http://www.legislation.gov.uk/id/eudr/2004/33/contents

1.‘Autologous donation’ means blood and blood components collected from an...2.‘Allogeneic donation’ means blood and blood components collected from an...3.‘Validation’ means the establishment of documented and objective evidence that...4.‘Whole blood’ means a single blood donation. 5.‘Cryopreservation’ means prolongation of the storage life of blood components...6.‘Plasma’ means the liquid portion of the blood in which...7.‘Cryoprecipitate’ means a plasma component prepared from plasma, fresh-frozen, by...8.‘Washed’ means a process of removing plasma or storage medium...9.‘Red cells’ means the red cells from a single whole...10.‘Red cells, buffy coat removed’ means the red cells from...11.‘Red cells, leucocyte-depleted’ means the red cells from a single...12.‘Red cells in additive solution’ means the red cells from...13.‘Additive solution’ means a solution specifically formulated to maintain beneficial...14.‘Red cells, buffy coat removed, in additive solution’ means the...15.‘Buffy coat’ means a blood component prepared by centrifugation of...16.‘Red cells, leucocyte-depleted, in additive solution’ means the red cells...17.‘Red cells, apheresis’ means the red cells from an apheresis...18.‘Apheresis’ means a method of obtaining one or more blood...19.‘Platelets, apheresis’ means a concentrated suspension of blood platelets obtained...20.‘Platelets, apheresis, leucocyte-depleted’ means a concentrated suspension of blood platelets,...21.‘Platelets, recovered, pooled’ means a concentrated suspension of blood platelets,...22.‘Platelets, recovered, pooled, leucocyte-depleted’ means a concentrated suspension of blood...23.‘Platelets, recovered, single unit’ means a concentrated suspension of blood...24.‘Platelets, recovered, single unit, leucocyte-depleted’ means a concentrated suspension of...25.‘Plasma, fresh-frozen’ means the supernatant plasma separated from a whole...26.‘Plasma, cryoprecipitate-depleted for transfusion’ means a plasma component prepared from...27.‘Granulocytes, apheresis’ means a concentrated suspension of granulocytes obtained by...28.‘Statistical process control’ means a method of quality control of...

ANNEX IIINFORMATION REQUIREMENTS

PART AInformation to be provided to prospective donors of blood or blood components1.Accurate educational materials, which are understandable for members of the...2.For both allogeneic and autologous donations, the reasons for requiring...3.Information on the protection of personal data: no unauthorised disclosure...4.The reasons why individuals are not to make donations which...5.Specific information on the nature of the procedures involved either...6.Information on the option for donors to change their mind...7.The reasons why it is important that donors inform the...8.Information on the responsibility of the blood establishment to inform...9.Information why unused autologous blood and blood components will be...10.Information that test results detecting markers for viruses, such as...11.Information on the opportunity for donors to ask questions at...PART BInformation to be obtained from donors by blood establishments at every donation1.Identification of the donor 2.Health and medical history of the donor 3.Signature of the donor

ANNEX IIIELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS

1.ACCEPTANCE CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS...1.1.Age and body weight of donors 1.2.Haemoglobin levels in donor's blood 1.3.Protein levels in donor's blood 1.4.Platelet levels in donor's blood 2.DEFERRAL CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS...2.1.Permanent deferral criteria for donors of allogeneic donations 2.2.Temporary deferral criteria for donors of allogeneic donations 2.2.1.Infections Duration of deferral period 2.2.2.Exposure to risk of acquiring a transfusion-transmissible infection 2.2.3.Vaccination 2.2.4.Other temporary deferrals 2.3.Deferral for particular epidemiological situations 2.4.Deferral criteria for donors of autologous donations

ANNEX IVSTORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS

1.STORAGE 1.1.Liquid storage 1.2.Cryopreservation 2.TRANSPORT AND DISTRIBUTION 3.ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS 3.1.Autologous blood and blood components must be clearly identified as...3.2.Autologous blood and blood components must be labelled as required...

ANNEX VQUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

1.THE BLOOD COMPONENTS 2.QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS 2.1.Blood and blood components must comply with the following technical...2.2.Appropriate bacteriological control of the collection and manufacturing process must...2.3.Member States must take all necessary measures to ensure that...2.4.For autologous donations, the measures marked with an asterisk (*)...

Commission Directive 2004/33/EC

of 22 March 2004

implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC1, and in particular points (b) to (g) of the second paragraph of Article 29 thereof,

Whereas:

(1)

Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection.

(2)

In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements.

(3)

This Directive lays down those technical requirements, which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community2, certain recommendations of the Council of Europe, the opinion of the Scientific Committee for Medicinal Products and Medical Devices, the monographs of the European Pharmacopoeia, particularly in respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products and recommendations of the World Health Organisation (WHO), as well as international experience in this field.

(4)

Blood and blood components imported from third countries, including those used as starting material/raw material for the manufacture of medicinal products derived from human blood and human plasma, should meet the quality and safety requirements set out in this Directive.

(5)

With regard to blood and blood components collected for the sole purpose of, and exclusive use in, autologous transfusion (autologous donation), specific technical requirements should be laid down, as required by Article 2(2) of Directive 2002/98/EC. Such donations should be clearly identified and kept separate from other donations to ensure that they are not used for transfusion to other patients.

(6)

It is necessary to determine common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.

(7)

The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC,

HAS ADOPTED THIS DIRECTIVE: