Company Core Data Sheet definition
Company Core Data Sheet means the global reference labeling document used to direct the content of country-specific labeling for Licensed Products.
Company Core Data Sheet or “CCDS” means, a document prepared by the Marketing Authorization Holder containing, in addition to safety information, material related to indications, dosing, pharmacology and other information concerning the Product (see GVP Annex IV, ICH-E2C(R2) Guideline).
Company Core Data Sheet is defined in Section 5.2(a).
Examples of Company Core Data Sheet in a sentence
The Lead Regulatory Party in the applicable country shall be responsible for creating and updating the local product information for the Licensed Product in the applicable country; provided that the Lead Regulatory Party shall submit such information to the JDC for approval by the JDC if any deviations are made from the Company Core Data Sheet.
Subject to Section 4.2, BioNTech shall own, and be responsible for, the Company Core Data Sheet and manage its development and maintenance, in consultation with BMS.
More Definitions of Company Core Data Sheet
Company Core Data Sheet means a document setting forth information relating to safety, efficacy, indications, dosing, pharmacology, and other information concerning the Licensed Product.