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Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance)

Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (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/EC(1), and in particular points (a) and (i) 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 dealing with traceability, a Community procedure for notifying serious adverse reactions and events and the notification format.

  3. Notification of suspected serious adverse reactions or serious adverse events should be submitted to the competent authority as soon as known. This Directive therefore establishes the notification format defining the minimum data needed, without prejudice to the faculty of Member States to maintain or introduce in their territory more stringent protective measures which comply with the provisions of the Treaty as provided under Article 4(2) of Directive 2002/98/EC.

  4. 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 Community(2), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(3), 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(4), and certain recommendations of the Council of Europe.

  5. Accordingly, blood and blood components imported from third countries, including those used as starting material or raw material for the manufacture of medicinal products derived from human blood and human plasma, intended for distribution in the Community, should meet equivalent Community standards and specifications relating to traceability and serious adverse reaction and serious adverse event notification requirements as set out in this Directive.

  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:

Article 1 Definitions

For the purposes of this Directive, the following definitions shall apply:

  1. ‘traceability’ means the ability to trace each individual unit of blood or blood component derived thereof from the donor to its final destination, whether this is a recipient, a manufacturer of medicinal products or disposal, and vice versa;

  2. ‘reporting establishment’ means the blood establishment, the hospital blood bank or facilities where the transfusion takes place that reports serious adverse reactions and/or serious adverse events to the competent authority;

  3. ‘recipient’ means someone who has been transfused with blood or blood components;

  4. ‘issue’ means the provision of blood or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient;

  5. ‘imputability’ means the likelihood that a serious adverse reaction in a recipient can be attributed to the blood or blood component transfused or that a serious adverse reaction in a donor can be attributed to the donation process;

  6. ‘facilities’ means hospitals, clinics, manufacturers, and bio-medical research institutions to which blood or blood components may be delivered.

Article 2 Traceability

1.

Member States shall ensure the traceability of blood and blood components through accurate identification procedures, record maintenance and an appropriate labelling system.

2.

Member States shall ensure that the traceability system in place in the blood establishment enables the tracing of blood components to their location and processing stage.

3.

Member States shall ensure that every blood establishment has a system in place to uniquely identify each donor, each blood unit collected and each blood component prepared, whatever its intended purpose, and the facilities to which a given blood component has been delivered.

4.

Member States shall ensure that all facilities have a system in place to record each blood unit or blood component received, whether or not locally processed, and the final destination of that received unit, whether transfused, discarded or returned to the distributing blood establishment.

5.

Member States shall ensure that every blood establishment has a unique identifier that enables it to be precisely linked to each unit of blood that it has collected and to each blood component that it has prepared.

Article 3 Verification procedure for issuing blood or blood components

Member States shall ensure that the blood establishment, when it issues units of blood or blood components for transfusion, or the hospital blood bank has in place a procedure to verify that each unit issued has been transfused to the intended recipient or if not transfused to verify its subsequent disposition.

Article 4 Record of data on traceability

Member States shall ensure that blood establishments, hospital blood banks, or facilities retain the data set out in Annex I for at least 30 years in an appropriate and readable storage medium in order to ensure traceability.

Article 5 Notification of serious adverse reactions

Article 6 Notification of serious adverse events

Article 7 Requirements for imported blood and blood components

Article 8 Annual reports

Article 9 Communication of information between competent authorities

Article 10 Transposition

Article 11 Entry into force

Article 12 Addressees

ANNEX I

ANNEX II

ANNEX III