Human Tissue And Organ Accumulation, Storage And Usage Procedures

Original Language Title: Cilvēka audu un orgānu uzkrāšanas, uzglabāšanas un izmantošanas kārtība

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/155224

Cabinet of Ministers Regulations No. 208 in Riga in 2007 (March 27. No 21 23) human tissue and organ accumulation, storage and use of the arrangements made in accordance with the law "on the dead man's body and human tissues and organs for medical use" 18. the second paragraph of article i. General questions 1. determines the human tissue and organ accumulation, storage and use.
2. Human tissues are all constituent parts of the human body formed by cells. The cells are individual human cells or a collection of cells that are not bound by any form of connective tissue.
3. serious adverse reaction is unexpected response, including a communicable disease, in the donor or in the recipient associated with tissue, cell and organ procurement or human application, and that is fatal, life-threatening, disabling, incapacitating, or illness or disability which requires hospitalization and its extension.
4. Adverse event any adverse event associated with tissue, cell and organ procurement, testing, processing, storage and distribution and which may endanger life, induce, the transmission of infectious diseases, disability, disability or death or hospitalization is required and its extension.
5. Human tissues, cells and organs authorized to collect, store and use the following objectives: 5.1 sterile medical transplant production and use;
5.2. the transplantation;
5.3. pathological studies;
5.4. scientific research;
5.5. the implementation of the programme of study in academia.
6. the provisions do not apply to: 6.1. blood and blood components;
6.2. tissues and cells used as an autologous graft in the same surgical procedure. 
II. Tissue and organ procurement and storage centre creation 7. Donor tissues, cells, and organs for transplantation to accumulate and store the resulting tissue and organ procurement and storage centres (hereinafter referred to as the mining and storage centre). Collection and storage centre of the relevance of those activities and the ability to deliver the requirements laid down in these provisions shall assess the health statistics and medical technologies State Agency (hereinafter the Agency).
8. Collection and storage centre premises, which obtained the donor's tissues and cells, it is appropriate to ensure the donor tissue and cell procurement personnel involved in security. If necessary, staff with appropriate personal protective equipment.
9. get a tissue and cells, shall take the necessary measures to ensure the avoidance of contamination of tissues and cells and minimize the risk of contamination when tissues and cells after collection is not possible to be sterilized. People who have the infection vectors, it is forbidden to participate in the procurement of tissues and cells.
10. This provision provided for in chapter IX of the laboratory investigations of procurement and storage of donor Center performs medical laboratory that is accredited by the national agency "Latvian National Accreditation Bureau" in the standard LVS EN ISO 15189 medical laboratories ": 2006-quality and special requirements of competency" requirements or other Member State of the European Union laboratory for which the economy Ministry published a notice in the newspaper "journal", or medical laboratory, which has been assessed and meets the minimum requirements that law established the medical institutions and their departments.
11. All mining and storage Center for medical devices in accordance with the regulations on the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures should be validated, kalib scars and maintained according to the intended purpose of use.
12. Collection and storage centre is precise and quick procedure to remove tissue from the donor, the distribution of cells and organs for transplants and from those drinks, which could have caused serious side effects or adverse events.
13. the quality management system for the collection and storage Centre developed and documented: 13.1. what standard operating procedures in order to verify: 13.1.1. donor identity;
13.1.2. the donor's written consent;
13.1.3. the donor selection criteria of assessment in accordance with Chapter VIII of these rules;
13.1.4. donor evaluation of laboratory test results in accordance with the provisions of chapter IX;
13.1.5. tissue, cell and organ procurement, packaging, labelling and transport procedures for traceability to the time of their use or to a laboratory investigation of the samples (if the tissues, cells and organs are distributed and used directly, and use the time medical institution) in accordance with chapters X and XI of these regulations;
13.2. the education and training of personnel;
13.3. the Protocol and results in message form samples. 
III. Tissue and organ procurement and storage centre operational supervision and control 14. The Agency shall establish, maintain and add to collection and storage centre. The register shall include details of the activities of the Centre. The Agency provides news on the register of public availability.
15. in order to ensure compliance with these provisions, the Agency regularly, but not less frequently than once every two years: 15.1 the controls collection and storage centre, as well as third party equipment used on the donor tissue, cell and organ procurement, Stockpiling, storage and use;
15.2. all records, procedures and activities related to these rules above requirements collection and storage centre.
