, the report may include the date and time of collection.
p.000002: 1.2.3. * Products of human tissues and cells intended for human applications shall bear the following identification data:
p.000002: (a) the identifier of the tissue establishment;
p.000002: (b) type of tissue and cell / product,
p.000002: (c) the number of item groups,
p.000002: (d) the number of sublots,
p.000002: (e) the expiry date,
p.000002: (f) tissue / cell status (ie quarantined, fit for use, etc.),
p.000002: (g) the description and origin of the products, the processing steps applied, the tissue and cell contact and quality; and / or
p.000002: substances and additives affecting safety,
p.000002: (h) the identity of the health care provider issuing the final label.
p.000002: 1.2.4. * The user organization must keep at least the following information:
p.000002: (a) the identifier of the transporting tissue establishment;
p.000002: (b) the identity of the medical practitioner or the end-user;
p.000002: (c) type of tissues and cells,
p.000002: (d) the product identifier,
p.000002: (e) the identity of the recipient,
p.000002: (f) the date of use.
p.000002: 1.3. * Packing
p.000002: 1.3.1. After collection, all tissues and cells harvested must be packed in such a way as to minimize the risk of contamination,
p.000002: and stored at a temperature that preserves the required cell / tissue characteristics and biological function. The packaging should be
p.000002: prevent contamination of persons carrying out the packaging and transport of tissues and cells.
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Searching for indicator property:
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p.000002: Depending on the nature of the tissue or cell being donated, additional specific exclusion criteria may be applied, such as:
p.000002: (a) pregnancy (excluding donors of umbilical cord blood cells and amniotic donors and blood progenitor cells between siblings),
p.000002: (b) breastfeeding,
p.000002: (c) in the case of hematopoietic stem cells, the possibility of transmitting hereditary factors
p.000002: fact.
p.000002: Annex No 8 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000002: Laboratory tests for tissue and cell donors (except donors of reproductive cells)
p.000002: 1. * In a ministerial decree on epidemiological measures required to prevent infectious diseases and epidemics at the donor
p.000002: specific tests must be carried out.
p.000002: 1.2. * If the medical history of the donor and the characteristics of the tissue or cells to be donated so warrant, further investigations should be performed. Need
p.000002: for example, RhD, HLA, malaria, CMV, Toxoplasma, EBV, Trypanosoma cruzi. HTLV-I antibody testing should be performed
p.000002: donors who live in or come from an area with a high prevalence or sexual
p.000002: partners or parents come from such an area.
p.000002: 1.3. In the case of autologous donors, the requirements of Annex 7, paragraph 2.1. shall apply.
p.000002: 1.4. * If the tests described in point 1 have not been performed until the umbilical cord stem / mesenchymal stem cell has been removed
p.000002: the tissue bank must ensure that the umbilical cord blood stem cell / mesenchymal stem cell is quarantined for the screening result
p.000002: complete understanding.
p.000002: 2. When determining the biological property (marker), the following general requirements must be met
p.000002: 2.1. The tests shall be carried out in an immuno-laboratory as defined in the legislation on the minimum standards of professional health services
p.000002: must be done.
p.000002: 2.2. Biological tests should be performed on donor blood serum or plasma and should not be performed on other body fluids or secretions -
p.000002: such as aqueous or glassy body fluids - unless a study using a validated test for such fluids is clinically
p.000002: It justified.
p.000002: 2.3. If potential donors have lost blood and blood to replace blood loss immediately prior to donation,
p.000002: blood components, colloids or crystalloids have been obtained, due to the presence of blood
p.000002: can be invaluable if
p.000002: (a) in the case of ante mortem blood sampling, blood, blood components and / or colloids prior to blood sampling
p.000002: They were injected within 48 hours, or if crystalloids were injected within one hour before the blood sample was taken, or
p.000002: (b) post mortem (post mortem) blood, blood components and / or colloids prior to death 48
p.000002: or if crystalloids were injected within one hour prior to death.
p.000002: Tissue and cell processing and storage units may receive tissues and donations from donors with a plasma dilution of more than 50%.
p.000002: cells if the assay methods used have been validated for such plasma or a pre-transfusion sample is available.
p.000002: 2.4. In the case of tissue removal from the dead, blood samples must be taken immediately prior to death; such a pattern
p.000002: in the absence of blood, blood samples must be collected as early as possible after death, but not later than 24 hours after death.
p.000002: 2.5. Sampling
p.000002: 2.5.1. For live tissue removal (for practical reasons, the use of allogeneic bone marrow cell donors and peripheral blood haematopo
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Social / Threat of Stigma
Searching for indicator threat:
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p.000002: Article 4 (1) The Ethics Committee shall take its decision at the meeting. The resolution shall be communicated by the chairman of the Ethics Committee to those present. Where ethical
p.000002: If the Committee does not accept the request, those concerned shall be informed of the remedies available.
p.000002: 2. The Ethics Committee shall record its decision in the minutes of the proceedings within three working days of their adoption. THE
p.000002: The decision shall be forwarded to the parties concerned, together with the reasons for the decision.
p.000002: (3) *
p.000002: 4 / A. § * (1) There are two provisions of the Eütv. 206 (2) or (3) of the Act, in the case of a donor and recipient couple who: a
p.000002: approved organ transplantation - making a decision of the ethics committee in accordance with Section 4, or 208
p.000002: for medical reasons - cannot be performed, but according to specialist advice, two organ transplants can be done by exchanging donor and recipient pairs,
p.000002: submitted jointly to the Ethics Committee for Specialist Advice and Transplant Health Care -
p.000002: At their joint request and with the approval of the Ethics Committee, the two organs may be transplanted.
p.000002: 2. The joint application referred to in paragraph 1 shall contain
p.000002: (a) the contents of Annex 1 for the two donors and the two recipients,
p.000002: (b) a joint declaration by the two donors
p.000002: (ba) that offerings are made without consideration, without compulsion, threat, deception, and
p.000002: bb) taking note that the provisions of the § 209 (4), the other simultaneous organ removal and
p.000002: organ transplantation may take place in the absence of medical advice to that effect,
p.000002: (c) a declaration by both donors and two recipients that they Information on the contents of subsections (4) and (5) of Section 209 has been received and
p.000002: they took note.
p.000002: 3. The health care provider referred to in paragraph 1 shall, where practicable,
p.000002: you can do organ transplants at the same time.
p.000002: § 5 Invasive testing in the context of a donor investigation may only be performed after the decision of the hospital ethics committee.
p.000002: 5 / A. § * Cell or tissue extraction of living donors for the procurement of umbilical cord blood for transplantation of haemopoietic stem cells
p.000002: rules apply.
p.000002: Organ, tissue removal from the dead
p.000002: § 6 Removal of organs and tissues from a dead person for transplantation into another person's body may commence if
p.000002: a) * a health worker designated by the head of the donor institution (hereinafter referred to as a designated health worker) -
p.000002: - ensure that the deceased person has not made a statement to the contrary, and
p.000002: (b) the cause of death has been established by medical examination in accordance with professional rules, or the cause of brain death has been established in
p.000002: established by the three - member Medical Committee, hereinafter referred to as "the Committee", and
p.000002: (c) the organ, tissue removal physician has determined that the organ, tissue to be removed, the examinations carried out and the deceased
p.000002: is available for transplantation from a professional standpoint.
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Social / Trade Union Membership
Searching for indicator union:
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p.000002: taken out;
p.000002: 25. organ procurement: the process by which donated organs become available;
p.000002: 26. * cell bank: a healthcare provider that performs screening of cell donors, processing, preserving, storing, and
p.000002: distributes cells to the transplanting health care provider;
p.000002: 26a. * Tissue bank: a health care provider that performs screening of tissue donors, processing, preserving, storing,
p.000002: as well as distribution and transfer of tissues to the transplanting health care provider;
p.000002: 27. storage: storage of tissues and cells under controlled conditions until distribution;
p.000002: 28. * Donation Identification String: The first part of the Single European Code, which is the code for the tissue bank and the unique donation code.
p.000002: consists of numbers;
p.000002: 29. * Number of Items: A number that distinguishes and uniquely identifies with the same unique donation number and the same
p.000002: tissues and cells with a product code from the same tissue bank as set out in Annex 15;
p.000002: 30. * unique donation number: the unique number assigned to a specific donation of tissues and cells in that Member State
p.000002: in accordance with the applicable system for assigning numbers as set out in Annex 15;
p.000002: 31. * fusion: the physical contact of tissues and cells from more than one collection from the same donor or from two or more donors; or
p.000002: mixing in a single container;
p.000002: 32. * single European code: the unique identifier for tissues and cells distributed in the European Union, containing
p.000002: the donation identification string and the product identification string as set out in Annex 15;
p.000002: 33. * EUTC: The product code system developed by the European Union for tissues and cells and found in the European Union.
p.000002: records all types of tissues and cells and the corresponding product codes;
p.000002: 34. * placed on the market: cellular and tissue products distributed or transmitted for human use whether or not they are returned
p.000002: to the original tissue bank;
p.000002: 35. * Expiry date: The date until which the tissues and cells can be used;
p.000002: 36. * Tissue Bank Union Code: The unique identifier of the Tissue Bank, which is the ISO country code and the Tissue Bank is the T
p.000002: consists of a specific number in its collection;
p.000002: 37. * EU Collection of Tissue and Cellular Products: Tissue and Cell Types circulating in the European Union and permitted coding
p.000002: a collection of product codes corresponding to the systems (EUTC, ISBT128 and Eurocode);
p.000002: 38. * Union collection of tissue banks: all accredited, designated, authorized or authorized by the competent authority of Member States
p.000002: a collection of tissue banks containing information in accordance with Annex 15;
p.000002: 39. * product identifier string: the second part of the uniform European code comprising the product code, the number of sublots and the expiry date;
p.000002: 40. * Product code: identifier that identifies the specific type of tissue and cell that identifies the coding system used by the tissue bank.
p.000002: product code system identifier ("E" for EUTC, "A" for ISBT128, "B" for Eurocode) and the relevant coding system or tissue and
p.000002: The EU collection of cellular products shall consist of the number of tissues and cells of the product type.
p.000002: 1 / B. § * As the competent authority in relation to organ transplantation in this Regulation and in organ transplantation as a health service
p.000002: the National Chief Medical Officer, the OVSZ and the Minister for Health (hereinafter:
p.000002: Minister).
p.000002: 1 / C. § * When donating, collecting, testing, processing, storing and distributing human tissues, cells - if personal data
p.000002: protection legislation - make sure that the donor and recipient as well as their families are not
p.000002: each other's person.
p.000002: Organ, tissue removal from a living person
p.000002: Section 2 (1) Organ transplantation and tissue transplantation shall be governed by the provisions of Art. In the case defined in Article 206 (3), he is employed by that health care provider
...
p.000002: as required.
p.000002: (2) The OVSZ shall provide a unique identifier for each donation and for each donation and associated organs and recipients,
p.000002: and in accordance with the legal requirements for the protection of the recipient's health and personal information. The system should provide it
p.000002: should prevent unauthorized access to, and unauthorized access to, such data
p.000002: Any use of data.
p.000002: (3) * OVSZ maintains National Register of Organ Donation and Transplantation and living donors applying for organ donation
p.000002: A register is kept by the health care providers providing the care according to the procedure of the OVSZ.
p.000002: (4) In the case of an organ, the data necessary for traceability shall be kept by the OVSZ for 30 years after the donation. Retention of data
p.000002: it can also be done electronically.
p.000002: 16 / E. § * For organ harvesting, materials and equipment must be used that comply with the requirements of the Minister for Medical Devices
p.000002: and the applicable professional rules.
p.000002: 16 / F. § * The OVSZ
p.000002: (a) participate in the network of competent authorities and coordinate at national level the contribution to the activities of the network;
p.000002: (b) keep a record of the activities of transplantation centers, showing the total number of living and deceased donors and
p.000002: and contains the types and quantities of organs transplanted or otherwise disposed of,
p.000002: (c) prepare an annual report on the activities under point (b) and publish it on its website;
p.000002: d) ensure that in the case of organ exchange between Hungary and a Member State of the European Union, Article 9 / a. organs and organs according to Annex
p.000002: donor data to the Member State affected by the exchange of organs,
p.000002: e) * monitor organ transplant effectiveness and analyze the national situation of transplants.
p.000002: 16 / G. § * The National Chief Medical Officer shall keep records in accordance with the provisions of the legislation on the registration of health care providers.
p.000002: about transplant centers.
p.000002: Human organs intended for transplantation are party to the Agreement on the European Economic Area
p.000002: general rules of procedure for the exchange of information between Member States *
p.000002: 16 / Mon. § * (1) OVSZ shall be issued pursuant to Section 16 / I. Shall act in accordance with the provisions of paragraphs (2) and (3).
p.000002: 2. The data shall be in writing, by electronic means or by fax in the language agreed with the Member State of destination or, failing that, in English.
p.000002: shall be sent immediately after the availability of the data, including the date of transmission and
p.000002: the contact person responsible for the transfer. Following the transmission, it shall be ensured that the Member State of destination is the data
p.000002: confirm receipt.
p.000002: 3. When transferring data pursuant to paragraph 1, it shall be indicated, subject to compliance with data protection legislation, that personal data
p.000002: contains data.
p.000002: 4. In cases of urgency, data may be communicated orally, in particular in accordance with Article 16 / K. § report serious adverse events and events
p.000002: in case of. Following oral transmission, the procedure set out in paragraphs 2 and 3 shall apply.
...
p.000002: can affect the quality and safety of tissues for human use. The National Chief Medical Officer shall notify them in Section 14
p.000002: specific healthcare providers and the Minister.
p.000002: (2) * The health care provider referred to in Section 14 shall promptly notify the National Chief Medical Officer of any serious complication
p.000002: which have been detected during or after the implantation or removal of tissue and which are of inadequate quality for human tissue
p.000002: can be traced back.
p.000002: (3) * Upon notification pursuant to paragraphs 1 and 2, the National Chief Medical Officer shall immediately take the necessary measures, including
p.000002: - if the consequences of a serious adverse event or serious incident could affect another Member State, the European Commission or the European Commission
p.000002: The competent authorities of the Member States of the Economic Area likely to be affected by a serious adverse event or serious complication shall:
p.000002: notification.
p.000002: 3a. * Except as provided in paragraph 3, the National Chief Medical Officer shall commence an investigation and take the necessary measures if
p.000002: Upon reasoned request by a competent authority of a Member State of the European Economic Area.
p.000002: (4) Notifications under paragraphs (1) and (2) shall be made on the form set out in Annex 10.
p.000002: (5) * By 30 June of the year following the reference year, the National Chief Medical Officer shall submit to the Commission of the European Union an annual report in accordance with Annex 11.
p.000002: forms. Healthcare providers under Section 14 shall provide information on the data required for the annual report in Annex 11 a
p.000002: by 30 April of the year following the reference year, inform the National Chief Medical Officer.
p.000002: 17 / C. § * (1) * Serious adverse event or serious complication to an organ known to the health care provider
p.000002: immediately inform OVSZ, which, with immediate notification to the Minister and the transplant centers,
p.000002: notifies the National Chief Medical Officer of the notification and investigation of the case. The OVSZ shall take the necessary measures without delay, including:
p.000002: if the consequences of a serious adverse event or serious incident could affect another Member State, the European Commission or the European Commission
p.000002: The competent authorities of the Member States of the Economic Area likely to be affected by a serious adverse event or serious complication shall:
p.000002: notification.
p.000002: 2. The formal requirements for the timely notification and treatment of serious adverse events and reactions in the organ shall be
p.000002: OVSZ issues an Operational Order which is published on its website.
p.000002: 17 / D. § * The National Chief Medical Officer, indicating the number and nature of serious adverse events and events
p.000002: keep a record.
p.000002: 17 / E. § * Compliance with the provisions of this Regulation shall also be examined in the course of professional supervision.
p.000002: 17 / F. § * The competent authorities shall be the Member States party to the Agreement on the European Economic Area or the European Commission
p.000002: they shall, on request, provide information on the results of the inspections and controls carried out in relation to the requirements of this Regulation.
