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Statistics "Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)" Date: 20. September 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.

Current Processing Statistics of the BfArM PDF, 265KB, File does not meet accessibility standards Date: 19. September 2024 Topics: Licensing Type: Download

State: August 2024

Processing Statistics Date: 19. September 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: 18. September 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 …

Responsibilities for IgG Fc fusion proteins Date: 28. August 2024 Topics: Licensing Type: Article

Information for Pharmaceutical Companies: Specifications regarding responsibilities for IgG Fc fusion proteins

Recommendations on complex clinical trials in mono-national clinical trials in the early development phase (Early Phase Complex Clinical Trials) Date: 25. July 2024 Topics: Licensing Type: Article

Modern study protocols for phase I or phase I/IIa clinical trials (‘early phase clinical trials’) often include several classic phase I clinical trials in the form of integrated, consecutive sub-studies.

Clinical Trials Information System – CTIS Date: 19. July 2024 Topics: Licensing Type: Article

Clinical trials data publication now more transparent in the EU - Article in EUobserver, July 19, 2024

Pharmacopoeia Commissions Date: 18. July 2024 Topics: Licensing Type: Article

Pharmacopoeia Commissions

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

CHMP Meeting Highlights July 2024

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

CHMP Meeting Highlights June 2024

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 …

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

PharmNet.Bund Date: 28. May 2024 Topics: Licensing Type: Article

PharmNet.Bund is the Drug Information Portal of Bund (Federal Government) and Laender (States) and through it an integrated, centralised drug information system develops iteratively.

Statistics related to advice procedures Date: 14. May 2024 Topics: Licensing Type: Article

The statistics related to advice procedures have been updated.

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.

Sunset Clause Date: 23. April 2024 Topics: Licensing Type: Article

The BfArM informs about the start of the electronic application portal for exemptions and suspensions to the sunset clause

CHMP Meeting Highlights March 2024 Date: 03. April 2024 Topics: Licensing Type: Article

CHMP Meeting Highlights March 2024

CHMP Meeting Highlights April 2024 Date: 03. April 2024 Topics: Licensing Type: Article

CHMP Meeting Highlights April 2024

CHMP Meeting Highlights February 2024 Date: 28. February 2024 Topics: Licensing Type: Article

CHMP Meeting Highlights February 2024

Processing Statistics 2023 of the BfArM PDF, 361KB, File does not meet accessibility standards Date: 23. February 2024 Topics: Licensing Type: Download

State: December 2023

New information regarding allocation of DCP slots Date: 20. February 2024 Topics: Licensing Type: Article

Update on allocation of DCP slots

CHMP Meeting Highlights January 2024 Date: 09. February 2024 Topics: Licensing Type: Article

CHMP Meeting Highlights January 2024