Filing Acceptance definition

Filing Acceptance means, as applicable, the acceptance for filing of a complete NDA (or its equivalent) by the FDA in the United States, or acceptance for filing of a comparable application by a Regulatory Authority in Europe for the manufacture, supply, marketing and sale of a pharmaceutical product.
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Filing Acceptance means the written notification by the FDA or equivalent Regulatory Authority for a country in the Territory that a MAA has been accepted for filing pursuant to 21 C.F.R. §314.101 for drugs or 21 C.F.R. §601.2 for biologics or the foreign equivalent if such filing is outside the U.S.
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Examples of Filing Acceptance in a sentence

  • Under the EFAST (ERISA Filing Acceptance System) processing effort, processed filings are loaded into an Oracle relational database called the EFAST Master File (EMF) each month.

  • ERISA Filing Acceptance System (EFAST) - EFAST is a system, built and operated by NCS Pearson in Lawrence, Kansas, under contract to the Department of Labor, to process Form 5500 series returns.

  • Effective January 2010, the Employee Retirement Security Act of 1973 (ERISA) Filing Acceptance System II (EFAST2), an all- electronic system, began receiving and displaying Forms 5500 and 5500-SF Annual Returns/Reports.

  • MC2016–165, CP2016–239.Service of Change in Prices Pursuant to Amendment to Priority Mail & First- Class Package Service Contract 7; Filing Acceptance Date: July 8, 2016; Filing Authority: 39 CFR 3015.5 et seq.; Public Representative: Natalie R.

  • CP2016–237; Filing Title: Notice of United States Postal Service of Filing a Functionally Equivalent Global Expedited Package Services 3 Negotiated Service Agreement and Application for Non- Public Treatment of Materials Filed Under Seal; Filing Acceptance Date: July 6, 2016; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Kenneth R.

  • CP2016–70; Filing Title: Notice of United States Postal Service of Change in Prices Pursuant to Amendment to Priority Mail Express, Priority Mail & First-Class Package Service Contract 7, with Portions Filed Under Seal; Filing Acceptance Date: January 27, 2017; Filing Authority: 39 CFR 3015.5; Public Representative: Curtis E.

  • Starting with the 2009 plan year, filers are required to file electronically using the ERISA Filing Acceptance System (EFAST2).

  • MC2017–82 and CP2017–111; Filing Title: Request of the United States Postal Service to Add Alternative Delivery Provider 1 Contracts to the Competitive Products List and Notice of Filing (Under Seal) of Contract and Application for Non- Public Treatment of Materials Filed Under Seal; Filing Acceptance Date: January 30, 2017; Filing Authority: 39U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Gregory S.

  • MC2016–165 and CP2016–239; Filing Title: Request of the United States Postal Service to Add Priority Mail & First-Class Package Service Contract 21 to Competitive Product List and Notice of Filing (Under Seal) of Unredacted Governors’ Decision, Contract, and Supporting Data; Filing Acceptance Date: July 8, 2016; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Curtis E.

  • MC2016–164 and CP2016–238; Filing Title: Request of the United States Postal Service to Add Priority Mail Express Contract 39 to Competitive Product List and Notice of Filing (Under Seal) of Unredacted Governors’ Decision, Contract, and Supporting Data; Filing Acceptance Date: July 8, 2016; Filing Authority: 39U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Natalie R.

Related to Filing Acceptance

  • Letter of Acceptance means the letter of formal acceptance, signed by the contractor. Procuring Entity, including any annexed memoranda comprising agreements between and signed by both Parties.

  • Letter of Acceptance of Tender means letter giving intimation to the tenderer that his tender has been accepted in accordance with the provisions contained in that letter.

  • Assignment and Acceptance means an assignment and acceptance entered into by a Lender and an Eligible Assignee, and accepted by the Agent, in substantially the form of Exhibit C hereto.

  • Auto-Extension Letter of Credit has the meaning specified in Section 2.03(b)(iii).

  • Acceptance Date has the meaning set forth in Section 2.05(a)(v)(D)(2).