20/21 February 2024
The German BfArM (Federal Institute for Drugs and Medical Devices) and the German PEI (Paul Ehrlich Institute - the Federal Institute for Vaccines and Biomedicines) published version 8.2 of the "Guideline on the Designation of Medicinal Products" (Leitlinie zur Bezeichnung von Arzneimitteln) at the end of July, which can be viewed on both websites of the institutes. The above-mentioned guideline was fundamentally revised in 2023 and applies exclusively to medicinal products for human use. It is intended to support marketing authorisation holders and applicants in the selection of the designation of the respective medicinal products.
The new version consists of 9 chapters, Annex 1 "List of possible designation supplements" and three annexes on references. Chapters 4, 5, 6 and 7 are each subdivided into subchapters. In addition to the elements of the medicinal product designation (Chapter 3), the general requirements for the medicinal product designation (Chapter 4) as well as the pharmaceutical dosage form (Chapter 8) and strength (Chapter 7) are discussed and explained. Further topics are presented and described in Chapter 5 Phantasy Names and in Chapter 6 Generic Drug Designations.
The new version 8.2 of the "Leitlinie des BfArM und des PEI zur Bezeichnung von Arzneimitteln" (Guideline on the Designation of Medicinal Products) can be viewed on the BfArM website (in German only).