DMF definition

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.

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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, 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

Halozyme shall own any DMF for the PH20 Drug substance of each Product.
Company shall promptly notify Halozyme of any changes mandated or requested by any Regulatory Authority prior to making any such changes to the dossier or (if applicable) DMF for the PH20 Drug in order to enable the Parties to agree on the appropriate changes to be made.
Halozyme shall promptly notify Company of any changes to the dossier or (if applicable) DMF or regulatory registration for the PH20 Drug substance.
If Halozyme files, holds, or controls a DMF or other regulatory registration for the PH20 Drug substance: (a) Company shall have the right to cross-reference such DMF or regulatory registration; or (b) in countries where this is not feasible, Halozyme shall provide Company, at Company’s cost, with such information in Halozyme’s Control regarding the PH20 Drug substance of each Product as is reasonably necessary for Company to include in the applicable Regulatory Approval filings for such Product.

More Definitions of DMF

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 maintained with a Regulatory Authority in any country within the Territory.

DMF means a Drug Master File as described in 21 CFR 14.420.

DMF means a Drug Master File filed with the FDA, EMA, MHLW or another foreign equivalent.

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.

DMF means a Drug Master File in the United States or equivalent filing or filing serving a similar purpose in another regulatory jurisdiction.