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How can an acceleration or prioritisation of the assessment of a variation procedure be requested from BfArM, and what information is required? Date: 05. November 2025 Topics: Licensing Type: FAQ

Generally, applications are processed in the order in which they are received. Exceptions to this rule may be made in justified cases if this leads to an improvement in an existing critical supply situation or if it can avert a critical supply …

Are variations to purely national licences that contain only one single change but several marketing authorisations regarded as a grouping? Date: 03. July 2025 Topics: Licensing Type: FAQ

Yes. These variations are categorised as “horizontal groupings” according to Article 13.d.2) of Regulation 712/2012/EC. However, when submitting such variations to the BfArM they should not be submitted as a grouping but as a collective notification …

How are the data on antibiotic resistance in section 5.1 of the SmPC to be updated? Date: 10. June 2025 Topics: Licensing Type: FAQ

Data on the resistance situation of systemically available antibiotics in Germany is regularly reassessed in the Z.A.R.S. project and is considered in the resistance table for Section 5.1 of the SmPC.

The previously requested EUCAST table (European …

How is the reference to the digital package leaflet implemented for centrally authorised medicinal products? Date: 17. February 2025 Topics: Licensing Type: FAQ

The European Medicines Agency (EMA) is the competent authority for centrally authorised medicinal products. The BfArM recommends to contact the EMA in case of questions.

Can the package leaflet refer to a digital package leaflet? Date: 26. June 2024 Topics: Licensing Type: FAQ

Yes, according to the CMDh position papier on the use of mobile scanning of package leaflets and labelling, the following options are available:

  1. A website of the national regulatory authority
  2. Dedicated pages set up by the marketing authorisation …

Can the reference to the digital package leaflet for national marketing authorisations be included as part of a type IA variation or must it be submitted with a type IB variation? Date: 26. June 2024 Topics: Licensing Type: FAQ

The submission can either be made via a so-called "P-Procedure", as only the package leaflet is affected, or as an additional change ("editorial change") in the context of a type IB or type II variation concerning the product information.

E.2. How and when are applications for exemptions pursuant to Section 31 sub-section 1 sentence 2 AMG or applications for suspension of the 3-year period in accordance with Section 31 sub-section 1 number 1 AMG to be submitted? Date: 13. May 2024 Topics: Licensing Type: FAQ

An electronic application portal for exemptions and suspensions to the sunset clause was developed which should be used for submitting such applications. We expressly request to use this electronic procedure as opposed to conventional applications.

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 …