Cabinet of Ministers Regulations No. 1176 in 2013 (22 October. No 55 49) of human tissues and cells for application in the order Issued in accordance with the law "on the dead man's body and human tissues and organs for medical use" in the fourth paragraph of article 4.1, the first paragraph of article 12, paragraph 2, and article 14, paragraphs 2 and 3 General questions 1. determines: 1.1. procedures for the treatment and the University, which is implemented by the accredited medical study programme (hereinafter referred to as graduate school) the issue of human tissues and cells of the body (hereinafter referred to as the tissue and cells) the authorisation (hereinafter permit) and a duplicate, as well as revoke the permissions, stop and restore its functioning; 1.2. the requirements for obtaining permission and use of tissues and cells; 1.3. the sample form; 1.4. the use of tissues and cells for evaluation, monitoring and control procedures; 1.5. quality and safety standards for the living donor and the dead human tissue and cells. 2. the terms used in the rules: 2.1.-alotransplantācij person for the removal of cells or tissues and use to another person; 2.2. processing-the transaction associated with the tissue or cell preparation, manipulation, preservation and packaging, intended for use in humans; 2.3. Audi: all constituent parts of the human body formed by cells; 2.4. the tissue establishment, medical institution or body, which is made of certain actions (for example, processing, preservation, storage, distribution) with the tissues or cells. The tissue establishment can also take the tissue and cell procurement and testing; 2.5. autotransplantācij – personal cell or tissue removal and use of the same person; 2.6. donor – living or dead people, who are the source of cells or tissues; 2.7. gametes-tissues and cells intended to be used for medical fertilisation; 2.8. extraction – a process by which tissue or cells are made available; 2.9. procurement organisation – the medical institution or body, not a tissue establishment and where donor tissue and cell procurement carried out by specially trained personnel; 2.10. the use of human tissues or cells, the use of the recipient and extracorporal applications; 2.11. the organisation of use-medical establishment or unit that uses the tissues and cells; 2.12. distribution, transportation and delivery of tissues or cells intended for human applications; 2.13. traceability – tissue and cell identification in any stage, starting with procurement, processing, testing and storage, to distribution to recipient or disposal, able to identify the donor and the tissue establishment or organization receiving, processing or storing tissues and cells, medical institution and a third party, which the tissues and cells shall be transmitted to the recipient, as well as the ability to identify the relevant information (data) related to the products (products) and materials which come into contact with tissues and cells; 2.14. the quarantine – of retrieved tissue or cells, or tissue isolated physically or by other effective means status while awaiting a decision on their acceptance or rejection; 2.15. preservation – the use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological cells or tissues, or physical characteristics; 2.16. the quality system – the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management that includes all activities that directly or indirectly contribute to quality; 2.17. quality management: coordinated activities to manage and control the quality of the tissue Center; 2.18. serious adverse reaction – the donor or the recipient of an unexpected response, including a communicable disease, associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, disability, hospitalization or disease duration; 2.19. serious adverse event: any untoward with tissue and cell procurement, testing, processing, storage and distribution-related case that could lead to the transmission of a communicable disease, to death or endanger life, cause incapacity for work or disability to the patient or which might lead to or extend the duration of hospitalization or illness; 2.20. partner donation-donation of germ cells by the man or woman who has mutual intimate physical relationship; 2.21. the recipient, the recipient of the tissue or cells that are transplanted tissue or cells; 2.22.-written guideline SOPs describing specific process, including the materials and methods used, as well as the expected end product; 2.23. cells, single cells or a collection of cells when not bound by connective tissue; 2.24. explicit – any procedure where cells are donated and used without tissue storage Center; 2.25. a third person-a person who, on the basis of a contract with the Center, any tissue with the use of tissues and cells related activities; 2.26. third country-any country that is not European Union or European economic area Member State; 2.27. storage-product range the appropriate controlled conditions until distribution; 2.28. validation (in the case of equipment or the environment – classification)-the documented evidence, which confirms that a particular process, standard operating procedures, equipment or environment will result in a consistent product that meets specifications and quality requirements. Process validated to ensure the effective operation of the system, based on the intended use of the tissues and cells; 2.29. the donation of tissues and cells – a royalty for the use of people or medical studies. 3. the rules do not apply to: 3.1. blood and blood components (except the hematopoetic cell precursors); 3.2. tissues and cells used in the autotransplantācij in the same surgical procedure; 3.3. human organs or parts of organs if their function is to be used for the same purpose as the entire organ in the human body; 3.4. the animal organs, tissues and cells; 3.5. studies in which the tissues and cells are not designed for use in the human body (for example, in vitro studies, in vivo studies in animal models); 3.6. tissues and cells used for the pathological, cytological and judicial medical examination. 4. allow tissues and cells get, donate, process, store, preserve, and distribute the following objectives: 4.1 medical transplant (including sterile) production and use; 4.2. the transplantation; 4.3. scientific (including clinical) research; 4.4. as raw materials or medicinal products, veterinary medicinal products, including newly introduced therapy medicinal product; 4.5. for the production of medical devices; 4.6. the learning objectives; 4.7. medical and related to assisted reproduction methods. 5. the use of tissues and cells, including donations are made anonymously (except in the case of living people is taken in the tissues and cells intended to be the same person is or the donor's relative), voluntary, informed consent by the donor (proof of receipt). 6. Tissue establishments and the organizations compliance with the requirements contained in these provisions is monitored by the national agency of medicinal products (hereinafter referred to as the Agency). 7. the use of tissues and cells treatments according to medical, epidemiological safety and pharmaceutical regulatory laws and monitors and controls the health inspection. 2. The order in which the tissue Center and its duplicate is authorized, as well as revoke the authorization, suspension and renewed its activity 8. tissue establishments, seeking authorisation submitted to the Agency submissions 8.1:. The application specifies the following information: 8.1.1. the tissue establishment's name, registration number, registered office; 8.1.2. the responsible person name, qualifications, practical experience, and contact information. 8.1.3. information on the contracts concluded with other medical institutions on the tissue or cell procurement, testing, processing, preservation, storage and distribution, as well as the agreements on the basis of which it is planned to export of tissues and cells and imports (for example, between tissue establishments and donor or recipient (if it is related to the germ cells)); 8.2. This provision 8.1. an application referred to in paragraph add: 8.2.1. documents of tissue establishments, including the person in charge responsibilities and obligations; 8.2.2. Description of the quality management system in accordance with Chapter 4 of these rules. The description shall include at least the following documents: 22.214.171.124. standard operating procedures; 126.96.36.199. staff training and manuals; 188.8.131.52. guidelines; 184.108.40.206. reporting forms; 220.127.116.11. donor records; 18.104.22.168. information on the use of tissues and cells for final use; 8.3. provide the Agency with a copy of the contract concluded with the other centres, tissue procurement organisations or third parties for the delivery of basic services. 9. the Agency shall evaluate these rules referred to in point 8 of the application and accompanying documents, find out whether the tissue establishment is registered in the medical register or the institutions and meet the medical institutions and their departments set out minimum requirements, evaluates the compliance of the tissue establishment this provision in Chapter 3 and 4 requirements concerning the use of tissues and cells, and in the month following receipt of the application, shall take a decision on the the authorisation or refusal to issue the permit. The decision on authorisation or refusal to issue the permit Agency shall notify the applicant of the Notification law. 10. If, in considering the provisions referred to in point 8 of the application and accompanying documents, the agency finds that they are incomplete or do not comply with this provision in Chapter 3 and 4 requirements, so within five working days after receipt of the written application requires tissue establishments to clarify information. 11. The tissue establishment within 10 working days of that rule 10 referred to in paragraph shall submit to the Agency in receipt of the documents showing that the deficiencies have been rectified. 12. the Agency shall evaluate these regulations 11. documents listed and assessed the compliance of the tissue establishment this provision in Chapter 3 and 4 requirements concerning the use of tissues and cells. The Agency in the month following the provision referred to in paragraph 11 of document receipt shall take a decision on the authorisation (annex 1) for the issue or refusal to issue a permit. The decision on authorisation or refusal to issue the permit Agency shall notify the applicant of the Notification law. 13. This provision 9, 16 and 20 of the decision referred to in the Agency official has the right to visit the Center, and the tissue the tissue establishment must provide access to the Agency's official decision the necessary documents, premises, equipment, as well as the persons responsible for the tissue establishment's presence during a visit. 14. The decision on the refusal to issue a licence, the Agency shall adopt, if at least one of the following reasons: for 14.1. tissue establishments submitted documents containing false information; 14.2. the tissue establishment does not comply with this provision in Chapter 3 and 4 requirements concerning the use of tissues and cells and could not provide them; 14.3. the Agency had become aware that the medical establishment has not been registered in the register of medical institutions; 14.4. the Agency had become aware that the medical establishment does not meet the medical institutions and their departments regulations set the minimum requirements; 14.5. the tissue establishment has not submitted all this rule 8 the information referred to in paragraph 11 of these provisions within the time limit referred to in paragraph. 15. Permit Agency submits: 15.1. special operating conditions, including the tissue and cell preparation processes which the tissue establishment may carry out in accordance with the provisions of section 3.2 of these requirements; 15.2. information about procurement organisations and third parties concerned, which carries out operations in accordance with the contracts concluded; 15.3. information about the laboratory, carried out on the basis of the agreement, the donor's blood donation samples or laboratory investigations and complying with medical institutions and their departments regulations set minimum requirements. 16. the Agency, in making a decision on the permit and the permit that the tissue establishments shall be entitled to carry out export of tissues and cells to third countries or receive from third countries imports of tissues and cells, take into account information about the tissue establishment but not obtained used tissues and cells that are included in this rule referred to in paragraph 142 of the tissue Center annual report. 17. If permission is damaged, destroyed, lost or stolen, the tissue establishment within three working days to inform the Agency in writing, and submit the application for a duplicate permit. The agency within three working days after receipt of the application, shall take a decision on the issue of a duplicate of the licence and issue a replacement authorization. A decision on the issue of a replacement authorization shall notify the applicant, the Agency notification in accordance with the procedure prescribed by law. 18. the Agency shall suspend the permit of the tissue establishment if the surveillance, it finds that the tissue Center does not provide this provision in Chapter 3 and 4 the said requirements, and shall set the exact deadline for correcting the discrepancy found. 19. in order to restore the suspended permit, the tissue establishment shall submit to the Agency an application for renewal of the authorisation suspended and documents showing that the lack of authorisation suspended, is eliminated. 20. the Agency shall evaluate these rules referred to in point 19 of the application and the accompanying documents, shall assess the compliance of the tissue establishment this provision in Chapter 3 and 4 requirements concerning the use of tissues and cells, and in the month following receipt of the application, shall take a decision on the renewal of the authorisation, if the deficiencies for which authorisation is suspended or eliminated for the withdrawal of the authorisation, if the deficiencies for which authorisation suspended , not resolved. The decision of the Agency shall notify the applicant of the Notification law. 21. the Agency shall revoke the authorisation if there is at least one of the following reasons: 21.1. the tissue establishment has asked to cancel the authorisation; 21.2. the tissue establishment has violated these rules in Chapter 3 and 4 of that quality and safety requirements for the use of tissues and cells; 21.3. the tissue establishments and tissue activities endanger the staff, both the donor and recipient health and safety; 21.4. the tissue establishment does not comply with the authorization referred to in the use of tissues and cells operating conditions; 21.5. the tissue establishment this provision in paragraph 18 does not resolve shortcomings, which permits operation suspended; 21.6. the Agency became known that tissue is suspended from the medical register of the institutions; 21.7. the Agency became aware that the tissue does not meet the medical institutions and their departments regulations set the minimum requirements; 21.8. the tissue establishment shall submit to the Agency the false information. 22. the Agency's decision on the withdrawal of the authorisation shall notify the tissue Center notification in accordance with the procedure prescribed by law. 23. the major changes (such as changing the person in charge) activities given in the tissue establishment must receive a new permit. 24. the Agency shall establish and maintain information on estimated tissue establishments for which an authorisation has been issued, including the provision of the information referred to in paragraph 15, and to register, which is available on the Agency's Web site. 25. the Agency's decisions on the authorization or refusal to issue the permit, as well as the suspension of an authorisation or cancellation of the tissue establishment may be challenged in the Ministry of health of the administrative procedure law. 26. The Ministry of health decision may appeal to the Court of Justice of the administrative procedure law. 27. If the tissue and cell transplant recipients must take immediately, including tissues and cells need to import or export, the tissue establishment shall apply to the Agency. The Agency immediately, but not later than two working days after receipt of the application to decide whether or not to authorise the use of tissues and cells for direct distribution. The decision of the Agency shall notify the tissue Center notification in accordance with the procedure prescribed by law. 3. Requirements to be met by the medical authority to obtain permission, and tissue or cell conditions 3.1. requirements for tissue establishments and Mining Organization for tissue and cell procurement 28. Tissue and cell procurement takes place the tissue establishments or procurement organisations. 29. The tissue establishment and the organisation shall establish and maintain a quality system based on the principles of good practice. 30. personnel directly involved in activities relating to the tissue and cell procurement, processing, preservation, storage and distribution of tissue establishments, is qualified to perform their tasks and have mastered the training program as determined by the area specialized in clinical personnel or tissue Centre, which has permission to perform the procurement of tissues and cells. Staff competency is assessed under this rule 106. 31. The tissue establishment and procurement organisation shall establish written agreements with the staff or clinical staff in charge: 31.1. the donor selection (if they are not the tissue establishment or procurement organisation of salaried workers). The contract specifies the requirements which must be met to ensure compliance with donor selection criteria in accordance with the provisions of annex 2; 31.2. the procurement of tissues or cells (if they are not the tissue establishment or procurement organisation of salaried workers). The contract shall specify the type of tissues and cells and test sample types, as well as information on compliance with SOPs. 32. The tissue establishment shall designate a responsible person who shall comply with the following criteria and have the following qualifications: 32.1. higher education diploma in medical or biological sciences; 32.2. at least two years of practical work experience in tissue and cell acquisition, testing, processing, preservation, storage or distribution. 33. the responsible person shall ensure that tissue establishments in the following requirements: 33.1. any transaction with the tissues and cells shall be in accordance with these terms and other health care regulatory laws; 33.2. the Agency provided that the information referred to in paragraph 8; 33.3. compliance with this provision 3.1., 3.2., 3.3., 3.5., 3.6, 3.7 and 3.9 section, 2, 4 and 7, as well as in chapters 2, 3, and 4. the requirements referred to in the annex. 34. the responsible person shall register and examine any events that happened in the procurement of tissues and cells, cause or may cause damage to the living donor, as well as perform analysis to determine the root cause of unwanted events. 35. the responsible person shall determine the possible critical situations or factors that may influence the quality and safety of tissues and cells or having contact with tissues and cells. 36. the tissue the Center shall inform the Agency of the liable person, specifying its name, address and contact information. If the responsible person permanently or for a period of more than three months, replaced by another person, the tissue establishment shall immediately inform the Agency of this person, specifying its name and contact information, as well as the day when the person takes up. 37. The tissue establishment and the organisation shall establish and approve the action standard operating procedures in order to verify: 37.1. donor identity; 37.2. the consent of the living donor or a deceased donor's permission or prohibition, or the coming of a deceased donor, the ban does not belong being about the use of tissues and cells; 37.3. the donor selection criteria of assessment in accordance with the provisions of this subchapter 3.3; 23.2. the donor assessment of laboratory examination results in accordance with the provisions of annexes 3 and 4. 38. The tissue establishment and the organization developed and approved SopS that describe the tissue and cell procurement, packaging, labelling and traceability of the SOPs of transport (from the production site to the delivery or use of the tissue in the Centre of the Organization) up to the time of their use or to a laboratory examination of samples (when tissues and cells directly use and disseminate, to the time of use medical institution) in accordance with the provisions of subsection 3.5 and 3.4. 39. The procurement of tissues and cells is carried out on the premises, subject to the corresponding standard operating procedures by the tissue establishment and the organisation has developed, getting to tissues and cells, protect its properties of tissues and cells that are required for their clinical use, and at the same time ensure that minimize the risk of contamination of the microbial process, including opportunities to staff to infect the tissues and cells, do not allow a person who is a carrier of infectious diseases , to participate in the procurement of tissues and cells, in particular where tissues and cells of the impossibility to sterilize. 40. The tissue establishment and organization of procurement the procurement of tissues and cells from living donor performed in an environment that supports the donor's health, safety and privacy. 41. If tissues and cells obtained from a deceased donor, access should be limited and should be used a local sterile area with sterile drapes. Personnel performing the procurement of tissues or cells must be dressed according to the type of collection to use appropriate detergents, sterile garments, as well as the need to use sterile gloves, face mask and emergency escape mask. 42. The procurement standard operating procedures comply with the donor and the donated tissues and cells. Tissue Center and the organisation has developed standard operating procedures to protect the security of living donors. 43. This provision in annex 3 and 4 laboratory investigations provided the tissue establishment or procurement organisation shall take the donor medical laboratory that complies with medical institutions and their departments regulations set out the minimum requirements, or other European Union Member State laboratory by the national competent authority assessed as adequate. 44. each tissue establishment and organization of medical devices in accordance with the regulations on the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures should be validated, calibrated and maintained according to the intended purpose of use. 45. the tissue establishments and the facilities of the procurement organisation according to its type and intensity of use maintained, serviced, cleaned, sterilized and disinfected, and these activities are documented. Medical device validation, calibration and technical supervision results shall be documented in accordance with the provisions of Chapter 4. 46. The tissue establishment's SOPs, precise to remove from distribution of tissues and cells donors and of those drinks to the transplant, which could have caused serious unwanted reactions or serious adverse events. 47. The tissue establishment shall develop standard operating procedures, how to deal with the requirements of this regulation are not appropriate for tissues and cells, to prevent other tissues or cells, the processing environment or personnel contamination. 48. The tissue establishment has developed agreements and standard operating procedures that determine the order in which the tissue Center after its dissolution stored tissues and cells to another tissue Centre that has the proper permission of the Agency. 3.2. requirements for tissue establishments standard operating procedures for the preparation of tissues and cells 49. Agency regularly checks all the tissue and cell preparation, handling, storage, and distribution of output related processes and standard operating procedures, as well as the quality management criteria compliance with the requirements of this subchapter. 50. The tissue establishment the tissue and cells received complies with the provisions of section 3.6. 51. If the tissue Center deals with the processing of tissues and cells, the tissue establishment's SOPs meets the following criteria: 51.1. the critical processing standard operating procedures are validated and provide the recipient with a clinically effective tissue or cells. This validation may be based on Tissue Research Centre or to the study published in the scientific literature, data or tissue Center delivered tissue clinical results of the previous evaluation at pāratzītaj processing standard operating procedures; 51.2. the tissue establishment has confirmed that the tissue Center staff can consistently and efficiently perform a validated process; 51.3. the standard operating procedures are documented in accordance with this provision, 111.3 111.1, 111.2..., and section 111.4.; 51.4. tissue establishments shall ensure that all the processes are carried out according to approved SopS the tissue establishment; 51.5. tissues or cells the applicable microbiological inactivation process is appropriately specified, documented, and validated; 51.6. processing the redesigned process before significant changes are validated and documented; 32.1. the processing standard operating procedures are critically evaluated regularly to ensure that they comply with the expected results; 32.2. the disposal of tissues and cells (destruction) of standard operating procedures preclude other donations, product processing environment or personnel contamination. These standard operating procedures comply with the laws and regulations of the medical institution management of historical waste. 52. If the tissue establishment to deal with the storage of tissues and cells and tissue Center output, standard operating procedures meet the following criteria: 52.1. indicates the maximum storage time according to the tissue and cell storage type, taking into account the potential properties of tissues and cells deterioration over a given period; 52.2. the tissue establishment has fixed tissue and cell tracking system, which provides that the tissues and cells can be distributed only subject to the all of these rules, and has developed SOPs that specify the distribution of tissues and cells; 52.3. tissue and cell identification system at all stages of the processing of tissues and cells distributed is not clearly separated from the common (quarantined) and mismatched tissue and cells; 52.4. logging that is fixed before release of tissues and cells was all the relevant requirements. The relevant medical records, processing records and test results according to approved SopS have been verified by the authorized person and the person in charge. If the results of testing using the computerised system, controls the logging for this output reflected a responsible person; 52.5. all tissues and cells stored for use by all new donor selection or testing criterion or any significantly modified processing step that facilitates the implementation of quality and safety, in accordance with the provisions of this subchapter 3.1. the tissue establishment shall take the person in charge of the documented risk assessment approved. 53. If the tissue establishments dealing with tissues and cells, the tissue establishment standard operating procedures meet the following criteria: 53.1. certain critical transport conditions, such as temperature and time limits, in order to maintain the required tissue and cell properties; 53.2. containers (packaging) is safe, the tissues and cells are stored under appropriate conditions, all containers and packages are validated according to their purpose; 53.3. the tissue establishment has entered into a written agreement for the distribution of tissues and cells conditions (to ensure that you maintain the required conditions), if the distribution of tissues and cells is linked to the third party; 53.4. the tissue establishment authorised staff who assess the recall of tissues and cells, as well as the need to initiate and coordinate the activities concerned; 13. the tissue establishment has developed effective revocation of SOPs, which contains a description of the obligations and activities. This includes the communication agency; 53.6. the tissue establishment is performed above certain periods and includes all related traceability of tissues and cells and, where appropriate, disclosure of origin. The target of the investigation is to identify the donor, which could cause the reaction caused by the recipient, and withdraw the available tissues and cells from the donor, as well as from the same donor to inform the recipient of tissues and cells, where they would be at risk; 53.7. tissue establishments shall establish tissue and cell processing request standard operating procedures. Cell and tissue distribution terms for specific patients or medical authorities are documented and are available on request to those parties; 53.8. tissue establishments shall establish a back checked in tissue and cell processing system, including the criteria for their acceptance, if any, as well as documented. 3.3. Tissue and cell donors 54. Evaluating the selection of tissue and cell compatibility of specific donor tissue and cell procurement and use the tissue Center, doctors take into account: 54.1. selection criteria of donors (except donors of gametes) in accordance with the provisions of annex 2; 54.2. laboratory examination of donors (except donors of gametes) evaluation of results in accordance with the provisions of annex 3; 54.3. gamete donor selection criteria and laboratory evaluation of the results of the study in accordance with the provisions of annex 4. 55. In assessing the potential of each tissue and cell donors (with the exception of partner donation of germ cells or autologous donors) compliance with relevant procurement of tissues and cells and use the tissue Center, doctors take into account: 55.1. information obtained in a conversation with a potential donor or the person who's well known donor (if the donor is dead), and what is the documentary evidence; 55.2. information obtained in a conversation with a potential donor's family doctor or treating doctor and is a documentary evidence; 55.3. potential donor disease history data: 55.3.1. life and disease history; 55.3.2. physical, clinical and laboratory investigation results; 55.4. autopsy results (if the donor is dead); 55.5. requirement that must be carried out a physical check of the body (if justified) to detect any signs that may be sufficient to decline a donor, or conditions to be assessed in the light of the donor's medical and personal history. 56. The tissue establishment donor database for each donor a donor creates a case, including the following: 56.1. the donor's name, surname, gender, date of birth and age; 56.2. If involved in the donation of the mother and child, the mother's first name, last name, date of birth, the child's first name and last name, if known, and date of birth; 56.3. consent: 56.3.1. donor acknowledgement that he agrees to become donors of tissues and cells (living donors); 56.3.2. information on the deceased donor lifetime expressed will: 22.214.171.124., or the population register contains details of prohibition or permission to use the body, tissues, cells and organs after death; 126.96.36.199. the closest non-written acknowledgement of receipt of donor lifetime expressed will permit the use of the body, tissues, cells and organs after death (if not specified in the following details in the population register); 56.4. life and disease history, indicating the following data: 56.4.1. health examination results or, if necessary, the results of the verification body; 56.4.2. hemodilūcij's formula (if needed); 56.4.3. clinical and laboratory examination results, as well as other study results; 56.4.4. If you have performed an autopsy, they include the donor in case results (for tissues and cells, which cannot be stored for long periods, records the previous oral report on the autopsy); 56.4.5. hematopoetic stem cell donor match the selected recipient; 56.5. the tissue establishment authorised treatment person's approval of the information contained in the case of the donor matches (except for gamete donations or partner autologous donors). 57. The tissue establishment or organisation that made the use of tissues or cells for transplantation, should have access to information about donors to confirm compliance of the donor, if the procurement organization has limited access cases of the recipient data for unrelated donations. 58. the Donor and the donated tissues and cells, in the process of production or the tissue establishment assigned unique identification code and enter it in the register set up for this purpose. 59. before the procurement of tissues and cells at the tissue establishment's doctor does the following: 59.1. If tissues and cells intended to be obtained from living donor, inform the donor in an understandable way about him: 59.1.1. tissue and cell procurement goals and nature of mining consequences and potential risks; 59.1.2. tissue and cell procurement objectives and possible therapeutic benefits; 59.1.3. the donor data fixation and protection measures (donor privacy); 59.1.4. measures for the protection of the donor; 59.1.5. laboratory examinations (if any) and the right to receive the examination results and their interpretation; 59.1.6. any significant change (abnormality), which is found in the evaluation and testing procedures that are documented; 59.1.7. the need to obtain the consent of the donor and the compulsory authorisation before the procurement of tissues and cells; 59.2. If tissues and cells intended to be obtained from a deceased donor, make sure: 59.2.1. for deceased donor permission or prohibition of the presence or not of a deceased donor, the nearest non-validity of the prohibition on the use of tissues and cells under the law "on the dead man's body and human tissues and organs for medical use" requirements; 59.2.2. the deceased donor's closest relatives are announced and explained the results of the donor evaluation confirmed. 60. the tissue establishment shall ensure that these rules 56 and 59 above information is true, clearly legible, without corrections and complete. Donor information is documented verifiable. 61. The tissue establishment authorised person before the procurement of tissues and cells: examination of 61.1. is living donor consent in writing or, if the donor is deceased, the deceased donor permission or prohibition of the existence or not of a deceased donor, the nearest non-policing the ban on the use of tissues and cells under the law "on the dead man's body and human tissues and organs for medical use" requirements; 61.2. donor identity and captures who and in what way the donor identified; 38.1. that has fixed this rule 64.6. information referred to in (a), if the donor is dead; 61.4. or donor (if alive): 61.4.1. this rule 59.1 understood. information referred to in (a); 61.4.2. used the opportunity to ask questions and receive answers; 61.4.3. She confirmed that all information provided is true. 3.4. Tissue and cell donation and procurement 62. Tissue and cell alotransplantācij in favour of the recipient can be performed only in the case if the following conditions are met: 62.1. tissue and cells are removed for medical or scientific and therapeutic purposes; 62.2. all of the removed tissues and cells are donated. 63. the procurement of tissues or cells is allowed only if all the requirements that are set out in these terms and the law "on the dead man's body and human tissues and organs for medical use", in relation to the mandatory consent and permission. 64. Procurement Organisation prepares the tissue Center report and include the following information: 64.1. the identification of the tissue establishment (name and address), the receiving tissue or cells; 64.2. donor identification data (including the fact that the donor is identified and what made them); 64.3. tissues or cells obtained description and identification (including sample testing); 64.4. persons responsible for collection identification (including signatures); 64.5. acquisition date, time, where appropriate-the beginning and the end, the site, the technology used, environmental conditions in the extraction site (in some cases), as well as in the standard operating procedures used, including any relating to incidents; 64.6. for deceased donors – death date and time (if known), the conditions under which the cadaver is kept, refrigerated (or not), cooling the start and end time; 64.7. reagents and curing solution identification (batch) number. 65. If the semen was obtained in the home, procurement organisation report and include the following: 65.1. the tissue establishment (name and address), the receiving tissue or cells; 65.2. donor identification; 65.3. the acquisition date and time (if known). 66. After extracting tissues and cells shall be packed in such a way as to minimise the risk of infection, and kept at a temperature that ensures the properties of tissues and cells and biological function. The package also provides for tissue and cell packing and transportation of the staff to be responsible for the contamination risk. 67. the donor's body after the dead tissue and cell procurement restores its original external appearance. Tissue Center and procurement organisation provides the necessary personnel and equipment. 3.5. The resulting tissue and cell labelling and transportation. Each package of 68, which is tissue and cells, during procurement labelled. 69. The labelling of tissues or cells the primary container: 69.1. tissue and cell type, identification number or code, and the lot or parcel number, if any; EB 69.2. identification of the tissue establishment; 69.3. validity period; 69.4. "for autologous use only" and "identify the donor (recipient)" autologous donation, if; the intended recipient of 69.5. (on the label), if there is a direct donation; 72.2. the marking "bio-hazard", if it is known that the tissue and cells are positive for infectious disease markers. 70. The attached tissue, cell or blood samples shall be labelled to ensure identification of the donor, as well as indicate the time and place where the sample was taken. 71. On the primary container label or accompanying documents shall bear the following information: 71.1. Description and – where appropriate – tissue or cell product size; 71.2. morphology and functional data, if any; 71.3. the distribution of tissues and cells; 71.4. donor carried out laboratory investigations; 71.5. storage recommendations; 71.6. tanks, packaging and any necessary manipulation or renewal; 71.7. expiry date after opening or tampering; 44.6. the indications of a serious adverse reaction or serious adverse event reporting in accordance with the provisions of subsection 3.9; 71.9. possible presence of harmful substances (such as antibiotics, ethylene oxide); 71.10. these terms and 69.4 69.5. information referred to in point. If it is not possible to specify the main tank on the package label to indicate on a separate sheet accompanying the primary container so that they can be together. 72. Tissues and cells transport the transport of biological materials in suitable containers, providing their current safety of tissues and cells and quality, appropriate temperature and prevent tissue, cell and responsible employee contamination. 73. During the main tank into the transport tank, which contain at least the following: 73.1. indication that the package contains human tissue and cells, and the words "act carefully"; 73.2. it the origin of the tissue Center identification (address and phone number) from which the shipment is transported, as well as contact if it encounters any problems during transport; 73.3. for human application of tissues and cells in a tissue establishment or the responsible use of the Organization's identification (address and telephone number), to which the shipment is transported, as well as the person to contact to get the tank; 45.6. the transport and launch time; 73.5. specification of transport conditions that are essential for tissue and cell quality and safety; 73.6. "do not irradiate the cells transport products; 45.8. "do not irradiate when live cells graft functioning is needed (for example, stem cells, germ cells); 73.8. "bio-hazard", if it is known that the product is positive for a relevant infectious disease markers; 73.9. "for autologous use Only", if it is autologous donation; 73.10. storage conditions specification (for example, "do not freeze"); 73.11. safety instructions and method of cooling (if required); 73.12. recommended transport conditions (such as "keep refrigerated", "move vertically"). 3.6. Tissue and cell reception at the tissue establishment 74. The tissue establishment received a consignment of tissues and cells are documented, making sure it meets this rule 3.3, 3.4, 3.5, 3.6, 3.7 and 3.9 the requirements in subdivision, including the transport conditions, packaging, labelling, accompanying documents and samples, as well as news about the acceptance or rejection of the consignment. 75. the tissue establishment shall ensure that the tissue and cells received are quarantined until the person in charge checked the accompanying documents and received donations and confirmed their compliance with the requirements laid down in these rules, as well as informed about the donor. 76. The tissue establishment has developed a procedure for checking every consignment of tissues and cells, including samples. Tissues and cells, which do not meet the requirements in these rules and for which the donor does not receive these rules that laboratory test results, documented and stored separately from the rest of the tissues and cells, and it is prohibited to use these provisions to the above requirements. 77. The tissue establishment database of tissues and cells contain this information (except for information on gamete donors, intended for partner donation): 77.1. the use of tissues and cells of the target (therapeutic, scientific); 77.2. donor's consent (except dead donors) and donor guidelines on tissue and cell destruction, if they are not used for the purpose for which consent was obtained; 77.3. procurement of tissues and cells (the donor health history of living and illness); 77.4. physical checks, clinical and laboratory examination and the results of other studies, such as the results of the autopsy and the cause of death (deceased donors); 77.5. assessment of the donor according to the rules set out in annex 2 of the donor selection criteria (if the allogeneic donor); 77.6. medication intolerance the likelihood of the recipient, if the tissues and cells intended for autologous use (if intended to be used in the cell). 78. The tissue establishment information on the germ cells intended for partner donation, which is recorded in the database, the tissue establishment shall specify: 78.1. tissue and cell usage purpose (therapeutic, scientific); 78.2. written confirmation of the acceptance of the donor tissues and cells used for a specific purpose; 78.3. indication of tissue and cell destruction (if they are not used for the purpose for which it was obtained the consent of the donor); 78.4. donor identification and characteristics: type of donor, age, sex, presence of risk factors (the cause of death, if the donor is dead); 78.5. partner identification; 78.6. procurement of tissues and cells; 78.7. for tissues and cells, characteristics. 3.7. The procurement of tissues and cells traceability requirements 79. To ensure that all tissues and cells traceability and identification of received tissues and cells, tissues and tissue Centre organisation creates the use of efficient and accurate traceability system. 80. all the tissue establishment and organization of the use of the tissue procured, processed, stored and distributed to tissues and cells can be traced from the donor to the recipient and the recipient to the donor from regardless of the tissues and cells intended use and treatment services, in which the tissues and cells are delivered. This traceability also applies to all data related to the products and materials that have been in contact with tissues and cells. 81. in order to ensure the identification of the donor and the traceability, each resulting samples of tissues and cells from the graft and prepared it for the grant identification code according to paragraph 58 of these rules. 82. The tissue establishment traceability system shall include at least the following: 82.1. donor identification; 82.2. donation identification which shall include at least the following information: 82.2.1. the tissue establishment or procurement organisation identification; 82.2.2. unique donation identification number; 82.2.3. the procurement of tissues or cells date; 82.2.4. the procurement of tissues and cells; 82.2.5. type of donation (e.g., one or more of the autologous or allogeneic tissue, living or dead); 82.3. product identification, which shall include at least the following information: 82.3.1. the identification of the tissue establishment; 82.3.2. tissue or cell (products); 82.3.3. the Fund's number (if applicable); 82.3.4. split number (if applicable); 82.3.5. the period of validity; 82.3.6. status of tissues or cells (e.g., in quarantine); 82.3.7. Description of products originating, processing steps applied, materials and additives coming into contact with the cells and tissues and affect their quality and safety; 82.3.8. identification of the facility which carried out the last label; 82.4. the identification of tissues or cells intended for human use: 82.4.1. date of distribution (destruction); 82.4.2. clinical or end user (equipment). 83. the use of body Tissue traceability system shall include at least the following information: 83.1. supplier's identification of the tissue establishment; 51.7. clinical or end user (equipment) identification; 83.3. tissue and cell type; 83.4. product identification; 83.5. tissues or cells identification of the recipient; 83.6. the use of tissues or cells. 84. The tissue establishment shall conclude a written agreement with the third parties in all cases, if an external activity takes place which influences the quality and safety of tissues and cells processed in cooperation with a third party, as well as in the following cases: 84.1. a tissue establishment entrusts a third party with one of the stages of tissue or cell processing; 52.3. a third party provides goods and services that affect tissue or cell quality and safety, including their distribution; 84.3. a tissue establishment provides services to a tissue establishment which is not authorised; 84.4. the tissue establishment distributes tissue or cells processed by third parties. 85. Tissue establishments shall evaluate and contract with third parties in accordance with their ability to comply with the requirements laid down in these provisions. 86. The tissue establishment may enter into contracts for the procurement of tissues and cells transport and other processes, which are not associated with tissue and cell acquisition and use by third parties, which may not be the medical establishment. 87. Agreements between tissue establishments and third parties shall indicate the duties and responsibilities of the parties, as well as detailed procedures for cooperation. Tissue establishments maintain complete this contract database. 88. The tissue establishment, procurement and the use of tissue organization provides tissue and cell donors anonymity, as well as the protection of genetic data and privacy. 89. To ensure that specified in paragraph 82 of the requirements, including the circulation of information, the regulations referred to in paragraph 88 of the organisation: organise 89.1. security measures to prevent unauthorised data additions, deletions, or modification of the donor in case or rejected the transplant registry and ensure safe transfer of information; 89.2. take appropriate action if it finds a mismatch of data; 89.3. ensure non-disclosure of personal data, as well as the functioning of the system of traceability. 90. the tissue establishments and tissue organization of use ensures that information about the donor's personal data are not disclosed to the recipient and his relatives, but information about the recipient of the personal data will not be disclosed to the donor and his relatives, particularly with regard to gamete donation. 91. The rules referred to in paragraph 56 of the donor and 82. these rules and 83. the data referred to in paragraph 1 of document and archives management of regulatory legislation requirements shall be kept for at least 30 years after the tissues or cells for clinical use. 3.8. Tissue and cell 92. imports and exports of tissues and cells from other European economic area countries and third countries and exports to those monitored by the Agency. 