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

14 results

Results per page: 10 20 30

Selected filter

Whom do I need to contact in order to apply for a PNR (pharmaceutical company number)? Which documents must be provided? Date: 07. August 2023 Topics: Licensing Type: FAQ

For the allocation of a PNR, please contact the e-mail account Partnerinformationen@bfarm.de stating "Application for a new PNR" in the subject line.

In order to create a PNR in the pharmaceutical companies database "Partnerinformationen", the …

According to section B.11 of annex I of Regulation (EU) No 536/2014, the cover letter shall indicate where to find the reference safety information (RSI) in the application dossier. Should reference be made to a specific version of the investigator’s brochure (IB) or summary of product characteristics (SmPC) or to the version valid at the time of SUSAR reporting? Date: 07. July 2023 Topics: Licensing Type: FAQ

Reference should not be made to a specific version of the IB or SmPC, but to the most recently approved version at the time of SUSAR reporting, so the information remains valid even in case of subsequent amendments to the IB or SmPC. If, in contrast, …

How long shall adverse events be recorded, documented and reported to the sponsor? Date: 07. July 2023 Topics: Licensing Type: FAQ

According to article 41(2) of Regulation (EU) No 536/2014, investigators shall record and document all adverse events and report all serious adverse events to the sponsor, unless the protocol provides differently. The start and end time for …

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 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 …

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

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, …

How to submit ASRs? Date: 07. July 2023 Type: FAQ

ASRs exclusively covering 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 …

Are there additional reporting requirements related to safety reporting under Chapter VII of Regulation (EU) No 536/2014, such as the submission of monthly, quarterly or half-yearly safety reports or SUSAR line listings? Date: 07. July 2023 Type: FAQ

Documents covering shorter than annual reporting periods, such as monthly, quarterly or half-yearly safety reports or monthly, quarterly or half-yearly SUSAR line listings, are not to be submitted unless explicitly requested.

The submission of …