p.000002: 17 / G. § * The National Chief Medical Officer shall carry out regular inspections of tissue processing and storage facilities and may inspect
p.000002: procedures and activities relating to the requirements of this Regulation and may be subject to inspection in the framework of this Regulation
p.000002: requirements.
p.000002: Single European Code *
p.000002: 17 / Mon. § * (1) The single European code shall apply to all tissues and cells distributed for human use. The tissues
p.000002: and, in the case of the placing on the market of cells and cells for other purposes, at least the accompanying documentation shall contain the donation identification character.
p.000002: 2. Paragraph 1 shall not apply
p.000002: (a) the donation of reproductive cells between partners,
p.000002: (b) tissues and cells delivered directly to the recipient for immediate transplantation;
p.000002: (c) in urgent cases, with the express authorization of the competent authority, for tissues and cells introduced into the European Union.
p.000002: 3. The following shall be exempted from the requirements of paragraph 1:
p.000002: (a) tissues and cells other than gametes intended for donation between partners, provided that they remain with the same healthcare provider,
p.000002: (b) tissues and cells imported into the European Union, provided that they remain with the same healthcare provider from import to use;
p.000002: provided that the healthcare provider is accredited, designated, authorized or licensed for import activities
p.000002: tissue bank.
p.000002: 4. For the purposes of paragraph 3, the same healthcare provider shall be considered to be a healthcare provider where the collection of human
p.000002: all steps in the process leading up to the use under the responsibility of the same person, same quality assurance and
p.000002: traceability system and where at least one authorized tissue processing and storage unit is located in the same location,
p.000002: and an organization responsible for human use.
p.000002: 5. The specifications for the structure of the uniform European code referred to in paragraph 1 are set out in Annex 15.
p.000002: (6) The Common European Code should be legible and preceded by the abbreviation "SEC". The single European code
p.000002: use of another label or traceability system is permitted.
p.000002: (7) The European Uniform Code should be indicated either by the donation identifier and the product identifier or by a single identifier.
p.000002: spaces, or two consecutive rows.
p.000002: 17 / I. § * The application of the single European code shall not preclude the application of additional codes in accordance with national requirements
p.000002: They are.
p.000002: Requirements for the application of the single European code *
p.000002: 17 / J. § * (1) The Tissue Bank, including the Tissue Bank of Import, shall provide the following with respect to the application of the Single European Code:
p.000002: conditions:
p.000002: (a) at the latest before distribution for human use, assign a single European code to all tissues and cells which:
p.000002: in the case of such a code;
p.000002: (b) the tissue and cell donation assigns an identification string after collection, or
p.000002: on arrival at a service provider or on importation from a healthcare provider in a third country;
p.000002: (c) notify the national officer in the following cases:
p.000002: (ca) where the information contained in the Union collection of tissue banks needs to be updated or corrected;
p.000002: (cb) when the Union collection of tissue and cell products needs to be updated;
p.000002: (cc) if the tissue bank establishes that a single European code has been obtained for tissues and cells from another Union tissue bank;
p.000002: does not meet the requirements of this Chapter.
p.000002: 2. The donation identification string referred to in paragraph 1 (b) shall consist of the following elements:
p.000002: (a) the Union Tissue Bank code, according to the Union Tissue Bank Collection,
p.000002: (b) the unique donation number issued by the tissue bank, unless it is a worldwide unique donation number.
p.000002: 3. In the case of tissue and cell fusion, the end product shall be assigned a new donation identification number. The individual donations
p.000002: the tissue bank which carries out the merger shall ensure its traceability.
p.000002: 17 / Tues § * (1) The National Chief Medical Officer shall assign a unique identification number to each authorized tissue bank. If the tissue bank is more different
p.000002: but has a single system for issuing unique donation numbers, then it can be considered as a tissue bank. If the
p.000002: tissue bank uses two or more systems to issue unique donation numbers, the number of systems used by a given site
p.000002: have a sufficient number of dedicated tissue bank codes.
p.000002: 2. The donation identification string assigned to tissues and cells already placed on the market shall not be altered unless
p.000002: needed to fix a coding error. In the event of a coding error, all patches must be properly documented.
p.000002: 3. § 37 and in the EU Tissue and Cellular Product Collection
p.000002: shall be applied at the latest before distribution for human consumption. The tissue and
p.000002: the label of your cell product shall indicate the appropriate batch number and the expiry date. In the case of tissues and cells in which
p.000002: no expiry date specified, the expiry date shall be 00000000 which shall be indicated at the latest before distribution for human consumption.
p.000002: 4. Prior to distribution of the product for human consumption, the labeling shall be indelibly and indelibly marked on the product.
p.000002: European code and should be included in the accompanying documentation. The tissue bank may entrust this task to a third party or parties, provided that:
p.000002: the third party ensures compliance with the provisions of this Regulation, in particular regarding the uniqueness of the single European code. If, due to the size of the label,
p.000002: the single European code cannot be included on the label, the code shall be included in the accompanying documentation, which shall be clearly
p.000002: affected tissues and cells.
p.000002: (5) The tissue bank and organizations responsible for human use shall keep at least 30 records as specified in Annex 14,
p.000002: for years.
p.000002: 17 / L. § * (1) The National Chief Medical Officer
p.000002: (a) examine, in its audit of the tissue bank, the application of the single European code;
p.000002: (b) ensure the validation of data on tissue banks in the Union Collection of Tissue Banks as set out in Annex 16;
p.000002: and update the collection within 10 business days at the latest, especially in the following cases:
p.000002: (ba) where a new tissue bank is authorized;
p.000002: (bb) in the event of changes in tissue bank information or misrepresentation of tissue banks in the Union collection;
p.000002: (bc) in the event of a change in the tissue bank authorization referred to in paragraph 2;
p.000002: (c) alert the competent authorities of another Member State if it detects incorrect information in relation to a Member
p.000002: or if it finds that the provisions of a European code are significant for the other Member State
p.000002: a case of non-compliance;
p.000002: (d) advise the European Commission and the competent authorities of other Member States of any collection of EU code numbers for tissues and cells;
p.000002: need to be updated.
p.000002: 2. In the Union Collection of Tissue Banks, the national officer in charge of carrying out the activities referred to in paragraph 1 (b) (bc) shall:
p.000002: leads the change:
p.000002: (a) an authorization for a new type of tissue or cell,
p.000002: (b) a permit for a new prescribed activity,
p.000002: (c) a condition or exception to any permit;
p.000002: (d) suspension of operation in relation to a particular activity or type of tissue or cell,
p.000002: (e) withdrawal of the tissue bank authorization,
p.000002: (f) situations where a tissue bank voluntarily ceases the activity or activities covered by the authorization.
p.000002: Provisions applicable to imports into the European Union of human tissues and cells *
p.000002: 17 / M. § * (1) The rules of this Decree shall apply to human tissues and cells intended for human
p.000002: the importation into the European Union of products derived from tissues and cells shall be subject to the derogations provided for in this Chapter.
p.000002: apply.
p.000002: (2) Where the human tissues and cells to be imported are only processed products covered by other Union legislation
p.000002: for the purposes of this Chapter, the donation, collection and testing outside the European Union and from the donor to the
p.000002: to the recipient and from the recipient to the donor.
p.000002: 3. The provisions of this Chapter shall not apply
p.000002: a) 15 / C. § 1 for direct importation;
p.000002: (b) in cases of urgency, the importation of tissues and cells directly authorized by the national officer in charge.
p.000002: 17 / N. § * For the purposes of this Chapter
p.000002: 1. "single import" means the importation of any type of tissue and cell for single use to a specified known recipient;
p.000002: 2. "third country healthcare provider" means a tissue bank or healthcare provider established in a third country that:
p.000002: responsible for the export to the European Union of tissues and cells which it supplies to a tissue bank;
p.000002: 3. "Importing tissue bank" means a tissue bank established in the European Union and established with a healthcare provider in a third country.
p.000002: on the contracted importation into the European Union of knitted tissues and cells of human origin from third countries
p.000002: party to the agreement;
p.000002: 4. Urgent case: an unforeseeable situation where, in practice, there is no other option than urgent tissue and
p.000002: to import cells into the European Union for immediate use in a known recipient whose health is seriously compromised without such imports
p.000002: would be in danger.
p.000002: 17 / O. § * (1) The importation of tissues and cells from third countries shall be subject to an operating license issued by the
p.000002: may be carried out by an importing tissue bank holding an official certificate issued for that purpose.
p.000002: 2. When applying for an import authorization, the applicant importing tissue bank shall send to the national officer in charge of:
p.000002: Attach the information in Annex 17 and attach the documents in Annex 18 to the application. The nationwide
p.000002: The Chief Medical Officer shall verify the data transmitted and the existence of the requirements of this Regulation and shall authorize the application on the basis of
p.000002: and, where necessary, establish the conditions and restrictions for import and issue the
p.000002: (c) an official certificate in accordance with Annex II for authorized tissue establishment banks.
p.000002: (3) The importing tissue bank shall notify the National Chief Medical Officer of any material change in its import activities.
p.000002: for. The official officer shall amend the official certificate referred to in paragraph 2 upon notification.
p.000002: (4) A substantial change is the change in the type of tissues and cells to be imported, the quality and quality of the tissues and cells to be imported.
p.000002: a change in the safety of a third country activity or a third country healthcare provider.
...
p.000002: in the event of refusal of inspection, the national officer in charge shall give reasons for his decision in the requesting Member State referred to in paragraph 3.
p.000002: direction.
p.000002: 17 / Q. § * The documentation according to Annex 17 F and Annex 19 need not be attached for single import.
p.000002: One-time import must ensure that the imported tissues and cells are tracked from donor to recipient and from recipient to donor
p.000002: and that the imported tissues and cells are used only at the intended recipient.
p.000002: 17 / R. § * (1) The importing tissue bank shall promptly notify the National Chief Medical Officer of any suspected or
p.000002: an event or complication of which you are aware of a third country health care provider that may affect
p.000002: quality and safety of imported tissues and cells. The notification shall contain the information specified in Annex 10.
p.000002: 2. In addition to paragraph 1, the importing tissue bank shall promptly notify the National Chief Medical Officer if it becomes aware that:
p.000002: a healthcare provider in a third country
p.000002: (a) the authorization to export the tissues and cells has been withdrawn or suspended; or
p.000002: (b) the competent authority of the Member State of establishment has taken a decision which is essential for the quality and safety of the tissues and cells imported.
p.000002: 17 / S. § * (1) In the case of the donation, procurement, testing, processing, preservation of tissues and cells to be imported into the European Union,
p.000002: any storage and distribution activities are carried out outside the European Union by the importing tissue bank
p.000002: have a written agreement with the health care provider in the third country.
p.000002: 2. A written agreement between the importing tissue bank and the healthcare provider in the third country shall specify what is to be fulfilled
p.000002: quality and safety requirements to ensure that the tissues and cells to be imported comply with this Regulation
p.000002: quality and safety standards equivalent to those laid down. The written agreement shall include at least clause 20
p.000002: The information listed in Annex II.
p.000002: 17 / T. § * (1) The importing tissue bank shall keep a record of its activities, including in the case of a single import, the
p.000002: type, amount, origin and destination of tissues and cells.
p.000002: (2) The data referred to in paragraph (1) shall also be included in the annual report in accordance with Annex 12.
p.000002: (3) A 17 / O. Section 15 / D. Shall also be indicated in the register.
p.000002: Transitional and final provisions
p.000002: Article 18 (1) This Decree, with the exception of paragraph (2), shall enter into force on 1 January 1999 and shall at the same time repeal
p.000002: Act II of 1972 18/1972 on the implementation of the provisions of Act IV of 1975 on the removal and transplantation of organs and tissues (XI. 4.) EüM,
p.000002: 3/1988, as amended. (II. 17.) SZEM decree.
p.000002: (2) * of Decree 44/2016 amending this ministerial decree on health and health insurance. (XII. 28.) EMMI
p.000002: 17 / H. And Annex 15 to the Common European Code a
p.000002: Mode. It shall not apply to tissues and cells already in storage on the date of entry into force of this Directive, provided that such tissues and cells are
p.000002: Mode. shall be placed on the market within the European Union within five years of the date of its entry into force and shall be fully traceable to this Regulation.
p.000002: otherwise insured.
p.000002: (3) * For tissues and cells which have a long storage life and only after the expiry of the five-year period referred to in paragraph 2
p.000002: and which are not eligible for the uniform European code because they are stored under refrigeration,
p.000002: tissue banks shall apply procedures for labeled products in accordance with Section 16.
p.000002: (4) * This Regulation is intended to comply with the following acts of the Union:
p.000002: (a) Directive 2004/23 / EC of the European Parliament and of the Council of 31 March 2004 on the donation and collection of human tissues and cells;
p.000002: laying down quality and safety standards for testing, processing, preservation, storage and distribution;
p.000002: (b) Commission Directive 2006/17 / EC of 8 February 2006 amending Directive 2004/23 / EC of the European Parliament and of the
p.000002: implementation of certain technical requirements for donation, collection, testing;
p.000002: (c) Commission Directive 2006/86 / EC of 24 October 2006 amending Directive 2004/23 / EC of the European Parliament and of the Council as regards traceability
p.000002: requirements, reporting serious complications and adverse events, and coding, processing of human tissues and cells,
p.000002: implementing certain technical requirements for its conservation, storage and distribution;
p.000002: (d) * Directive 2010/53 / EU of the European Parliament and of the Council of 7 July 2010 on the quality and quality of human organs
p.000002: setting safety standards;
p.000002: e) * of 9 October 2012 laying down the information procedure on the exchange of human organs intended for transplantation between Member States
p.000002: Commission Directive 2012/25 / EU;
p.000002: (f) * with regard to certain technical requirements of Directive 2006/17 / EC relating to the examination of human tissues and cells
p.000002: amending Directive 2012/39 / EU of the European Parliament and of the Council of 26 November 2012;
p.000002: (g) * with regard to certain technical requirements of Directive 2006/86 / EC relating to the coding of human tissues and cells
p.000002: amending Directive 2015/565 / EU of 8 April 2015;
p.000002: (h) * verification of the equivalence of the quality and safety standards for imported tissues and cells under Directive 2004/23 / EC
...
p.000002: antibiotic therapy, inotropic support or transfusion therapy.
p.000002: 2. Container labeling
p.000002: 2.1. where organs are transported by intermediary, each container shall be labeled with at least the following:
p.000002: 2.1.1. "HUMAN ORGAN TRANSPLANTATION" and "CAREFUL CARE!" Hungarian or English subtitles;
p.000002: 2.1.2. identification of the sending and receiving institutions (address and telephone number), contact person;
p.000002: 2.1.3. place and date of organ harvesting;
p.000002: 2.1.4. requirements for transport conditions relevant to the quality and safety of organs;
p.000002: 2.1.5. if the organ is known to be a positive marker for an important infectious disease, the words 'BIOLOGICAL HAZARD' must also be included;
p.000002: 2.1.6. specifications for storage conditions (such as "FREEZE");
p.000002: 2.1.7. recommended transport conditions (eg refrigerated, transport in stowed position, etc.);
p.000002: 2.1.8. safety instructions / (where appropriate) cooling methods.
p.000002: 3. Acquisition of an organ by an implanted health care provider
p.000002: 3.1. The following information shall be recorded by the transplant provider:
p.000002: 3.1.1. identification of the organ procurement organization,
p.000002: 3.1.2. type of organ implanted,
p.000002: 3.1.3. the identification of the transplanted organ,
p.000002: 3.1.4. the recipient's ID,
p.000002: 3.1.5. donor data,
p.000002: 3.1.6. date of implantation,
p.000002: 3.1.7. all necessary data for organ removal,
p.000002: 3.1.8. instructions for the disposal of unused organs.
p.000002: Annex No. 10 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000002: I. Reporting of serious complications
p.000002: A. Reporting of suspected serious complication
p.000002: Tissue bank name, operating license number
p.000002: Union code for tissue bank
p.000002: Application ID
p.000002: Date of notification (year / month / day)
p.000002: Indication that the person concerned is a recipient or a donor
p.000002: Date and place (year / month / day) of collection or human use
p.000002: Unique donation number
p.000002: Date of suspicion of serious complication (year / month / day)
p.000002: The type of tissues and cells involved in a suspected serious complication
p.000002: Uniform European code for tissues and cells suspected of having serious complication (s)
p.000002: Type of suspected serious complication (s)
p.000002: B. Conclusions of the investigation into the suspicion of serious complications
p.000002: Tissue bank name, operating license number
p.000002: Union code for tissue bank
p.000002: Application ID
p.000002: Confirmation date (year / month / day)
p.000002: Date of serious complication (year / month / day)
p.000002: Unique donation number
p.000002: Confirmation of serious complication (yes / no)
p.000002: A European code for tissues and cells affected by a confirmed serious complication
p.000002: Change in type of serious complication (yes / no). If yes, specify:
p.000002: Clinical result (if known)
p.000002: - Full recovery
p.000002: - Smaller consequence
p.000002: - Serious consequence
p.000002: - Death
p.000002: The result of the tissue bank investigation and the final conclusions
p.000002: Recommendations of the tissue bank for preventive and corrective actions
p.000002: II. Report serious adverse events
p.000002: A. Reporting of Serious Adverse Events
p.000002: Tissue bank name, operating license number
p.000002: Union code for tissue bank
p.000002: Application ID
p.000002: Date of notification (year / month / day)
p.000002: Date of serious adverse event (year / month / day)
p.000002: Tissues and Cells Detailing
p.000002: quality and safety of Tissue and Cellular Fault Equipment Failure Human Failure Other
p.000002: occurred (specify)
p.000002: serious adverse event due to error:
p.000002: Collection
p.000002: test
p.000002: Transport
p.000002: Processing
p.000002: Storage
p.000002: dispersion
p.000002: Materials
p.000002: Other (specify)
p.000002: B. Conclusions of the investigation into serious adverse events
p.000002: Tissue bank name, operating license number
p.000002: Union code for tissue bank
p.000002: Application ID
p.000002: Confirmation date (year / month / day)
p.000002: Date of serious adverse event (year / month / day)
p.000002: Analyzing the root cause (details)
p.000002: Corrective actions taken (details)
p.000002: Annex No 11 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000002: Forms to be used for the annual report
p.000002: A. Standard form for the annual report on serious adverse events
p.000002: Reporting country
p.000002: Reporting period (year) January 1 - December 31
p.000002: Number of serious complications (s) per tissue and cell type
p.000002: (or type of product that comes into contact with tissues and cells)
p.000002: Tissue / Cell (or Tissue Serious Complication (s))
p.000002: and product in contact with cells, total (if
p.000002: type of data available)
p.000001: 1
p.000002: 2
p.000003: 3
p.000004: 4
p.000004: ...
p.000004: Altogether
p.000004: Total number of tissues and cells distributed (including tissue and cell types for which no serious
p.000004: complications)
p.000004: Number of recipients affected (total number of recipients):
p.000004: Nature of serious complications reported Total number of serious complications (s) reported
p.000004: Transmitted bacterial infection
p.000004: Transmitted viral infection HBV
p.000004: HCV
p.000004: HIV 1/2
p.000004: Other (specify)
p.000004: Transmitted parasitic infection is malaria
p.000004: Other (specify)
p.000004: Transmitted malignant diseases
p.000004: Transmission of other diseases
p.000004: Other serious complications (specify)
p.000004: B. Standard form for the annual report on serious adverse events
p.000004: Reporting country
p.000004: Reporting period (year) January 1 - December 31
p.000004: Total number of tissues and cells processed
p.000004: For the quality and safety of tissues and cells,
...
p.000004: A. FOR FABRIC BANKS
p.000004: (1) Identity of the donor (given name, surname, date of birth, if the donation involves a mother and child, both the mother's name and
p.000004: date of birth and date of birth of the child and, if known, name, nationality, ID number)
p.000004: 2. Identification of the donation, which shall include at least the following information:
p.000004: - Identification (name, address) or tissue bank (name, address) of the collection healthcare provider
p.000004: - Unique donation number
p.000004: - Date of collection
p.000004: - The place of collection
p.000004: - Type of donation (eg tissue of one or more cell types, autologous or allogeneic, living or deceased donor)
p.000004: 3. The product identifier, which shall include at least the following information:
p.000004: - Identification of the tissue bank (name, address)
p.000004: - Tissue / cell / product type (basic nomenclature)
p.000004: - Number of item groups (in case of merger)
p.000004: - Number of sublots
p.000004: - Expiration date (year / month / day)
p.000004: Tissue / cell status (ie quarantined, usable, etc.)
p.000004: - Description and origin of the products, the processing steps used, the contact with and the quality of the tissues and cells, and
p.000004: substances and additives affecting safety
p.000004: - Identification of the establishment issuing the final label
p.000004: (4) Single European code
p.000004: 5. Identity of the human use, which shall include at least the following information:
p.000004: - Date of distribution / destruction
p.000004: - Identity of the doctor or end user / provider
p.000004: B. FOR THE HUMAN CONSUMPTION ORGANIZATION (1) Union code for tissue establishment
p.000004: (2) Identifier of the physician or end user / facility
p.000004: (3) Type of tissues and cells
p.000004: (4) Product ID
p.000004: (5) Identity of the recipient
p.000004: (6) Date of use
p.000004: (7) Single European code
p.000004: Annex No 15 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: STRUCTURE OF THE SINGLE EUROPEAN CODE
p.000004: GIVING IDENTIFICATION CHARACTER PRODUCT IDENTIFICATION CHARACTERISTICS
p.000004: FEDERAL BANK CODE SPECIFIC DONATION PRODUCT CODE TERMS EXPIRY DATE
p.000004: NUMBER * NUMBER (year / month / day)
p.000004: ISO country code The tissue bank Product code Product number
p.000004: number system
p.000004: identification
p.000004: 2 alphabetic 6 alpha-13 alpha-1 alpha-bet 7 alpha-3 alpha-8 numeric characters
p.000004: Character Numeric Numeric Character Numeric Character Numeric
p.000004: character character
p.000004: * If the tissue bank is not compatible with the Uniform European Code, Section 1 / A shall apply. § 37, is unique
p.000004: To assign a donation number, the tissue bank assigns a unique donation number, which is the date of collection of the tissue and cell (year / month / day -
p.000004: eight numeric characters), plus the donor's serial number, followed by zeros up to 13 characters.
p.000004: Annex 16 to the Act No 18/1998. (XII. 27.) EüM Decree *
p.000004: DATA TO BE RECORDED IN THE UNION COLLECTION OF BANKING BANKS
p.000004: A. Tissue Bank Information
p.000004: 1. Name of the tissue bank
p.000004: 2. The national or EU code of the tissue bank
p.000004: 3. Name of the organization within which the tissue bank is located
p.000004: 4. Address of the tissue bank
p.000004: 5. Available contact information: working email address, telephone and fax number
p.000004: B. Tissue Bank Authorization Information
p.000004: 1. Competent Authorizing Authority (s)
p.000004: 2. Name of the competent authority (ies) responsible for the management of the Union collection of tissue banks
p.000004: 3. Name of the authorization holder
p.000004: 4. The tissues and cells to which the authorization applies
p.000004: 5. Actual activities to which the permit relates
p.000004: 6. Authorization status (authorized, suspended, partially or totally withdrawn, voluntary cessation of activities)
p.000004: 7. Information on additional license conditions and exemptions.
p.000004: Annex No 17 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: The content of the application to be submitted by a tissue bank seeking authorization for import activities
p.000004: requirements
p.000004: When applying for import licenses for import activities, the applicant shall provide the importing tissue bank with the most up-to-date information.
p.000004: information or documentation for Section F, unless you are a tissue bank or an import tissue bank
p.000004: has already submitted, as part of its previous application for authorization:
p.000004: A. General Information on the Importing Tissue Establishment (ITE)
p.000004: 1. Name of the tissue bank
p.000004: 2. Address of the seat of the tissue bank
p.000004: 3. Address of the tissue bank (if different)
p.000004: 4. Name of the department
p.000004: 5. Address of the department's headquarters
p.000004: 6. Departmental postal address (if different)
p.000004: 7. Tissue Bank Applicant Status: It must be stated that the first application for a Tissue Bank operating license or, where applicable,
p.000004: This is a request for amendment. If the applicant is already an authorized tissue establishment (TE), the tissue banks must be provided
p.000004: Union collection code.
p.000004: 8. Name of place of importation (if not the name of the tissue bank or the applicant unit)
p.000004: 9. Visiting address of the betting site
p.000004: 10. Address of destination (if different)
p.000004: B. The Tissue Bank
p.000004: 1. Head of department
p.000004: 2. Phone number
p.000004: 3. Email address
p.000004: 4. Name of the responsible person
p.000004: 5. Phone number
p.000004: 6. Email address
p.000004: 7. Website address of the importing tissue bank
p.000004: C. Tissues and cells to be imported
p.000004: 1. List of types of tissues and cells to be imported, including single import of any type of tissues and cells.
p.000004: 2. Product names of all types of tissues and cells to be imported (where applicable in accordance with the EU Common List).
p.000004: 3. Trade names of all types of tissues and cells to be imported (if not the product name).
p.000004: 4. The name of the third country healthcare provider for all types of tissues and cells to be imported.
p.000004: D. Location of activities
p.000004: 1. List of activities for the purpose of donation, collection, testing, processing, preservation or storage
p.000004: prior to import by a third country healthcare provider, broken down by type of tissue or cell.
p.000004: 2. List of activities for the purpose of donation, collection, testing, processing, preservation or storage
p.000004: prior to importation by a third country healthcare provider by subcontractor, by type of tissue or cell
p.000004: breakdown.
p.000004: 3. List of activities carried out by the tissue bank after importation, broken down by type of tissue or cell.
p.000004: 4. The name of the third countries in which the activities take place prior to import, broken down by type of tissue or cell.
p.000004: E. Information concerning the third country healthcare provider
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Social / Youth/Minors
Searching for indicator minor:
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p.000002: protection legislation - make sure that the donor and recipient as well as their families are not
p.000002: each other's person.
p.000002: Organ, tissue removal from a living person
p.000002: Section 2 (1) Organ transplantation and tissue transplantation shall be governed by the provisions of Art. In the case defined in Article 206 (3), he is employed by that health care provider
p.000002: hospital ethics committee (hereinafter: ethics committee) where organ, tissue transplantation is performed.
p.000002: (2) Tissue transplantation shall be subject to In the case specified in Section 206 (5), the Ethics Committee of that healthcare provider
p.000002: where the tissue removal is performed.
p.000002: 3. The Ethics Committee shall not be a member of the Ethics Committee for the consideration of the matter set out in paragraphs 1 to 2,
p.000002: (a) involved in the removal or implantation of organs, tissue,
p.000002: (b) who carries out the treatment of the recipient,
p.000002: (c) over which the doctor, directly or indirectly, directly involved in the removal or implantation of the organ, tissue
p.000002: exercise.
p.000002: 4. In the cases referred to in paragraphs 1 to 2, the procedure of the Ethics Committee, with the exception of paragraph 5, shall be at the joint request of the donor and the recipient.
p.000002: starts. The application shall be made on the form set out in Annex 1. In the case of a minor, the application is legal for the minor
p.000002: representative shall submit it to the Ethics Committee.
p.000002: (5) A joint application shall also be deemed to constitute a separate request for the transplantation of organs and tissues from the donor and the recipient.
p.000002: (6) If, due to the state of health of the recipient, the application is not able to submit the application, Article 16 (1) to (2)
p.000002: apply, mutatis mutandis, that the person declaring on behalf of the donor and the recipient cannot be the same person unless the recipient is a minor.
p.000002: 7. The Ethics Committee shall, within a period justified by the recipient's state of health, preferably within 15 working days of receipt of the application.
p.000002: meeting.
p.000002: Section 3 (1) The ethics committee shall hear the donor and the recipient personally. If at the discretion of the donor or recipient
p.000002: If you are a minor, your statement should be taken into consideration as far as is professionally possible.
p.000002: (2) If, due to his state of health, it is not possible to hear the recipient, the provisions of Article 2 (6) shall apply mutatis mutandis.
p.000002: apply.
p.000002: 3. The donor and the recipient shall be heard pursuant to paragraph 1 separately. The donor and the recipient may be heard together if one
p.000002: The Ethics Committee assumes that their joint hearing is essential to a thorough knowledge of the facts and circumstances.
p.000002: At the hearing, the Ethics Committee shall in particular ascertain that:
p.000002: a. Whether it has been informed pursuant to Article 209 (1), in particular as to whether the declaration is formally binding
p.000002: can be withdrawn without
p.000002: (b) the donor's willingness to consent in the case of organ donation to a public deed or, in the case of tissue donation, to a fully authentic private deed
p.000002: book printing,
p.000002: (c) the recipient is subject to the Whether the recipient has been informed in accordance with Article 209 (5) and is willing to transpose
p.000002: your written consent,
p.000002: d) the provisions of the Act on Organ and Tissue Donation; Are the conditions of Article 206 (3) and (5) and Article 207 (1) fulfilled?
p.000002: (5) The Ethics Committee shall, if necessary, consult a physician who performs organ or tissue removal or transplantation in accordance with the Euthv. 208.
...
p.000002: in order to detect any bacterial contamination of the tissue prior to implantation.
p.000002: 1.1.6. * History, clinical or laboratory evidence of HIV infection, acute or chronic hepatitis B (except with proven immune status)
p.000002: individuals), the risk of transmission of hepatitis C and HTLV-I / II, or the presence of risk factors for these infections.
p.000002: 1.1.7. A chronic, generalized autoimmune disease history that may have adversely affected the quality of the tissue to be removed.
p.000002: 1.1.8. Signs that donor blood test results will be inadequate due to:
p.000002: a) incidence of blood thinning, Annex 8, paragraph 2.3. if no pre-transfusion sample is available
p.000002: available, or
p.000002: (b) treatment with immunosuppressive agents.
p.000002: 1.1.9. Based on the risk assessment, the presence of any other risk factor for transmissible diseases, taking into account the
p.000002: and exposure history and local incidence of infectious diseases.
p.000002: 1.1.10. The donor body exhibits physical lesions that justify the exclusion of the donor, especially with regard to transmissible diseases.
p.000002: risk.
p.000002: 1.1.11. Poisoning (eg cyanide, lead, mercury, gold).
p.000002: 1.1.12. Vaccination with a live virus diluted history.
p.000002: 1.1.13. According to medical history, he was the recipient of deceased organ and tissue transplantation.
p.000002: 1.2. Additional exclusion criteria for a minor donor
p.000002: An HIV-positive mother's child should not be listed as a donor.
p.000002: 2. Tissue removal from a living person
p.000002: 2.1. Autologous use (removal and application of cells or tissues in the same person)
p.000002: If the removed tissues and cells are to be stored or cultured, the same biological tests as for allogeneic living donors are required.
p.000002: minimum tests should be applied. A positive test result does not necessarily prevent the tissues or cells from either
p.000002: any product made therefrom shall be stored, processed or replanted if a separate storage facility is available
p.000002: to ensure that there is no cross-contamination with other tissues, contamination with contaminants or exchange
p.000002: the risk.
p.000002: 2.2. Allogeneic use (removing cells or tissues from one person and using them in another person)
p.000002: 2.2.1. Allogeneic donors should be selected based on their health and medical history: a questionnaire completed by the donor,
p.000002: professional qualifications and experience relevant to the personal conditions of the legislation on minimum professional conditions for services
p.000002: on the basis of a medical history recorded by a person with the courtesy of 2.2.2. . This assessment must include a significant one
p.000002: including factors that can help identify and screen out individuals who are endowed with a health risk to others
p.000002: This may pose a risk, for example, to the possibility of transmitting disease or a health risk to yourself. The collection process is
...
