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  1. #284903

    - táirge a ndearnadh innealtóireacht fhíocháin air faoi mar a shainmhínítear i bpointe (b) é.

    - a tissue engineered product as defined in point (b).

    Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004

  2. #284904

    (b) Ciallaíonn "táirge a ndearnadh innealtóireacht fhíocháin air":

    (b) "Tissue engineered product" means a product that:

    Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004

  3. #284907

    Féadfaidh cealla nó fíocháin de bhunús daonna nó ainmhíoch, nó iad araon, a bheith i dtáirge a ndearnadh innealtóireacht fíocháin air.

    A tissue engineered product may contain cells or tissues of human or animal origin, or both.

    Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004

  4. #284923

    - ar tháirge íocshláinte theiripe na gceall sómach nó ar tháirge a ndearnadh innealtóireacht fhíocháin air, agus

    - a somatic cell therapy medicinal product or a tissue engineered product, and

    Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004

  5. #284921

    4. Measfar gur táirge a ndearnadh innealtóireacht fhíocháin air táirge a fhéadfaidh teacht faoin sainmhíniú ar tháirge a ndearnadh innealtóireacht fhíocháin air agus faoin sainmhíniú ar tháirge íocshláinte theiripe na gceall sómach.

    4. A product which may fall within the definition of a tissue engineered product and within the definition of a somatic cell therapy medicinal product shall be considered as a tissue engineered product.

    Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004