10/11 March 2021
The German Federal Institute for Drugs and Medical Devices (BfArM ) announced the release of the DAB 2020 (Deutsches Arzneibuch = German Pharmacopoeia) on 5 March 2020 (published in the (German) Bundesanzeiger of 18 March 2020). The announcement lists the texts and monographs adopted by the German Pharmacopoeial Commission on 11 October 2019. According to the announcement the DAB monograph entitled "Cannabis Extract, Standardized (Cannabis extractum normatum)" will be added to the DAB 2020. The draft monograph on cannabis extract was published last year in the German "Bundesanzeiger".
As a result of the comments and remarks received on the draft monograph "Cannabis Extract, Standardized" - (BAnz. AT 06.05.2019 B6), the monograph has been revised. It is anticipated that the DAB monograph will be published as agreed in the protocol of the 62nd consultation of the DAB Committee for Pharmaceutical Biology (to be found on the BfArM website under "DAB Commission Expert Groups" (Fachausschüsse der DAB-Kommission). Thus, it is expetced that the DAB monograph will
The DAB already contains the monograph "Cannabis flowers" (Cannabis flos). The amended and revised German Pharmacopoeia will be renamed "Deutsches Arzneibuch 2020 (DAB 2020)" and will be effective as of 1 June 2020. It is expected to be available by mid-May 2020. The final (official) version of the text is currently not available. The German Pharmacopoeia 2020 can be purchased from "Deutscher Apotheker Verlag".
In addition, the European Pharmacopeia (Ph. Eur.) is currently working on a Cannabis Monograph. However, some specific challenges for the development of the Ph. Eur. Cannabis monograph (e.g. inclusion of preparations, sample availability) have been recently discussed (please see Committee on Herbal Medicinal Products (HMPC) Minutes for the meeting on 23-25 September 2019).