EMEA Authority definition

EMEA Authority means EMEA or the applicable Regulatory Authority (as hereinafter defined) in a country which is an EMEA member at the time in question.
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Examples of EMEA Authority in a sentence

  • The Development Plan shall be divided into the following phases of development: (a) pre-clinical development until the first IND filing, (b) until initiation of the first Phase 2 Clinical Trial, (c) until initiation of the first Phase 3 Clinical Trial, and (d) until the first submission of either an NDA to the FDA or an MAA to an EMEA Authority.

  • Indevus shall use commercially reasonable efforts to see that the Manufacturing Facilities pass inspection by the FDA, any EMEA Authority or any other Regulatory Authority in the Other Major Countries; and any costs incurred by Indevus that are associated with such inspection, or responding to such inspection, by any EMEA Authority or any Regulatory Authority in the Other Major Countries once the Manufacturing Facility has passed inspection by the FDA shall likewise be the sole responsibility of Indevus.