BfArM - Federal Institute for Drugs and Medical Devices

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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 …