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CHMP Meeting Highlights June 2024 Date: 08. July 2024 Topics: Licensing Type: Article

CHMP Meeting Highlights June 2024

Statistics "Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)" Date: 05. July 2024 Topics: Licensing Type: Article

The following table gives an overview of the herbal, homeopathic and anthroposophic medicinal products with completed marketing authorisation or registration procedure which are available on the German market.

Index of European Pharmacopoeia 11.6 PDF, 523KB, File does not meet accessibility standards Date: 03. July 2024 Topics: Licensing Type: Download

Index of European Pharmacopoeia 11.6

6CONTENTS OF SUPPLEMENT 11.6 PDF, 84KB, File does not meet accessibility standards Date: 02. July 2024 Topics: Licensing Type: Download

CONTENTS OF SUPPLEMENT 11.6

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