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Marketable medicinal products in the responsibility of the BfArM Date: 24. November 2025 Topics: Licensing Type: Article

On the following page you will find the figures of marketable medicinal products in the responsibility of the BfArM, broken down according to type of authorisation procedure as well as details of the authorisation status. The figures are …

Processing statistics Date: 24. November 2025 Topics: Licensing Type: Article

Here the BfArM publishes the current processing statistics of authorisations and registrations as well as of renewals. The figures are updated on a monthly basis.

Statistics Date: 20. November 2025 Topics: Licensing Type: Article

The statistics have been updated.

Most common considerations when submitting an initial application or a substantial modification Date: 12. November 2025 Topics: Licensing Type: Article

The following is a list of the most common considerations that occur in the area of validation.

Clinical Trials Information System – CTIS Date: 06. November 2025 Topics: Licensing Type: Article

EMA Clinical trials Map

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 …

eSubmission Date: 02. October 2025 Topics: Licensing Type: Article

As of 1 December 2025 new validation criteria v8.2 for eCTD submissions are mandatory.

Radiation Protection Act Date: 25. July 2025 Topics: Licensing Type: Article

Below you will find all important information about the changes in the radiation protection act applicable since 01.07.2025.

Submission of Variations Date: 04. July 2025 Topics: Licensing Type: Article

Aerosol dispensers containing fluorinated greenhouse gases, including medicinal metered dose inhalers, may only be placed on the market, supplied or made available to third parties in the EU from 1 January 2025 if they are labelled in accordance with …

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 …