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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.

How is the reference to the digital package leaflet implemented for centrally authorised medicinal products? Date: 26. June 2024 Topics: Licensing Type: FAQ

In the BfArM's view, the information can be included at the national level at the end of the package leaflet under the heading „Weitere Informationsquellen“ without a reference in the English text. The BfArM does not consider a change notification to …

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 …

Current Processing Statistics of the BfArM PDF, 168KB, File does not meet accessibility standards Date: 19. June 2024 Topics: Licensing Type: Download

State: May 2024

Processing Statistics Date: 19. June 2024 Topics: Licensing Type: Article

Here the BfArM publishes the current processing statistics of authorisations and registrations as well as of renewals. The figures are updated on a monthly basis.

Marketable Medicinal Products in the Responsibility of the BfArM Date: 19. June 2024 Topics: Licensing Type: Article

On the following page you will find the figures of marketable medicinal products in the responsibility of the BfArM, broken down according to type of authorisation procedure as well as details of the authorisation status. The figures are …

CHMP Meeting Highlights May 2024 Date: 10. June 2024 Topics: Licensing Type: Article

CHMP Meeting Highlights May 2024

German Act to Combat and Improve the Supply of Medicines Date: 07. June 2024 Topics: Licensing Type: Article

The Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz (ALBVVG) was published on 26 July 2023 in the Federal Law Gazette (Bundesgesetzblatt).

Pharmacopoeia Date: 02. June 2024 Topics: Licensing Type: Article

Pharmacopoeia