29/30 October 2019
Germany published its official DAB ("Deutsches Arzneibuch", German Pharmacopoeia) Monograph for Cannabis Flower "Cannabisblüten" (Cannabis flos) in 2017 and a draft DAB Monograph for Cannabis Extracts in May 2019. Now Denmark has its official Monograph "Cannabisblomst" (Cannabis flos) with reference to Ph. Eur. tests (e.g. Pesticides, Aflatoxines, Heavy Metals, Microbial Contamination) and to Ph. Eur. General Monographs. Manufacturers and suppliers are expected to comply with the requirements of the new DK monograph if they want to sell their cannabis products to the Danish market.
According to the publication, the Danish Cannabis Monograph is based on the Dutch OMC (Dutch Office for Medicinal Cannabis) monograph ”Cannabis inflorescence” (version 7.1, November 2014) and the (non-public) EDQM-working-document (PA/PH/Exp. 13B/T (16) 38, August 2016).
There are some differences and similarities between these national pharmacopoeial monographs. For example, the Danish Monograph "Cannabisblomst" lists supplementary dosage forms for medicinal cannabis, like "herbal tea/ inhalation vapour, herbal drug", at the end of the monograph. Such a listing does not appear in the German counterpart. Both the German DAB Monograph "Cannabisblüten" and the Danish Monograph "Cannabisblomst" do not specify a THC (Tetrahydrocannabinol) or CBD (Cannabidiol) content. But both set a limit for CBN (Cannabinol) of max. 1 %.
In addition, the German draft DAB Monograph for Cannabis Extracts limits the THC content to be in the range of 1-25 % and the CBD content to be max. 10 %. Moreover, in Germany there currently also exists a DAC (Deutscher Arzneimittel Codex ) Monograph for Cannabis resin (Cannabis oleoresina raffinata et normata) where the THC content is defined to be approx. 5 % and the CBD content is not defined.
It is expected that the Ph. Eur will publish a (draft) Monograph for Cannabis flowers in Pharmeuropa in the near future (see also New Zealand´s new legislation for medical cannabis). However, since there is currently no harmonized Monograph available in the EU, national legislations and monographs regarding the quality of medicinal cannabis apply and have to be followed respectively (for further information see also Medicinal cannabis: What it takes to be GMP-ready).
More information can be found in the Danish Monograph Cannabisblomst (Cannabis flos).