16. the Agency shall organise inspections and carry out control measures, if there were serious side effects or adverse events or are suspicious of them, and if you have received other European Union Member State competent authorities unjustified demand.
17. the Agency rescinds the provision referred to in paragraph 7 of the collection and storage centre of the conformity assessment results, if inspection or control, it finds that the collection and storage centre does not provide that the requirements of these regulations.
18. Collection and storage centre each year before 15 February, prepare and submit to the Agency a report on the activities of the previous year. The report shall contain information on the acquired, tested, preserved, processed, stored, distributed and used tissue, cell and organ type and quantity, as well as tissue, cell and organ of origin and use are given. The Agency provides the information contained in the report publicly available.
19. Mining and storage centre without the written approval of the Agency may not amend the documents governing the actions and operations standard operating procedures.
20. every three years, the Agency shall prepare and submit to the European Commission report on activities associated with human tissue, cell and organ accumulation, storage and use, as well as checks and controls on the acquisition and storage Center. 
IV. the traceability requirements and notification of serious adverse reactions and adverse events 21. Extraction and storage centre shall ensure that all findings, accumulated and stored tissues, cells and organs would be traced from the donor to the recipient and the recipient to the donor regardless of the tissues, cells and organs intended use and treatment services, in which the tissues, cells or organs is delivered. This traceability also applies to all data related to the products and materials that have been in contact with the tissues, cells and organs. To ensure that the donor identification, each derived tissues, cells and organs and prepared to give the graft from the identification code of the information.
22. The acquisition and storage Center highlights all the donor's tissues, cells and organs. The labelling shall bear the following information: 22.1. identification code;
22.2. tissue, cell or organ type;
22.3. the acquisition date (if possible, also indicate the time of the acquisition);
22.4. added substances (if any);
22.5. "for autologous use only", if the organs, cells or tissues intended for autologous use;
22.6. tissue, cell or organ recipient (if the donor tissue, cell or organ will be distributed and used directly);
14.1. information on dangers (such as infected tissue).
23. If all these rules., 22.4., 22.3 22.5 22.6 14.1., and the information referred to is not possible to specify the labels to indicate on a separate sheet, which shall be annexed to the mark.
24. Collection and storage centre have a system in place to notify and inform about serious adverse reactions and adverse events that may affect tissue, cell and organ quality and safety that can be associated with tissue, cell and organ procurement, testing, processing, storage, distribution and use (and for any serious adverse reactions observed during use or after them, and may be associated with tissue , cell and organ quality and safety), as well as to investigate and register the following serious adverse reactions, and adverse events.

25. Medical institutions that use the donor's tissues, cells and organs, have procedures to ensure the communication of essential information collection and storage Center, which require traceability systems in the equestrian and ensure tissue, cell and organ quality and safety control.
26. The provisions referred to in paragraph 35, the responsible person shall ensure that the Agency notification of serious adverse reactions and adverse events, including their causes and outcomes.
27. If transplantation need to provide emergency medical assistance, and delay may endanger achieving therapeutic results, individual donor tissues, cells or organs with the authorization of the agency procurement and storage centre is allowed to distribute and use directly to recipient immediately perform the transplants. 
V. living donor and recipient information 28. Extraction and storage centre of treatment a person before tissue, cell or organ procurement inform donors of tissue, cell: 28.1. or organ procurement goals and nature of mining consequences and potential risks;
28.2. tissue, cell or organ procurement objectives and possible therapeutic benefits;
28.3. the donor's possible protective measures;
28.4. the donor-type data, data protection and privacy compliance purposes;
28.5. laboratory examinations (if any) and the right to receive this study results in an understandable way;
28.6. the need to obtain the consent of the donor before a mandatory tissue, cell or organ procurement.
29. This provision of the information referred to in paragraph 28 of the treatment the person provides a suitable donor, in a clear and easily understandable way. Donor information is documented verifiable.
