ew. Dokumentacja główna substancji czynnej

Czasem wszystkie wyrazy pisane są wielkimi literami (ale to niezbyt zgodne z regułami polskiej pisowni).

Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
http://en.wikipedia.org/wiki/Drug_Master_File

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