Social / education
Searching for indicator education:
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p.000002: shall forward the competent authorities of all Member States of destination within three months of the forwarding of the prior report referred to in paragraph 1, or
p.000002: to its authorized organization, as specified in Annex 13 (B). For final report, destination
p.000002: the information sent by the competent authority or its authorized body in the Member States shall be used.
p.000002: 16 / L. § * In order to ensure interconnection between Member States that are parties to the Agreement on the European Economic Area, OVSZ shall send the
p.000002: Contact details of the European Commission (organization name, telephone number, e-mail address, fax number, postal address). If the data changes, please
p.000002: inform the European Commission.
p.000002: Histopathological examination
p.000002: § 17 Organ from living body - Histopathologic examination is not required for tissue removal in the following organs
p.000002: [EUT. Section 204 (2) (c)]:
p.000002: the tooth,
p.000002: (b) vitreous,
p.000002: (c) nails,
p.000002: (d) in the case of physiological birth, the placenta.
p.000002: Person in charge *
p.000002: 17 / A. § * (1) Within the tissue bank, the head of the tissue bank and the person responsible for the protection, registration and preservation of tissues
p.000002: a designated person (hereinafter referred to as "responsible person") shall be responsible.
p.000002: 2. The responsible person shall meet at least the following qualification criteria:
p.000002: (a) advanced vocational education or training in the field of medicine or biological sciences; and
p.000002: (b) at least two years' professional experience in the field referred to in point (a).
p.000002: (3) Responsible person
p.000002: (a) enforce the legal requirements for the collection, storage, processing and distribution of human tissues for human use;
p.000002: regulations and institutional rules;
p.000002: (b) regularly inform the tissue bank manager of the activities of the tissue bank;
p.000002: (c) initiates, in the event of malfunctioning, the restoration of legitimate or professional operations by the head of the tissue bank
p.000002: taking the necessary measures;
p.000002: d) * if, in its opinion, suspension of the activity of stored tissue would be warranted,
p.000002: inform the National Chief Medical Officer directly, giving notice, to take the necessary measures;
p.000002: (e) inform, upon request, the authorities responsible for overseeing the operation of the tissue bank for operational review purposes
p.000002: essential data and the initiative under point (c);
p.000002: f) provide for the provisions of § 3, 6-8. §, a 12 §, a 15 / A. And the requirements of Section 16 at the tissue bank;
p.000002: g) * approve donor evaluation based on exclusion criteria in Annex 7.
p.000002: (4) * The tissue bank shall inform the National Chief Medical Officer of the name of the responsible person referred to in paragraph 1 within the specific area for which it is responsible.
p.000002: with institutional responsibilities.
p.000002: Reporting of serious adverse events and events *
p.000002: 17 / B. § * (1) * The health care provider shall promptly notify the National Chief Medical Officer for examination, processing,
...
Searching for indicator educational:
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p.000002: It is intended to minimize the potential for bacterial or other contamination of tissues and cells.
p.000002: (9) Tissue and cell harvesting shall be carried out using the means, collectors and equipment referred to in Annex 9, which:
p.000002: they comply with the requirements of the in vitro medical device legislation and the applicable professional rules.
p.000002: Quality and safety requirements for organ harvesting *
p.000002: 16 / B. § * (1) Prior to transplantation, the details of the donated organ and the donor are specified in Section 9 / a. to be determined according to Annex.
p.000002: (2) When determining donor data, to assess the suitability of the donor for organ donation
p.000002: the necessary data must be collected to carry out an appropriate risk assessment, minimize the risks to the recipient and
p.000002: optimization.
p.000002: 3. When determining organ data, the data on the organ characteristics necessary to assess the suitability of the organ shall be collected.
p.000002: to perform an appropriate risk assessment to minimize the risk to the recipient and optimize organ allocation.
p.000002: (4) Healthcare professionals qualified and experienced in the definition of organ and donor data are health services
p.000002: in a laboratory which complies with the conditions laid down in the Ministerial Decree laying down the minimum professional conditions required for the performance of the service
p.000002: carried out. Include data that require medical examination, including donor selection and evaluation,
p.000002: a doctor should do it.
p.000002: (5) Educational activities related to organ donation are coordinated by OVSZ.
p.000002: (6) In FIG. Annex II contains the minimum information which, subject to paragraph 8, shall be minimum
p.000002: in the case of organ donation, must be collected.
p.000002: (7) In FIG. Annex II contains the additional data to be collected in addition to the data under paragraph 6
p.000002: by a group of doctors. When deciding on the team, it will take into account the availability of data and the specific circumstances of the case.
p.000002: 8. By way of derogation from paragraph 6, where the risk-benefit analysis shows that in a given case, including life-threatening situations,
p.000002: the expected benefits to the recipient outweigh the risks due to the lack of data,
p.000002: for the purpose of transposition, even if 9 / a. Not all of the minimum data set out in Annex II are available.
p.000002: 9. The data collected pursuant to paragraphs 1 to 8 shall be notified to the OVSZ.
p.000002: (10) The medical team shall endeavor to obtain all necessary information in order to meet the quality and safety requirements
p.000002: and shall provide them with the information they need to understand the implications of the donation. Deceased
p.000002: in the case of organ donation from a donor, where possible and necessary, the OVSZ and the donor health service provider designated
p.000002: the health care professional shall seek such information from relatives or other persons of the deceased donor, and shall
p.000002: also call on all parties called upon to provide information for the importance of rapidly communicating that information.
p.000002: (11) During organ harvesting, it must be ensured that:
p.000002: (a) be carried out in accordance with professional rules regarding the nature of both the donor and the organs to be removed,
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Social / embryo
Searching for indicator embryo:
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p.000004: Tissue Bank Annual Report
p.000004: Tissue and Cell Bank 15 / E. § The annual report pursuant to § 1 shall include:
p.000004: 1. Tissue bank activities
p.000004: 1.1. Number of tissue donors
p.000004: 1.2. Number of tissues donated (number of individual donations)
p.000004: 1.3. Number (units) of tissue from the eye (cornea) *
p.000004: 1.4. Skin (epithelial cell)
p.000004: 1.4.1. Skin (epithelial cell) (number of units) *
p.000004: 1.4.2. Skin (epithelial cell) cm 2 *
p.000004: 1.5. Number of heart valves (units) *
p.000004: 1.6. Number of blood vessels (units) *
p.000004: 1.7. Knitting and support fabric
p.000004: 1.7.1. Total or partial bones (units) *
p.000004: 1.7.2. Number of tendons / ligaments (units) *
p.000004: 1.7.3. Number of cartilage (units) *
p.000004: 1.7.4. Number of bone fillers (units) *
p.000004: 1.7.5. Number of other connective and support tissues (units) (eg, intervertebral disc, auditory bone, etc.) *
p.000004: 1.8. Amniomembrán
p.000004: 1.8.1. Amniotic membrane unit number *
p.000004: 1.8.2. Amniotic membrane cm 2 *
p.000004: 1.9. * Testicular tissue (units) *
p.000004: 1:10. Number of other tissues (adipose tissue, pericardium, etc.) *
p.000004: 2. Activities in haemopoietic stem cell bank [with autologous, allogeneic (non-related) origin]
p.000004: 2.1. Number of cell donors
p.000004: 2.2. Number of donations
p.000004: 2.2.1. bone marrow *
p.000004: 2.2.2. From peripheral blood *
p.000004: 2.3. Number of bags
p.000004: 2.3.1. bone marrow *
p.000004: 2.3.2. From peripheral blood *
p.000004: 3. Cord blood bank activities
p.000004: 3.1. Number of cell donors
p.000004: 3.2. Number of umbilical cord blood units *
p.000004: 4. Germ cell banking activities
p.000004: 4.1. Number of cell donors
p.000004: 4.2. Number of donations
p.000004: 4.2.1. sperm *
p.000004: 4.2.2. Ovum **
p.000004: 4.2.3. Embryo*
p.000004: 4.3. Number of units stored
p.000004: 4.3.1. sperm *
p.000004: 4.3.2. Ovum *
p.000004: 4.3.3. Embryo*
p.000004: * Number of tissues stored on January 1 and December 31 of the previous year and collected, processed, destroyed, distributed in the previous year
p.000004: (unit) should be displayed sequentially by number.
p.000004: ** Number of donations and number of ova donated in the previous year.
p.000004: 5. Import and export from abroad ***
p.000004: 5.1. Number (units) of tissue from the eye (cornea)
p.000004: 5.2. Skin (epithelial cell) (number of units)
p.000004: 5.3. Number of heart valves (units)
p.000004: 5.4. Number of blood vessels (units)
p.000004: 5.5. Number of connective and support fabrics
p.000004: 5.5.1. Total or partial bone number (units)
p.000004: 5.5.2. Number of tendons / ligaments (units)
p.000004: 5.5.3. Number of cartilage (units)
p.000004: 5.5.4. Number of bone fillers (units)
p.000004: 5.5.5. Number of other connective and support tissues (units) (for example, intervertebral disc, auditory bone, etc.)
p.000004: 5.6. Amniotic membrane number (units)
p.000004: 5.7. Ovarian and testicular tissue (units)
p.000004: 5.8. Number of other tissues (adipose tissue, peritoneum, etc.)
p.000004: 5.9. Bone marrow (number of pouches)
p.000004: 5:10. Peripheral blood (number of pouches)
p.000004: *** The place of origin and the place of destination shall be recorded for a given cell or tissue.
p.000004: In the case of tissues and cells, the above data shall be collected, examined, preserved, processed, stored and distributed or otherwise
p.000004: use.
p.000004: Annex No. 13 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000004: (A) Preliminary report of suspected serious adverse events or reactions
p.000004: 1. Designation of the notifying Member State
p.000004: 2. Report reference number: country (ISO code) / national number
...
Social / parents
Searching for indicator parents:
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p.000002: 2.2.2. Criteria for selection of allogeneic donor for tissue establishment and, in the case of direct use, for transplantation
p.000002: is determined and documented by the attending physician, the specific tissues or cells to be donated, and the medical history and medical history of the donor
p.000002: and behavioral history together with the results of clinical and laboratory tests to confirm the donor's health
p.000002: based on his earnings.
p.000002: 2.2.3. The exclusion criteria for tissue removal from the dead shall also apply to the removal from the body. The
p.000002: Depending on the nature of the tissue or cell being donated, additional specific exclusion criteria may be applied, such as:
p.000002: (a) pregnancy (excluding donors of umbilical cord blood cells and amniotic donors and blood progenitor cells between siblings),
p.000002: (b) breastfeeding,
p.000002: (c) in the case of hematopoietic stem cells, the possibility of transmitting hereditary factors
p.000002: fact.
p.000002: Annex No 8 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000002: Laboratory tests for tissue and cell donors (except donors of reproductive cells)
p.000002: 1. * In a ministerial decree on epidemiological measures required to prevent infectious diseases and epidemics at the donor
p.000002: specific tests must be carried out.
p.000002: 1.2. * If the medical history of the donor and the characteristics of the tissue or cells to be donated so warrant, further investigations should be performed. Need
p.000002: for example, RhD, HLA, malaria, CMV, Toxoplasma, EBV, Trypanosoma cruzi. HTLV-I antibody testing should be performed
p.000002: donors who live in or come from an area with a high prevalence or sexual
p.000002: partners or parents come from such an area.
p.000002: 1.3. In the case of autologous donors, the requirements of Annex 7, paragraph 2.1. shall apply.
p.000002: 1.4. * If the tests described in point 1 have not been performed until the umbilical cord stem / mesenchymal stem cell has been removed
p.000002: the tissue bank must ensure that the umbilical cord blood stem cell / mesenchymal stem cell is quarantined for the screening result
p.000002: complete understanding.
p.000002: 2. When determining the biological property (marker), the following general requirements must be met
p.000002: 2.1. The tests shall be carried out in an immuno-laboratory as defined in the legislation on the minimum standards of professional health services
p.000002: must be done.
p.000002: 2.2. Biological tests should be performed on donor blood serum or plasma and should not be performed on other body fluids or secretions -
p.000002: such as aqueous or glassy body fluids - unless a study using a validated test for such fluids is clinically
p.000002: It justified.
p.000002: 2.3. If potential donors have lost blood and blood to replace blood loss immediately prior to donation,
p.000002: blood components, colloids or crystalloids have been obtained, due to the presence of blood
p.000002: can be invaluable if
p.000002: (a) in the case of ante mortem blood sampling, blood, blood components and / or colloids prior to blood sampling
p.000002: They were injected within 48 hours, or if crystalloids were injected within one hour before the blood sample was taken, or
p.000002: (b) post mortem (post mortem) blood, blood components and / or colloids prior to death 48
p.000002: or if crystalloids were injected within one hour prior to death.
p.000002: Tissue and cell processing and storage units may receive tissues and donations from donors with a plasma dilution of more than 50%.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000002: Contact details of the European Commission (organization name, telephone number, e-mail address, fax number, postal address). If the data changes, please
p.000002: inform the European Commission.
p.000002: Histopathological examination
p.000002: § 17 Organ from living body - Histopathologic examination is not required for tissue removal in the following organs
p.000002: [EUT. Section 204 (2) (c)]:
p.000002: the tooth,
p.000002: (b) vitreous,
p.000002: (c) nails,
p.000002: (d) in the case of physiological birth, the placenta.
p.000002: Person in charge *
p.000002: 17 / A. § * (1) Within the tissue bank, the head of the tissue bank and the person responsible for the protection, registration and preservation of tissues
p.000002: a designated person (hereinafter referred to as "responsible person") shall be responsible.
p.000002: 2. The responsible person shall meet at least the following qualification criteria:
p.000002: (a) advanced vocational education or training in the field of medicine or biological sciences; and
p.000002: (b) at least two years' professional experience in the field referred to in point (a).
p.000002: (3) Responsible person
p.000002: (a) enforce the legal requirements for the collection, storage, processing and distribution of human tissues for human use;
p.000002: regulations and institutional rules;
p.000002: (b) regularly inform the tissue bank manager of the activities of the tissue bank;
p.000002: (c) initiates, in the event of malfunctioning, the restoration of legitimate or professional operations by the head of the tissue bank
p.000002: taking the necessary measures;
p.000002: d) * if, in its opinion, suspension of the activity of stored tissue would be warranted,
p.000002: inform the National Chief Medical Officer directly, giving notice, to take the necessary measures;
p.000002: (e) inform, upon request, the authorities responsible for overseeing the operation of the tissue bank for operational review purposes
p.000002: essential data and the initiative under point (c);
p.000002: f) provide for the provisions of § 3, 6-8. §, a 12 §, a 15 / A. And the requirements of Section 16 at the tissue bank;
p.000002: g) * approve donor evaluation based on exclusion criteria in Annex 7.
p.000002: (4) * The tissue bank shall inform the National Chief Medical Officer of the name of the responsible person referred to in paragraph 1 within the specific area for which it is responsible.
p.000002: with institutional responsibilities.
p.000002: Reporting of serious adverse events and events *
p.000002: 17 / B. § * (1) * The health care provider shall promptly notify the National Chief Medical Officer for examination, processing,
p.000002: all relevant information relating to the storage and distribution of data and any serious adverse event, including that which:
p.000002: can affect the quality and safety of tissues for human use. The National Chief Medical Officer shall notify them in Section 14
p.000002: specific healthcare providers and the Minister.
p.000002: (2) * The health care provider referred to in Section 14 shall promptly notify the National Chief Medical Officer of any serious complication
p.000002: which have been detected during or after the implantation or removal of tissue and which are of inadequate quality for human tissue
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General/Other / Natural Hazards
Searching for indicator hazard:
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p.000002: 1.3.2. The packed cells / tissues must be transported in a container that is capable of transporting biological material and preserving
p.000002: safety and quality of tissues or cells.
p.000002: 1.3.3. All accompanying tissue and blood samples for testing must be accurately labeled to ensure their identity to the donor and attached
p.000002: a record indicating the time and place of the collection of the sample shall also be provided.
p.000002: 1.3.4. * Unique European Code for Tissues and Cells Distributed for Human Use or Donation ID
p.000002: string for tissues and cells placed on the market for non-human use.
p.000002: If 1.3.2, 1.3.3. and 1.3.4. of any of the information listed in paragraph 1 shall not appear on the label of the primary container;
p.000002: shall be provided on a separate sheet attached to the container. This sheet should be packed together with the primary container to ensure that they cannot separate.
p.000002: 1.4. Container Labeling
p.000002: Where tissues / cells are transported by an intermediary, each container shall be labeled with at least the following:
p.000002: (a) "TISSUES AND CELLS" and "BEWARE, fragile" subtitle;
p.000002: (b) the identification (address and telephone number) of the establishment from which the parcel is shipped and the contact person;
p.000002: (c) identification of the tissue bank (with address and telephone number) and identification of the person to be contacted for receipt of the container;
p.000002: (d) the date and time of commencement of shipment;
p.000002: (e) requirements for transport conditions that are essential for the quality and safety of tissues and cells;
p.000002: (f) in the case of cellular products, the indication "DO NOT EXPOSE RADIATION"; and
p.000002: (g) if the product is known to be a positive marker for an important infectious disease, the words 'BIOLOGICAL HAZARD' must also be included;
p.000002: (h) in the case of autologous donors, the words "FOR AUTO USE ONLY";
p.000002: (i) specifications for the storage conditions (for example, "FREEZE");
p.000002: (j) * recommended transport conditions (eg refrigerated, transport in stowed position, etc.);
p.000002: (k) * safety standards / (where appropriate) cooling methods;
p.000002: (l) * definition and size of the tissue or cell product as well as morphological and functional data;
p.000002: (m) * in the case of imported tissues and cells, the country of collection and the exporting country (if different from the country of collection)
p.000002: country).
p.000002: 1.5. Acceptance of Tissues / Cells in the Tissue Processing and Storage Facility
p.000002: 1.5.1. Upon receipt of the harvested tissues / cells into the tissue bank, it shall be documented that the shipment, including the shipment
p.000002: conditions, packaging, labeling and related documentation and samples - comply with the requirements of this Annex and
p.000002: professional bank.
p.000002: 1.5.2. The tissue bank must ensure that the received tissues and cells are quarantined as long as they and associated
p.000002: documentation is not verified or compliance is not otherwise verified. Responsible people need it
p.000002: Verify relevant donor / fundraising information and accept donation.
p.000002: 1.5.3. The tissue bank must have a professional code of conduct for each consignment of tissues and cells.
p.000002: These should include the technical requirements and other essentials required by the tissue bank to maintain acceptable quality.
p.000002: criteria. The tissue bank shall have a professional code of conduct with inadequate or incomplete test results
...
p.000002: The medical history of the donor, in particular those conditions that may affect the suitability of the organ for transplantation and
p.000002: may carry the risk of transmission of disease.
p.000002: 1.2.4. Physical and clinical data
p.000002: To evaluate the potential donor's ziology and to identify diseases that have not been identified in the donor's medical history
p.000002: data from clinical trials that may affect the suitability of the organ for transplantation and may include
p.000002: risk of disease transmission.
p.000002: 1.2.5. Laboratory data
p.000002: To assess the functional characteristics of organs and to identify potentially transmissible diseases and the potential for organ donation
p.000002: data necessary to determine contraindications.
p.000002: 1.2.6. Imaging examinations
p.000002: Imaging tests to assess the anatomical status of organs for transplantation.
p.000002: 1.2.7. Therapy
p.000002: Donor treatments relevant to the assessment of organ function and organ fitness, in particular:
p.000002: antibiotic therapy, inotropic support or transfusion therapy.
p.000002: 2. Container labeling
p.000002: 2.1. where organs are transported by intermediary, each container shall be labeled with at least the following:
p.000002: 2.1.1. "HUMAN ORGAN TRANSPLANTATION" and "CAREFUL CARE!" Hungarian or English subtitles;
p.000002: 2.1.2. identification of the sending and receiving institutions (address and telephone number), contact person;
p.000002: 2.1.3. place and date of organ harvesting;
p.000002: 2.1.4. requirements for transport conditions relevant to the quality and safety of organs;
p.000002: 2.1.5. if the organ is known to be a positive marker for an important infectious disease, the words 'BIOLOGICAL HAZARD' must also be included;
p.000002: 2.1.6. specifications for storage conditions (such as "FREEZE");
p.000002: 2.1.7. recommended transport conditions (eg refrigerated, transport in stowed position, etc.);
p.000002: 2.1.8. safety instructions / (where appropriate) cooling methods.
p.000002: 3. Acquisition of an organ by an implanted health care provider
p.000002: 3.1. The following information shall be recorded by the transplant provider:
p.000002: 3.1.1. identification of the organ procurement organization,
p.000002: 3.1.2. type of organ implanted,
p.000002: 3.1.3. the identification of the transplanted organ,
p.000002: 3.1.4. the recipient's ID,
p.000002: 3.1.5. donor data,
p.000002: 3.1.6. date of implantation,
p.000002: 3.1.7. all necessary data for organ removal,
p.000002: 3.1.8. instructions for the disposal of unused organs.
p.000002: Annex No. 10 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000002: I. Reporting of serious complications
p.000002: A. Reporting of suspected serious complication
p.000002: Tissue bank name, operating license number
p.000002: Union code for tissue bank
p.000002: Application ID
p.000002: Date of notification (year / month / day)
p.000002: Indication that the person concerned is a recipient or a donor
p.000002: Date and place (year / month / day) of collection or human use
p.000002: Unique donation number
p.000002: Date of suspicion of serious complication (year / month / day)
p.000002: The type of tissues and cells involved in a suspected serious complication
p.000002: Uniform European code for tissues and cells suspected of having serious complication (s)
p.000002: Type of suspected serious complication (s)
p.000002: B. Conclusions of the investigation into the suspicion of serious complications
p.000002: Tissue bank name, operating license number
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000002: e) * monitor organ transplant effectiveness and analyze the national situation of transplants.
p.000002: 16 / G. § * The National Chief Medical Officer shall keep records in accordance with the provisions of the legislation on the registration of health care providers.
p.000002: about transplant centers.
p.000002: Human organs intended for transplantation are party to the Agreement on the European Economic Area
p.000002: general rules of procedure for the exchange of information between Member States *
p.000002: 16 / Mon. § * (1) OVSZ shall be issued pursuant to Section 16 / I. Shall act in accordance with the provisions of paragraphs (2) and (3).
p.000002: 2. The data shall be in writing, by electronic means or by fax in the language agreed with the Member State of destination or, failing that, in English.
p.000002: shall be sent immediately after the availability of the data, including the date of transmission and
p.000002: the contact person responsible for the transfer. Following the transmission, it shall be ensured that the Member State of destination is the data
p.000002: confirm receipt.
p.000002: 3. When transferring data pursuant to paragraph 1, it shall be indicated, subject to compliance with data protection legislation, that personal data
p.000002: contains data.
p.000002: 4. In cases of urgency, data may be communicated orally, in particular in accordance with Article 16 / K. § report serious adverse events and events
p.000002: in case of. Following oral transmission, the procedure set out in paragraphs 2 and 3 shall apply.
p.000002: (5) The OVSZ shall provide a 24-hour reception for emergency data.
p.000002: 16 / I. § * (1) The OVSZ shall forward the information specified in Section 9 / a before the organ exchange takes place. Organ and donor data in accordance with Annex III
p.000002: workers to the competent authorities or authorized bodies in the Member State of destination.
p.000002: 2. If the transmission pursuant to paragraph 1 did not provide all the information required by Article 9 / a. to be provided in accordance with Annex
p.000002: data, the OVSZ shall ensure that the necessary data is transmitted as soon as it becomes available.
p.000002: (3) A 9 / a. of Annex 16 / B. (1) and (2) shall be determined and sent to the OVSZ
p.000002: data transfer.
p.000002: Organ traceability data *
p.000002: 16 / J. § * (1) OVSZ to ensure traceability of organs - Section 9 / a. In addition to the information contained in Annex I -
p.000002: In the case of a body originating in Hungary, forwarded by the competent authorities of the Member State of destination or its authorized organizations
p.000002: and the national donor identification number.
p.000002: 2. The data referred to in paragraph 1 relating to the definition of the organ shall be the anatomical description (organ name) of the organ,
p.000002: position, lateral position, and the whole organ, a part of it, and which lobes and segments of the organ
p.000002: it is.
p.000002: 3. In the case of a body arriving in Hungary, the OVSZ shall forward it to the competent authorities of the Member State of origin or to an authorized person
p.000002: your organization:
p.000002: (a) the national recipient identification number or, in the absence of an implant, the purpose of the organ,
p.000002: (b) the date of transposition,
p.000002: (c) the name and contact details of the transplantation center.
p.000002: 16 / Tues § * (1) If OVSZ becomes aware of a serious adverse event or complication that may be due to another
...
p.000002: zip code: ............ place name: .................................. .................................................. .....
p.000002: Street Address: .............................................. .................................................. ........................
p.000002: notification address: ............................................... .................................................. ......................
p.000002: postal code: ............ place name: .................................. .................................................. .....
p.000002: Street Address: .............................................. .................................................. ........................
p.000002: I consent to my full-proof private or public statement of opposition to the National Organ and Tissue Donation
p.000002: For the purposes of registering your objections and managing my personal information, I undertake to comply with any
p.000002: I will report any changes to my records to the National Organ and Tissue Donation Protests Registry within 30 days.
p.000002: Date of declaration: ............................................... ..........
p.000002: .................................................. .. ................................................. ....
p.000002: signatory's signature signatory's signature *
p.000002: The validity of the protest statement is not a prerequisite for the protest declaration in the National Organ and Tissue Donation Registry
p.000002: recording. If you keep the protest statement only to yourself, your protest statement may be lost or destroyed.
p.000002: etc However, if the protest is recorded by the National Organ and Tissue Donation Registry, you will be
p.000002: In the event of a medical emergency, the health personnel will be aware of the protest. A confirmation will inform you of the registration, therefore
p.000002: we recommend that you keep a copy of the statement of objection pending receipt of this notification. As part of the records, your information is
p.000002: is handled in compliance with data protection laws. The National Register of Organ and Tissue Disputes provides an additional guarantee that
p.000002: even in the event of deceased, have organs and tissues. Withdrawal of the protest in person or through your GP
p.000002: It is held at the National Register of Organ and Tissue Disputes. You can initiate the withdrawal at any time if you believe
p.000002: to offer organs, tissues for transplantation.
p.000002: b) * Withdrawal of the Statement of Objections (concerning organ and tissue transplantation) *
p.000002: declarant
p.000002: last name: * ............................................... .................................................. ........................
p.000002: first name: * ............................................... .................................................. ...............................
p.000002: TAJ: ................................................. .................................................. ..........................
p.000002: date of birth: ............................................... .................................................. ...................
p.000002: Place of birth: ............................................... .................................................. .....................
p.000002: mother's maiden name: .............................................. .................................................. .
p.000002: mother's maiden name: .............................................. .................................................. ........
...
p.000004: 3. Email address
p.000004: 4. Name of the responsible person
p.000004: 5. Phone number
p.000004: 6. Email address
p.000004: 7. Website address of the importing tissue bank
p.000004: C. Tissues and cells to be imported
p.000004: 1. List of types of tissues and cells to be imported, including single import of any type of tissues and cells.
p.000004: 2. Product names of all types of tissues and cells to be imported (where applicable in accordance with the EU Common List).
p.000004: 3. Trade names of all types of tissues and cells to be imported (if not the product name).
p.000004: 4. The name of the third country healthcare provider for all types of tissues and cells to be imported.
p.000004: D. Location of activities
p.000004: 1. List of activities for the purpose of donation, collection, testing, processing, preservation or storage
p.000004: prior to import by a third country healthcare provider, broken down by type of tissue or cell.
p.000004: 2. List of activities for the purpose of donation, collection, testing, processing, preservation or storage
p.000004: prior to importation by a third country healthcare provider by subcontractor, by type of tissue or cell
p.000004: breakdown.
p.000004: 3. List of activities carried out by the tissue bank after importation, broken down by type of tissue or cell.
p.000004: 4. The name of the third countries in which the activities take place prior to import, broken down by type of tissue or cell.
p.000004: E. Information concerning the third country healthcare provider
p.000004: 1. Name (company name) of the third country service partner (s)
p.000004: 2. Name of the contact person
p.000004: 3. Visiting address
p.000004: 4. Postal address (if different)
p.000004: 5. Telephone number including the international country code
p.000004: 6. Emergency telephone number (if different)
p.000004: 7. Email
p.000004: F. Documentation to accompany the application
p.000004: 1. Copy of the written contract with the third country healthcare provider.
p.000004: 2. Detailed description of the path of the imported tissues and cells from collection to arrival at the importing tissue bank.
p.000004: 3. Copy of the export license of the third country healthcare provider or, if no such specific certificate has been issued
p.000004: certified by the competent authority (ies) of the third country concerned,
p.000004: and of its cellular activities, including export activities.
p.000004: That documentation shall also include contact details of the competent authority or authorities of the third country. In countries where it is not
p.000004: If such documentation is available, other documentation, such as audit reports from a third country healthcare provider, must be provided.
p.000004: Annex No. 18 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000004: Imported by a tissue bank intending to import tissues and cells from third countries is national
p.000004: Requirements for documentation to be provided to the Chief Medical Officer to accompany the application
p.000004: A. Documentation relating to the importing tissue bank
p.000004: 1. The job description of the responsible person and the relevant qualifications and training information as defined in this Regulation.
p.000004: 2. Copy of the label on the primary packaging and the label used on the repackaging, as well as a document on the outer packaging
p.000004: and from the container.
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000002: mixing in a single container;
p.000002: 32. * single European code: the unique identifier for tissues and cells distributed in the European Union, containing
p.000002: the donation identification string and the product identification string as set out in Annex 15;
p.000002: 33. * EUTC: The product code system developed by the European Union for tissues and cells and found in the European Union.
p.000002: records all types of tissues and cells and the corresponding product codes;
p.000002: 34. * placed on the market: cellular and tissue products distributed or transmitted for human use whether or not they are returned
p.000002: to the original tissue bank;
p.000002: 35. * Expiry date: The date until which the tissues and cells can be used;
p.000002: 36. * Tissue Bank Union Code: The unique identifier of the Tissue Bank, which is the ISO country code and the Tissue Bank is the T
p.000002: consists of a specific number in its collection;
p.000002: 37. * EU Collection of Tissue and Cellular Products: Tissue and Cell Types circulating in the European Union and permitted coding
p.000002: a collection of product codes corresponding to the systems (EUTC, ISBT128 and Eurocode);
p.000002: 38. * Union collection of tissue banks: all accredited, designated, authorized or authorized by the competent authority of Member States
p.000002: a collection of tissue banks containing information in accordance with Annex 15;
p.000002: 39. * product identifier string: the second part of the uniform European code comprising the product code, the number of sublots and the expiry date;
p.000002: 40. * Product code: identifier that identifies the specific type of tissue and cell that identifies the coding system used by the tissue bank.
p.000002: product code system identifier ("E" for EUTC, "A" for ISBT128, "B" for Eurocode) and the relevant coding system or tissue and
p.000002: The EU collection of cellular products shall consist of the number of tissues and cells of the product type.
p.000002: 1 / B. § * As the competent authority in relation to organ transplantation in this Regulation and in organ transplantation as a health service
p.000002: the National Chief Medical Officer, the OVSZ and the Minister for Health (hereinafter:
p.000002: Minister).
p.000002: 1 / C. § * When donating, collecting, testing, processing, storing and distributing human tissues, cells - if personal data
p.000002: protection legislation - make sure that the donor and recipient as well as their families are not
p.000002: each other's person.
p.000002: Organ, tissue removal from a living person
p.000002: Section 2 (1) Organ transplantation and tissue transplantation shall be governed by the provisions of Art. In the case defined in Article 206 (3), he is employed by that health care provider
p.000002: hospital ethics committee (hereinafter: ethics committee) where organ, tissue transplantation is performed.
p.000002: (2) Tissue transplantation shall be subject to In the case specified in Section 206 (5), the Ethics Committee of that healthcare provider
p.000002: where the tissue removal is performed.
p.000002: 3. The Ethics Committee shall not be a member of the Ethics Committee for the consideration of the matter set out in paragraphs 1 to 2,
p.000002: (a) involved in the removal or implantation of organs, tissue,
p.000002: (b) who carries out the treatment of the recipient,
p.000002: (c) over which the doctor, directly or indirectly, directly involved in the removal or implantation of the organ, tissue
p.000002: exercise.
