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.
View Source
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.
View Source
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.
View Source

Examples of Product Labeling in a sentence

  • The packaging, Promotional Materials and Product Labeling for POZEN Products will carry the POZEN House Marks only if and to the extent required by Applicable Law.

  • The JCC shall determine which Party shall be responsible for designing and supplying the Product Labeling and Promotional Materials for each Collaboration Product in the Territory.

  • Company shall be solely responsible for the preparation, content, and method of distribution of the Product Promotional Materials and the Product Labeling.

  • ELITE is responsible for submitting the content of labeling in Structured Product Labeling (“SPL”) format to the FDA for LANNETT’S NDC numbers within fourteen (14) days of ANDA approval to ensure proper drug listing.

  • To the extent required by Applicable Law in a country or other jurisdiction in the Territory, the promotional materials, packaging, and Product Labeling for the Licensed Products used by AbbVie and its Affiliates in connection with the Licensed Products in such country or other jurisdiction shall contain (a) the Corporate Name of Licensor, and (b) the logo and corporate name of the manufacturer (if other than AbbVie or an Affiliate) (collectively, the “Markings”).


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.
View Source
Product Labeling shall have the same meaning as defined in the Act and as interpreted by the FDA.
View Source
Product Labeling means all labels and other written,
View Source
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.
View Source
Product Labeling or “Product Label” means, with respect to a Collaboration Product in a country in the Territory, (a) the Regulatory Authority‑approved prescribing information for such Collaboration Product for such 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 such Collaboration Product in such country.
View Source
Product Labeling means all labels and other written, printed, or graphic matter
View Source
Product Labeling means, with respect to the Product: (a) the Regulatory Authority-approved full prescribing information for the Product for a 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 the Product in such country or other jurisdiction.
View Source