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January 9, 2026
Approximately 5 minutes
eSubmission Requirements for Medicinal Product Licensing at BfArM
eSubmission Requirements for Medicinal Product Licensing at BfArM
Mandatory Use of Electronic Submissions
BfArM has fully transitioned to electronic-only submissions for all marketing authorisation procedures, including national, decentralised, mutual recognition, and support for centralised applications. Paper submissions are no longer accepted, except in exceptional cases with prior agreement. This aligns with EU eSubmission initiatives and the Common European Submission Platform (CESP) framework. eSubmission - BfArM
Standard Format: eCTD
- The electronic Common Technical Document (eCTD) is the mandatory format for all applications and lifecycle documents.
- eCTD version 3.2.2 or higher is required, compliant with ICH specifications.
- BfArM accepts submissions via the CESP portal or directly through the BfArM eSubmission Gateway.
- Benefits include faster validation, automated processing, and improved tracking of variations and renewals.
Technical Requirements and Validation
- Submissions must pass technical validation criteria before scientific assessment begins.
- BfArM uses Lorenz docuBridge and other tools for validation against EU Module 1 regional specifications.
- Common validation issues include incorrect file naming, missing XML backbone, or non-PDF content.
- Applicants should use the latest EU validation criteria and BfArM-specific checklists.
Submission Types Covered
- Initial marketing authorisation applications (national, DCP, MRP).
- Variations (Type IA, IB, II), including worksharing.
- Renewals and periodic benefit-risk evaluation reports (PBRERs/PSURs).
- Responses to questions during assessment.
- Post-authorisation commitments and additional data.
Practical Guidance for Applicants
- Register for CESP or BfArM Gateway access in advance.
- Use the eSubmission Roadmap and BfArM guidance documents for preparation.
- Submit cover letters, application forms, and fee documentation electronically.
- BfArM provides a helpdesk for technical eSubmission queries.
eSubmission streamlines the licensing process at BfArM, reduces administrative burden, enhances data integrity, and supports harmonised EU-wide electronic workflows for medicinal product authorisation. eSubmission - BfArM
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