93. The tissue establishment receiving the tissues and cells from third countries shall ensure that they comply with equivalent standards of quality and safety, as set out in Chapter 4 of these rules. 94. the tissue establishment shall ensure the imported tissues and cells traceability in accordance with this provision, section 3.7. 2.4. Notification of serious adverse reactions and serious adverse events 95. Mining Organization standard operating procedures have been developed to preserve the records of tissues and cells and reported immediately to the tissue establishments of any serious adverse reaction that is found in the living donor and can affect the quality and safety of tissues and cells. 96. Procurement organisations and tissue establishments have developed standard operating procedures to save the record and to immediately notify tissue establishments of any serious adverse events at the time of procurement, which can affect a person's quality and safety of tissues and cells. 97. the Organization has developed the use of standard operating procedures to keep tissues and cells used for record and immediately reported to the tissue of any serious adverse reactions and serious adverse events observed in the tissues or cells for clinical use during or after, and which can be linked to the quality and safety of tissues and cells. 98. The tissue establishment shall provide information on the use of tissue organization of it, how is the reporting of serious adverse reactions and serious adverse events which may affect the quality and safety of tissues and cells. 99. The tissue establishment shall develop procedures to inform the Agency about potential serious adverse reactions and potential serious adverse events, and to immediately notify the opinion of the inquiry, for analysis of serious adverse reactions and events of causes and effects. 100. the responsible person shall ensure that the Agency be notified of serious adverse reactions, as they have become known, but not later than 48 hours, a statement under this rule to part A of annex 5, and on serious adverse events, the dispatch of a notice pursuant to the provisions of part A of annex 6. Five days after the completion of the investigation, tissue establishments provide the Agency investigation opinion on serious adverse reactions, the dispatch of a notice under this rule to part B of annex 5, and on serious adverse events, the dispatch of a notice under this rule to part B of annex 6. 101. The tissue establishment shall report to the Agency on the actions taken in relation to the rest of the tissues and cells that have been distributed for use in humans. 102. The tissue establishment to assess serious adverse events and their causes to promptly remove them in tissue and cell acquisition, testing, processing, storage and distribution process. 103. the medical fertilisation, gametes or embryo or wrong mixing is considered a serious adverse event. Procurement organisation or tissue use an organization that conducted a medical insemination, report on such cases to the tissue Center, which made the delivery, to carry out investigations and inform the Agency. 4. quality and safety standards for living donor and the dead man's use of tissues and cells in a tissue establishment 104. tissue establishments, work organisation and management procedures ensure that: 104.1. responsible persons qualifications comply with the provisions of section 3.1 of these requirements; 104.2. a tissue establishment must determine and clearly defined structure and standard operating procedures, including a clearly defined responsibilities and reporting hierarchy; 104.3. the tissue establishment's medical practitioner to advise and monitor the tissue Center medical activities (selection of donors of tissues and cells used for the clinical outcomes review) or communicate with patients the tissue establishment; 104.4. tissue establishments shall establish a quality system pursuant to these rules; 104.5. using biological materials and working with them, the existing risks are identified and mitigated and steps in accordance with quality and safety requirements. Important to perform a risk analysis relating to standard operating procedures, environment, staff health status; 104.6. tissue establishments shall contract with third parties for any of the stages of tissue or cell processing to a third party specified the duties and responsibilities, as well as the procedures to be followed to meet the required performance specifications; 104.7. documented system is developed, supervised by a responsible person to confirm that the tissues and cells comply with quality and safety standards set by their release and distribution; 104.8. contracts and SOPs include traceability data and material in relation to the quality and safety of tissues and cells, in case the tissue establishment's activities are terminated; 104.9. procedures have been developed to ensure that all units of the tissue or cell ID in all stages of the operation. 105. The tissue establishment have sufficient qualified staff. 106. staff competence according to the quality system requirements is regularly evaluated. To do this: 106.1. have developed a staff job description, to which certain responsibilities and obligations; 106.2. provide initial training of staff, as well as in the case where a change in the standard operating procedures or scientific knowledge, are provided in-depth training and appropriate professional development opportunities; 106.3. staff is informed about your work for more ethical, legal and regulatory context. Training is provided and documented that every person: 106.3.1. demonstrated its expertise, through its tasks; 106.3.2. it is with the appropriate knowledge and understanding of scientific processes and (technical) principles that are related to the tasks of the person concerned; 106.3.3. understanding the organizational structure of the tissue Center, quality systems and safety regulations. 107. The tissue establishment in determining the required equipment and materials ensure that: 107.1. equipment and materials are designed and maintained to suit its intended purpose, reducing any kind of injury to the recipient and personnel; 107.2. all critical equipment and technical devices are identified, validated and are regularly checked, and in accordance with the manufacturer's instructions, it is carried out preventive maintenance. If the equipment or materials affect critical processing or storage (e.g., temperature, pressure, particle counts, microbial contamination levels), it identifies and appropriately monitor using the alarm, the alarm and corrective actions to determine interference and faults and ensure that the most important indicators are always maintained in the appropriate range. All of the equipment with a critical measuring function shall be calibrated by a traceable standard if available; 107.3. equipment installed or repaired before use are tested and validated and the results of the test are documented; all critical equipment 107.4 are regularly disinfected, cleaned and maintained and the activity is documented; 107.5. all critical equipment parts using standard operating procedures, which are said to be malfunctioning or failure; 107.6. standard operating procedures have been developed reusable equipment (instruments) validated cleaning and sterilizing to remove infectious agents; 107.7. is the equipment and material transactions standard operating procedures for all critical materials and reagents. In particular additives (e.g. solutions) and packaging material specifications. Critical reagents and materials meet the documented requirements and specifications and, if necessary, the laws governing the registration of medical devices, conformity assessment, distribution, operation and technical supervision. 108. The tissue establishment suitable premises are set to make an authorization included in the special actions with tissues and cells. 109. The tissue establishment shall ensure that the following requirements are complied with: 109.1. activities that include processing of tissues and cells in a certain environment, air quality and cleanliness, to reduce the risk of contamination, including the donation of mutual contamination. Effectiveness validated and monitored; 109.2. in rooms where the resulting donor tissues and cells to come into direct contact with the external environment and that it is not possible to ensure microbiological inactivation process (sterilization), air quality with particle counts and microbial colony counts meets this provision set out in annex 7 A class, but the other rooms-7. these provisions set out in Annex D; 109.3. in the light of the donor tissue and cell application purpose and nature, as well as the recipient's immunological status, air quality can be applied to the lower requirements than those set out in (A) class, in the following cases: 109.3.1 rooms provide validated inactivation of microbiological processes (sterilization); 109.3.2. application of requirements harm the donor tissues and cells; 109.3.3. using the donor's tissues and cells, it is a low risk of contamination; 109.3.4. processing of tissues and cells donors, the application of technological requirements; 109.4. activities that require a permit, include the storage of tissues and cells, determines the storage conditions necessary to maintain the required tissue and cell properties, including relevant parameters such as temperature, humidity and air quality controlled (monitored) and documented; 109.5. in order to prevent the risk of infection, ensure the donor tissue and cell storage separately from the rest of the donated tissues and cells that are already separated for further use. In the quarantine the tissues and cells stored separately from the others for further use for tissue and cells. Unused or damaged tissues and cells destroyed in accordance with the laws and regulations that govern the treatment of waste management; 109.6. staff are provided with appropriate clothing and equipment, as well as written instructions have been developed laying down hygiene and clothing. personnel requirements 110. the tissue establishment shall ensure that an investigation of Bacteriological indicators satisfy this provision laid down in annex 7. 111. tissue establishments shall establish a system of clearly defined as being created and maintain documentation, including electronic documents, records and registers, and standard operating procedures approved activities that require authorization: 111.1. documents are regularly reviewed to meet the requirements set out in these provisions. System ensures that work is standardized and all stages-coding, donor eligibility assessment, procurement, processing, preservation, storage, transport, distribution or destruction – is transparent, including aspects relating to quality control and quality assurance; 111.2. all critical activities identified and documented in the materials, equipment and staff involved; 111.3. tissue establishments shall be reviewed by the person responsible, shall be approved, documented and accurately implemented all the changes to the documents, including electronic; 111.4. tissue establishments shall develop SOPs, document management to ensure review and document change history, and their use of only current versions of documents, including electronic documents; 111.5. records made is incredible and reflects the real results; 111.6. Notes are legible and indelible, and may be carried over in handwriting or another validated system, such as a computer; 111.7. Notes (except for the data that are required for full traceability), including the original findings, which is critical to the safety of tissues and cells and quality, at least 10 years after the end of the term; 111.8. record correspond to individual data protection requirements and the requirements of this provision, section 3.3. Registers and data can be accessed only by persons authorized by the person in charge, as well as the Agency for inspection and control measures. 