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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2Sample 3

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 (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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2Sample 3
Product Labeling shall have the same meaning as defined in the Act and as interpreted by the FDA.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2Sample 3
Product Labeling means (a) the full prescribing information for a POZEN Product approved by the applicable Regulatory Authority in the Territory, 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 POZEN Product in the Territory.
Sample 1Sample 2Sample 3
Product Labeling means all labels and other written,
Sample 1Sample 2Sample 3
Product Labeling means (i) the FDA approved full prescribing information for the Product, including any required patient information, and (ii) all labels and other written, printed, or graphic matter upon any container, wrapper, or any package insert, utilized with or for the Product.
Sample 1Sample 2