DMF definition

DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.
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.
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.

Examples of DMF in a sentence

  • Within 9 months after the Effective Date, BR with the support of consultants shall establish a project performance monitoring system in line with the targets, indicators set in the DMF.


More Definitions of DMF

DMF means a Drug Master File maintained with a Regulatory Authority in any country within the Territory.
DMF means a Drug Master File as more fully defined in 21 C.F.R. §314.420 in the United States or similar documents filed with a Regulatory Authority in another jurisdiction.
DMF means a Drug Master File for Captisol, as filed as of the Effective Date, or as hereafter updated from time to time during the Term, by CyDex with the FDA.
DMF means a Drug Master File filed with the FDA, EMA, MHLW or another foreign equivalent.
DMF means a drug master file filed with the FDA which includes the information relating to the manufacture of the API.
DMF means a version of 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 reportedly died. The Death Master File must include at least one full version of the file and may include update files.
DMF means a drug master file for Product in the United States (as such term is defined in 21 C.F.R. Part 314.420) or Europe.