351/2010 Sb.



DECREE



on 2 December. December 2010,



amending Decree No 143/2008 Coll., laying down detailed requirements

in order to ensure the quality and safety of human blood and its components

(the Decree on human blood)



The Ministry of health shall, pursuant to section 114 para. 1 of law No.

378/2007 Coll., on pharmaceuticals and on amendments to some related laws

(law on medicinal products):



Article. (I)



Decree No 143/2008 Coll., laying down detailed requirements to ensure

the quality and safety of human blood and its components (the Decree on the human

the blood), is amended as follows:



1. in section 12 at the end of paragraph 2, the period is replaced by a comma and the following

the letter d) including footnote # 7:



"(d)) Declaration that the distribution, import or export of blood products

for the production of blood and plasma derivatives will be implemented only from donations

blood or plasma from voluntary unpaid donors ^ 7).



7) article 2, paragraph 1 of the guideline on the preparation, use and quality assurance of

blood components (Guide to the preparation, use and quality assurance of

blood components), as amended. ".



2. In annex 1, point 5.2 sub-item 5 reads as follows:



"5. the part of the records is to report on the activities of transfusion services at the device

the past year involving



and the number of donors), and it



1. the total number of donors, with the exclude first time donors, who in the period

donated blood repeatedly, in the total number of donors indicate just once,



2. total number of recurring donors,



3. the total number of prvodárců,



(b)) the total numbers of individual types of subscriptions and the sum of all subscriptions,



(c)) the updated list of blood banks, transfusion services that

in the reference period of the supply,



(d)) the total number of unused full subscriptions,



(e)) the number of each type of subscription,



(f) the quantities produced and distributed), blood products and

raw materials for further production, whose name is given in annex No 4 section

And,



g) incidence and prevalence indicators on individual infections transmissible

the total number of transfusions and recurring donors, or prvodárců,



(h)) the number of packages downloaded blood products or raw materials for further

the production,



I) the number of reported serious adverse reactions and events.

The information in subparagraphs (a) (b)), d) and (e)) shall be reported separately for each of the types

subscriptions, in particular the collection of whole blood or plasma exchange or subscription

cytaferézou. The information in subparagraph (f)) shall be shown separately in the relevant

units for whole blood, red blood cells, platelets, plasma, and any

other types of products, whose name is indicated. Report on operations under the

the past year in electronic form shall be forwarded to the Ministry of health

until 31 December 2006. January of the following year in a manner allowing remote access. ".



3. In annex 1, point 7.1 of the final part of the provision in the first sentence

the words "and (h))" shall be replaced by "and i)".



4. In annex 1, point 7.2 is added at the end of subsection 2 sentence "in

where is the service used, validated method of blood transfusion

inactivation of pathogens in the plasma, which was allowed by the Institute pursuant to § 67

paragraph. 2 of the Act, the repeated examination of the donor does not. ".



5. In annex 1, point 9 (i)(a) 1 final part of the provision, the words

"(b). a) "is replaced by" (a). (b)) ".



6. in annex # 11 point (i)(a) 9 2, the words "(a). and) point 2 "are replaced by

the words "point 1 (b). (b)) ".



7. in annex 3, part A, point 2.3 is added at the end of subparagraph 2, sentence

"Minimum interval between two device subscriptions plasma is 14 days.".



8. in annex 3, part C, point 3, the text at the end of the first sentence, the following shall

the words "in the State Health Institute ^ 8)."



Footnote # 8 reads as follows:



"8) section 74 para. 1 Act No. 258/2000 Coll., on the protection of public health, in

amended by Act No. 320/2002 Coll. ".



9. in annex No 4, part A, the heading "Full blood" in the column "adopted by the

the results of measurements of the quality of "deleted the word" than ".



10. in annex 6, point 1, subparagraph 1.1 at the end after the words "the number of

issued by the Pack blood products ", the words" namely

referred to, where the size of the package is given in the relevant quantitative

units ".



11. in annex 6, point 2, the words "the total number of processed

units of blood and blood components ", the words" namely

referred to in the relevant quantitative units ".



Article. (II)



The effectiveness of the



This Decree shall enter into force on 1 January 2000. January 2011.



Minister:



doc. MUDr. Heger, CSc., r.