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.
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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)”).
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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).
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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.

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

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

  • BLIF Master Files include listings for residence and/or business and/or government classifications.

  • Master Files include listings for residence and/or business and/or government classifications.

  • Courses are listed in the City Colleges of Chicago catalogs and City Colleges of Chicago Course Master Files or are eligible for listing.

  • Special closure of opened assigned cases.CValid on all Master Files.

  • Classifying Maintenance Performance Measures Arts and Mann (1994) use the time horizon to classify maintenance decisions into three categories, namely strategic, tactical, and operational.

  • Valid on all Master Files except CAWR and PMF.AAutomatic correction of name control.


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.
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Master Files shall have the meaning set forth in the Supply Agreement.
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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 any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • 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 regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • 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 means the documents specified in Section 2.1 of the Sale Agreement.

  • Servicing Records All documents, books, records and other information (including, without limitation, computer programs, tapes, disks, data processing software and related property rights) prepared and maintained by the Servicer with respect to the Loans and the related Obligors.

  • 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.

  • 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 (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing.

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

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.