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311. Regulation of the Federal Minister of Health, amending the Regulation on medicinal products derived from human blood
On the basis of § § 5 and 62a of the German Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I No 146/2009 shall be prescribed:
The Regulation on medicinal products derived from human blood, BGBl. II No 187/2005, as last amended by the BGBl Regulation. II No 156/2007 is hereby amended as follows:
1. § 10 reads:
" § 10. The following Directives of the European Communities and of the European Union are implemented by this Regulation:
| 1. |
Directive 2002/98/EC laying down 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 311, 28.9.2002.. OJ L 33, 08.02.2003 p. 30; |
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| 2. |
Directive 2004 /33/EC on the implementation of Directive 2002/98/EC as regards certain technical requirements for blood and blood components, OJ L 327, 30.4.2004, p. OJ L 91, 30.03.2004, p. 25; |
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| 3. |
Directive 2005 /61/EC on the implementation of Directive 2002/98/EC as regards traceability requirements and the reporting of serious incidents and serious adverse reactions, OJ L 327, 30.12.2005, p. OJ L 256, 01.10.2005 p. 32; |
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| 4. |
Implementing Directive 2011 /38/EU amending Annex V to Directive 2004 /33/EC on the maximum pH levels of platelet concentrates at the end-of-life period, OJ L 206, 22.7.2011, p. OJ L 97 of 12.04.2011 p. 28. |
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2. Annex A reads:
Annex A
QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS
| 1. |
BLOOD COMPONENTS |
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| 1. Erythrocyte preparations |
The blood components listed in 1.1 to 1.8 may be further processed in blood establishments and must be labelled accordingly. |
| 1.1 |
Erythrocytes |
| 1.2 |
Erythrocytes, buffy-coat-free |
| 1.3 |
Erythrocytes, leucocyte depletion |
| 1.4 |
Erythrocytes, in additive solution |
| 1.5 |
Erythrocytes, buffy-coat-free, in additive solution |
| 1.6 |
Erythrocytes, leucocyte depletion, in additive solution |
| 1.7 |
Apheresis-erythrocytes |
| 1.8 |
Whole blood |
| Thrombocyte preparations |
The constituents listed under 2.1 to 2.6 may be further processed in blood establishments and shall be labelled accordingly. |
| 2.1 |
Apheresis platelets |
| 2.2 |
Apheresis thrombocytes, leucocyte depletion |
| 2.3 |
Pooled thrombocytes, recovered |
| 2.4 |
Pooled thrombocytes, recovered, leucocyte depletion |
| 2.5 |
Thrombocytes, recovered, single donation |
| 2.6 |
Thrombocytes, recovered, single donation, leucocyte depletion |
| 3. Plasma preparations |
The constituents listed under 3.1 to 3.3 may be further processed in blood establishments and shall be labelled accordingly. |
| 3.1 |
Frozen fresh plasma |
| 3.2 |
Frozen fresh plasma, cryoprecipitate |
| 3.3 |
Cryoprecipitate |
| 4. |
Apheresis granulocytes |
| 2. |
QUALITY CONTROL CHARACTERISTICS FOR BLOOD AND BLOOD COMPONENTS |
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2.1. Blood and blood components must comply with the following technical quality measurements and the acceptable results.
2.2. The extraction and production process must be monitored appropriately bacteriologically.
2.3. In the case of own blood donations, the measurements marked with an asterisk (*) are only recommended.
2.4. As a unit, the amount of blood or blood components obtained by a donor in the case of a decrease is designated.
| Component |
Quality measurements required The required sampling frequency for all measurements shall be determined on the basis of the statistical process monitoring |
Acceptable results in quality measurement |
| Erythrocytes |
Volume |
According to the bearing characteristics, to keep the product within the specifications for hemoglobin and hemolysis |
| Haemoglobin (*) |
At least 45 g per unit |
|
| Haemolysis |
Less than 0.8% of the erythrocyte mass at the end of the shelf life |
|
| Erythrocytes, buffy-coatfree |
Volume |
According to the bearing characteristics, to keep the product within the specifications for hemoglobin and hemolysis |
| Haemoglobin (*) |
At least 43 g per unit |
|
| Haemolysis |
Less than 0.8% of the erythrocyte mass at the end of the shelf life |
|
| Erythrocytes, leucocyte depletion |
Volume |
According to the bearing characteristics, to keep the product within the specifications for hemoglobin and hemolysis |
| Haemoglobin (*) |
At least 40 g per unit |
|
| Leukocyte content |
< 1 × 10 6 /Unit |
|
| Haemolysis |
Less than 0.8% of the erythrocyte mass at the end of the shelf life |
|
| Erythrocytes in Additives |
Volume |
According to the bearing characteristics, to keep the product within the specifications for hemoglobin and hemolysis |
| Haemoglobin (*) |
At least 45 g per unit |
|
| Haemolysis |
Less than 0.8% of the erythrocyte mass at the end of the shelf life |
