Drug Master File definition

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.

Drug Master File or “DMF” means any drug master file filed with the FDA or the equivalent filed with any other Governmental Authority with respect to a Licensed Compound or Product or any component or intermediate thereof.

Drug Master File means any drug master file filed with the FDA with respect to a Product, and any equivalent filing in other countries or regulatory jurisdictions.

Examples of Drug Master File in a sentence

• The main objective of the ASMF procedure, commonly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the applicant or marketing authorisation holder (MAH) to take full responsibility for the medicinal product, the quality and quality control of the active substance.

• The main objective of the ASMF procedure, commonly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know‐how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the applicant or marketing authorisation holder (MAH) to take full responsibility for the medicinal product, the quality and quality control of the active substance.

• Documentation in Pharmaceutical industry: Master formula record, DMF (Drug Master File), distribution records.

• The main objective of the ASMF procedure, commonly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the MAH or marketing authorisation holder (MAH) to take full responsibility for the medicinal product, the quality and quality control of the active substance.

• The main objective of the ASMF procedure, commonly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the two manufacturers of the active substance (ASM) to be protected, while at the same time allowing the applicant or marketing authorisation holder (MAH) to take full responsibility for the medicinal product, the quality and quality control of the active substance.

More Definitions of Drug Master File

Drug Master File means a submission to a Regulatory Authority of information concerning the chemistry, manufacturing and controls of the Antibody to permit such Regulatory Authority to review such information in support of any application for Regulatory Approval.

Drug Master File or “DMF’ means a submission to the FDA by ASL that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of the Active Ingredient.

Drug Master File means a Drug Master File filed with the FDA as described in 21 C.F.R. §314.420.

Drug Master File or “DMF” means a drug master file document containing detailed information about the manufacturing of the Product the active pharmaceutical ingredient of the Product packaging, and/or excipient, colorant, flavour, essence, or material including information describing the manufacturing site, the manufacturing facility, the operating procedures, the personnel, the manufacture, chemistry and control of the drug substance and the drug substance intermediates.

Drug Master File means a drug master file, when filed by PN or medac, as required under the United States Food Drug & Cosmetic Act, and under the regulations promulgated thereunder, specifically 21 C.F.R. 314.420, et. seq., and any successor regulations thereto, and any other Regulatory Authority.

Drug Master File means a drug master file maintained by the PDA with respect to a prospective product for which Regulatory Approval is sought;

Drug Master File or “DMF” as used in Section 4.3, means the drug master file (as such term is defined in 21 C.F.R. Part 314.420) that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drug products intended for human use.