AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the comprehensive medicinal products information system AMIce, managed and updated by the German drug regulatory authorities BfArM, BVL, and PEI.

AMIce contains the authorisation data of the German drug regulatory authorities BfArM (Federal Institute for Drugs and Medical Devices), PEI ( Paul-Ehrlich-Institut - Federal Institute for Vaccines and Biomedicines) and BVL (Federal Agency for Consumer Protection and Food Safety).

AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the Federal Drug Application Database (AmAnDa), which is maintained and updated by the German drug regulatory authorities BfArM, BVL, and PEI.

AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the Federal Drug Application Database (AmAnDa), which is maintained and updated by the German drug regulatory authorities BfArM, BVL, and PEI.

AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the Federal Drug Application Database (AmAnDa), which is maintained and updated by the German drug regulatory authorities BfArM, BVL, and PEI.

The opinion on the classification of dehydroepiandrosterone is available.

The statistics related to advice procedures have been updated.

As of 1^st March 2025 new validation criteria for eCTD submissions are mandatory.

On the occasion of the new Variation Regulation (EC) No 1234/2008 which applies since 1 January 2010 a new web page "Variations" has been created and should be considered.

Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)

Publication of the Joint Announcement by BfArM and PEI on the Notification of Variations for Purely National Marketing Authorisations in Accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013 dated 16 April 2025

As from 09.02.2019, for medicinal products subject to Directive 2011/62/EC in conjuction with Commission Delegated Regulation (EU) 2016/161 amending Directive 2001/83/EC, a unique identifier (UI) has to be included on the packaging as well as a device allowing verification of whether the packaging has been tampered with (anti-tempering device = ATD).

The following table gives an overview of the herbal, homeopathic and anthroposophic medicinal products with completed marketing authorisation or registration procedure which are available on the German market.

This article provides information on the correct procedure for reporting a notification procedure in accordance with Section 32 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) as part of CTR submission and for Substantial Modifications in CTIS.

The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.

Effective July 1, 2025, new regulations will apply to radiation protection approvals or notifications for clinical trials.

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 Article 12(3) of Regulation (EU) 2024/573 on fluorinated greenhouse gases (F-Gas Regulation).

For studies with submission in CTIS and DMIDS, only one radiation protection submission is required - depending on the study focus CTIS or DMIDS.

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.

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 updated on a monthly basis.