BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.
  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

149 results

Results per page: 10 20 30

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

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 …

CHMP Meeting Highlights May 2025 Date: 16. June 2025 Topics: Licensing Type: Article

CHMP Meeting Highlights May 2025

CHMP Meeting Highlights June 2025 Date: 16. June 2025 Topics: Licensing Type: Article

CHMP Meeting Highlights June 2025