...
p.000002: 2. If the transmission pursuant to paragraph 1 did not provide all the information required by Article 9 / a. to be provided in accordance with Annex
p.000002: data, the OVSZ shall ensure that the necessary data is transmitted as soon as it becomes available.
p.000002: (3) A 9 / a. of Annex 16 / B. (1) and (2) shall be determined and sent to the OVSZ
p.000002: data transfer.
p.000002: Organ traceability data *
p.000002: 16 / J. § * (1) OVSZ to ensure traceability of organs - Section 9 / a. In addition to the information contained in Annex I -
p.000002: In the case of a body originating in Hungary, forwarded by the competent authorities of the Member State of destination or its authorized organizations
p.000002: and the national donor identification number.
p.000002: 2. The data referred to in paragraph 1 relating to the definition of the organ shall be the anatomical description (organ name) of the organ,
p.000002: position, lateral position, and the whole organ, a part of it, and which lobes and segments of the organ
p.000002: it is.
p.000002: 3. In the case of a body arriving in Hungary, the OVSZ shall forward it to the competent authorities of the Member State of origin or to an authorized person
p.000002: your organization:
p.000002: (a) the national recipient identification number or, in the absence of an implant, the purpose of the organ,
p.000002: (b) the date of transposition,
p.000002: (c) the name and contact details of the transplantation center.
p.000002: 16 / Tues § * (1) If OVSZ becomes aware of a serious adverse event or complication that may be due to another
p.000002: It relates to a body received from a Member State which is party to a regional agreement, - Article 17 / C. § - without delay
p.000002: inform the competent authority or the authorized organization of the Member State of origin and of Annex 13 (A)
p.000002: send to them a preliminary report containing the information available.
p.000002: (2) If the OVSZ is informed of a serious adverse event or complication that may be related to a donor whose
p.000002: organs of the European Economic Area have been sent to another Member State party to the Agreement on the European Economic Area;
p.000002: The competent authority of the Member State of destination or its authorized organization shall provide a prior report containing the information referred to in paragraph
p.000002: for.
p.000002: 3. Where, following the submission of a prior report pursuant to paragraphs 1 and 2, a serious adverse event and
p.000002: Any additional information relating to this matter shall be communicated to the OVSZ without delay and forwarded to the bodies referred to in paragraphs 1 and 2.
p.000002: 4. Where a serious adverse event or complication is suspected to be related to a donor whose organs are other than those of the European Economic Area,
p.000002: Has also been sent to a Member State which is a party to a regional agreement, the OVSZ being the competent authority of the Member State of origin in accordance with paragraph 2.
p.000002: shall forward the competent authorities of all Member States of destination within three months of the forwarding of the prior report referred to in paragraph 1, or
p.000002: to its authorized organization, as specified in Annex 13 (B). For final report, destination
p.000002: the information sent by the competent authority or its authorized body in the Member States shall be used.
p.000002: 16 / L. § * In order to ensure interconnection between Member States that are parties to the Agreement on the European Economic Area, OVSZ shall send the
p.000002: Contact details of the European Commission (organization name, telephone number, e-mail address, fax number, postal address). If the data changes, please
p.000002: inform the European Commission.
p.000002: Histopathological examination
p.000002: § 17 Organ from living body - Histopathologic examination is not required for tissue removal in the following organs
p.000002: [EUT. Section 204 (2) (c)]:
p.000002: the tooth,
p.000002: (b) vitreous,
p.000002: (c) nails,
p.000002: (d) in the case of physiological birth, the placenta.
p.000002: Person in charge *
p.000002: 17 / A. § * (1) Within the tissue bank, the head of the tissue bank and the person responsible for the protection, registration and preservation of tissues
p.000002: a designated person (hereinafter referred to as "responsible person") shall be responsible.
p.000002: 2. The responsible person shall meet at least the following qualification criteria:
p.000002: (a) advanced vocational education or training in the field of medicine or biological sciences; and
p.000002: (b) at least two years' professional experience in the field referred to in point (a).
p.000002: (3) Responsible person
p.000002: (a) enforce the legal requirements for the collection, storage, processing and distribution of human tissues for human use;
p.000002: regulations and institutional rules;
p.000002: (b) regularly inform the tissue bank manager of the activities of the tissue bank;
p.000002: (c) initiates, in the event of malfunctioning, the restoration of legitimate or professional operations by the head of the tissue bank
...
p.000002: with institutional responsibilities.
p.000002: Reporting of serious adverse events and events *
p.000002: 17 / B. § * (1) * The health care provider shall promptly notify the National Chief Medical Officer for examination, processing,
p.000002: all relevant information relating to the storage and distribution of data and any serious adverse event, including that which:
p.000002: can affect the quality and safety of tissues for human use. The National Chief Medical Officer shall notify them in Section 14
p.000002: specific healthcare providers and the Minister.
p.000002: (2) * The health care provider referred to in Section 14 shall promptly notify the National Chief Medical Officer of any serious complication
p.000002: which have been detected during or after the implantation or removal of tissue and which are of inadequate quality for human tissue
p.000002: can be traced back.
p.000002: (3) * Upon notification pursuant to paragraphs 1 and 2, the National Chief Medical Officer shall immediately take the necessary measures, including
p.000002: - if the consequences of a serious adverse event or serious incident could affect another Member State, the European Commission or the European Commission
p.000002: The competent authorities of the Member States of the Economic Area likely to be affected by a serious adverse event or serious complication shall:
p.000002: notification.
p.000002: 3a. * Except as provided in paragraph 3, the National Chief Medical Officer shall commence an investigation and take the necessary measures if
p.000002: Upon reasoned request by a competent authority of a Member State of the European Economic Area.
p.000002: (4) Notifications under paragraphs (1) and (2) shall be made on the form set out in Annex 10.
p.000002: (5) * By 30 June of the year following the reference year, the National Chief Medical Officer shall submit to the Commission of the European Union an annual report in accordance with Annex 11.
p.000002: forms. Healthcare providers under Section 14 shall provide information on the data required for the annual report in Annex 11 a
p.000002: by 30 April of the year following the reference year, inform the National Chief Medical Officer.
p.000002: 17 / C. § * (1) * Serious adverse event or serious complication to an organ known to the health care provider
p.000002: immediately inform OVSZ, which, with immediate notification to the Minister and the transplant centers,
p.000002: notifies the National Chief Medical Officer of the notification and investigation of the case. The OVSZ shall take the necessary measures without delay, including:
p.000002: if the consequences of a serious adverse event or serious incident could affect another Member State, the European Commission or the European Commission
p.000002: The competent authorities of the Member States of the Economic Area likely to be affected by a serious adverse event or serious complication shall:
p.000002: notification.
p.000002: 2. The formal requirements for the timely notification and treatment of serious adverse events and reactions in the organ shall be
p.000002: OVSZ issues an Operational Order which is published on its website.
p.000002: 17 / D. § * The National Chief Medical Officer, indicating the number and nature of serious adverse events and events
p.000002: keep a record.
p.000002: 17 / E. § * Compliance with the provisions of this Regulation shall also be examined in the course of professional supervision.
p.000002: 17 / F. § * The competent authorities shall be the Member States party to the Agreement on the European Economic Area or the European Commission
p.000002: they shall, on request, provide information on the results of the inspections and controls carried out in relation to the requirements of this Regulation.
p.000002: 17 / G. § * The National Chief Medical Officer shall carry out regular inspections of tissue processing and storage facilities and may inspect
p.000002: procedures and activities relating to the requirements of this Regulation and may be subject to inspection in the framework of this Regulation
p.000002: requirements.
p.000002: Single European Code *
p.000002: 17 / Mon. § * (1) The single European code shall apply to all tissues and cells distributed for human use. The tissues
p.000002: and, in the case of the placing on the market of cells and cells for other purposes, at least the accompanying documentation shall contain the donation identification character.
p.000002: 2. Paragraph 1 shall not apply
p.000002: (a) the donation of reproductive cells between partners,
p.000002: (b) tissues and cells delivered directly to the recipient for immediate transplantation;
p.000002: (c) in urgent cases, with the express authorization of the competent authority, for tissues and cells introduced into the European Union.
p.000002: 3. The following shall be exempted from the requirements of paragraph 1:
p.000002: (a) tissues and cells other than gametes intended for donation between partners, provided that they remain with the same healthcare provider,
p.000002: (b) tissues and cells imported into the European Union, provided that they remain with the same healthcare provider from import to use;
p.000002: provided that the healthcare provider is accredited, designated, authorized or licensed for import activities
p.000002: tissue bank.
p.000002: 4. For the purposes of paragraph 3, the same healthcare provider shall be considered to be a healthcare provider where the collection of human
p.000002: all steps in the process leading up to the use under the responsibility of the same person, same quality assurance and
p.000002: traceability system and where at least one authorized tissue processing and storage unit is located in the same location,
p.000002: and an organization responsible for human use.
p.000002: 5. The specifications for the structure of the uniform European code referred to in paragraph 1 are set out in Annex 15.
p.000002: (6) The Common European Code should be legible and preceded by the abbreviation "SEC". The single European code
p.000002: use of another label or traceability system is permitted.
p.000002: (7) The European Uniform Code should be indicated either by the donation identifier and the product identifier or by a single identifier.
p.000002: spaces, or two consecutive rows.
...
p.000002: (4) A substantial change is the change in the type of tissues and cells to be imported, the quality and quality of the tissues and cells to be imported.
p.000002: a change in the safety of a third country activity or a third country healthcare provider.
p.000002: 5. Single tissues or cells originating from a third country healthcare provider shall not be considered as a substantial change
p.000002: Imports not covered by an existing official certificate of the importing tissue bank but subject to an official certificate
p.000002: for imports of tissues or cells of the same type from another healthcare provider in the same third country.
p.000002: 17 / Fri. § * (1) In the case of an import tissue bank, the National Chief Medical Officer 17 / G. The interval between inspections pursuant to Article 2 shall not exceed two years.
p.000002: (2) * At the reasoned request of another Member State or the European Commission, the National Chief Medical Officer shall provide information to the importing tissue banks.
p.000002: the results of inspections and controls in relation to.
p.000002: (3) * At the reasoned request of the Member State of distribution of the imported tissues and cells, the Chief Medical Officer shall examine whether
p.000002: control of the activity of the importing tissue bank and of the healthcare provider in the third country.
p.000002: 4. If an on-the-spot inspection is carried out pursuant to a request under paragraph 3, the national officer in charge shall be competent for the requesting Member State.
p.000002: the competent authority of the requesting Member State referred to in paragraph 3, in agreement with its competent authority. The
p.000002: in the event of refusal of inspection, the national officer in charge shall give reasons for his decision in the requesting Member State referred to in paragraph 3.
p.000002: direction.
p.000002: 17 / Q. § * The documentation according to Annex 17 F and Annex 19 need not be attached for single import.
p.000002: One-time import must ensure that the imported tissues and cells are tracked from donor to recipient and from recipient to donor
p.000002: and that the imported tissues and cells are used only at the intended recipient.
p.000002: 17 / R. § * (1) The importing tissue bank shall promptly notify the National Chief Medical Officer of any suspected or
p.000002: an event or complication of which you are aware of a third country health care provider that may affect
p.000002: quality and safety of imported tissues and cells. The notification shall contain the information specified in Annex 10.
p.000002: 2. In addition to paragraph 1, the importing tissue bank shall promptly notify the National Chief Medical Officer if it becomes aware that:
p.000002: a healthcare provider in a third country
p.000002: (a) the authorization to export the tissues and cells has been withdrawn or suspended; or
p.000002: (b) the competent authority of the Member State of establishment has taken a decision which is essential for the quality and safety of the tissues and cells imported.
p.000002: 17 / S. § * (1) In the case of the donation, procurement, testing, processing, preservation of tissues and cells to be imported into the European Union,
p.000002: any storage and distribution activities are carried out outside the European Union by the importing tissue bank
p.000002: have a written agreement with the health care provider in the third country.
p.000002: 2. A written agreement between the importing tissue bank and the healthcare provider in the third country shall specify what is to be fulfilled
p.000002: quality and safety requirements to ensure that the tissues and cells to be imported comply with this Regulation
p.000002: quality and safety standards equivalent to those laid down. The written agreement shall include at least clause 20
p.000002: The information listed in Annex II.
p.000002: 17 / T. § * (1) The importing tissue bank shall keep a record of its activities, including in the case of a single import, the
p.000002: type, amount, origin and destination of tissues and cells.
p.000002: (2) The data referred to in paragraph (1) shall also be included in the annual report in accordance with Annex 12.
p.000002: (3) A 17 / O. Section 15 / D. Shall also be indicated in the register.
p.000002: Transitional and final provisions
p.000002: Article 18 (1) This Decree, with the exception of paragraph (2), shall enter into force on 1 January 1999 and shall at the same time repeal
p.000002: Act II of 1972 18/1972 on the implementation of the provisions of Act IV of 1975 on the removal and transplantation of organs and tissues (XI. 4.) EüM,
p.000002: 3/1988, as amended. (II. 17.) SZEM decree.
