Amendment Of The Regulation On Medicinal Products From Human Blood

Original Language Title: Änderung der Verordnung betreffend Arzneimittel aus menschlichem Blut

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311. Regulation of the Federal Minister for health, modifies the regulation on medicinal products from human blood

On the basis of § § 5 and 62a of the medicines Act, Federal Law Gazette No. 185/1983, as last amended by Federal Law Gazette I no. 146/2009 is prescribed:

The regulation on medicinal products from human blood, BGBl. II no 187/2005, as last amended by regulation BGBl. II No 156/2007 is amended as follows:

1. paragraph 10:

"§ 10. Through this regulation, following directives of the European communities and the European Union are implemented: 1. Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of blood and blood components and amending Directive 2001/83/EC, OJ L 33 of the 08.02.2003 S. 30;

2. Directive 2004/33/EC implementing Directive 2002/98/EC as regards certain technical requirements for blood and blood components OJ L 91 of the 30.03.2004 p. 25;

3. Directive 2005/61/EC implementing Directive 2002/98/EC as regards the requirements for traceability and the reporting of serious adverse events and serious adverse reactions, OJ L 256 of the 1 October 2005 p. 32;

4. implementing directive 2011/38/EC amending Annex V of Directive 2004/33/EC on the pH levels of platelet concentrates at the end of its shelf life, OJ "L 97 of the 12.04.2011 p. 28."

2. Annex A is as follows:

Appendix A

QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS 1 BLOOD COMPONENTS



1 red cell preparations



Under 1.1 blood components to 1.8 can be processed further in blood establishments and must be labelled accordingly.



1.1



Red blood cells



1.2



Red cells, buffy coat removed



1.3



Red cells, leucocyte-depleted



1.4



Red cells, in additive solution



1.5



Red cells, buffy coat removed, in additive solution



1.6



Red cells, leucocyte-depleted, in additive solution



1.7



Apheresis red blood cells



1.8



Whole blood



2. platelet preparations



The under 2.1 components listed up to 2.6 can be processed further in blood establishments and must be labelled accordingly.



2.1



Platelets, Apheresis



2.2



Platelets, Apheresis, leucocyte-depleted



2.3



Pool platelets, recovered



2.4



Reset won, leucocyte-depleted platelets, pool,



2.5



Platelets, recovered, single unit



2.6



Platelets, recovered, single unit, leukozytendepletiert



3. plasma preparations



The under 3.1 components listed to 3.3 can be processed further in blood establishments and must be labelled accordingly.



3.1



Fresh-frozen plasma



3.2



Fresh-frozen plasma, Cryoprecipitate



3.3



Cryoprecipitate



4.



Granulocytes, Apheresis 2. quality control for blood and blood components 2.1. blood and blood components the following technical quality measurements and acceptable results comply.

2.2. which is bacteriologically adequately to monitor extraction and production process.

2.3. for autologous donations which will be with an asterisk (*) marked measurements only recommended.

2.4. when unit is known from a donor in a loss obtained amount of blood or blood components.



Part



Quality measurements the required frequency of sampling for all measurements is required to determine on the basis of the statistical process monitoring



Acceptable results in the quality measurement



Red blood cells



Volume



Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis



Hemoglobin (*)



At least 45 g per unit



Hemolysis



Less than 0.8% of red cell mass at the end of the shelf life



Red cells, buffy-coatfrei



Volume



Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis



Hemoglobin (*)



At least 43 g per unit



Hemolysis



Less than 0.8% of red cell mass at the end of the shelf life



Red cells, leucocyte-depleted



Volume



Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis



Hemoglobin (*)



At least 40 g per unit



Leukocyte content



< 1 × 106/unit



Hemolysis



Less than 0.8% of red cell mass at the end of the shelf life



Red cells in additive solution



Volume



Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis



Hemoglobin (*)



At least 45 g per unit



Hemolysis



Less than 0.8% of red cell mass at the end of the shelf life



Red cells, buffy-coatfrei, in additive solution



Volume



Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis



Hemoglobin (*)



At least 43 g per unit



Hemolysis



Less than 0.8% of red cell mass at the end of the shelf life



Red cells, leucocyte-depleted, in additive solution



Volume



Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis



Hemoglobin (*)



At least 40 g per unit



Leukocyte content



< 1 × 106/unit



Hemolysis



Less than 0.8% of red cell mass at the end of the shelf life



Apheresis red blood cells



Volume



Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis



Hemoglobin (*)



At least 40 g per unit



Hemolysis



Less than 0.8% of red cell mass at the end of the shelf life



Whole blood



Volume



Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis

450 ml +/-50 ml

For paediatric autologous whole blood samples - not exceed 10,5 ml per kg of body weight



Hemoglobin (*)



At least 45 g per unit



Hemolysis



Less than 0.8% of red cell mass at the end of the shelf life



Platelets, Apheresis



Volume



According to the storage characteristics to maintain product within specifications for Ph



Platelet count



Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to



pH



At least 6.4 cleans up to 22 ° C at the end of the shelf life



Platelets, Apheresis, leucocyte-depleted



Volume



According to the storage characteristics to maintain product within specifications for Ph



Platelet count



Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to



Leukocyte content



< 1 × 106/unit



pH



At least 6.4 cleans up to 22 ° C at the end of the shelf life



Pool platelets, recovered



Volume



According to the storage characteristics to maintain product within specifications for Ph



Platelet count



Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to



Leukocyte content



< 0,2 × 109/single donation (PRP method)

< 0,05 × 109/single unit (Buffy coat method)



pH



At least 6.4 cleans up to 22 ° C at the end of the shelf life



Reset won, leucocyte-depleted platelets, pool,



Volume



According to the storage characteristics to maintain product within specifications for Ph



Platelet count



Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to



Leukocyte content



< 1 × 106/pool



pH



At least 6.4 cleans up to 22 ° C at the end of the shelf life



Platelets, recovered, single unit



Volume



According to the storage characteristics to maintain product within specifications for Ph



Platelet count



Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to



Leukocyte content



< 0,2 × 109/single donation (PRP method)

< 0,05 × 109/single unit (Buffy coat method)



pH



At least 6.4 cleans up to 22 ° C at the end of the shelf life



Platelets, recovered, single unit, leukozytendepletiert



Volume



According to the storage characteristics to maintain product within specifications for Ph



Platelet count



Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to



Leukocyte content



< 1 × 106/unit



pH



At least 6.4 cleans up to 22 ° C at the end of the shelf life



Fresh-frozen plasma



Volume



Specified volume +/-10%



Factor VIIIc (*)



Average (after freezing and thawing): at least 70% of the value of the freshly collected plasma unit



Total protein (*)



At least 50 g / l



Remaining cells (*)



Erythrocytes: < 6.0 × 109/l

Leukocytes :< 0.1 × 109/l

Platelets: < 50 × 109/l



Fresh-frozen plasma, Cryoprecipitate



Volume



Specified volume +/-10%



Remaining cells (*)



Erythrocytes: < 6.0 × 109/l

Leukocytes :< 0.1 × 109/l

Platelets: < 50 × 109/l



Cryoprecipitate



Fibrinogen content (*)



≥ 140 mg per unit



Salary factor VIIIc (*)



≥ 70 international units/unit



Granulocytes, Apheresis



Volume



< 500 ml



Granulozytenzahl




> 1 × 1010 granulocytes per unit of sands