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

430 results

Results per page: 10 20 30

Selected filter

How to report SUSARs in case of a failure of the EudraVigilance database or other technical issues? Date: 07. July 2023 Topics: Licensing Type: FAQ

Generally, in case of a system failure or other technical issues, SUSARs can be reported via the joint portal for reporting adverse reactions by healthcare professionals of the BfArM and the PEI after prior consultation with the BfArM. However, the …

How to report SUSARs from clinical trials not falling within the scope of Regulation (EU) No 536/2014 but within the scope of the German Medicinal Products Act (Arzneimittelgesetz) in the version in force on 26 January 2022 (corresponding to Directive 2001/20/EC)? Date: 07. July 2023 Topics: Licensing Type: FAQ

As communicated in the sponsor handbook on the Clinical Trials Information System (EMA/923413/2022 – v. 3.01, 20 December 2022, section 9.1), SUSARs should be reported to the EudraVigilance database only, even if they occurred in clinical trials …

Which scale should be used to determine a causal relationship between an event and an investigational medicinal product? Date: 07. July 2023 Topics: Licensing Type: FAQ

We recommend the use of a binary scale that only distinguishes between “related” and “not related”. See also: Council for International Organisation of Medical Sciences (CIOMS): Management of Safety Information from Clinical Trials: Report of CIOMS

How to report SUSARs from compassionate use programmes? Date: 07. July 2023 Topics: Licensing Type: FAQ

In contrast to SUSARs from clinical trials, SUSARs from compassionate use programmes must be reported to the competent higher federal authority according to section 6(6)(1) of the German Ordinance on Medicinal Products for Compassionate Use …

What to do in case of missing acknowledgment (ACK) for a SUSAR report? Date: 07. July 2023 Topics: Licensing Type: FAQ

The EMA is responsible for ACK transmission and this can take up to 48 hours. Before inquiring the status of ACK, please wait at least three working days. The sender should also check whether a “Message Disposition Notification” (MDN) is available, …

Opinion No. 01/2023 of the Joint Expert Commission on Classification of Substances PDF, 1MB, File does not meet accessibility standards Date: 03. July 2023 Topics: Licensing Type: Download

Classification of products containing zinc

CHMP Meeting Highlights June 2023 Date: 30. June 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights June 2023

Are there shortened deadlines for phase I studies? Date: 14. June 2023 Topics: Licensing Type: FAQ

Mononational phase I studies are assessed within 26 days after successful validation. Should the application be free of defects, a decision can be made by day 31. This also applies to other mononational studies of other phases.

Should it be a …

CHMP Meeting Highlights May 2023 Date: 01. June 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights May 2023

"Compassionate Use" Programmes Date: 09. May 2023 Topics: Licensing Type: Article

"Compassionate Use" was introduced into the German legislation with the 14th amendment of the German Medicinal Product Act (AMG) and modified by the amendment of the German Medicinal Product Act in July 2009.