30. Collection and storage centre of treatment a person before tissue, cell or organ procurement: 30.1. received from the donor's written consent;
30.2. the verification of the identity of the donor, on the basis of identity documents;
30.3. ensure that the donor has: 30.3.1. understood this provision the information referred to in paragraph 28;
30.3.2. used the opportunity to ask questions and receive answers;
30.3.3. She confirmed that all information provided is true. 
Vi. Data storage and protection 31. Extraction and storage centre of tissue, cell and organ donor anonymity, as well as the protection of genetic data and privacy.
32. in order to ensure that the provisions referred to in paragraph 31 of requirements, procurement and storage Center: 32.1. organised 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;
32.2. the procedure, if the data does not conform;
32.3. ensure non-disclosure of personal data, and at the same time operation of the system of traceability.
33. Collection and storage centre shall ensure that the information on 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.
34. The information content of the donor identification, extraction and storage centre for at least 30 years after the tissue, cell or organ. Allowed to store information electronically. 
VII. The responsible person 35. Mining and storage centre designated by the responsible person. The person responsible is: 21.8. higher education diplomas awarded on completion of a university course of medical or biological sciences;
35.2. at least two years of practical experience in human tissues, cells and organs of accumulation, storage and use.
36. the responsible person shall organise measures to ensure such compliance: 36.1. every action with human tissues, cells and organs in accordance with these rules and regulations;
36.2. the Agency receives information necessary to carry out the conformity assessment procedure in accordance with point 7 of these rules;
36.3. tissue, cell and organ procurement, packaging, labelling, transportation, storage, distribution, provisioning, and personnel directly involved in the exercise is properly qualified, and staff is to ensure early learning in the development of the kvalifik;
36.4. compliance with this provision 9, 11, 12, 13, 21, 24, 26 and 33, as well as chapters V, VII and X in the above requirements.
37. Collection and storage centre in writing or electronically notify the person responsible for the Agency's name. If the person in charge temporarily or permanently replaces another person, collection and storage centre shall immediately notify to the Agency, on behalf of the new responsible person and the date on which the designated person in charge. 
VIII. Procurement of tissues and cells of donor selection and storage 38. the Centre shall establish, maintain and supplement the tissue and cell donors database. Donor database include the following: 38.1. donor's name;
38.2. the age;
38.3. the sex;
23.9. consent written confirmation to become donors of tissues and cells (living donors);
38.5. the life and history of the disease;
24.0. health examination results;
36.6. blood type and rhesus;
24.1. clinical and laboratory examination results;
24.2. the autopsy results (deceased donors);
38.10. donor match the selected recipient (hematopoetic stem cell donors).
39. In assessing the potential of each tissue and cell donors (except donors of gametes) compliance with relevant procurement of tissues and cells and use, extraction and storage centre of treatment of the person shall take into account: 24.3. information obtained in a conversation with a potential donor or the person who's well known donor (donor), and which is documented verifiable;
24.4. information obtained in a conversation with a potential donor's family doctor or treating doctor and has documented proven;
39.3. the potential donor's disease history data: 39.3.1. life and disease history;
39.3.2. physical, clinical and laboratory investigation results;
24.5. the autopsy results (deceased donors);
24.5. the law "On the dead man's body and human tissues and organs for medical use" in article 3 and 4 under certain conditions relating to the collection and use of tissues.
40. In considering the potential in each tissue and cell donors (except donors of gametes) compliance with relevant procurement of tissues and cells and use, extraction and storage centre of treatment of persons take note that tissues and cells can be obtained, allowing for minimal risk to the donor's health and other persons (such as pregnancy, child breastfeeding mothers the option of putting inherited diseases (if using hematopoetic stem cells)), as well as that of the living donor can only be taken capable of regenerating tissues.
41. In assessing the potential of each of the dead tissue and cell compatibility of specific donor tissue and cell procurement and use, extraction and storage centre of treatment of the person shall take account of the following criteria to prevent the use of the deceased donors: 25.5. cause of death unknown (if the cause of death has not been established by autopsy tissue and cell procurement);
41.2. a history of unknown etiology;
41.3. malignant tumors, except for primary basal cell carcinoma and cervical carcinoma in situ, as well as of primary central nervous system tumors;
25.7. prion diseases transmission risk: 41.4.1. diagnosed with variant Creutzfeldt-Jakob disease or variant Creutzfeldt-Jakob disease, as well as family history, not iatrogenic Creutzfeldt-Jakob originating in disease;
41.4.2. history of rapid progressive dementia or degenerative disease of the nervous system, also unknown etiology;
41.4.3. applied human pituitary hormones (such as growth hormones)-containing preparations;
41.4.4. performed corneal, cīpslen or hard shell brain transplant;
41.4.5. made in neurosurgical operations, for which no potential donor's medical records documentation (there is a possibility that previously made hard brain membrane transplantation);
25.8. bacterial, viral, fungal or parasitic infections, also infected tissues and cells for transplantation be obtained;
25.8. history or clinical laboratory confirmed HIV infection, acute or chronic hepatitis B (except persons with a proven immune status), as well as hepatitis C, HTLV-1 and HTLV-2 virus infection and the infection transmission risk or evidence found on this infection transmission risk factors;
25.9. history of chronic, systemic autoimmune connective tissue disease that affects the quality of tissues and cells that are intended to get the transplant tation!;
41.8. risk of transmission of transmissible diseases (found in the donor's body view);
41.9. poisoning by chemical substances (lead, mercury, gold, cyanide) which affect the quality of tissues and cells for transplantation, or get the recipient's health;
41.10. recently, vaccination with live attenuated virus vaccine containing;
41.11. made ksenotransplantācij (still used in preparations).

42. The evaluation of each potential deceased donors of tissues and cells (the child's) compliance with relevant procurement of tissues and cells and use, extraction and storage centre of treatment people take into account that the dead children under the age of 18 months and born to a mother with HIV infection, hepatitis B, hepatitis C or HTLV infection or virus that has found the infection transmission risk and who fed with breast feeding for at least 12 months is not allowed as a donor. The dead child that is born to a mother with HIV infection, hepatitis B, hepatitis C or HTLV infection or virus that has found the infection transmission risk and who is not fed with breast feeding for at least 12 months, allowed as a donor, if the clinical and laboratory tests found that the child does not have HIV infection, hepatitis B, hepatitis C or HTLV virus infections.
43. This rule 41.3. referred to in criterion does not apply to dead corneal donors, except that the donor was found in retinoblastom, haematological neoplasms or cancerous tumor of the anterior part of the eye. 
IX. donors of tissues and cells in the laboratory investigation. 44 Before the procurement of tissues and cells of the potential tissue and cell donors (except donors of gametes) laboratory test, or not to the donor: 44.1. antibodies against HIV ½ (anti-HIV ½);
44.2. HBV marker (Ag HBS, anti-HBc);
27.5. antibodies against the hepatitis C virus (anti-HCV-ab);
27.6. the agent of syphilis antibodies (positive test, specific active syphilis).
45. before the procurement of tissues and cells of the germ cells, the potential donor gametes which are intended for use in his dzimumpartner, take this rule 44.1, 44.2 and 44.3... referred to laboratory tests. If the potential donor gametes intended for a person who is not his dzimumpartner, in addition to the donor, make this provision 27.6. referred to laboratory examination, as well as using a nucleic acid amplification test, check whether the donor's urine does not have Chlamydia.
46. in paragraph 45 of these rules, the above requirements shall not apply if the donor of the gametes, germ cells intended for use in his dzimumpartner and they are not intended for storage.
47. A Donor who lived in regions where there is a high incidence of HTLV-1 virus infection, or a parent or dzimumpartner has lived in these regions, in addition to the provisions referred to in paragraph 44 of the laboratory testing determines if the donor does not have antibodies against the HTLV-1 virus (HTLV-1 anti-).
48. According to the procurement of tissues and cells and uses and donor of life and disease history in addition to the provisions referred to in paragraph 44, laboratory tests can determine the donor's rhesus factor (Rh) membership in compatibility count and a phenotype, as well as whether the donor has no malaria infections, toksoplazmoz, citomegalovīrus, Ebštein-Barr virus infection or tripanosomoz.
49. Tissues and cells allowed to obtain and use autologous transplantation if the donor also found that rule 44, paragraph or marker antibodies, providing for the storage of tissues and cells isolated from the rest of the transplants. This also applies to the gamete donors, which was born of the cells for use in his dzimumpartner.
50. the Donor found a bacterial septicaemia, allowed to become cornea donors if the corneal transplant kept in tissue culture, to be able to detect bacterial infection of the tissue.
51. If the donor establishes this rule 44.2. referred to anti-HBc antibodies, but absent the Antigen HBS Ag, compliance with specific donor tissue and cell procurement and use evaluation, determining the hepatitis B virus transmission risk.
52. This provision, paragraph 44, laboratory examinations for prospective donors of tissues and cells shall be carried out using the donor's serum or plasma. These tests use other donor organic liquids (eye internal fluid, vitreous body), unless specifically warranted such a liquid test validated clinical use.
53. the living tissue and cell donors (except donors of gametes, bone marrow and peripheral blood stem-cell donors) the blood of these provisions referred to in paragraph 44 of the laboratory tests take the procurement of tissues and cells, but if this is not possible, no later than seven days after the procurement of tissues and cells.
54. If the tissue and cell donors is neonatal, that provision referred to in paragraph 44 of the laboratory tests carried out on the donor mother.
55. If a living donor tissues and cells intended to be kept for long periods, after 180 days from the procurement of tissues and cells shall be carried out again in this rule referred to in paragraph 44 of the laboratory tests. In this case, a first-time donor blood samples for tests taken not earlier than 30 days before the procurement of tissues and cells or tissue and cells, or no later than seven days after the procurement of tissues and cells.
56. in paragraph 55 of these rules, the above requirements shall not apply to: 56.1. living donors of tissues and cells, except donors of gametes gametes intended for his dzimumpartner, and bone marrow and peripheral blood stem cell donor, which, using nucleic acid amplification test, perform additional laboratory tests to determine if the donor does not have HIV, HBV and HCV markers;
56.2. If the tissue and cell processing performed HIV virus, hepatitis B virus and hepatitis C virus inactivation.
57. Bone marrow and peripheral blood stem cell donor blood 44. these provisions referred to laboratory checks take 30 days before the procurement of tissues and cells.
58. Gamete donor blood that rule 44 in laboratory tests take the procurement of tissues and cells.
59. The potential deceased donor blood that rule 44 in laboratory tests taken immediately before the death, but if this is not possible, no later than 24 hours after death.
60. If the deceased tissue and cell donors before the death of lost a lot of blood and is transfused blood or blood circulation of the blood products have been entered or medication, blood hemodilūcij may be invalid, that provision referred to in paragraph 44 of the laboratory tests. In this case, evaluate the extent of blood hemodilūcij before death (if transfused blood and blood products entered into 48 hours preceding blood sampling or medication in the blood circulation of the entered one hour preceding blood sampling) and after the death (if transfused blood and blood products entered into the 48 hours preceding death, or medication for blood circulation to enter one hour before death). If blood hemodilūcij rate exceeds 50%, the blood is allowed to take this provision referred to in paragraph 44 of the laboratory tests, if used in accordance with the methods of laboratory examination of blood samples is available, taken before blood transfusion and blood circulation of the blood products or prescribed medication. 
X. procurement of tissues and cells in the treatment of the persons responsible, 61. the Act concerning the donor tissue and cell procurement (hereinafter referred to as the Act). The Act specifies the following information: 61.1. tissues and cells obtained the name and address of the consignee;
61.2. donor's name and identification code (the person who assigned the identification number);
38.1. the resulting tissue and cell description and identification code (including sample testing);
61.4. for tissue and cell procurement the responsible medical person name and signature;
61.5. tissue and cell procurement date, start and end time;
61.6. procurement of tissues and cells and its description;
38.3. the procurement of tissues and cells used in the operation of standard operating procedures;
38.4. the side effects or adverse events associated with the procurement of tissues and cells (if any);
61.9. added substances and reagents (if used);
61.10. or to get the tissue is subjected to the law "on the dead man's body and human tissues and organs for use in medicine".
62. If tissues and cells obtained from a deceased donor, the addition of this provision in the Act referred to in paragraph 61 the information indicates the following: 62.1. the date and time when the donor's death occurred;
62.2. time of death of the donor and the procurement of tissues and cells;
38.7. deceased donor body storage conditions (cooling, start and end time).
63. If the gamete donor gametes (sperm) produced in the home, the Act specifies that rule 61.1 and 61.2. bottom. above shall report the following information and if possible – this provision 61.5. information referred to in the subparagraph.
64.61. These provisions and information referred to in paragraph 62 is true, clearly legible, without corrections and complete.
