Manufacturing Approval definition

Manufacturing Approval means all filings, applications, licenses, permits, and other authorizations which are required for the manufacture of the Materials in compliance with applicable laws and regulations of the country of manufacture.
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Manufacturing Approval means a Product License (yao pin xxxxx xxxx xu xx xxxxx 药品生产许可证) or any other license issued by a Governmental Authority in the Territory that authorizes a party to conduct manufacturing of the Product for commercial sale.
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Manufacturing Approval means sufficient approval or a Permit from the applicable Governmental Entity(ies) as necessary to perform any Manufacturing activities relating to a therapeutic product or compound or other intervention in humans in the facility concerned.
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Examples of Manufacturing Approval in a sentence

  • NK shall develop and submit to the MHW (in Aspect's name and on Aspect's behalf) the application dossier which is necessary for Aspect to obtain each such Foreign Manufacturing Approval.

  • For each Product for which the approval of the MHW is required (I.E., for which a Shonxx xx necessary), Aspect shall obtain a Foreign Manufacturing Approval (I.E., Gaikoku Seizx Xxxxxx) xxd NK shall be Aspect's In-Country Caretaker (I.E., Kokunai Kanrinin, as this term is defined in 19-2 of Japan's Pharmaceutical Affairs Law).

  • That is, Appellants fail to allege facts regarding how Superior improperly obtained and used their trade secrets to develop the designs and manufacturing processes, or what trade secrets, designs and processes were unlawfully used, and, as the bankruptcy court explained, submit no allegations linking any particular conduct to any particular part number or PMA (Parts Manufacturing Approval).

  • Hye-Tech is a California limited liability company formed in 1999 engaged in the business of manufacturing Federal Aviation Administration (“FAA”) approved Part Manufacturing Approval (“PMA”) aftermarket replacement parts for Honeywell, Pratt & Whitney, Lycoming, Rolls-Royce, Argo-Tech and General Electric engines.

  • See the FAA Order 8110.42C, Parts Manufacturing Approval Procedures dated 23 June 2008 for more FAA PMA information.

  • In order for a Vendor to deliver Vendor parts directly to Buyer, Vendor may be required to obtain Parts Manufacturing Approval (PMA) for such parts.

  • A part or module developed and/or manufactured by a third party and not approved by, under contract to, or affiliated with an OEM, pursuant to a Parts Manufacturing Approval (PMA) issued by the U.S. Federal Aviation Administration.

  • 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.

  • Not later than [***] days after the Manufacturing Approval date, AMAG shall submit to DSM a written non-binding estimate of its monthly requirements for each Product for the succeeding [***] period (the “Monthly Forecast”).

  • Following the Closing, the Company will, and Buyer shall cause the Company to, use commercially reasonable efforts to complete the Technology Transfer and achieve FDA Manufacturing Approval, the Primary COGS Milestone and the Secondary COGS Milestone as promptly as possible.


More Definitions of Manufacturing Approval

Manufacturing Approval means all authorizations, permissions, applications and/or registrations from the relevant regulatory and/or local government health authorities in each of the countries in the Territory, which are necessary and required for the manufacture of the Bulk Active Material.
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Manufacturing Approval. The term "Manufacturing Approval" (i.e. XXXXX XXXXXX) shall mean the approval granted by the MHW to manufacture a drug or medical device for sale in Japan.
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Manufacturing Approval means a Product License (yao pin sheng chan xu ke zheng □□□□□□□) or any other license issued by a Governmental Authority in the Territory that authorizes a party to conduct manufacturing of the Product for commercial sale.
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Manufacturing Approval means all filings, applications, licenses, permits, and other authorizations which are required for the manufacture of LX Bulk Drug Substance in compliance with applicable laws and regulations of the country of manufacture.
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Manufacturing Approval means approval granted by FDA or other applicable regulatory authority for the jurisdiction in which the Product will be produced, used, or sold authorizing DSM as a qualified and valid manufacturing source of the Product for AMAG.
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Manufacturing Approval means the act of a Regulatory Authority necessary for the Manufacture of the Product in a country or regulatory jurisdiction.
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Related to Manufacturing Approval

  • Marketing Approval means any approval, including price approval, registration, license or authorization from any Regulatory Authority required to market and sell a Licensed Product in a jurisdiction and shall include an approval, registration, license or authorization granted in connection with an NDA.

  • Regulatory Approval means the approval and authorization of a Regulatory Authority in a country necessary to develop, manufacture, distribute, sell, or market a Product in that country, including pricing and reimbursement approval.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

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

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • ANDA means an abbreviated new drug application submitted pursuant to 21 U.S.C. § 355(j).

  • Licensed Territory means worldwide.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.