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.
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.
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.
Examples of Product Labeling in a sentence
Accordingly, the Commission has submitted this notice of proposed rulemaking and associated Supporting Statement to OMB for review under the PRA.32Package and Product Labeling: Theproposed amendments require manufacturers to label several new bulb types.
This step-by-step document provides instructions on how to properly submit Structured Product Labeling (SPL) files to the FDA.
Launch the Pragmatic Structures Product Labeling tool by clicking on the SPL Xforms link to launch the FDA Xforms tool.
The teacher announces the topic – „Components and Forms of Product Labeling ", type (development of new skills), Specific Competence (Unit of learning outcomes), along with their knowledge, skills and attitudes and operational objectives.
Refer to SOPP 8412: Review of Product Labeling for additional information.
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.
Product Labeling means (a) the full prescribing information for any Collaboration Product, as approved by the FDA, including any required patient information; and (b) all labels and other written, printed or graphic matter relating to a Collaboration Product itself (or a component thereof) or any container, wrapper or any package insert utilized with or for any Collaboration Product required to be approved by the FDA, in each case solely to the extent required for commercial launch.
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.
Product Labeling has the same meaning as defined in the Act and as interpreted by the FDA, and any analogous Laws as interpreted by an applicable Regulatory Authority elsewhere in the Territory.
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.
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.
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.