| Drug Master File | Методы контроля качества (МКК) – нормативный документ на лекарственный препарат (является частью регистрационного досье); The European Drug Master File (DMF) procedure may be used when the active substance manufacturer (ASM) is not the applicant for a product marketing authorisation (applicant), with a view to protecting valuable know-how on the manufacture of the active substance. A DMF is a document containing the information required to demonstrate that the quality of the active substance is adequately controlled by the specification proposed by the applicant. 4uzhoj) |
