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Product Labeling definition

Product Labeling means (a) the full prescribing information for the Product approved by the applicable Regulatory Authority, and (b) all labels and other written, printed or graphic information included in or placed upon any container, wrapper or package insert used with or for the Product.
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Product Labeling means, with respect to a Licensed Product in a country in the Territory, (i) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country, including any required patient information and (ii) all labels and other written, printed or graphic matter upon a container, wrapper or any package insert utilized with or for such Licensed Product in such country.
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Product Labeling shall have the same meaning as defined in the Act and as interpreted by the Regulatory Authority in each country in the Territory.
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Examples of Product Labeling in a sentence

  • Electronic Drug Registration and Listing System (eDRLS) databaseThe electronic Drug Registration and Listing System (eDRLS) was established to supports the FDA’s Center for Drug Evaluation and Research (CDER) goal to establish a common Structured Product Labeling (SPL) repository for all facilities that manufacture regulated drugs.

  • See Santa Fe Natural Tobacco Company’s Supplemental Brief inSupport of Motion to Dismiss Responding to the Court’s Question Regarding Status of Agreement with FDA Regarding NAS Product Labeling and Advertising, filed November 29, 2017 (Doc.

  • Investors must read the KIM, Instructions and Product Labeling on front page before completing this Form.

  • The electronic Drug Registration and Listing System (eDRLS) was established to supports the FDA’s Center for Drug Evaluation and Research (CDER) goal to establish a common Structured Product Labeling (SPL) repository for all facilities that manufacture regulated drugs.

  • Advertising and Product Labeling RestrictionsNeither the name nor emblem nor any advertising or labeling indicating or implying any connection with Family, Career and Community Leaders of America, Inc.


More Definitions of Product Labeling

Product Labeling means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.
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Product Labeling shall have the same meaning as defined in the Act and as interpreted by the FDA.
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Product Labeling means (i) the full prescribing information for any Product, as approved by the relevant Regulatory Authority and (ii) all labels and other written, printed or graphic information included in or placed upon any container, wrapper or package insert used with or for any Product that complies with the Regulatory Approval for such product.
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Product Labeling means all labels and other written,
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Product Labeling means the labels and other written, printed, or graphic matter upon an article, or the containers or wrappers that accompany an article, except for letters, numbers, and symbols stamped into the container as required by the federal Department of Transportation.
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Product Labeling means, with respect to a Product in a country or other jurisdiction in the Territory, (a) the full prescribing information for such Product for such country or other jurisdiction, including any required patient information, approved by the applicable Regulatory Authority; and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Product in such country or other jurisdiction.
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Product Labeling means all labels and other written, printed, or graphic matter
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