Approved Labeling means, with respect to the Licensed Product: (a) the Regulatory Authority-approved full prescribing information for the Licensed Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for the Licensed Product.
Approved Labeling means, with respect to a Licensed Product: (a) the Regulatory Authority-approved full prescribing information for such Licensed Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Licensed Product.
Approved Labeling means the Food and Drug Administration’s (FDA) approved labeling which contains FDA approved information for the diluent, the resultant strength, the container closure system, and storage time.
Examples of Approved Labeling in a sentence
It will, and will ensure that its Affiliates, comply with all Applicable Law and, to the extent applicable, Professional Requirements, with respect to the performance of its obligations under this Agreement, including, as applicable, the Approved Labeling, the European Data Protection Directive 95/46/EC, the European General Data Protection Regulation (Regulation (EU) 2016/679), and any other applicable national data protection legislation.
More Definitions of Approved Labeling
Approved Labeling means the Food and Drug Administration’s (FDA) approved labeling in accordance with sections 201.56 and 201.57 of title 21, Code of Federal Regulations that contains FDA approved information for the diluent, the resultant strength, the container closure system, and storage time.
Approved Labeling means the approved labeling for Product or Infusion set as set forth in the applicable Regulatory Approval in a particular jurisdiction.
Approved Labeling means, with respect to a Collaboration Product: (a) the Regulatory Authority-approved full prescribing information for such Collaboration Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Collaboration Product.
Approved Labeling means, with respect to a Licensed Product that has obtained Marketing Approval in the Shared Territory, (a) the FDA-approved full prescribing information for such Licensed Product; and (b) the FDA-approved labels and other written, printed, or graphic materials on any container, wrapper, or package insert that is used with or for such Licensed Product in the Shared Territory.
Approved Labeling means, with respect to a Cost Profit Sharing Product: (a) the Regulatory Authority-approved full prescribing information for such Cost Profit Sharing Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Cost Profit Sharing Product.
Approved Labeling shall include all of the following : (i) the Product label to be affixed to the bottle; (ii) the Product package insert (the "Insert"); and (iii) the Product patient-information leaflet, in the form attached as Exhibit E.
Approved Labeling means, with respect to each Product in a country in the Territory: (a) the Regulatory Authority-approved full prescribing information for such Product in such country; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Product in such country.