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 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
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

Examples of Master Files in a sentence

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

  • Information for the ICCB Master Files: Completed Form 22 (in duplicate) for the proposed new curriculum.

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

  • Licensee shall make certain data generated during the research and development of Testim accessible to Licensor through the preparation and filing of one or more Drug Master Files (“DMF”).

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

  • Monitoring visits will be conducted in a supportive manner with the objective of supporting centres in delivering the study safely and in accordance with the principles of GCP.The Trial Co-ordinator(s) will check that all Site Master Files documents are up to date at least once during the trial.

  • Any paper non-Internet compatible report attachments must be submitted to GSU Central Master Files by the specific report due date.

  • The BLA/supplement(s) may also refer to Master Files for information regarding containers and closures.

  • We recommend that a license manufacturer cross reference a contract manufacturing facility’s Master Files only in circumstances involving certain proprietary information of the contract manufacturer, such as: • a list of all products manufactured in a contract facility (in this situation the license manufacturer should be kept informed of the types or categories of all products manufactured in the contract facility).

  • Against the backdrop of ethnic diversity, rapid economic growth and modernization in recent years, Indonesia is the world’s 16th largest economy according to McKinsey (www.mckinsey.com/global-themes/asia-pacific/the-archipelago- economy) and its recent growth has been predominantly fuelled by consumption due to increasing income as opposed to exporting and manufacturing.


More Definitions of Master Files

Master Files shall have the meaning set forth in the Supply Agreement.
Sample 1
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

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.

  • Servicer File means, collectively, all documents, records and copies pertaining to a Mortgage Loan which are required to be included in the related Servicer File pursuant to Section 3 thereof.

  • Receivable Files means the documents specified in Section 3.3.

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • 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, 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.

  • 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 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. 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.

  • 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 The items pertaining to a particular Mortgage Loan including, but not limited to, the computer files, data disks, books, records, data tapes, notes, and all additional documents generated as a result of or utilized in originating and/or servicing each Mortgage Loan, which are held in trust for the Trustee by the Servicer.

  • 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 high-efficiency particulate air filters that are rated to achieve a minimum initial particle-removal efficiency of 99.97 per cent using ASTM F 1471– 93 or equivalent standard;

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

  • IND means an investigational new drug application filed with the FDA with respect to a Product, or an equivalent application filed with a Regulatory Authority in a country other than the United States to commence a clinical trial of pharmaceutical product.

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