
Drug master file in the EAEU
The Drug Master File (DMF) is a document that contains detailed scientific information about the API, which is indicated under various headings in Module 3 of the registration dossier, in the form of a common technical document.
The scientific information in the DMF is divided into two physical parts:
- an open part and
- a closed part.
The open part contains information that the holder of the DMF does not consider confidential, while the closed part contains confidential information.
In all cases, the open part should provide sufficient information for the applicant (holder of the Registration Certificate) to fully assess the suitability of the API specifications and quality control measures for using the API in the production of the medicinal product. The closed part of the document contains additional information, such as details about the individual stages of production, including reaction conditions, temperature, and validation and evaluation of critical stages of production. It also includes information on quality control measures taken during the production process of the API.
Authorized bodies of Member States may disagree with certain API information that has not been transferred to the applicant (holder of the registration certificate). In such cases, these bodies have the right to request corrections to the open part of the data management file (DMF).
In addition to the open and closed sections, DMFs should also include separate general quality summaries for each section. Each version of the closed and open sections should have unique and independently tracked version numbers. DMF is only allowed to be submitted in support of the registration of a medicinal product in the EAEU, or as part of a variation to the registration dossier for a medicinal product already registered in the EAEU.
The relationship between the active pharmaceutical ingredient quality and its use in a medicinal product composition must be clearly justified in the registration or variation dossier.
If you have any questions about the rules for submitting a DMF, please contact us at info@beawire.com.