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/EC
Print Options
PrintThe Whole
Directive
PrintThe
Annexes
only
Changes over time for: Directive 2002/98/EC of the European Parliament and of the Council (Annexes only)
Timeline of Changes
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
Status:
EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
ANNEX IU.K.INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY FOR THE PURPOSES OF DESIGNATION, AUTHORISATION, ACCREDITATION OR LICENSING IN ACCORDANCE WITH ARTICLE 5(2)
Part A:U.K.General information:
identification of the blood establishment
name, qualification and contact details of responsible persons
a list of hospital blood banks which it supplies.
Part B:U.K.A description of the quality system, to include:
documentation, such as an organisation chart, including responsibilities of responsible persons and reporting relationships
documentation such as site master file or quality manual describing the quality system in accordance with Article 11(1)
number and qualifications of personnel
hygiene provisions
premises and equipment
list of standard operating procedures for recruitment, retention and assessment of donors, for processing and testing, distribution and recall of blood and blood components and for the reporting and recording of serious adverse reactions and events.
ANNEX IIU.K.REPORT OF THE BLOOD ESTABLISHMENT'S PRECEDING YEAR'S ACTIVITY
This annual report will include:
total number of donors who give blood and blood components
total number of donations
an updated list of the hospital blood banks which it supplies
total number of whole donations not used
number of each component produced and distributed
incidence and prevalence of transfusion transmissible infectious markers in donors of blood and blood components
number of product recalls
number of serious adverse events and reactions reported.
ANNEX IIIU.K.LABELLING REQUIREMENTS
The label on the component must contain the following information:
the official name of the component
the volume or weight or number of cells in the component (as appropriate)
the unique numeric or alphanumeric donation identification
the name of producing blood establishment
the ABO Group (not required for plasma intended only for fractionation)
the Rh D Group, either Rh D positive or Rh D negative (not required for plasma intended only for fractionation)
the date or time of expiry (as appropriate)
the temperature of storage
the name, composition and volume of anticoagulant and/or additive solution (if any).
ANNEX IVU.K.BASIC TESTING REQUIREMENTS FOR WHOLE BLOOD AND PLASMA DONATIONS
The following tests must be performed for whole blood and apheresis donations, including autologous predeposit donations:
ABO Group (not required for plasma intended only for fractionation)
Rh D Group (not required for plasma intended only for fractionation)
testing for the following infections in the donors:
Hepatitis B (HBs-Ag)
Hepatitis C (Anti-HCV)
HIV 1/2 (Anti-HIV 1/2)
Additional tests may be required for specific components or donors or epidemiological situations.
Back to top