Cabinet of Ministers Regulations No. 1629 in Riga 2009 (22 December. 89 123) amendments to the Cabinet of Ministers of 27 December 2005, regulations No 1035 "rules of human blood and blood components collection, testing, processing, storage and distribution of the quality and safety standards, and compensation for expenses in the amount of blood lost renewal" Issued under the medical law of article 34 of the third to make a Cabinet of 27 December 2005, regulations No 1035 "rules of human blood and blood components collection testing, processing, storage and distribution of the quality and safety standards, and compensation for expenses in the amount of blood lost for renewal "(Latvian journal, 2006, 8, 163. no) the following amendments: 1. To replace paragraph 1, the words" medical products "with the word" medicine ".
2. Express 4 by the following: "4. the distribution of blood or blood components is the delivery of the national blood center, blood preparation departments, medical institutions, or the study of blood drug manufacturers from human blood and plasma for manufacture of medicinal products. Dissemination does not include blood or blood components for transfusion issue. "
3. To make point 7 by the following: "7. Medicine Government Agency (hereinafter Agency) registered therapeutic institutions for the study of blood (blood study), and the national blood establishments blood preparation Department and assess their compliance with the requirements set out in these rules."
4. To supplement the provisions of 8.1.4 and 8.1.5 to 8.1.6.,.: the following paragraph "8.1.4. information about the conclusion of a contract for the supply of plasma from human blood and plasma for manufacture of medicinal products, indicating contract number, date, manufacturer company in the commercial register, registration number, registered office, special permission (license) for the manufacture of medicinal products;
8.1.5. information concerning temporary or mobile site, which is the responsibility of the blood establishment and which are used for the collection of blood and blood components blood establishments outside the premises (hereinafter referred to as the mobile site), if any;
8.1.6. information on the agreement with the other hospital's or the company's testing laboratory on human blood or blood components testing under contract; "
5. Make the paragraph 9 by the following: "9. the conformity assessment the agency determines what actions and under what conditions can make the national blood center, blood and blood of the preparatory Division Office. This information indicates the registry, available on the Agency's website on the internet. "
6. Make a point 15 as follows: "15. national blood establishments and blood preparation Department shall establish and maintain a quality assurance system in accordance with the principles of good practice set out in annex 6 of these rules."
7. Add to the introductory part of paragraph 17 behind the words "blood preparation Division provides" with the words "using validated processes and procedures".
8. Express 17.2. subparagraph by the following: "17.2. blood and blood components quality and safety requirements and testing in testing laboratories accredited in accordance with this annex 2 provisions. After receiving test results test report copies shall submit to the Agency a month; ".
9. Express and 10.9. paragraph 17.5. the following wording: "17.5. assessment procedures all blood and blood components donors, as well as donor acceptance criteria in accordance with the provisions of annex 4. The donor evaluation and testing procedures shall be documented and the results of the five working days notify the donor of any significant deviation from the norm;
10.9. the investigation of the donor, the donor provided to and from them the information obtained pursuant to this provision, paragraph 38 and 39, as well as in assessing the eligibility of donors, supports blood and plasma donor eligibility criteria in accordance with the provisions of annex 5. The criteria include: 17.6.1. regular blood and blood components the criteria for refusal of transfer and the associated potential donor rejection;
17.6.2. temporary blood and blood components the transfer refusal criteria; ".
10. Add to subparagraph 17.7 behind the words "quality system" with the words "standards and".
11. To supplement the provisions under section 18.5.1 the following: "the number and types of samples 18.5.1, tested in accordance with this rule 17.2. requirements set out in point, and a summary of the test results;".
12. Express 21 as follows: "21. national blood establishments shall develop and submit to the approval of the health economy in the center of the blood and blood component preparation and use of technology."
13. Express 22.1. subparagraph by the following: "22.1. appropriate control measures in blood establishments in the country, blood and blood in the Preparatory Department offices to ensure compliance with the requirements of these regulations;".
