Manufacturing Authorization definition

Manufacturing Authorization means the authorization to Manufacture the Products as granted by the relevant Governmental or Regulatory Authorities.
View Source
Manufacturing Authorization means any and all consents or other authorizations or approvals from the China Food and Drug Administration (“CFDA”) that is necessary for the manufacture of the Product in the Territory, (including the Manufacturing License Approvals), and any supplement, amendment or variation thereof.
View Source
Manufacturing Authorization means the authorization of SUPPLIER as manufacturer of PRODUCT according to the applicable regulations.
View Source

Examples of Manufacturing Authorization in a sentence

  • If ▇▇▇▇▇, in its discretion, recalls, detains or retains the Product (voluntarily or by order of a Regulatory Authority, which shall be promptly notified to Lilly by the Manufacturing Authorization holder), ▇▇▇▇▇▇▇▇▇ agrees to reasonably cooperate in such actions, at Lilly’s sole expense.

  • ALLERGAN shall be diligent in its efforts to obtain Manufacturing Authorization in the country of Manufacture to any Product Changes, with the support of GSK, in order to ensure that ALLERGAN may implement such Product Changes as soon as possible.

  • Pfizer Dalian shall be responsible for filing all submissions or other correspondence with the applicable Governmental or Regulatory Authorities for China to obtain the Manufacturing Authorization, provided, however, that ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall have the right to review such submissions or correspondence prior to filing.

  • If such corrective action or market action is necessitated by the breach by one of the parties of any of its warranties, representations, obligations, covenants or agreements contained herein, or in any Manufacturing Authorization, then such party shall be liable, and shall reimburse the other party, for all reasonable costs incurred by the non-breaching party in connection with such action (including, without limitation, reasonable attorney’s fees and expenses).

  • In the event Pfizer elects not to continue such manufacturing and/or packaging and distribution activities, as the case may be, Pfizer agrees to use its best efforts to transfer promptly the Manufacturing Authorization to such party designated by Export, in its sole discretion, so as to not materially disrupt Export's or its designee's ability to distribute the Product in Morocco.

  • Notwithstanding the foregoing, however, it is agreed that within one (1) year from the date of Election ("Supply Election Term"), ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall have the right, but not the obligation, to assume responsibility for the supply of Products within China and obtain the Manufacturing Authorization and all other necessary related Governmental or Regulatory Approvals.

  • Pfizer Overseas shall bear its own costs in obtaining such Marketing Authorization, Price Approval and the Manufacturing Authorization.

  • Pfizer shall provide ▇▇▇▇▇▇-▇▇▇▇▇▇▇ for its prior review and approval, copies of all submissions to Governmental or Regulatory Authorities in China that are intended to revise the conditions of the Marketing Authorization, Price Approval or Manufacturing Authorization or change or modify the label or labeling for, or the indications of, Atorvastatin or any of the Products.

  • If such corrective action or market action is caused by the action of or necessitated by the breach by one of the parties of any of its warranties, representations, obligations, covenants or agreements contained herein, or in any Manufacturing Authorization, then such party shall be liable, and shall reimburse the other party, for all reasonable costs incurred by the non-breaching party in connection with such action (including, without limitation, reasonable attorney’s fees and expenses).

  • The bidder must attach Manufacturing Authorization certificate for all the items/item/articles to be covered through this tender.


More Definitions of Manufacturing Authorization

Manufacturing Authorization means any and all consents or other authorizations or approvals from a Governmental Authority or Regulatory Authority in a country in the Territory, that is necessary for the Manufacture of the Covered Product in such country in the Territory, and any supplement, amendment or variation thereof.
View Source
Manufacturing Authorization means the authorization necessary to Package the Products as granted by the relevant Governmental or Regulatory Authorities in China."
View Source
Manufacturing Authorization means the official written permission issued either by the KMA or KVS for manufacturers located in Kosovo, or by an equivalent competent authority for manufacturers located in other states or entities, authorizing the holder to manufacture medicinal products, in accordance with this law and normative acts issued pursuant to this law.
View Source

Related to Manufacturing Authorization

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.