BfArM - Federal Institute for Drugs and Medical Devices

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CHMP Meeting Highlights September 2021 Date: 23. September 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights September 2021

CHMP Highlights Special Edition August 2021 Date: 31. August 2021 Topics: Licensing Type: Article

CHMP Highlights Special Edition August 2021

CHMP Meeting Highlights July 2021 Date: 30. July 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights July 2021

GCP Inspections Unit Date: 23. July 2021 Topics: Licensing Type: Article

The GCP Inspections Unit is responsible for verifying compliance with the regulatory requirements for clinical trials in procedures of the BfArM and the European Medicines Agency (EMA), as well as any related issues.

CHMP Meeting Highlights June 2021 Date: 05. July 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights June 2021

Medicines for children Date: 01. July 2021 Topics: Licensing Type: Article

The so-called "Paediatric Regulation" which aims at improving drug safety in children and adolescents has been in force since 2007. The BfArM is significantly involved in this important task and is active in several committees for this purpose both …

I do not know my processing number (ENR) or pharmaceutical entrepreneur Number (PNR) - how can I find out my numbers? Date: 30. June 2021 Topics: Licensing Type: FAQ

You can search for medicines free of charge at www.pharmnet-bund.de. The ENR for the medicinal product and the PNR for the pharmaceutical entrepreneur are also available here.
For new marketing authorizations, the ENR and PNR will be provided to you …

Is the PNR number of the pharmaceutical entrepreneur identical with the number of the applicant in the drug facts database? Date: 30. June 2021 Topics: Licensing Type: FAQ

Yes, the 7-digit number of the pharmaceutical entrepreneur (PNR) is identical to the number of the applicant in the medicinal product database.

Procedure for submitting product information texts for publication Date: 29. June 2021 Topics: Licensing Type: FAQ

Pursuant to Sections 11 sub-section 1a, 11a sub-section 3 of the Medicinal Products Act (AMG), the submission of the current product information texts (Summary of Product Characteristics (SmPC) and Package Leaflet (PIL) is required. These current …

Procedures to obtain a National Marketing Authorisation for the Same Medicinal Product in more than one Member State of the European Union/European Economic Area (EEA) Date: 22. June 2021 Topics: Licensing Type: Article

Decentralised Procedure (DCP) / Mutual Recognition Procedure (MRP)