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 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;

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;

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;

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.

2. Annex A reads:

Annex A

QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

1.

BLOOD COMPONENTS

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

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