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.
Commission Directive 91/507/EEC. In “Rules Governing Medicinal Products in the European Community,”Vol. I. Brussels, Belgium: Commission of the European Communities; 1991.
2.
European Drug Master File Procedures. In “Rules Governing Medicinal Products in the European Community,”Vol. III (Addendum 1990). Brussels, Belgium: Commission of the European Communities; 1990.
3.
Requirements in Relation to Active Substances. In “Rules Governing Medicinal Products in the European Community,”Vol. III (Addendum 1991). Brussels, Belgium: Commission of the European Communities; 1991.
4.
Chemistry of Active Ingredients. In “Rules Governing Medicinal Products in the European Community,”Vol. IIIBrussels, Belgium: Commission of the European Communities; 1991.