|
| Erythrocytes, buffy-coate-free, in additive solution |
Volume |
According to the bearing characteristics, to keep the product within the specifications for hemoglobin and hemolysis |
| Haemoglobin (*) |
At least 43 g per unit |
|
| Haemolysis |
Less than 0.8% of the erythrocyte mass at the end of the shelf life |
|
| Erythrocytes, leucocyte depletion, in additive solution |
Volume |
According to the bearing characteristics, to keep the product within the specifications for hemoglobin and hemolysis |
| Haemoglobin (*) |
At least 40 g per unit |
|
| Leukocyte content |
< 1 × 10 6 /Unit |
|
| Haemolysis |
Less than 0.8% of the erythrocyte mass at the end of the shelf life |
|
| Apheresis-erythrocytes |
Volume |
According to the bearing characteristics, to keep the product within the specifications for hemoglobin and hemolysis |
| Haemoglobin (*) |
At least 40 g per unit |
|
| Haemolysis |
Less than 0.8% of the erythrocyte mass at the end of the shelf life |
|
| Whole blood |
Volume |
According to the bearing characteristics, to keep the product within the specifications for hemoglobin and hemolysis 450 ml +/-50 ml In paediatric autologous full-blood withdrawal-no more than 10.5 ml per kg body weight |
| Haemoglobin (*) |
At least 45 g per unit |
|
| Haemolysis |
Less than 0.8% of the erythrocyte mass at the end of the shelf life |
|
| Apheresis platelets |
Volume |
According to the bearing characteristics, to keep the product within the specifications for the pH |
| Platelet count |
Fluctuations in the platelet count per individual donation are permitted within the limits which correspond to validated processing and preservation conditions |
|
| pH |
At least 6.4 adjusted for 22 ° C at the end of the shelf life |
|
| Apheresis thrombocytes, leucocyte depletion |
Volume |
According to the bearing characteristics, to keep the product within the specifications for the pH |
| Platelet count |
Fluctuations in the platelet count per individual donation are permitted within the limits which correspond to validated processing and preservation conditions |
|
| Leukocyte content |
< 1 × 10 6 /Unit |
|
| pH |
At least 6.4 adjusted for 22 ° C at the end of the shelf life |
|
| Pooled thrombocytes, recovered |
Volume |
According to the bearing characteristics, to keep the product within the specifications for the pH |
| Platelet count |
Fluctuations in the platelet count per individual donation are permitted within the limits which correspond to validated processing and preservation conditions |
|
| Leukocyte content |
< 0.2 × 10 9 /single donation (PRP method) < 0.05 × 10 9 /Individual donation (Buffy-Coat method) |
|
| pH |
At least 6.4 adjusted for 22 ° C at the end of the shelf life |
|
| Pooled thrombocytes, recovered, leucocyte depletion |
Volume |
According to the bearing characteristics, to keep the product within the specifications for the pH |
| Platelet count |
Fluctuations in the platelet count per individual donation are permitted within the limits which correspond to validated processing and preservation conditions |
|
| Leukocyte content |
< 1 × 10 6 /Pool |
|
| pH |
At least 6.4 adjusted for 22 ° C at the end of the shelf life |
|
| Thrombocytes, recovered, single donation |
Volume |
According to the bearing characteristics, to keep the product within the specifications for the pH |
| Platelet count |
Fluctuations in the platelet count per individual donation are permitted within the limits which correspond to validated processing and preservation conditions |
|
| Leukocyte content |
< 0.2 × 10 9 /single donation (PRP method) < 0.05 × 10 9 /Individual donation (Buffy-Coat method) |
|
| pH |
At least 6.4 adjusted for 22 ° C at the end of the shelf life |
|
| Thrombocytes, recovered, single donation, leucocyte depletion |
Volume |
According to the bearing characteristics, to keep the product within the specifications for the pH |
| Platelet count |
Fluctuations in the platelet count per individual donation are permitted within the limits which correspond to validated processing and preservation conditions |
|
| Leukocyte content |
< 1 × 10 6 /Unit |
|
| pH |
At least 6.4 adjusted for 22 ° C at the end of the shelf life |
|
| Frozen fresh plasma |
Volume |
Specified volume +/-10% |
| Factor VIIIc (*) |
Average (after freezing and thawing): at least 70% of the value of the freshly taken plasma unit |
|
| Total protein (*) |
At least 50 g/l |
|
| Remaining Cells (*) |
Erythrocytes: < 6,0 × 10 9 /l Leukocytes: < 0.1 × 10 9 /l Platelets: < 50 × 10 9 /l |
|
| Frozen fresh plasma, cryoprecipitate |
Volume |
Specified volume +/-10% |
| Remaining Cells (*) |
Erythrocytes: < 6,0 × 10 9 /l Leukocytes: < 0.1 × 10 9 /l Platelets: < 50 × 10 9 /l |
|
| Cryoprecipitate |
Fibrinogen content (*) |
≥ 140 mg per unit |
| Factor VIIIc content (*) |
≥ 70 international units/unit |
|
| Apheresis granulocytes |
Volume |
< 500 ml |
| Granulocyte count |
> 1 × 10 10 Granulocytes per unit |
Stöger