14. paragraph 23 of the following expressions: "23. To ensure that these regulations are complied with, the Agency, on a regular basis, but not less frequently than once every two years: 23.1. the control of the blood establishment and preparation of blood units, including mobile sites, if any, as well as third-party, having blood preparation conferring authority to make this rule 17.5. referred to donor evaluation and testing procedures;
23.2. the examination and take samples for analysis;
23.3. check all controls related documents;
23.4. controlled treatment study of blood institutions compliance with this provision in paragraph 36 and 37;
14.6. the certificate of conformity shall be issued, if the national blood center, blood or blood of the preparatory Division Office complies with the requirements of this regulation. "
15. Supplement with 22.6 22.6 22.7.,., and 22.7. subparagraph by the following: "maintain and store the 36.3. documentation on operational procedures, staff training, guidance and reference manuals, sample forms, as well as provide officials carrying out control measures, access to those documents;
36.4. the traceability data storage followed these rules 27, 28 and the requirements set out in paragraph 41.2;
22.7. the reporting of adverse events and serious adverse reactions that follow that rule 29, 30, 31, 32 and 33 the requirements set out in paragraph;
22.7. support data, as well as the protection of genetic information and privacy. "
16. Replace the words "paragraph 23.7 as medical products" with the words "for medicinal raw materials".
17. the title of chapter X be expressed as follows: "X. concluding issues".
18. To supplement the rules with 43 as follows: "43. National statistics and medical technologies State Agency certificates issued by the national blood center, blood and blood of the preparatory departments of the cabinet shall be valid until they expire."
19. Add to the informative reference to European Union directives, with 5, 6, and 7, paragraph by the following: "(5)) of the European Parliament and of the Council of 6 November 2001, Directive 2001/83/EC on the Community code relating to medicinal products for human use;
6) Commission of 8 October 2003 Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use;
7) 2009 of the Commission on November 3 of Directive 2009/135/EC authorising a temporary derogation from whole blood and blood components donor eligibility criteria laid down in Directive 2004/33/EC, annex III, due to the risk of lack of blood caused by A (H1N1) influenza pandemic. "
20. Put 1 point 2.1 of the annex by the following: "2.1. Hepatitis B virus surface antigen (HBsAg);".
21. Put 4 (2) of the annex by the following: "2. the level of hemoglobin in the blood donor hemoglobin * 125 g/l for women > men > 135 g/l of blood and cells Applied components are homologous donors note. * Due to the lack of risk of blood caused by A (H1N1) influenza pandemic, up to 30 June 2010 Hb level detectable: women > 120 g/l, men > 130 g/l (entry into force, if the competent national authority shall issue A (H1N1) influenza epidemic and of national blood establishments have received information that there is a lack of blood to the risk). "
22. Make of annex 5, paragraph 2.1.9. the following wording: "2.1.9. Colds disease two weeks from the day of the disappearance of the symptoms of the disease of" 23. Make note of annex 5, as follows: "notes".
the test and the period of prohibition shall not apply where the blood or blood components are used for plasma for fractionation.
** Due to the risk of lack of blood caused by A (H1N1) influenza pandemic, up to 30 June 2010 the refusal would be seven days after the disappearance of the symptoms of the disease, if the competent national authority issuing the A (H1N1) influenza epidemic and of national blood establishments have received information that there is a lack of blood to the risk. "
24. Make 6.18.1. subparagraph by the following:

18.1. National "blood establishments and blood preparations chapter quality system provides for the production of medicines for blood and blood component storage and distribution requirements for compliance with the laws and regulations on the production and control of medicinal products laid down the principles and guidelines of good manufacturing practice, as well as the European Commission's guidelines on medicinal products and investigational medicinal product good manufacturing practice requirements (European Union drug regulatory document item 14.) , which is published by the national agency of Medicine home page on the internet (URwww.zva.gov.lv). "
25. Express 6.18.6. subparagraph by the following: "18.6. Blood and blood components blood establishments to the national adoption Center and blood preparation section to put them into circulation is allowed if you have met all quality requirements and procedures established to ensure blood component compatibility."
Prime Minister v. Minister of health B dombrovsky. Brown»