...
p.000004: * Number of tissues stored on January 1 and December 31 of the previous year and collected, processed, destroyed, distributed in the previous year
p.000004: (unit) should be displayed sequentially by number.
p.000004: ** Number of donations and number of ova donated in the previous year.
p.000004: 5. Import and export from abroad ***
p.000004: 5.1. Number (units) of tissue from the eye (cornea)
p.000004: 5.2. Skin (epithelial cell) (number of units)
p.000004: 5.3. Number of heart valves (units)
p.000004: 5.4. Number of blood vessels (units)
p.000004: 5.5. Number of connective and support fabrics
p.000004: 5.5.1. Total or partial bone number (units)
p.000004: 5.5.2. Number of tendons / ligaments (units)
p.000004: 5.5.3. Number of cartilage (units)
p.000004: 5.5.4. Number of bone fillers (units)
p.000004: 5.5.5. Number of other connective and support tissues (units) (for example, intervertebral disc, auditory bone, etc.)
p.000004: 5.6. Amniotic membrane number (units)
p.000004: 5.7. Ovarian and testicular tissue (units)
p.000004: 5.8. Number of other tissues (adipose tissue, peritoneum, etc.)
p.000004: 5.9. Bone marrow (number of pouches)
p.000004: 5:10. Peripheral blood (number of pouches)
p.000004: *** The place of origin and the place of destination shall be recorded for a given cell or tissue.
p.000004: In the case of tissues and cells, the above data shall be collected, examined, preserved, processed, stored and distributed or otherwise
p.000004: use.
p.000004: Annex No. 13 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000004: (A) Preliminary report of suspected serious adverse events or reactions
p.000004: 1. Designation of the notifying Member State
p.000004: 2. Report reference number: country (ISO code) / national number
p.000004: 3. Contact details of the notifying competent authority: telephone number, e-mail address and fax number
p.000004: 4. Contact transplant center contact information: telephone number, e-mail address, and fax number
p.000004: 5. Date and time of filing (year / month / day / hour / minute)
p.000004: 6. Member State of origin
p.000004: 7. National donor identification number
p.000004: 8. Designation of Member State (s) of destination (if known)
p.000004: 9. National Recipient Identification Number (s)
p.000004: 10. Date and time of commencement of serious adverse event or event (year / month / day / hour / minute)
p.000004: 11. Date and time of detection of major adverse event or event (year / month / day / hour / minute)
p.000004: 12. Description of the serious adverse event or event
p.000004: 13. Immediate measures taken / proposed
p.000004: B) Final Report on Serious Adverse Events or Complications
p.000004: 1. Designation of the notifying Member State
p.000004: 2. Report reference number: country (ISO code) / national number
p.000004: 3. Contact details of the notifying authority: telephone number, e-mail address and fax number
p.000004: 4. Date and time of notification (year / month / day / hour / minute)
p.000004: 5. Identification number (s) of preliminary report (s)
p.000004: 6. Description of the case
p.000004: 7. Member States concerned
p.000004: 8. Result of the investigation and final conclusion
p.000004: 9. Preventive and remedial measures taken
p.000004: 10. Conclusion / Follow-up (if necessary)
p.000004: Annex No 14 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: Minimum data to be retained
p.000004: A. FOR FABRIC BANKS
p.000004: (1) Identity of the donor (given name, surname, date of birth, if the donation involves a mother and child, both the mother's name and
p.000004: date of birth and date of birth of the child and, if known, name, nationality, ID number)
p.000004: 2. Identification of the donation, which shall include at least the following information:
p.000004: - Identification (name, address) or tissue bank (name, address) of the collection healthcare provider
p.000004: - Unique donation number
p.000004: - Date of collection
p.000004: - The place of collection
p.000004: - Type of donation (eg tissue of one or more cell types, autologous or allogeneic, living or deceased donor)
p.000004: 3. The product identifier, which shall include at least the following information:
p.000004: - Identification of the tissue bank (name, address)
p.000004: - Tissue / cell / product type (basic nomenclature)
p.000004: - Number of item groups (in case of merger)
p.000004: - Number of sublots
p.000004: - Expiration date (year / month / day)
p.000004: Tissue / cell status (ie quarantined, usable, etc.)
p.000004: - Description and origin of the products, the processing steps used, the contact with and the quality of the tissues and cells, and
...
p.000004: (5) Identity of the recipient
p.000004: (6) Date of use
p.000004: (7) Single European code
p.000004: Annex No 15 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: STRUCTURE OF THE SINGLE EUROPEAN CODE
p.000004: GIVING IDENTIFICATION CHARACTER PRODUCT IDENTIFICATION CHARACTERISTICS
p.000004: FEDERAL BANK CODE SPECIFIC DONATION PRODUCT CODE TERMS EXPIRY DATE
p.000004: NUMBER * NUMBER (year / month / day)
p.000004: ISO country code The tissue bank Product code Product number
p.000004: number system
p.000004: identification
p.000004: 2 alphabetic 6 alpha-13 alpha-1 alpha-bet 7 alpha-3 alpha-8 numeric characters
p.000004: Character Numeric Numeric Character Numeric Character Numeric
p.000004: character character
p.000004: * If the tissue bank is not compatible with the Uniform European Code, Section 1 / A shall apply. § 37, is unique
p.000004: To assign a donation number, the tissue bank assigns a unique donation number, which is the date of collection of the tissue and cell (year / month / day -
p.000004: eight numeric characters), plus the donor's serial number, followed by zeros up to 13 characters.
p.000004: Annex 16 to the Act No 18/1998. (XII. 27.) EüM Decree *
p.000004: DATA TO BE RECORDED IN THE UNION COLLECTION OF BANKING BANKS
p.000004: A. Tissue Bank Information
p.000004: 1. Name of the tissue bank
p.000004: 2. The national or EU code of the tissue bank
p.000004: 3. Name of the organization within which the tissue bank is located
p.000004: 4. Address of the tissue bank
p.000004: 5. Available contact information: working email address, telephone and fax number
p.000004: B. Tissue Bank Authorization Information
p.000004: 1. Competent Authorizing Authority (s)
p.000004: 2. Name of the competent authority (ies) responsible for the management of the Union collection of tissue banks
p.000004: 3. Name of the authorization holder
p.000004: 4. The tissues and cells to which the authorization applies
p.000004: 5. Actual activities to which the permit relates
p.000004: 6. Authorization status (authorized, suspended, partially or totally withdrawn, voluntary cessation of activities)
p.000004: 7. Information on additional license conditions and exemptions.
p.000004: Annex No 17 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: The content of the application to be submitted by a tissue bank seeking authorization for import activities
p.000004: requirements
p.000004: When applying for import licenses for import activities, the applicant shall provide the importing tissue bank with the most up-to-date information.
p.000004: information or documentation for Section F, unless you are a tissue bank or an import tissue bank
p.000004: has already submitted, as part of its previous application for authorization:
p.000004: A. General Information on the Importing Tissue Establishment (ITE)
p.000004: 1. Name of the tissue bank
p.000004: 2. Address of the seat of the tissue bank
p.000004: 3. Address of the tissue bank (if different)
p.000004: 4. Name of the department
p.000004: 5. Address of the department's headquarters
p.000004: 6. Departmental postal address (if different)
p.000004: 7. Tissue Bank Applicant Status: It must be stated that the first application for a Tissue Bank operating license or, where applicable,
p.000004: This is a request for amendment. If the applicant is already an authorized tissue establishment (TE), the tissue banks must be provided
p.000004: Union collection code.
p.000004: 8. Name of place of importation (if not the name of the tissue bank or the applicant unit)
...
p.000004: 4. The name of the third country healthcare provider for all types of tissues and cells to be imported.
p.000004: D. Location of activities
p.000004: 1. List of activities for the purpose of donation, collection, testing, processing, preservation or storage
p.000004: prior to import by a third country healthcare provider, broken down by type of tissue or cell.
p.000004: 2. List of activities for the purpose of donation, collection, testing, processing, preservation or storage
p.000004: prior to importation by a third country healthcare provider by subcontractor, by type of tissue or cell
p.000004: breakdown.
p.000004: 3. List of activities carried out by the tissue bank after importation, broken down by type of tissue or cell.
p.000004: 4. The name of the third countries in which the activities take place prior to import, broken down by type of tissue or cell.
p.000004: E. Information concerning the third country healthcare provider
p.000004: 1. Name (company name) of the third country service partner (s)
p.000004: 2. Name of the contact person
p.000004: 3. Visiting address
p.000004: 4. Postal address (if different)
p.000004: 5. Telephone number including the international country code
p.000004: 6. Emergency telephone number (if different)
p.000004: 7. Email
p.000004: F. Documentation to accompany the application
p.000004: 1. Copy of the written contract with the third country healthcare provider.
p.000004: 2. Detailed description of the path of the imported tissues and cells from collection to arrival at the importing tissue bank.
p.000004: 3. Copy of the export license of the third country healthcare provider or, if no such specific certificate has been issued
p.000004: certified by the competent authority (ies) of the third country concerned,
p.000004: and of its cellular activities, including export activities.
p.000004: That documentation shall also include contact details of the competent authority or authorities of the third country. In countries where it is not
p.000004: If such documentation is available, other documentation, such as audit reports from a third country healthcare provider, must be provided.
p.000004: Annex No. 18 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000004: Imported by a tissue bank intending to import tissues and cells from third countries is national
p.000004: Requirements for documentation to be provided to the Chief Medical Officer to accompany the application
p.000004: A. Documentation relating to the importing tissue bank
p.000004: 1. The job description of the responsible person and the relevant qualifications and training information as defined in this Regulation.
p.000004: 2. Copy of the label on the primary packaging and the label used on the repackaging, as well as a document on the outer packaging
p.000004: and from the container.
p.000004: 3. In relation to the import activities of a tissue bank, including the application of the Single European Code,
p.000004: receiving and storing cells at the importing tissue bank, treating serious complications and adverse events, recalling
p.000004: management and donor-to-recipient traceability - relevant operational standards procedures relevant, up-to-date
p.000004: list of variations.
p.000004: B. Documentation relating to the third country healthcare provider
p.000004: 1. Detailed information on the criteria used to identify and evaluate the donor, information on the donor and his / her family
p.000004: how they obtained the donor's or their family's consent, and whether the donation was voluntary and unpaid.
p.000004: 2. Detailed information on the test center or centers used by the third country healthcare provider
p.000004: .
p.000004: 3. Detailed information on the techniques used in tissue and cell processing, including critical processing techniques
p.000004: Validation.
p.000004: 4. Detailed information on the quality control of each activity performed by the third country healthcare provider; and
p.000004: equipment, materials and criteria used for environmental inspections.
p.000004: 5. Detailed information on the conditions under which tissues and cells are made available by a healthcare provider in a third country.
p.000004: 6. Details of all subcontractors used by the third country healthcare provider, including name, address and
p.000004: activity performed.
p.000004: 7. Recent inquiries by the competent authority of the third country concerning the third country healthcare provider
p.000004: summary, including date, type and main conclusions of the study.
p.000004: 8. Recent investigation of a third country healthcare provider by or on behalf of the importing tissue bank
p.000004: Summary.
p.000004: 9. Any relevant national or international accreditation.
p.000004: Annex No 19 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: Details of the official certificate to be issued by the National Chief Medical Officer to the importing tissue bank a
p.000004: for imports of cells and tissues from third countries
p.000004: Official Certificate for the Importing Tissue Bank
p.000004: 1. Data on the Importing Tissue Establishment (ITE)
p.000004: 1.1. The name of the tissue bank
p.000004: 1.2. Code according to the EU Collection of Tissue Banks
p.000004: 1.3. Tissue bank address and postal address (if different)
p.000004: 1.4. Place of importation (if not the above address)
p.000004: 1.5 Tissue bank telephone number (optional)
p.000004: 1.6. Tissue bank email (optional)
p.000004: 1.7. The web address of the tissue bank
p.000004: 2. Scope of the activity
p.000004: 2.1. Type of tissues and cells Activities in third countries Imports
p.000004: (specify the status M given
p.000004: tissue processing and storage F suspended
p.000004: units EU V withdrawn
p.000004: collection
p.000004: listed Tissue and Ado- Collection Test-Up-Storage
p.000004: cell categories mammal guarding work
p.000004: using the need
p.000004: additional lines
p.000004: addition)
p.000004: - a third country healthcare provider
p.000004: - subcontracting to a third country healthcare provider
p.000004: 2.2. One-off imports
p.000004: 2.3. Product name (s) of imported tissues and cells
p.000004: 2.4. Conditions or explanatory notes on imports
p.000004: 2.5. Designation of third country (ies) of collection (a)
p.000004: for each import of tissues and cells)
p.000004: 2.6. Identification of third country (ies) where other activities are carried out
p.000004: takes place (if different)
p.000004: 2.7. Name and country of the third country healthcare provider
p.000004: (for each import of tissues and cells
p.000004: on)
p.000004: 2.8. Designation of EU Member States which:
p.000004: serve as a destination for imported tissues and cells for distribution
p.000004: (if known)
p.000004: 3. The competent authority (MA) responsible for issuing the official certificate is the national officer in charge
p.000004: 3.1. The tissue bank operating license number
p.000004: 3.2.Legal basis for the authorization
p.000004: 3.3. Expiry of the license
p.000004: 3.4. Tissue Bank Operating License Release Date Date Modified
p.000004: 3.5. Certificate of Authorization Issued to the Importing Tissue Bank Date Issued Date Modified
p.000004: 3.6. Additional notes
p.000004: 3.7. The name of the IH
p.000004: 3.8. Name of the IH official
p.000004: 3.9. Signature of the IH official
p.000004: 3:11. Stamp of the IH
p.000004: Annex No 20 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000004: Written agreement between the importing tissue bank and the healthcare provider in the third country
p.000004: content requirements
p.000004: Except in the case of one-off imports, a written agreement between the importing tissue bank and a health care provider in a third country
p.000004: shall contain at least the following provisions.
p.000004: 1. Detailed information on the importing tissue bank's procedures for quality and safety as defined in this Regulation
p.000004: ensuring compliance, as well as detailed information on the mutually agreed role and responsibilities of the imported
p.000004: ensuring that tissues and cells are of equivalent quality and safety.
p.000004: 2. Provision to ensure that the third country healthcare provider makes available to the importing tissue bank the information referred to in Article 18.
p.000004: The information set out in point B of Annex I to this Regulation.
p.000004: 3. Provision to ensure that the third country healthcare provider informs the importing tissue bank of such tissue bank
p.000004: of suspected or actual serious adverse events or events that could affect the
p.000004: or the quality and safety of the tissues and cells to be imported.
p.000004: 4. Provision to ensure that the third country healthcare provider informs the importing tissue bank about its activities
p.000004: - any substantial change in its authorization, including the partial or complete authorization of its export of tissues and cells
p.000004: withdrawal, suspension or other failure to comply with the third country's competent authority or authorities
p.000004: decisions that may affect the quality and safety of tissues and cells imported or to be imported by the importing tissue bank.
p.000004: 5. Provision guaranteeing the competent authority the right to inspect the third
p.000004: national healthcare provider if you wish to do so as part of an investigation into the importing tissue bank. To the order
p.000004: it should also guarantee the importing tissue bank the right to have its third-country service partner regularly audited.
p.000004: 6. Common for the transport of tissues and cells between a healthcare provider in a third country and an importing tissue bank
p.000004: conditions to be met by agreement.
p.000004: 7. Provision guaranteeing that donor and imported tissue and cell data are
p.000004: is retained by a service provider or subcontractor for a period of 30 years from the date of collection in accordance with EU data protection rules and
p.000004: measures to ensure their retention in the event of the cessation of activities of a third country healthcare provider.
p.000004: 8. Provisions for periodic review and, if necessary, amendment of the written agreement, inter alia: a
p.000004: to reflect changes in the quality and safety standards laid down in this Regulation.
p.000004: 9. Employed by a third country healthcare provider in relation to the quality and safety of imported tissues and cells
p.000004: a list of all standard operating procedures and an undertaking to make them available on request.
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...
