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January 5, 2026
Approximately 5 minutes
Contact Persons for Medicinal Product Licensing at BfArM
Contact Persons for Medicinal Product Licensing at BfArM
Purpose and Availability
BfArM designates specific contact persons to support applicants and stakeholders during the marketing authorisation process for medicinal products. These experts handle inquiries related to procedural, scientific, and regulatory aspects, ensuring efficient communication and guidance throughout licensing activities. Contact details are publicly listed to promote transparency and accessibility. Contact persons - BfArM
Main Contact Areas and Responsibilities
National Marketing Authorisation
- Dedicated contacts for full national applications, including generics, well-established use, and homeopathic/traditional herbal products.
- Assistance with dossier preparation, CTD format, and national-specific requirements.
Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP)
- Contacts acting as Reference Member State (RMS) or Concerned Member State (CMS) coordinators.
- Support during assessment phases, including questions on validation, scientific evaluation, and national implementation steps.
Variations and Renewals
- Specialists for classification and submission of variations (Type IA, IB, II).
- Contacts for renewal applications, including benefit-risk reassessment and supporting documentation.
Centralised Procedure Support
- Liaison persons for interactions with EMA, including rapporteur/co-rapporteur contributions, scientific advice, and inspection coordination.
Specific Product Types
- Separate contacts for biosimilars, orphan medicinal products, paediatric applications, and advanced therapy medicinal products (where BfArM has competence).
- Dedicated support for herbal, homeopathic, and traditional use registrations.
Additional Support Functions
- Pharmacovigilance and risk management contacts for post-authorisation obligations.
- General inquiries desk for initial routing and procedural questions.
- Email-based communication preferred; telephone contacts available for urgent matters.
BfArM encourages applicants to use the appropriate contact person early in the process to clarify requirements, avoid delays, and ensure smooth progression of licensing applications. Updated contact lists are maintained on the BfArM website for current information. Contact persons - BfArM
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