Product Labeling definition

Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority‑approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) 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 or other jurisdiction.
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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 (a) the Regulatory Authority-approved full prescribing information for the Licensed Product for that country, including any required patient information; and (b) all labels and other written, printed or graphic matter upon a container, wrapper or any package insert utilized with or for the Licensed Product.
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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.

  • SUBMISSION OF REMS DOCUMENT IN SPL FORMAT FDA can accept the REMS document in Structured Product Labeling (SPL) format.

  • 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.

  • 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.


More Definitions of Product Labeling

Product Labeling means all labels and other written, printed, or graphic matter provided by the Company including (i) any container or wrapper utilized with a Product, or (ii) any written material accompanying a Product, including, without limitation, Product package inserts.
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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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Product Labeling means, with respect to a Product in the Territory, (a) the Regulatory Authority-approved or authorized full prescribing information or instructions for use for such Product, including any required patient information and (b) all labels and other written, printed or graphic matter upon a container, wrapper or any package insert utilized with or for a Product in the Territory (but excluding any Intellectual Property Rights therein).
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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 means, with respect to a particular pharmaceutical product and a particular country, (a) the full prescribing information for the product approved by the applicable Regulatory Authorities in such country, including any required patient information; and (b) all labels and other written, printed or graphic matter physically upon a container, wrapper or any package insert utilized with or for the product in such country.
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Product Labeling means the labels and other written, printed or graphic matter upon (a) any container or wrapper utilized with the Product or (b) any written material accompanying the Product, including Product package inserts, in each case as approved by the FDA.
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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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