Manufacturing Authorization definition

Manufacturing Authorization means the authorization to Manufacture the Products as granted by the relevant Governmental or Regulatory Authorities.
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Manufacturing Authorization. Manufacturing Authorization" means, with respect to the Territory, the regulatory authorization required to Manufacture the Product and the API at the Manufacturing Facilities as granted by the relevant Regulatory Authority in the Territory or the country of Manufacture, as the case may be.
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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.
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Examples of Manufacturing Authorization in a sentence

  • If Xxxxx, 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), Xxxxxxxxx agrees to reasonably cooperate in such actions, at Lilly’s sole expense.

  • A Certificate of Pharmaceutical Product in the format recommended by the World Health Organization should be submitted together with a valid Manufacturing Authorization for pharmaceutical production.

  • It is further clarified that DIT shall not entertain any correspondence regarding delay or non-receipt of clarification from DIT.5. MAFThe Vendors have to submit the scanned copy of the Manufacturing Authorization Form (if any) for the products to be empanelled.

  • Submit a Certificate of Pharmaceutical Product in format recommended by the World Health Organization together with a valid Manufacturing Authorization for pharmaceutical production.

  • 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.

  • The bidder must attach Manufacturing Authorization & Back-to-back supportfor all the items to be covered through this tender.As per Annexure-86.CertificationsEquipments at serial no.

  • Successful tenderer shall have to submit all the undertakings and Manufacturing Authorization (MA) in notarized form before signing of the contract.

  • Formatted: Centered, Indent: Left: 0.5"(Rule 12 continued on next page) (Rule 12 Grantee Fee Schedule continued from previous page) $ 3,500 Manufacturing Authorization Request The fee will cover the Grantee expenses for processing the Manufacturing Approval Request, submission of the Request to the Board, and base support services required in the approval process.

  • Notwithstanding the foregoing, however, it is agreed that within one (1) year from the date of Election ("Supply Election Term"), Xxxxxx-Xxxxxxx 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.

  • Submit a Certificate of Pharmaceutical Product in format recommended by theWorld Health Organization together with a valid Manufacturing Authorization for pharmaceutical production.


More Definitions of Manufacturing Authorization

Manufacturing Authorization means the authorization of SUPPLIER as manufacturer of PRODUCT according to the applicable regulations.
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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.
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Manufacturing Authorization means the authorization necessary to Package the Products as granted by the relevant Governmental or Regulatory Authorities in China."
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Related to Manufacturing Authorization

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • 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, with respect to a country, region or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorisations of any Regulatory Authority necessary to commercially distribute, sell, or market Product in such country or other jurisdiction, including, where applicable, (a) pre- and post-approval regulatory approvals (including any prerequisite manufacturing approval or authorisation related thereto), and (b) approval of Product labelling.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Product Authorizations means any and all approvals, including applicable supplements, amendments, pre- and post-approvals, clearances, licenses, notifications, registrations, certifications or authorizations of any Governmental Authority, any Standard Body necessary for the manufacture, development, distribution, use storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority, including all INDs and NDAs.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Product Approvals means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Manufacturing Process means any process for—

  • Manufacturing Agreement has the meaning set forth in Section 4.3.