Master Files definition

Master Files means all drug master files and device master files relating to Product filed or that may be filed with any Regulatory Authority in any country or jurisdiction in the Territory.
Sample 1Sample 2Sample 3
Master Files means submissions made to the FDA in order to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more veterinary drugs, and includes both master files maintained by the FDA Center for Drug Evaluation and Research (generally referred to as drug master files) and those maintained by the FDA Center for Veterinary Medicine (generally referred to as veterinary master files).
Sample 1Sample 2
Master Files means submissions made to the FDA in order to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more veterinary drugs, and includes both the master files maintained by the FDA Center for Drug Evaluation and Research (generally referred to as “Drug Master File(s)” or “DMF(s)”) and those maintained by the FDA Center for Veterinary Medicine (generally referred to as “Veterinary Master File(s)” or “VMF(s)”).
Sample 1Sample 2

Examples of Master Files in a sentence

  • Final Approval ProcedurePreparation, review and submission of Drug Master Files to Regulatory Authorities as per their specific requirements.

  • For each of the Selected Receivables, compared the make per the Receivables Data Tape to the make listed in the Wholesale Master Files, and found them to be in agreement.

  • An Excel data file containing certain data fields for the Sample Receivables as of the Cutoff Date which Ford Credit represents is from Ford Credit’s U.S. Retail System Master Files (the “Sample Receivables Extract File”).

  • For each of the Selected Receivables, compared the loss amount per the Receivables Data Tape to the Wholesale Master Files, and found them to be in agreement.

  • An Excel data file containing certain data fields for the Sample Leases which Ford Credit represents is from Ford Credit’s U.S. Lease System Master Files (the “Sample Leases Extract File”).

  • Beginning May 5, 2017, the following submission types: NDA, ANDA, BLA and Master Files must be submitted in eCTD format.

  • For each of the Selected Receivables, calculated the current principal balance per the Wholesale Master Files and compared the amount to the Receivables Data Tape, and found them to be in agreement.

  • Contractor fails or refuses to perform or observe any term, covenant or condition contained in any of the following Sections of this Agreement: Submitting False Claims, Monetary Penalties; Taxes; Insurance; Proprietary or Confidential Information of TJPA; Protection of Private Information; Assignment; Drug-Free Workplace; Compliance With Laws; FTA Requirements.

  • DMF costs represent expenses incurred on development of processes and compliance with regulatory procedures of the USFDA, in filing Drug Master Files (DMF), in respect of products for which commercial value has been established by virtue of third party agreements/arrangements.

  • For each of the Selected Receivables, compared the last 17 digits of the VIN per the Receivables Data Tape and compared the initial funding amount per the Wholesale Master Files to the corresponding information per the applicable Funding Document, and found them to be in agreement.


More Definitions of Master Files

Master Files means all carbon product protocol master files and carbon measurement device master files relating to Product filed or that may be filed with any relevant carbon entity in any country or jurisdiction in the Territory.
Sample 1
Master Files shall have the meaning set forth in the Supply Agreement.
Sample 1

Related to Master Files

  • Master File has the meaning set forth in the CAISO Tariff.

  • Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Death master file means the United States social security administration’s death master file or any other database or service that is at least as comprehensive as the United States social security administration’s death master file for determining that a person has died.

  • Receivable Files means the documents specified in Section 3.3.

  • DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Death master file match means a search of the death master file that results in a match of the social security number or the name and date of birth of an insured, an annuity owner or a retained asset account holder.[PL 2017, c. 129, §1 (NEW).]

  • Regulatory Materials means, with respect to a Licensed Product for any particular indication in any particular jurisdiction, regulatory applications and submissions (and any supplements or amendments thereto), and any notifications, communications, correspondence, registrations, drug master files, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority, including BLAs and INDs, as applicable, that relate to such Licensed Product in such jurisdiction. Regulatory Materials also include presentations, responses, and applications for Regulatory Approvals.

  • Student Records Means both of the following: (1) Any information that directly relates to a student that is maintained by LEA and (2) any information acquired directly from the student through the use of instructional software or applications assigned to the student by a teacher or other LEA employee. For the purposes of this Agreement, Student Records shall be the same as Educational Records, and Covered Information, all of which are deemed Student Data for the purposes of this Agreement. Service Agreement: Refers to the Contract or Purchase Order to which this DPA supplements and modifies.

  • Loan Files is defined in Section 2.1 of the Purchase and Sale Agreement.

  • Servicing Records shall have the meaning provided in Section 11.14(b) hereof.

  • State Records means any and all State data, information, and records, regardless of physical form, including, but not limited to, information subject to disclosure under CORA.

