" /> Submission - CISMeF





Preferred Label : Submission;

NCIt definition : Something submitted for the judgment or consideration of others.;

Alternative definition : BRIDG 3.0.3: A compilation of the contents of one or more submission units that supports a specific regulatory purpose or decision. EXAMPLE(S): A request for approval to either market a product or to allow the applicant to start testing of a proposed product. NOTE(S): In most cases, the compilation of the submission units is used to assess a product's quality, safety and effectiveness. Submissions are always associated with some regulatory action (or inaction). Each submission contains their own regulatory action. Submissions (e.g., initial marketing application, supplemental marketing application) would generally be comprised of multiple submissions units. Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission.; BRIDG 5.3: A compilation of the contents of one or more submission units that supports a specific regulatory purpose or decision. EXAMPLE(S): A request for approval to either market a product or to allow the applicant to start testing of a proposed product. OTHER NAME(S): NOTE(S): In most cases, the compilation of the submission units is used to assess a product's quality, safety and effectiveness. Submissions are always associated with some regulatory action (or inaction). Each submission contains their own regulatory action. Submissions (e.g., initial marketing application, supplemental marketing application) would generally be comprised of multiple submissions units. Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission.;

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Keyword's position in hierarchy(ies) : arborescence

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11/05/2024


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