BfArM - Federal Institute for Drugs and Medical Devices

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AMIce - Public Part - Module Terms for Substances Date: 01. April 2022 Topics: Licensing Type: Article

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 - Public Part - Module Substances Date: 01. April 2022 Topics: Licensing Type: Article

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.

CHMP Meeting Highlights March 2022 Date: 31. March 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights March 2022

CHMP Meeting Highlights February 2022 Date: 03. March 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights February 2022

CHMP Meeting Highlights January 2022 Date: 03. February 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights January 2022

Variations Date: 25. January 2022 Topics: Licensing Type: Article

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.

How to register for CTIS? Date: 18. January 2022 Topics: Licensing Type: FAQ

Before using CTIS, users must have an EMA account. Users that have already an EMA account, for example to use Eudravigilance or the substances, products, organisations and referentials database (SPOR) do not need to create a new account. Users that …

How clinical trials will be processed in CTIS? Date: 18. January 2022 Topics: Licensing Type: FAQ

Clinical trial sponsors who want to gain regulatory approval for a clinical trial in one or more EU Member States and EEA countries will submit a single clinical trial application form and supporting dossier through CTIS. The submission of the single …

How to prepare for CTIS? Date: 05. January 2022 Topics: Licensing Type: FAQ

Sponsors can consult the CTIS Sponsor Handbook for guidance on how to prepare for CTIS.

In addition, sponsors can use the CTIS online training programme. The guide to the CTIS training material catalogue, which can be found on the training …

CHMP Meeting Highlights December 2021 Date: 23. December 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights December 2021

Opinion No. 02/2021 of the Joint Expert Commission on Classification of Substances PDF, 524KB, File does not meet accessibility standards Date: 22. December 2021 Topics: Licensing Type: Download

Classification of products containing selenium

Orphan Medicinal Products Date: 07. December 2021 Topics: Licensing Type: Article

In order to provide incentives for a potentially uneconomical development and marketing of a medicinal product intended for the diagnosis, prevention or treatment of a rare disease, the European Commission has established a voluntary and …

CHMP Meeting Highlights November 2021 Date: 18. November 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights November 2021

Registered Online Medicine Retailers Date: 09. November 2021 Topics: Licensing Type: Article

In the following overviews, you can look up whether your medicine retailers is included in the register. The links in the "Internet address(es)" column safely transfer you to the website(s) of the desired retailer. Furthermore, you will find contact …

EU Security Logo Date: 09. November 2021 Topics: Licensing Type: Article

The EU security logo can be found on websites of online medicine retailers that are included in the German Register of Online Medicine Retailers.
It does not have any significance in itself. However, in three simple steps, you can reduce the risk of …

How should the competent authority be informed of the inclusion of already authorised indications in the product texts due to expiry of the patent protection? Date: 04. November 2021 Topics: Licensing Type: FAQ

The inclusion of information on already authorised indications protected by a patent due to expiration of this patent should be applied for as a type IB variation C.I.z since this implies a change of the product texts.

How is a change in the dispensing classification (legal status) of a medicinal product to be notified? Date: 04. November 2021 Topics: Licensing Type: FAQ

The classification for dispensing of medicinal products is regulated by the Ordinance on the Prescription Requirement for Medicinal Products ("Arzneimittelverschreibungs-Verordnung", AMVV) as well as the Ordinance on Pharmacy-only Medicinal Products …

Clinical trials during the COVID-19 pandemic Date: 05. October 2021 Topics: Licensing Type: Article

With the end of the COVID-19 pandemic, this page will no longer be updated.

Opinion No. 01/2021 of the Joint Expert Committee on Classification of Substances PDF, 6MB, File does not meet accessibility standards Date: 27. September 2021 Topics: Licensing Type: Download

Classification of Citrus aurantium extract or synephrine alone and in combination with caffeine

CHMP Meeting Highlights October 2021 Date: 23. September 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights October 2021

CHMP Meeting Highlights September 2021 Date: 23. September 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights September 2021

CHMP Highlights Special Edition August 2021 Date: 31. August 2021 Topics: Licensing Type: Article

CHMP Highlights Special Edition August 2021

CHMP Meeting Highlights July 2021 Date: 30. July 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights July 2021

GCP Inspections Unit Date: 23. July 2021 Topics: Licensing Type: Article

The GCP Inspections Unit is responsible for verifying compliance with the regulatory requirements for clinical trials in procedures of the BfArM and the European Medicines Agency (EMA), as well as any related issues.

CHMP Meeting Highlights June 2021 Date: 05. July 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights June 2021

Medicines for children Date: 01. July 2021 Topics: Licensing Type: Article

The so-called "Paediatric Regulation" which aims at improving drug safety in children and adolescents has been in force since 2007. The BfArM is significantly involved in this important task and is active in several committees for this purpose both …

I do not know my processing number (ENR) or pharmaceutical entrepreneur Number (PNR) - how can I find out my numbers? Date: 30. June 2021 Topics: Licensing Type: FAQ

You can search for medicines free of charge at www.pharmnet-bund.de. The ENR for the medicinal product and the PNR for the pharmaceutical entrepreneur are also available here.
For new marketing authorizations, the ENR and PNR will be provided to you …

Is the PNR number of the pharmaceutical entrepreneur identical with the number of the applicant in the drug facts database? Date: 30. June 2021 Topics: Licensing Type: FAQ

Yes, the 7-digit number of the pharmaceutical entrepreneur (PNR) is identical to the number of the applicant in the medicinal product database.

Procedure for submitting product information texts for publication Date: 29. June 2021 Topics: Licensing Type: FAQ

Pursuant to Sections 11 sub-section 1a, 11a sub-section 3 of the Medicinal Products Act (AMG), the submission of the current product information texts (Summary of Product Characteristics (SmPC) and Package Leaflet (PIL) is required. These current …

Procedures to obtain a National Marketing Authorisation for the Same Medicinal Product in more than one Member State of the European Union/European Economic Area (EEA) Date: 22. June 2021 Topics: Licensing Type: Article

Decentralised Procedure (DCP) / Mutual Recognition Procedure (MRP)