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Document 22012D0047

    Decision of the EEA Joint Committee No 47/2012 of 30 March 2012 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

    IO L 207, 2.8.2012, p. 27–27 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    ⏵Foilsíodh an doiciméad seo in eagrán speisialta (HR)

    Legal status of the document In force

    ELI: http://data.europa.eu/eli/dec/2012/47/oj

    Date of document:
    30/03/2012
    Date of effect:
    31/03/2012; Teacht i bhfeidhm Féach Airt. 3
    Date of signature:
    30/03/2012; An Bhruiséil
    Date of end of validity:
    No end date
    Author:
    Comhchoiste an LEE
    Form:
    Cinneadh arna ghlacadh ag comhlachtaí a cruthaíodh trí chomhaontuithe idirnáisiúnta
    Legal basis:
    Link
    Link
    Link
    Select all documents mentioning this document
    Modifies:
    Relation Act Comment Subdivision concerned From To
    Modifies 21994A0103(52) Cur le caibidil XIII pointe 15zm 31/03/2012
    Instruments cited:
    Link

    2.8.2012   

    EN

    Official Journal of the European Union

    L 207/27

    DECISION OF THE EEA JOINT COMMITTEE

    No 47/2012

    of 30 March 2012

    amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

    THE EEA JOINT COMMITTEE,

    Having regard to the Agreement on the European Economic Area, as amended by the Protocol adjusting the Agreement on the European Economic Area, hereinafter referred to as ‘the Agreement’, and in particular Article 98 thereof,

    Whereas:

    (1)

    Annex II to the Agreement was amended by Decision of the EEA Joint Committee No 10/2012 of 10 February 2012 (1).

    (2)

    Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (2) is to be incorporated into the Agreement,

    HAS ADOPTED THIS DECISION:

    Article 1

    The following point shall be inserted after point 15zl (Commission Decision 2008/911/EC) in Chapter XIII of Annex II to the Agreement:

    ‘15zm.

    32009 R 0668: Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (OJ L 194, 25.7.2009, p. 7)’.

    Article 2

    The text of Regulation (EC) No 668/2009 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

    Article 3

    This Decision shall enter into force on 31 March 2012, provided that all the notifications under Article 103(1) of the Agreement have been made to the EEA Joint Committee (*1).

    Article 4

    This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

    Done at Brussels, 30 March 2012.

    For the EEA Joint Committee

    The Acting President

    Gianluca GRIPPA

    (1)   OJ L 161, 21.6.2012, p. 16.

    (2)   OJ L 194, 25.7.2009, p. 7.

    (*1)  No constitutional requirements indicated.

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