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

Consequences of Brexit for future and ongoing clinical trials Date: 11. January 2019 Topics: Licensing Type: News

Should there be no specific agreements regarding medicinal products between the European Union (EU) and the United Kingdom (UK), the following issues concerning clinical trials with medicinal products must be observed after
the United Kingdom …

Non-eCTD electronic Submission (NeeS) Date: 01. January 2019 Topics: Licensing Type: Article

Non-eCTD electronic Submission (NeeS)

How should the documentation requirement ”The variation application form should clearly outline the ‘present’ and ‘proposed’ [finished] product manufacturers as listed in section 2.5 of the application form.” according to section A.7, B.I.a.1 and B.II.b.1 as well as B.II.b.2 of the Variation Guideline be applied in a plausible manner? Date: 20. November 2018 Topics: Licensing Type: FAQ

The present/proposed section in the application form should list the complete information on the present as well as the proposed manufacturer of an active substance and/or finished product including their manufacturing sites with full addresses and …

Technical Validation Date: 06. September 2018 Topics: Licensing Type: Article

Technical Validation

validation profile for parallel import applications x-zip-compressed, 24KB, File does not meet accessibility standards Date: 06. September 2018 Topics: Licensing Type: Download

validation profile for parallel import applications in NeeS format

How is the BfArM to be notified of adaptions to the Analgetika-Warnhinweis-Verordnung (AnalgetikaWarnHV)? Date: 18. July 2018 Topics: Licensing Type: FAQ

The adaptation has to be submitted as national change notification pursuant to Section 29 (1) or for a German standard marketing authorisation pursuant to Section 67 (5) of the German Medicinal Products Act (AMG). The correct implementation in …

Which medicines are affected by the AnalgetikaWarnHV? Date: 18. July 2018 Topics: Licensing Type: FAQ

The regulation applies to:

  • Purely national marketing authorisations
  • Marketing authorisations following a mutual recognition procedure or a decentralised procedure (MRP / DCP)
  • Parallel import marketing authorisations
  • German standard …

Which transitional periods should be considered in connection with the AnalgetikaWarnHV? Date: 18. July 2018 Topics: Licensing Type: FAQ

Medicinal products authorised before 1 July 2018, and affected by the AnalgetikaWarnHV may be placed on the market without the required warning 2 years after the regulation became effective, which means until 30 June 2020.

All medicinal products …

How do I implement BfArM comments? Date: 13. June 2018 Topics: Licensing Type: FAQ

If the “Bescheidmaske commented upon by BfArM contains track-changes, these changes are accepted and the "Bescheidmaske" is drafted accordingly for all strengths / procedures.

When returning the drafts to BfArM, the applicant has to …

Which language is to be used for submission of dossier and product information texts in MRP/DCP, if only German-speaking member states (DE/AT) are involved? Date: 13. June 2018 Topics: Licensing Type: FAQ

All guidance documents of the CMDh refer to the use of English dossiers and English product information texts. At the end of the procedure, the RMS has to provide the final English texts for SmPC, PL and Labelling. This is also necessary for …

Implementation of the HMA eSubmission Roadmap in Germany - new marketing authorisation applications for national purpose only required in eCTD format as of 1 July 2018 Date: 19. March 2018 Topics: Licensing Type: Article

New marketing authorisation applications for national purpose only required in eCTD format as of 1 July 2018

Processing Statistics of the BfArM 2017 PDF, 220KB, File does not meet accessibility standards Date: 21. February 2018 Topics: Licensing Type: Download

State: February 2018

eValidator v5.9.1 x-zip-compressed, 15MB, File does not meet accessibility standards Date: 22. September 2017 Topics: Licensing Type: Download

BfArM-eValidator

Falsified Medicines Directive Date: 17. August 2017 Topics: Licensing Type: Article

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 …

Step-by-Step Guide PDF, 696KB, File does not meet accessibility standards Date: 19. May 2017 Topics: Licensing Type: Download

Step-by-Step Guide

Guideline for Notification of a Compassionate Use Programme PDF, 479KB, File does not meet accessibility standards Date: 19. May 2017 Topics: Licensing Type: Download

Guideline for Notification of a Compassionate Use Programme

Opinion No. 01/2016 Rev. 1.1 of the Joint Expert Committee on Classification of Substances PDF, 291KB, File is accessible Date: 22. March 2017 Topics: Licensing Type: Download

Evaluation of products containing vitamin D

Processing Statistics of the BfArM 2016 PDF, 220KB, File does not meet accessibility standards Date: 16. March 2017 Topics: Licensing Type: Download

State: March 2017

Are variations required if the marketing authorisation dossier is reformatted into the eCTD format? Date: 14. March 2017 Topics: Licensing Type: FAQ

A variation is not required, if no changes to the content of the marketing authorisation dossier are necessary for reformatting into the eCTD format and if a corresponding confirmation is given.

Please also consider the FAQs concerning eSubmissions

Will all documents submitted within a variation application be assessed by the BfArM, even if these or parts of these documents have no objective connection to the variation applied for? Date: 14. March 2017 Topics: Licensing Type: FAQ

No. The assessment within a variation procedure is restricted to the documentation which is required in accordance with the Guideline on the details of the various categories of variations and further relevant guidance.

Consequently, only …