112. in order to ensure that these regulations requirements are made in the tissue establishment control and quality checks: 112.1. activities that require a permit, develop audit system. In order to verify compliance with the approved procedure and requirements of these provisions, the audit is carried out by independent trained and competent persons at least every two years. Results and corrective action documented; If there are deviations from 112.2. the quality and safety standards laid down, take the documented actions (procedures), which include a decision on possible corrective and preventive actions. Not appropriate for tissues and cells shall be decided in accordance with written standard operating procedures that are monitored by the responsible person, and these discrepancies are recorded. All affected tissues and cells identify and inform the Agency; 112.3. corrective action document, launched and completed on time. Preventive and remedial action to evaluate the effectiveness of implementation; 112.4. tissue establishments have been developed in a process under which the quality check system performance to ensure continuous and systematic improvement. 5. Procedures for tertiary, a duplicate is authorized, revoke the authorization, suspension and renewed its 113. University seeking authorisation submitted to the Agency submissions 113.1.:. The application specifies the following information: 113.1.1. the University name, registration number, registered and actual address; 113.1.2. person in charge name, title, contact information (phone number, e-mail address), which is responsible for cooperation with the Agency; 113.2. these provisions 113.1. an application referred to in paragraph add descriptions of the SOPs of tissues and cells for application in the activities related to the medical study program implementation. 114. the Agency shall evaluate this rule 113. paragraph submissions and SOPs describing the use of tissues and cells of activities related to the medical study program implementation, assess the conformity of this provision the University Chapter 6 requirements regarding the use of tissues and cells, and in the month following receipt of the application, shall take a decision on the authorisation (annex 8) the issue or refusal to issue the permit. The decision on authorisation or refusal to issue the permit Agency shall notify the applicant of the Notification law. 115. If, in considering the provision referred to in paragraph 113 submissions and SOPs describing the use of tissues and cells of activities associated with the implementation of medical studies, the agency finds that they are incomplete or do not comply with these provisions in Chapter 6 of these requirements, so within five working days after the rules referred to in paragraph 113 receipt of application to make a request in writing to the University to clarify information. 116. the graduate school within 10 working days after this rule 115, paragraph shall submit to the Agency in receipt of the documents, which certify that the deficiencies have been rectified. 117. the Agency shall evaluate the tenders submitted that rule 116. documents referred to evaluate compliance with this provision of the school in Chapter 6 above requirements for tissues and cells and the month following this rule 113.1. referred to the receipt of the application, shall take a decision on the permit or to refuse to issue the permit. The decision on authorisation or refusal to issue the permit Agency shall notify the applicant of the Notification law. 118. This provision 114.117.123, and referred to in paragraph a decision agency official has the right to attend high school and the University is obliged to provide access to the Agency's official decision the necessary documents, premises, equipment, as well as the person in charge of the universities presence during the visit. 119. The decision on the refusal to issue a licence, the Agency shall adopt, if at least one of the following reasons: 119.1. the content of University documents submitted false information; 119.2. graduate school does not satisfy this provision in Chapter 6 requirements and failing to ensure the use of tissues and cells for compliance; 119.3. University has provided all these terms the information referred to in paragraph 113 of these provisions within the time limit referred to in paragraph 116. 120. If permission is damaged, destroyed, lost or stolen, the school within three working days to inform the Agency in writing, and submit the application for a duplicate permit. The agency within three working days after receipt of the application, shall take a decision on the issue of a replacement authorization and issued it. A decision on the issue of a replacement authorization shall notify the applicant, the Agency notification in accordance with the procedure prescribed by law. 121. If the agency finds that the University does not support this provision as referred to in Chapter 6, compliance, it suspended the operation of the permit and shall fix a time limit for the correction of deficiencies. 122. in order to restore the suspended permit shall submit to the Agency, University application for permit renewal stalled and documents showing that the lack of authorisation suspended, is eliminated. 123. the Agency shall evaluate these rules referred to in paragraph 122 of the application and accompanying documents, evaluates the compliance of these rules the University in Chapter 6 above requirements for tissues and cells, and in the month following receipt of the application, shall take a decision on the renewal of the authorisation, if flawed, which permit suspended, have been rectified, or the withdrawal of the authorisation, if flawed, which permit suspended, not resolved. The decision of the Agency shall notify the applicant of the Notification law. 124. the Agency shall revoke the authorisation if there is at least one of the following reasons: 124.1. University asked to withdraw the authorisation issued to it; 124.2. University the permission referred to in the conditions of operation; 124.3. these provisions 121 universities. the time limit referred to in paragraph 1 is not prevented, which permits operation suspended; 124.4. University has submitted false information. 125. the Agency's decision on the withdrawal of the authorisation shall notify the University's Notification law. 126. the Agency's decisions on the authorization or refusal to issue the permit, as well as the suspension of an authorisation or its cancellation of graduate school can be a challenge in the Ministry of health of the administrative procedure law. 127. The Ministry of health decision may appeal to the Court of Justice of the administrative procedure law. 128. Information on licences issued (University name, phone number, tissue and cell application places the actual address, permit number and date), the issued permit the suspension or withdrawal of the operating agency within three working days after the decision, the Agency put on the website. 6. Requirements to be met by the University to receive permission, tissue and cell application conditions and procedures for living donor tissues and cells used in medical studies 129. Tissues and cells used for the corresponding study programmes. 130. Implementation of the programme of the University of medicine, the use of tissues and cells is carried out according to established operating procedures. 131. the University has written requirements staff and student hygiene and the use of personal protective equipment. 132. Tissues and cells stored in the special school laboratory conditions according to standard operating procedures of operation. 7. the use of tissues and cells assessment monitoring and control procedures, as well as the procedure of reporting to the European Commission about serious adverse reactions and serious adverse events 133. the Agency shall take all measures to ensure that tissue and cell procurement and receipt under this provision 3.4. and section 3.6. 134. the Agency's authorized person on a regular basis, but not less frequently than once every two years, take the tissue Center. Monitoring: 134.1. checks the tissue establishments and third party equipment used in the light of this provision, the 86 84 85. and contracts referred to in paragraph; evaluate and verify the 134.2. standard operating procedures and the activities carried out in tissue establishments and the facilities of third parties, subject to the provisions of chapters 3 and 4 of such requirements; 134.3. all documents examined (records) that are associated with the provision of Chapter 3 and 4 that the requirements are fulfilled; 134.4. checks between tissue establishments and third party contracts and assess their compliance with the rules in paragraph 87. 135. The tissue establishment inspections carried out by the Agency provides this rule 8.2., referred to as well as other information available. 136. in order to ensure that the requirements of these regulations are complied with, the Agency's representative on a regular basis, but not less frequently than every three years out of high school. Monitoring: 136.1. assess the University premises and equipment takes place with the use of tissues and cells related activities; 136.2. measure all notes, standard operating procedures and activities related to these requirements in these rules. 137. the University supports this rule 113.2. standard operating procedures referred to in the description of the use of tissues and cells of activities associated with the implementation of medical studies, as well as other information available to the Agency's inspections. 138. the Agency shall organise and carry out the tissue establishment this provision the monitoring referred to in paragraph 134 (including extraordinary), if there were serious undesirable effects or serious adverse events or are suspicious of them, and if you have received other European Union Member State competent authorities justify the request. 139. every three years, the Agency shall prepare and submit to the European Commission a summary report on the tissue establishments activities associated with tissue and cell procurement, testing, processing, preservation, storage and use, as well as checks the tissue establishments. 140. the Agency each year up to 30 June shall be submitted to the European Commission communication about received serious adverse reactions and serious adverse event reports (annex 9). 141. the Agency shall provide the other Member States and the European Commission information on serious adverse reactions and serious adverse events, as well as by other Member States or the European Commission's request, providing information about the testing and the results of controls carried out in relation to the quality and safety standards in the areas associated with human tissue and cell donation, procurement, testing, processing, preservation, storage and distribution. 142. The tissue establishment shall prepare an annual report on the activities of the previous year and the current year to February 15, submit it to the Agency. The annual report of the activities carried out in tissue, including specifying the obtained, preserved, tested, processed, stored and distributed, or otherwise used tissue or cell type and quantity, as well as tissue and cell origin and destination, intended for use in humans. 143. the Agency shall publish the rules referred to in paragraph 142. annual report on its Web site, as well as to ensure the availability of the other Member States, the European Commission submitted a report summary. The information obtained by the Agency in the appropriate laws and regulations to the requirements of natural persons in the field of data protection. Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 31 March 2004, Directive 2004/23/EC on setting standards of quality and safety of tissues and cells for the donation, procurement, testing, processing, preservation, storage and distribution; 2) Commission February 8, 2006, Directive 2006/17/EC of the European Parliament and of the Council Directive 2004/23/EC on the specific technical requirements of human tissue and cell donation, procurement and testing; 3) Commission of 24 October 2006, Directive 2006/86/EC of the European Parliament and of the Council Directive 2004/23/EC on traceability requirements, notification of serious adverse reactions and events and certain technical requirements of human tissues and cells for encoding, processing, preservation, storage and distribution. Prime Minister Valdis Dombrovskis Health Minister Ingrida Cricket 1. Annex Cabinet 22 October 2013 regulations no 1176 of tissues and cells for application authorization no. _____ _____ Riga medicine State Agency (address, phone, registration No.)
