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  1. #640807

    Ciallaíonn “táirge íocshláinte imscrúdaitheach ardteiripe” táirge íocshláinte imscrúdaitheach ar táirge íocshláinte ardteiripe é mar atá sainmhínithe i bpointe (a) d'Airteagal 2(1) de Rialachán (CE) Uimh.1394/2007 ó Pharlaimint na hEorpa agus ón gComhairle(11);

    ‘Advanced therapy investigational medicinal product’ means an investigational medicinal product which is an advanced therapy medicinal product as defined in point (a) of Article 2(1) of Regulation (EC) No 1394/2007 of the European Parliament and of the Council(11);

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  2. #641045

    Chun críche comhairliúcháin le saineolaithe, féadfaidh an Ballstát tuairiscithe an tréimhse dá dtagraítear i mír 3 a fhadú 50 lá breise i gcás trialacha cliniciúla lena mbaineann táirgí íocshláinte imscrúdaitheacha ardteiripe nó táirgí íocshláinte mar a shainmhínítear i bpointe 1 den Iarscríbhinn a ghabhann le Rialachán (CE) Uimh.726/2004. I gcás den sórt sin, beidh feidhmmutatis mutandisag na tréimhsí dá dtagraítear i mír 4 agus i mír 6 den Airteagal seo.

    The reporting Member State may extend the period referred to in paragraph 3 by a further 50 days for clinical trials involving an advanced therapy investigational medicinal product or a medicinal product as set out in point 1 of the Annex to Regulation (EC) No 726/2004, for the purpose of consulting with experts.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance