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Document 62009CJ0013

    Judgment of the Court (Seventh Chamber) of 26 November 2009.
    Commission of the European Communities v Italian Republic.
    Failure of a Member State to fulfil its obligations - Directive 2006/86/EC - Traceability requirements - Notification of serious adverse reactions and events - Technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells - Failure to adopt within the prescribed period.
    Case C-13/09.

    European Court Reports 2009 I-00201*

    ECLI identifier: ECLI:EU:C:2009:734





    Judgment of the Court (Seventh Chamber) of 26 November 2009 – Commission v Italy

    (Case C‑13/09)

    Failure of a Member State to fulfil its obligations – Directive 2006/86/EC – Traceability requirements – Notification of serious adverse reactions and events – Technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells – Failure to adopt within the prescribed period

    1.                     Actions for failure to fulfil obligations – Examination of the merits by the Court – Situation to be taken into consideration – Situation on expiry of the period laid down in the reasoned opinion (Art. 226 EC) (see para. 9)

    2.                     Member States – Obligations – Implementation of directives – Failure to fulfil obligations – National system pleaded as justification – Not permissible (Art. 226 EC) (see para. 10)

    Re:

    Failure of a Member State to fulfil obligations – Failure to adopt, within the prescribed period, the provisions necessary to comply with Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ 2006 L 294, p. 32).

    Operative part

    The Court:

    1.

    Declares that, by failing to adopt within the prescribed period all the laws, regulations and administrative provisions necessary to comply with Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells, the Italian Republic has failed to fulfil its obligations under that directive;

    2.

    Orders the Italian Republic to pay the costs.

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