65. Deceased donors of tissues and cells of the body look after the collection of tissues and cells restored according to the original appearance.  
XI. Tissue and cell transport 66. Tissues and cells transport the transport of biological materials in suitable containers. Containers provide any safety of tissues and cells and quality (temperature, prevents tissue and cell contamination).
67. If tissues and cells by third parties, the shipping container shall be marked. The labelling shall bear the following information: 67.1. tissue and cell in the sender's and recipient's address, phone and contact person;
67.2. transport date and start time;
67.3. transport and storage conditions (indication: "do not irradiate," freeze ", Not" act carefully ");

41.9. "for autologous use only", if transported autologous use for tissues and cells;
information about the dangers of 67.5. (for example, infected tissue);
67.6. "tissues and cells". 
XII. Tissue and cell storage and storage 68. After receipt of the tissue and cell procurement and storage Center verifies that the tissues and cells are derived, marked and trans ported according to the requirements set out in these provisions.
69. Tissues and cells, which do not meet the requirements laid down in these provisions and for which the donor does not receive these rules determine the result of the laboratory examination, be kept separate from the rest of the tissues and cells. Such tissues and cells use these rules to the specific requirements.
70. The acquisition and storage centre creates, maintains and adds to the tissue and cells received by the database. The database shall contain the following information: 70.1. tissue and cell application purpose (therapeutic, scientific);
70.2. the written proof of the consent of the donor tissues and cells used for a specific purpose;
70.3. procurement of tissues and cells and conditions;
70.4. tissue and cell donors living and illness health history;
70.5. clinical and laboratory examination results, including the results of the autopsy and the cause of death (deceased donors);
70.6. donor evaluation according to these rules laid down by the donor selection criteria;
70.7. data on drug intolerance (if cell cultures intended for autologous use);
70.8. indication of tissue and cell destruction (if they are not used for the purpose for which it was received the donor's consent).
71. If the gametes for use dzimumpartner of the donor, tissue and cell in the database include this rule 70.1, 70.2, 70.3.. and 70.8. the information referred to in (a), as well as information about the donor dzimumpartner. 
XIII. acquisition and use of organs 72. for donor organs for transplantation, collection and storage centre creates a specialized team. The team is composed of two doctors (one of them – a certified transplantolog), transplant Coordinator and nurse.
73. the donor organs for Transplantation of a specialized Brigade served mining and storage Center and draw up legislation on human organ procurement and transplantation of transfers (annex 1). Act shall be drawn up in duplicate. One copy to accompany the donor's medical documentation (medical records) and stored in a collection and storage centre, but the second medical institution where obtained donor organs.
74. Transplantation donor organs not used for mining and storage centre shall provide to the morphological investigation and draw up legislation on the dead person's organs without the use of transplantation (annex 2). Keep the law collection and storage centre. 
XIV. use of tissues and organs for research and study for the implementation of the programme 75. If the dead person's body (tissue and whole organ) intended to be used for scientific research and for the implementation of the programme of study in academia, tissues and organs are stored in special school laboratory humidification cupboards, on the basis of the Act concerning a deceased human body tissue and organ transfers (annex 3). Act shall be drawn up in duplicate. One copy is kept at the institution, which has transferred the dead person's body or tissue and organs, and the other – universities.
76. a Dead human body or tissue and organs are used according to the plans of scientific research and study programmes. Study process of the body, tissues and organs Krems or bury. 
XV. Closing questions 77. Be declared unenforceable in the Cabinet of 15 July 2003 Regulation No 398 "human tissue and organ accumulation, storage and usage procedures" (Latvian journal, 2003, nr. 106; 2005, nr. 65).
78. the agency that referred to in paragraph 20 of the report on the above šēj the first time the European Commission provides up to 7 April 2009. 
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 human 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.
Prime Minister, the Defense Minister a. Slakter a Health Minister v. Veldr is the Editorial Note: regulations shall enter into force by 31 March 2007.
   
1. the annex to Cabinet of 27 March 2007, regulations No 208 Health Minister v. Veldr annex 2 Cabinet 27 March 2007 regulations No 208 Health Minister v. Veldr annex 3 Cabinet 27 March 2007 regulations No 208 Health Minister v. Veldr MC