Product Labelling definition

Product Labelling means (a) the Regulatory Authority-approved full prescribing information for an Antibody Product, including any required patient information and (b) all labels and other written, printed or graphic matter upon any container, wrapper or any package insert or outsert utilised with or for an Antibody Product.
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Product Labelling means, with respect to the Product and each country in the Territory, (a) the Regulatory Authority-approved full prescribing information for the 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 the Product in such country.
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Product Labelling means (i) the full prescribing information for any Licensed Product, 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 Licensed Product.
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Examples of Product Labelling in a sentence

  • Each Party shall be responsible for disseminating accurate information regarding any Antibody Product to its sales representatives based on Product Labelling and Promotional Materials.

  • The Territorial Commercial Lead shall be responsible for responding to all medical questions or inquiries relating to the Antibody Products sold in countries in its respective Lead Territory, except that the Co-Detailer, in the course of carrying out its activities under Article 5.11(c), may respond to any such question or inquiry which can be answered by reference to the Product Labelling and package insert in the applicable country.

  • In exercising their rights pursuant to this Article 5, Celltech and Amgen shall ensure that no claims or representations in respect of the Antibody Products or the characteristics thereof (e.g., safety or efficacy) are made by or on behalf of it (by members of its sales force or otherwise) which do not represent an accurate summary or explanation of the Product Labelling of the Antibody Product in the country in question.

  • The requirements in the approved Technical Document on Product Labelling requirements should be followed.

  • Only upon ETON’s approval shall Sintetica proceed to print the Product Labelling and Packaging.

  • Prior to the use thereof, the Territorial Commercial Lead shall provide to the other Party a prototype of any Promotional Materials or Product Labelling which contains the other Party’s corporate name and logo, so that the other Party may review the manner in which its corporate name and logo are used therein.

  • Sintetica shall be responsible and liable for the final content of the Product Labelling and Packaging and their compliance with Applicable Law in the Territory and Territory of Manufacture.

  • Prior to commencing into production, Sintetica shall submit the Product Labelling and Packaging to ETON for its review for accuracy.

  • For avoidance of doubt, ETON shall not modify the Product Labelling and Packaging in any way when distributing the Products in the Territory.

  • Additional information regarding Product Labelling Requirements can be found on the Suppliers/Trade section of NLC’s website.


More Definitions of Product Labelling

Product Labelling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory:
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Product Labelling means (i) the full prescribing information for any Licensed Product, approved by the relevant Regulatory Authority and
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Related to Product Labelling

  • Product Labeling means, with respect to a particular pharmaceutical product and a particular country, (a) the full prescribing information for the product approved by the applicable Regulatory Authorities in such country, including any required patient information; and (b) all labels and other written, printed or graphic matter physically upon a container, wrapper or any package insert utilized with or for the product in such country.

  • labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food;

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Finished Product means the final packaged product intended for human consumption;

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether