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282 results

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How can an acceleration or prioritisation of the assessment of a variation procedure be requested from BfArM, and what information is required? Date: 05. November 2025 Topics: Licensing Type: FAQ

Generally, applications are processed in the order in which they are received. Exceptions to this rule may be made in justified cases if this leads to an improvement in an existing critical supply situation or if it can avert a critical supply …

Comments concerning texts published in Issue 12.2 PDF, 329KB, File does not meet accessibility standards Date: 01. October 2025 Topics: Licensing Type: Download

Comments concerning texts published in Issue 12.2

Are variations to purely national licences that contain only one single change but several marketing authorisations regarded as a grouping? Date: 03. July 2025 Topics: Licensing Type: FAQ

Yes. These variations are categorised as “horizontal groupings” according to Article 13.d.2) of Regulation 712/2012/EC. However, when submitting such variations to the BfArM they should not be submitted as a grouping but as a collective notification …

How are the data on antibiotic resistance in section 5.1 of the SmPC to be updated? Date: 10. June 2025 Topics: Licensing Type: FAQ

Data on the resistance situation of systemically available antibiotics in Germany is regularly reassessed in the Z.A.R.S. project and is considered in the resistance table for Section 5.1 of the SmPC.

The previously requested EUCAST table (European …

How is the reference to the digital package leaflet implemented for centrally authorised medicinal products? Date: 17. February 2025 Topics: Licensing Type: FAQ

The European Medicines Agency (EMA) is the competent authority for centrally authorised medicinal products. The BfArM recommends to contact the EMA in case of questions.

Opinion No. 01/2025 of the Joint Expert Commission on Classification of Substances PDF, 2MB, File does not meet accessibility standards Date: 10. February 2025 Topics: Licensing Type: Download

Classification of dehydroepiandrosterone

Current processing statistics of the BfArM PDF, 289KB, File does not meet accessibility standards Date: 20. January 2025 Topics: Licensing Type: Download

State: December 2024

NEW CONTENT, ISSUE 12.1 PDF, 59KB, File does not meet accessibility standards Date: 06. January 2025 Topics: Licensing Type: Download

NEW CONTENT, ISSUE 12.1

Index of European Pharmacopoeia 11.8 PDF, 812KB, File does not meet accessibility standards Date: 06. January 2025 Topics: Licensing Type: Download

Index of European Pharmacopoeia 11.8

Practical advice for completing the "Bescheidmaske" 10/2024 docx, 73KB, File does not meet accessibility standards Date: 31. October 2024 Topics: Licensing Type: Download

Practical advice for completing the "Bescheidmaske" 10/2024