certify that 1. (medical institutions (departments) name)
2. a registered medical institutions with Register No.
3. (hospital's legal and actual address, phone, e-mail address) 4. Institutions (departments) responsible person (first name, last name, phone, e-mail address) is assessed (s) and meets a Cabinet of 22 October 2013 rules no 1176 "human application of tissues and cells in order to the requirements and has the right (s) to the use of tissues and cells: (indicates the desired tissue and (or) use of cells/s) 5 date _____ _____ _____ _____ _____ _____ 6. The State Agency of medicines (name, surname, signature) Z.v.
7. the annex and the number of pages of annexes note. Document properties in the "signature" and "Z.v." does not fill in, if the electronic document has been prepared according to the law on electronic document design. Annex 1: the use of tissues and cells for permission to no ____ ____ special operating conditions (required mark) tissue or cell type in the scope of the treatment process of the blood vessels in the skin Eye Bone tissue fruit shell ovarian tissue testicular tissue the tissue other (specify) bone marrow peripheral blood stem cells in the cord blood of Oocīt Sperm cells in other (specify) embryos Zigot other (specify) National Medicines Agency Director (name, surname, signature) Note. Document property "signature" does not fill in, if the document has been prepared according to the law on electronic document design. Annex 2 the use of tissues and cells for permission to no ____ ____ information about procurement organisations and third parties concerned, which carries out operations in accordance with the agreements concluded 1. Body 2. address, phone 3. person in charge name medicine State Agency Director (name, surname, signature) Note. Document property "signature" does not fill in, if the document has been prepared according to the law on electronic document design. 3. the use of tissues and cells for permission to no ____ ____ information about laboratory (s), which shall carry out the donor's blood donation samples or laboratory investigations on the basis of the Treaty and comply with the laws and regulations set out minimum requirements for medical laboratories 1. laboratory name laboratory address 2 phone 3. person in charge name medicine State Agency Director (name, surname, signature) Note. Document property "signature" does not fill in, if the electronic document has been prepared according to the law on electronic document design. Health Minister Ingrida Cricket annex 2 Cabinet of 22 October 2013 regulations no 1176 tissue or cell selection criteria for donors (except donors of gametes) of Donor selection criteria are based on specific tissues/cells related to the use of risk analysis. This risk indicators are found in physical examination, examining the medical and behavioural history, biological investigation, post-mortem inspection (deceased donors) and any other investigation. If it is not justified based on a documented risk assessment approved by the responsible person, the donor shall be declared invalid if the donation is one of the following criteria: 1. Deceased donor general rejection criteria: 1.1. cause of death unknown, unless the cause of death is not shown autopsy after procurement and none of the above in this section a general rejection criteria; 1.2. history of unknown etiology; 1.3. existing or a history of these malignant disease, except for primary Basal Cell Carcinoma, cervical carcinoma in situ, as well as some of the primary tumors of the nervous system, which is assessed in accordance with the scientific evidence. Donors with malignant diseases can be evaluated and considered for cornea donation (except for those suffering with retinoblastom, haematological neoplasms, anterior segment of the eye in cancerous tumors); 1.4. prion diseases that apply: 1.4.1 people diagnosed with Creutzfeldt-Jakob disease, variant Creutzfeldt-Jakob disease or a history of non-iatrogenic Creutzfeldt-Jakob disease. Creutzfeldt-Jakob disease variant can be recommended for further precautionary measures; 1.4.2. people whose history of rapid progressive dementia or degenerative neurological disease, including diseases of unknown origin; 1.4.3. from a human pituitary derived hormones (such as growth hormones) users and people who have transplanted cornea, sklēr and the brain of the hard shell, as well as persons who have undergone documented neurological surgery (when it may have used brain hard shell); 1.5. systemic infection which is not controlled at the time of the donation, including bacterial diseases, systemic viral, fungal or parasitic infections, or severe local infection in the tissues and for the donation. Donors with bacterial septicaemia may assess and consider as eye donors, but only if the stored organ the cornea in the culture to be able to detect tissue bacterial infection; 1.6. history, clinical or laboratory evidence of HIV, acute or chronic hepatitis B (except persons with a proven immune status), hepatitis C and HTLV I/II, this infection transmission risk or evidence of their risk factors; 1.7. history of chronic, systemic autoimmune diseases, which could have a harmful effect on the quality of the tissue; 1.8. found signs that the donor's blood sample test results are invalid due to treatment with hemodilūcij or imūnsupresīvaj substances; 1.9. found evidence of other risk factors for transmissible diseases on the basis of a risk assessment, as well as to the local spread of communicable diseases; 1.10. the donor's body is the physical signs that point to the risk of transmissible diseases; 1.11. information on such substances ingested or exposure to a substance (such as cyanide, lead, mercury, gold), which can be transferred to the recipient in a way that may endanger their health; 1.12. a recent vaccination with live attenuated virus (which is regarded as a hazard); 1.13. ksenotransplantācij; 1.14. the residence or custodial institution investigating jail before death (more than 72 hours in the past six months). 2. Dead children-donors: 2.1 under 18 months and were born to mothers with HIV, hepatitis B, hepatitis C or HTLV infection, or at risk of such infection, and who have nursed mothers breastfed during the previous 12 months, cannot serve as donors regardless of the results of the tests (in addition to this annex referred to in paragraph 1 the rejection criteria); 2.2. What is born of mothers with HIV, hepatitis B, hepatitis C, HTLV infection, or at risk of such infection, and who is not the mother nursed by mothers during the previous 12 months, and which analytical tests, physical examinations and examination of the records shows no sign of HIV, hepatitis B, hepatitis C or HTLV infection, might be for donors. 3. autologous living donor selection criteria: 3.1 if the removed tissues and cells are stored or cultured, the same minimum set of biological study of allogeneic living donors as; 3.2. positive test results does not mean that the tissue or cells, or any product obtained from them not to store, handle or implanted, repeatedly if there is proper isolated storage capabilities, to ensure that others are not reciprocal transplants of infection or contamination with substances and accidental mixing. 4. allogeneic living donor selection criteria: 4.1. allogeneic living donors are selected on the basis of their health and medical history, provided on a questionnaire, as well as the interview with the donor. The assessment includes the factors that can help to identify and reject persons whose donation could endanger other people's health, can lead to the possibility of transmitting diseases or health risks to themselves. Any donation to the acquisition process must not impede or endanger the health or care of donors. If you donated cord blood or fetal skin, this applies both to the mother and the child; 4.2. selection criteria for allogeneic living donors define and document the tissue establishment (and transplant the clinician in the case of direct service recipient), based on the specific tissue or cells intended to donate, as well as the donor's physical condition, medical history and behavioral and clinical research and laboratory examination results determine the donor's State of health; 4.3. these same rejection criteria apply to the deceased donors except 1.1. of this annex. Depending on the tissues or cells intended to donate, the following specific rejection criteria: 4.3.1. pregnancy (excluding cord blood cells, fetal skin donor and the hematopoetic stem cell donors who are brothers and sisters); 4.3.2. breastfeeding; 4.3.3. hematopoetic stem cells in case the option of putting a congenital disease. Health Minister Ingrida Cricket 3. attachment Cabinet 22 October 2013 regulations no 1176 tissue and cell donors (except donors of gametes) laboratory investigations 1. screening for infectious markers by donor: 1.1 all donors carry out at least the following laboratory investigations: anti HIV 1 and 2 HIV-1.2 hepatitis B HBsAg anti HBc hepatitis C anti-HCV-Ab syphilis see 1.4. Sub-paragraph 1.2. Htlv-i antibody testing must be performed for donors who live or have lived in places where there are high-incidence areas or with sexual partners originating from those areas or where the parents have lived in such places; 1.3. when anti-HBc is positive and HbsAg is negative, made further studies with risk assessment to determine eligibility for clinical use; 1.4. using approved testing algorithm to exclude active infection with pale treponemal. Specific or non-specific test results in the case of non-reactive can allow to distribute tissue and cells. If you make a non-specific test result does not prevent reactive extraction or distribution, if the specific treponemal confirmatory test is reactive. The donor, a specimen of which respond to specific treponemal tests should be carried out detailed risk assessment to determine eligibility for clinical use; 1.5. in certain circumstances, additional testing may be required depending on the donor's history and the donated tissues or cells characteristics (e.g. RhD, malaria, CMV, Toxoplasma, EBV, Trypanosoma cruzi cruz); 1.6. for autologous donors, this provision applies to annex 2, paragraph 3. 2. General requirements for the determination of biological markers: markers of infection screening 2.1, where appropriate using CE marked testing kits, made by the Agency of a qualified laboratory is qualified as a testing center. Infectious markers used screening test is validated according to the specific purpose according to scientific knowledge; 2.2. the infection marker screening out donors Sera or plasma. They may not perform other fluids or secretions such as the eye, the inner liquid and glassy body, unless it is specifically founded for this purpose, the test validated clinical use; 2.3. when potential donors have lost blood and have recently received donated blood, blood components, colloids or crystalloids, blood test may not be valid because the sample hemodilūcij. The degree of Hemodilūcij evaluated using the algorithm in the following cases: 2.3.1. ante-mortem blood sampling: if blood, blood components and/or colloids were infused in the 48 hours preceding blood sampling or if crystalloids were infused in the hour preceding blood sampling; 2.3.2. the post-mortem blood sampling: if blood, blood components and/or colloids were infused in the 48 hours preceding death or if crystalloids were infused in the hour preceding death; 2.4. the tissue establishments may accept tissues and cells from donors with plasma dilution of more than 50%, only if the test procedure used is validated for plasma or such is available pirmstransfūzij sample; 2.5. deceased donor, blood samples must be taken immediately before death, or, if possible, the sampling must take place as soon as possible after death, but not later than 24 hours after death; 2.6. If the donor is alive (except bone marrow stem-cell and peripheral blood stem cell alotransplantācij): 2.6.1. blood samples taken at the time of the donation, if that is not possible, then seven days post donation (this is the "donation sample"); 2.6.2. If in a living donor tissues and allogeneic cells can be stored for long periods, after 180 days to repeat sampling and testing. Repeated testing conditions, the donation sample can take up to 30 days before and seven days after donation; 2.6.3. If donors live tissues and allogeneic cells cannot be stored long and therefore is not possible, the sampling of this annex paragraph 2.6.1.; 2.7. If a living donor (except bone marrow stem-cell and peripheral blood stem-cell donors) the "donation sample", as defined in this annex, paragraph 2.6.1., in addition to the tested by the nucleic acid amplification technique (NAT) for HIV, HBV, HCV, repeated blood testing is required. Retesting is also not required if the processing includes an inactivation step that has been validated for specific viruses; 2.8. the bone marrow and peripheral blood stem cell collection in case blood samples taken for testing within 30 days before the donation; 2.9. newborn donor biological studies can take the donor's mother to avoid medically unnecessary procedures infant. Health Minister Ingrida Cricket 4. Annex Cabinet 22 October 2013 regulations no 1176 selection criteria and laboratory studies by the gamete donors 1. Donor selection criteria and laboratory tests are not required for germ cells, which give partners for direct use. 2. requirements for working with processed and stored gametes (partner donation, which is not intended for direct use), as well as germ cells for future embryo kriokonservācij: 2.1 the doctor who is responsible for donor selection, based on patient history and therapeutic indications, determine the justification for the donation and its safety for the recipient and the children that may be born as a result of donations; 2.2. to prevent the risk of cross-contamination, performs the following biological tests: anti HIV 1 and 2-HIV 1 and 2, hepatitis B HBsAg anti-HBc hepatitis C anti-HCV-Ab semen obtained () intrauterine fertilization purposes and which are not intended to store, laboratory studies is not mandatory if the tissue establishment using validated processes, it can be shown that the risk of infection is eliminated; 2.3. where HIV 1 and 2, hepatitis B or hepatitis C test results are positive or not available, or it is known that the donor's infection risk source, creates a separate storage system; 2.4. Htlv-i antibody testing must be performed for donors living in or originating from high incidence is that sexual partners or parents originate from those areas; 2.5. in certain circumstances, additional testing may be required depending on the donor travel and exposure history and donated the characteristics of cells or tissues (e.g. RhD, Hla, CMV, t. cruzi); 2.6. positive results does not necessarily mean that a partner may not be made in respect of the donation. 3. to use gametes other than partner donation, comply with the following conditions: 3.1. donor selection is based on their age, medical examinations, medical data provided in the questionnaire, as well as personal interviews conducted by qualified and trained medical personnel. This evaluation shall include relevant factors that may help to identify and reject persons whose donation could endanger other people's health, for example, raises the possibility of transmitting diseases (e.g. sexually transmitted infections), or create health problems themselves (for example, superovulācij, sedation or the risks associated with the procurement of ova or psychological consequences of the donation); 3.2. the donors are negative for HIV 1 and 2, HBV, HCV, syphilis, tested in accordance with the provisions of annex 3, paragraph 1.1, and sperm donors are negative for Chlamydia in urine sample that is tested by the nucleic acid amplification technique (NAT); 3.3. HTLV-1 antibody testing is performed for donors living in, or originating from high-incidence areas or with sexual partners or parents originate from those areas; 3.4. in certain circumstances, additional testing may be required depending on the donor's history and the donated tissues or cells characteristics (e.g. RhD, malaria, CMV, t. cruzi); 3.5. for autologous donors, this provision applies to annex 2, paragraph 3; 3.6. genetic screening for autosomal recessive genes, which, according to international scientific evidence prevail ethnic ancestors of the donor and family heredity transfer of existing risk assessment shall be carried out after the receipt of the consent. Notify the recipient and clearly explain the full information on the risks involved and the measures taken to reduce it. 4. General requirements that must be followed in order to determine infection markers (Biological) screening: 4.1. tests shall be carried out in accordance with the provisions of annex 3 paragraph 2.1 and 2.2; 4.2. blood samples taken at the time of the donation; 4.3. other person (not a partner) sperm donation are quarantined for at least 180 days, then repeat the test. If the blood donation samples tested by the nucleic acid additional amplification technique (NAT) for HIV, HBV, HCV, repeated blood testing is required. Retesting is also not required if the treatment involves inactivation, which has been validated for specific viruses. Health Minister Ingrida Cricket 5. Annex a Cabinet of 22 October 2013 regulations no 1176 notification of serious adverse reactions heading A quick notification of suspected serious adverse reactions 1. The tissue establishment name 2. identification of Message 3. reporting date (URgggg.mm.dd.) . . .
4. the affected individual (required mark) 4.1 4.2 the recipient donor 5. Extraction or exploitation of people day (URgggg.mm.dd.) and place ...
6. The unique donation identification number 7. Possible severe adverse reactions (URgggg.mm.dd.) . . .
8. type of tissues and cells that are involved in the alleged serious junk in adverse reactions (specify) 9. possible (-o) of serious adverse reactions (s) (s) (specify) part b: serious undesirable effects use opinion 10. tissue establishments name 11. identification of Message 12. Approval date (URgggg.mm.dd.) . . .
13. Serious undesirable effects date (URgggg.mm.dd.) . . .
14. The unique donation identification number 15. serious undesirable effects of approval (required mark) 15.1 15.2 16. is serious undesirable effects change (required mark) 16.1. is 16.2.17. If the paragraph 16 of this annex contains an affirmative answer, specify 18. Clinical results (if known) (mark the required) complete recovery 18.1 18.2 18.3. insignificant complications of serious complications 18.4. death 19. results of the investigation and the final opinion 20. Preventive measures and collective recommendations to the Minister of health Annex Summary of the Cricket 6. Cabinet of Ministers of 22 October 2013 regulations no 1176 notification of serious adverse events (A) quick notification of possible serious adverse events. the tissue establishment 1 name 2. identification of Message 3. reporting date (URgggg.mm.dd.) . . .
4. Serious event date (URgggg.mm.dd.) . . .
5. details of serious adverse events, serious adverse events that affect the quality and safety of tissues and cells due to a deviation in certain cells and specification Audi equipment failure error person other (specify) mining Storage Transportation treatment testing distribution materials other (specify) part b: a serious adverse event investigation opinion 6. tissue establishments name message ID 7 8. Approval date (URgggg.mm.dd.) . . .
9. Serious event date (URgggg.mm.dd.) . . .
10. Original causes analysis (detailed information) 11. corrective measures taken (details) Health Minister Ingrida Cricket 7. attachment Cabinet 22 October 2013 regulations no 1176 tissue Center room bacteriological investigation of rādītāji1 class air (CFU/m3) plate with a diameter of 90 mm (KVV2/