Commission Directive 2005/61/ECShow full title

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:

(1)

OJ L 33, 8.2.2003, p. 30.

(2)

OJ L 203, 21.7.1998, p. 14.

(3)

OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).

(4)

OJ L 91, 30.3.2004, p. 25.