  • Medical Records the Study Subjects’ primary medical records kept by the Institution on behalf of the Study Subjects, including, without limitation, treatment entries, x-rays, biopsy reports, ultrasound photographs and other diagnostic images. Zdravotní záznamy: primární zdravotní záznamy Subjektů studie vedené Zdravotnickým zařízením ve vztahu k Subjektu studie, zejména záznamy o poskytnuté péči, zázanym o RTG vyšetřeních, protokoly o provedených biopsiích, snímky z ultrazvukových vyšetření a další snímky diagnostické povahy. Study Data: all records and reports, other than Medical Records, collected or created pursuant to or prepared in connection with the Study including, without limitation, reports (e.g., CRFs, data summaries, interim reports and the final report) required to be delivered to Sponsor pursuant to the Protocol and all records regarding inventories and dispositions of all Investigational Product. Studijní data a údaje: veškeré záznamy, zprávy a protokoly, jež jsou odlišné od Zdravotních záznamů, a které jsou získány, shromážděny či vytvořeny v návaznosti na či připraveny v souvislosti se Studií, zejména zprávy, záznamy a protokoly (např., CRFs, datové přehledy, mezitímní zprávy a protokoly, a závěrečná zpráva), které jsou požadovány, aby byly poskytnuty Zadavateli v souladu s Protokolem a veškerými záznamy ohledně inventurní evidence a nakládání s veškerým množstvím Hodnoceného léčiva.

  • Contract File means with respect to each Contract, the physical and/or electronic files in which Credit Acceptance maintains the fully executed original counterpart or “authoritative copy” (in each case, for UCC purposes) of the Contract (to the extent required in accordance with Section 3.03 of this Agreement), either a standard assurance in the form commonly used in the industry relating to the provision of a certificate of title or other evidence of lien, the original or electronic instruments modifying the terms and conditions of such Contract and the original or electronic endorsements or assignments of such Contract.

  • APIs means SAP application programming interface and accompanying or related Documentation, source code, tools, executable applications, libraries, subroutines, widgets and other materials made available by SAP or through SAP tools or SAP Software Development Kit (and all derivative works or modifications thereof) to Provider that allow Provider to integrate the Provider Service with the Cloud Service, including any access code, authentication keys or similar mechanisms to enable access of the APIs.

  • Receivables Records means (i) all original copies of all documents, instruments or other writings or electronic records or other Records evidencing the Receivables, (ii) all books, correspondence, credit or other files, Records, ledger sheets or cards, invoices, and other papers relating to Receivables, including, without limitation, all tapes, cards, computer tapes, computer discs, computer runs, record keeping systems and other papers and documents relating to the Receivables, whether in the possession or under the control of Grantor or any computer bureau or agent from time to time acting for Grantor or otherwise, (iii) all evidences of the filing of financing statements and the registration of other instruments in connection therewith, and amendments, supplements or other modifications thereto, notices to other creditors or secured parties, and certificates, acknowledgments, or other writings, including, without limitation, lien search reports, from filing or other registration officers, (iv) all credit information, reports and memoranda relating thereto and (v) all other written or nonwritten forms of information related in any way to the foregoing or any Receivable.

  • Public records means all writings and recordings that consist of letters, words or numbers, or their equivalent, set down by handwriting, typewriting, printing, photostatting, photography, magnetic impulse, optical or magneto-optical form, mechanical or electronic recording or other form of data compilation, however stored, and regardless of physical form or characteristics, prepared or owned by, or in the possession of a public body or its officers, employees or agents in the transaction of public business.

  • Servicing File With respect to each Mortgage Loan, the file retained by the Company consisting of originals of all documents in the Mortgage File which are not delivered to the Custodian and copies of the Mortgage Loan Documents listed in the Custodial Agreement the originals of which are delivered to the Custodian pursuant to Section 2.03.

  • Portfolio Data means the Key Terms in relation to all outstanding Trades between you and us in a form and standard that is capable of being reconciled. The information comprising the Portfolio Data for Portfolio Data Delivery Date will be prepared as at the close of business New York time on the immediately preceding Business Day.

  • Client Records has the meaning set forth in Section 3.14.

  • Educational records means: those official records, files, and data directly related to a student and maintained by the school or local education agency, including but not limited to records encompassing all the material kept in the student's cumulative folder such as general identifying data, records of attendance and of academic work completed, records of achievement and results of evaluative tests, health data, disciplinary status, test protocols, and individualized education programs.

  • Manufactured products means items and construction materials composed in whole or in part of non-ferrous metals such as aluminum; plastics and polymer-based products such as polyvinyl chloride pipe; aggregates such as concrete; glass, including optical fiber; and lumber.

  • Files and Records means all files and records of Seller relating to the Business, whether in hard copy or magnetic or other format including customer and supplier lists and records; equipment maintenance records; equipment warranty information; plant plans, specifications and drawings; sales and advertising material; computer software; technical and research analyses; engineering, sales, marketing and other studies, data and plans; bid information; quality assurance records; and records relating to those employees of Seller who may become employed by Purchaser following the Closing.

  • HEPA filter means a high efficiency particulate absolute air filter capable of trapping and retaining 99.97 percent of fibers greater than 0.3 micrometers in mass median aerodynamic diameter equivalent.

  • Case file means a record that is assembled and maintained for each application approved for state cost sharing.

  • IND means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

  • Vital records means certificates or reports of birth, death, fetal death, marriage, dissolution, annulment, and related data.