1. The European Drug Master File
- Author
-
Giuseppe Battaglino
- Subjects
business.industry ,Section (typography) ,Public Health, Environmental and Occupational Health ,Drug Master File ,Pharmacology (nursing) ,Computer security ,computer.software_genre ,Marketing authorization ,Drug Guides ,Medicine ,Pharmacology (medical) ,Confidentiality ,business ,computer - Abstract
The submission of a drug master file (DMF) is one way of supplying confidential data on a drug substance to licensing authorities by the active ingredients manufacturer (AIM). In the European drug master file (EDMF), three types of active ingredients may be described: new active ingredients, off-patent active ingredients, and pharmacopoeial ingredients. As the EDMF contains some information which should be kept confidential, it should be divided into two sections: an applicant section and a restricted section. Possible advantages and disadvantages of this provision of data are discussed.
- Published
- 1993
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