Orphaned Trigger Words
p.000002: (c) the organ, tissue removal physician has determined that the organ, tissue to be removed, the examinations carried out and the deceased
p.000002: is available for transplantation from a professional standpoint.
p.000002: Article 7 (1) Until the establishment of brain death, the care of the patient, including resuscitation, shall be carried out with the utmost care and in accordance with professional rules and regulations.
p.000002: should be performed using all available options.
p.000002: (2) The members of the Committee shall complete and sign the minutes set out in Annex 3 when establishing the brain death. The record of the deceased
p.000002: health records.
p.000002: Section 8 (1) The designated health care professional shall verify by examining the medical records and records of the deceased that the patient
p.000002: has made a protest statement in his life. You will make a note of this in your health documentation.
p.000002: (2) * If a statement of opposition is sent to the treating physician within the time available to remove the organ tissue, the attending physician must
p.000002: hand over immediately to a designated health professional.
p.000002: (3) * If no statement of objection has been found in the procedure under paragraphs 1 and 2, the designated health care provider shall
p.000002: operated a query to verify the protest from the National Organ and Tissue Donation Protests Registry (hereafter: NSCR). If
p.000002: the NSZTR does not include the deceased's protest statement - respectfully Section 211 (4) - organ,
p.000002: tissue removal may begin.
p.000002: (4) * Depending on the biological and vegetative status of the prospective donor, the time available under paragraph (2) shall mean the period during which
p.000002: within the recipient, organ or tissue extraction can be performed without increased risk for the recipient. The rules of transplantability of individual organs and tissues a
p.000002: is determined by current professional guidelines.
p.000002: (5) * When contacting the deceased's relatives, the relatives must be informed that no objections have been found to the deceased.
p.000002: no statement or such was made by the NSSR, nor which organ or tissue was removed from the deceased.
p.000002: 8 / A. § * The body of the donor must be restored to the greatest possible degree, taking into account the aspects of grace
p.000002: to the original appearance.
p.000002: Making a Statement of Objection
p.000002: Section 9 * (1) * If a protest is made in accordance with Section 10 para. 211 (1) or with full probative value
p.000002: private letter, the patient
p.000002: (a) in person,
p.000002: (b) * by registered mail, or
p.000002: (c) with the assistance of a general practitioner
p.000002: submit it to the NSSR, together with the declaration pursuant to paragraph (a) of Annex 4 to this Decree (hereinafter referred to as the “declaration of consent”).
p.000002: By completing the consent form, the patient agrees to be registered with the NSSR and to manage their personal data.
p.000002: (2) * The inclusion of a statement of objection in the NSSR is not a condition for the protest to be valid.
p.000002: (3) * In the case referred to in paragraph 1 (c), the general practitioner shall, within 3 working days, issue a statement of opposition and a statement of consent.
p.000002: forwarded to the NSSR by post. This is recorded in the patient's medical records.
p.000002: (4) * The patient may withdraw the protest statement without any formality. However, the withdrawal of the declaration in the NSSR is a withdrawal of the declaration
p.000002: it shall become effective upon deletion from the NSSR.
p.000002: (5) * Deletion from the NSCTR
p.000002: (a) in person at the NSSR,
p.000002: (b) by registered mail addressed to the NSSR, or
p.000002: (c) your GP
p.000002: take the initiative.
p.000002: 6 (6) * In the case referred to in paragraph 5 (a), he shall furnish the patient with an identity card and shall complete form 4.
p.000002: (b) the form provided by the NFSA staff member to the patient.
p.000002: 7 (7) * In the case of paragraph 5 (c), the patient's GP shall complete the form in Annex 4 (b), which shall be completed within 3 working days.
p.000002: to OTNY by registered mail. This is recorded in the patient's medical records.
p.000002: Article 10 (1) * Statement of objection received in the form of registered mail, together with statement of consent, three days after arrival
p.000002: will be recorded in the NSSR within one business day. Entry in the NSSR is effective from the date of registration.
p.000002: 2 (2) * The NSSR shall include the statement of consent and the date of receipt, as well as the provisions of Art. Complete as defined in § 211
p.000002: the preservation of a private authentic instrument or an authentic instrument.
p.000002: (3) * If a protest is withdrawn, the protest shall be immediately withdrawn from the NSSR.
p.000002: (4) * Within 10 working days of receipt, NSZTR shall notify the registration or cancellation of a statement of opposition.
p.000002: patient or, in the case of Section 9 (1) (c) and (7), a general practitioner.
p.000002: 5 (5) * The data of the NSSR are governed by Act XLVII of 1997 on the Treatment and Protection of Health and Related Personal Data. law
p.000002: shall be handled in accordance with the provisions of. Individual patient data is only available to designated healthcare professionals.
p.000002: (6) * Data on the individual patient may be obtained from the NSSR by telephone or fax. Name of the designated health worker,
p.000002: the registration number and the unique identifier of the healthcare provider who is eligible for the NNRTR.
p.000002: (7) * For all queries made by the NSSR, a document shall be produced as to whether a record of the patient's protest can be found
p.000002: statement. The designated health worker designated by the OVSZ (hereinafter referred to as the responsible worker) will inform the designated health worker by telephone of the search.
p.000002: results. The patient's statement of protest or lack thereof shall be sent to the designated health professional by the responsible worker
p.000002: a staff member to be attached to the patient's medical records prior to commencing the planned organ, tissue removal.
p.000002: (8) * The NSAID shall keep records of the date of the request, the information provided and the information specified in paragraph 5.
p.000002: (9) * NFCS reporting is 24 hours.
p.000002: 10 (10) * When inquiring about the protest statement of a Hungarian citizen who has died abroad, the responsible employee shall ascertain that the deceased person is not
p.000002: made a protest. In this case, the quality and safety of the human organs intended for transplantation shall be the sole purpose of the communication
p.000002: Directive 2010/53 / EU of the European Parliament and of the Council laying down standards Chapter 19 of the competent authorities
p.000002: contacts between its members and the OVSZ.
p.000002: Article 11 * (1) * The person and number of the designated health workers shall be determined by the head of the health care provider (hereinafter referred to as the head of the institution)
p.000002: a. The head of the institution shall send the information sheet * (c) of Annex 4 to the NSSR by registered mail. The selection
p.000002: valid until revoked.
p.000002: (2) * The health care provider shall promptly report any change in the content of the information sheet in Annex 4 (c) to the NSCR.
p.000002: s.
p.000002: Health documentation
p.000002: Section 12 (1) The donor's health records shall be attached
p.000002: a. Documents pursuant to Article 209 (2) to (3),
p.000002: b. Article 208,
p.000002: (c) a copy of the minutes of the meeting of the Ethics Committee,
p.000002: (d) in the event of withdrawal of the donor's statement, a written statement by the donor to that effect,
p.000002: made a note,
p.000002: e) * in Annex 9, paragraph 1.2. of the donor documentation.
p.000002: 2. The recipient's medical file must be attached
p.000002: (a) a written declaration of consent by the recipient stating that it must contain the terms of the EWC; 209 (5)
p.000002: with regard to your acceptance or consent,
p.000002: (b) the provisions of paragraph 1 (b) to (c).
p.000002: Institutional conditions
p.000002: Section 13 (1) * In relation to the given organ, Annex 5 for the transplantation of organs and the removal of organs for transplantation from a living person
p.000002: Healthcare providers as defined in point 1 are eligible.
p.000002: (2) * With regard to the organ in question, for removal of an organ from a deceased person for transplantation in Annex 5, paragraph 2
p.000002: defined healthcare providers are eligible. Organ procurement is done at a health care provider that has a general one
p.000002: surgical operating room.
p.000002: (3) * The healthcare providers listed in Annex 5 are considered as transplant centers and must meet
p.000002: the personal and material conditions specified in the Ministerial Decree on the minimum professional conditions required for the provision of services. THE
p.000002: the operating license for the transplantation center shall contain the information set out in Annex 5.
p.000002: (4) * In addition to paragraph 2, they shall be entitled to withdraw the organ from the deceased for the purpose of transplantation.
p.000002: persons who come from a transplant center in another state under a convention or agreement concluded by the blood service who:
p.000002: meet the requirements of Art. Article 110 (2), (4), (10) or (10a). Organ harvesting shall be carried out in accordance with paragraph 2
p.000002: service provider.
p.000002: (5) * The law applicable to transplantation waiting lists shall apply in the case of organ transplantation.
p.000002: Article 14 (1) Implantation of tissue is authorized by the healthcare providers specified in Annex 6 (a).
p.000002: (2) For the purpose of tissue procurement for the purpose of transplantation from a living person, the healthcare providers specified in Annex 6 (b)
p.000002: eligible.
...
p.000002: (6) In FIG. Annex II contains the minimum information which, subject to paragraph 8, shall be minimum
p.000002: in the case of organ donation, must be collected.
p.000002: (7) In FIG. Annex II contains the additional data to be collected in addition to the data under paragraph 6
p.000002: by a group of doctors. When deciding on the team, it will take into account the availability of data and the specific circumstances of the case.
p.000002: 8. By way of derogation from paragraph 6, where the risk-benefit analysis shows that in a given case, including life-threatening situations,
p.000002: the expected benefits to the recipient outweigh the risks due to the lack of data,
p.000002: for the purpose of transposition, even if 9 / a. Not all of the minimum data set out in Annex II are available.
p.000002: 9. The data collected pursuant to paragraphs 1 to 8 shall be notified to the OVSZ.
p.000002: (10) The medical team shall endeavor to obtain all necessary information in order to meet the quality and safety requirements
p.000002: and shall provide them with the information they need to understand the implications of the donation. Deceased
p.000002: in the case of organ donation from a donor, where possible and necessary, the OVSZ and the donor health service provider designated
p.000002: the health care professional shall seek such information from relatives or other persons of the deceased donor, and shall
p.000002: also call on all parties called upon to provide information for the importance of rapidly communicating that information.
p.000002: (11) During organ harvesting, it must be ensured that:
p.000002: (a) be carried out in accordance with professional rules regarding the nature of both the donor and the organs to be removed,
p.000002: (b) do not compromise the quality of organs and minimize the risk of microbial contamination of organs,
p.000002: (c) the hygiene conditions laid down by law are observed in order to minimize the risk of contamination of organs.
p.000002: (12) After organ removal, the organs removed should be packed in such a way as to minimize the risk of contamination,
p.000002: and stored at a temperature that preserves the necessary organ characteristics and biological function. Packaging should be done this way
p.000002: to prevent contamination of organs and transporters.
p.000002: (13) Packaged organs should be transported in containers which preserve the safety and quality of the organs contained therein.
p.000002: (14) All accompanying tissues and blood samples for testing should be accurately labeled to ensure that they are identifiable to the donor and attached
p.000002: a record indicating the time and place of the collection of the sample shall also be provided.
p.000002: (15) The process of organ donation, including rules on the labeling of storage media used for the transportation of organs, is detailed in Section 9 / a. No.
p.000002: Annex.
p.000002: (16) * The competent authorities shall ensure that from donation to transplantation or disposal in accordance with this Regulation
p.000002: adherence to a quality and safety system throughout the chain. To this end, they may draw up a recommendation from the donation
p.000002: healthcare providers involved in all stages of the chain up to transplantation or disposal, which may include:
p.000002: relevant information for the assessment of the quality and safety of the transplanted organs after the transplantation
p.000002: recommendation to collect it. Based on the recommendation, participating health care providers can develop operational procedures.
p.000002: 16 / C. § * (1) The health care provider carrying out or assisting in the transport of organs shall be
p.000002: develops an operational protocol to ensure delivery time.
p.000002: 2. The organs transported shall be accompanied by a report identifying the organ and donor data.
...
p.000002: (b) Commission Directive 2006/17 / EC of 8 February 2006 amending Directive 2004/23 / EC of the European Parliament and of the
p.000002: implementation of certain technical requirements for donation, collection, testing;
p.000002: (c) Commission Directive 2006/86 / EC of 24 October 2006 amending Directive 2004/23 / EC of the European Parliament and of the Council as regards traceability
p.000002: requirements, reporting serious complications and adverse events, and coding, processing of human tissues and cells,
p.000002: implementing certain technical requirements for its conservation, storage and distribution;
p.000002: (d) * Directive 2010/53 / EU of the European Parliament and of the Council of 7 July 2010 on the quality and quality of human organs
p.000002: setting safety standards;
p.000002: e) * of 9 October 2012 laying down the information procedure on the exchange of human organs intended for transplantation between Member States
p.000002: Commission Directive 2012/25 / EU;
p.000002: (f) * with regard to certain technical requirements of Directive 2006/17 / EC relating to the examination of human tissues and cells
p.000002: amending Directive 2012/39 / EU of the European Parliament and of the Council of 26 November 2012;
p.000002: (g) * with regard to certain technical requirements of Directive 2006/86 / EC relating to the coding of human tissues and cells
p.000002: amending Directive 2015/565 / EU of 8 April 2015;
p.000002: (h) * verification of the equivalence of the quality and safety standards for imported tissues and cells under Directive 2004/23 / EC
p.000002: Commission Directive 2015/566 / EU of 8 April 2015 on the implementation of Council Regulation (EC) No 1782/2003 as regards the procedures for the application of Community law
p.000002: Annex No. 1 to Decree No. 18/1998. (XII. 27.) EüM Decree *
p.000002: Request to the hospital ethics committee
p.000002: Name of the institution:
p.000002: First
p.000002: Donor Name: .............................................. .................................................. ............................
p.000002: Place and date of birth: ............................................. .................................................. .................
p.000002: His mother's name: ............................................... .................................................. ..............................
p.000002: Permanent Address: ............................................... .................................................. ......................
p.000002: TAJ: ................................................. .................................................. ..............................
p.000002: Second
p.000002: Name of Recipient: .............................................. .................................................. .......................
p.000002: Place and date of birth: ............................................. .................................................. .................
p.000002: His mother's name: ............................................... .................................................. ..............................
p.000002: Permanent Address: ............................................... .................................................. ......................
p.000002: TAJ: ................................................. .................................................. ..............................
p.000002: We, the undersigned, apply to the Hospital Ethics Committee for consent to the following interventions. *
p.000002: .................................................. .................................................. ................................................
p.000002: .................................................. .................................................. ................................................
p.000002: .................................................. .................................................. ................................................
p.000002: .................................................. .................................................. ................................................
p.000002: .................................................. .................................................. ................................................
p.000002: .................................................. .................................................. ................................................
p.000002: Date: ................................................ ......................................
p.000002: .................................................. ...... ............................................. ............
p.000002: signature of donor (legal representative) signature of recipient (legal representative)
p.000002: .................................................. ......
p.000002: the doctor performing the intervention
p.000002: (Head of the medical team)
p.000002: Annex No 2 to Decree No 18/1998. (XII. 27.) EüM Decree *
p.000002: Determination of brain death
p.000002: Brain death can be caused by primary brain damage (direct damage to the brain) or secondary brain damage (indirect, hypoxic brain damage).
p.000002: Damage).
p.000002: Brain death, which is the complete and irreversible loss of brain function (including the brain stem) - primarily clinical trials
...
p.000002: 2.3. Cornea-re ex mko. miss
p.000002: 2.4. A pain stimulator applied to the trigeminal nerve
p.000002: the reaction is mko. miss
p.000002: 2.5. Vestibulo-ocularis re ex mko. miss
p.000002: 2.6. Cough re ex missing
p.000002: 2.7. There is a lack of spontaneous breathing, paralysis of the respiratory center
p.000002: apnea test
p.000002: 3. Demonstration of irreversibility of complete brain failure:
p.000002: 3.1. Instrumental examinations:
p.000002: The name of the instrumental test is the Outcome of its Date
p.000002: 3.1.1.
p.000002: 3.1.2.
p.000002: 3.1.3.
p.000002: 3.1.4.
p.000002: 3.2. Observation time:
p.000002: Time of interrogation The person (s) conducting the interrogation
p.000002: year month day hour hour minute name
p.000002: 4. Confirmation of Brain Death:
p.000002: Based on the studies documented in this protocol, brain death was clearly established:
p.000002: ............. years .......... snow ....... days ......... hours ..... minutes
p.000002: Doctors who determine brain death:
p.000002: Tester 1: Name (in block letters): ........................................ .............................. medical seal:
p.000002: signature: ................................................ .................................................. ............
p.000002: Examiner 2: Name (in block letters): ........................................ .............................. medical seal:
p.000002: signature: ................................................ .................................................. .............
p.000002: Examiner 3: Name (in block letters): ........................................ .............................. medical seal:
p.000002: signature: ................................................ .................................................. ............
p.000002: Annex 4 to the Act No 18/1998. (XII. 27.) EüM Decree *
p.000002: (a) * Declaration of consent for the processing of personal data and registration in the Federal Republic of Germany
p.000002: , tissue transplantation) *
p.000002: declarant
p.000002: last name: * ............................................... .................................................. ........................
p.000002: first name: * ............................................... .................................................. ...............................
p.000002: TAJ: ................................................. .................................................. ..........................
p.000002: date of birth: ............................................... .................................................. ...................
p.000002: Place of birth: ............................................... .................................................. .....................
p.000002: mother's maiden name: .............................................. .................................................. .
p.000002: mother's maiden name: .............................................. .................................................. ........
p.000002: where you live: * ............................................... .................................................. ............................
p.000002: zip code: ............ place name: .................................. .................................................. .....
p.000002: Street Address: .............................................. .................................................. ........................
p.000002: notification address: ............................................... .................................................. ......................
p.000002: postal code: ............ place name: .................................. .................................................. .....
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| breastfeeding | breastfeeding |
| child | Child |
| children | Child |
| coma | Comatose |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| embryo | embryo |
| emergency | Public Emergency |
| family | Motherhood/Family |
| hazard | Natural Hazards |
| home | Property Ownership |
| impairment | Cognitive Impairment |
| infant | Infant |
| intoxication | Intoxication |
| job | Occupation |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| parents | parents |
| party | political affiliation |
| physically | Physically Disabled |
| property | Property Ownership |
| single | Marital Status |
| stem cells | stem cells |
| threat | Threat of Stigma |
| union | Trade Union Membership |
| usage | Drug Usage |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| drug | ['usage'] |
| education | ['educational'] |
| educational | ['education'] |
| home | ['property'] |
| property | ['home'] |
| usage | ['drug'] |
Trigger Words
consent
developing
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input