With the Danish Medicines Agency’s recent grant of the first authorizations to manufacture cannabis bulk, the way for launch of the very first medicinal cannabis product from Danish grown cannabis under the Danish medicinal cannabis pilot programme has been paved.
Further, the Danish Medicines Agency has issued its first report on side effects reported to the agency during the first year of the pilot programme’s lifetime.
First authorizations to manufacture cannabis bulk
In May, the Danish Medicines Agency (the DMA) issued the first-to-be-granted authorizations to manufacture cannabis bulk (i.e. a processed cannabis product ready for further processing and not yet in consumer-ready packages). With such authorization the holders are permitted to grow and cultivate cannabis for medical use in Denmark, which under the pilot programme can be processed into cannabis bulk and further into so-called cannabis primary products (a product in consumer ready packages without the required labelling for being put on the market).
The authorizations are the prerequisite for medicinal cannabis products manufactured on the basis of Danish grown cannabis under the pilot programme to reach patients. The authorizations do, thus, also relate to the much-discussed possibility under the pilot programme to export medicinal cannabis, as it is only possible to export such if it is made from Danish grown cannabis.
Previously, patients in Denmark has under the pilot programme only had access to medicinal cannabis products imported from other countries. But it is now expected that the first medicinal cannabis product from Danish grown cannabis will be made available to Danish patients under the pilot programme in the Fall of 2019.
For further information on the pilot programme, feel free to (re)visit Accura’s previous newsletters from February 2019 and February 2018 with details on the programme, the different product types and authorizations.
Report for 2018 on side effects
In addition to the grant of authorizations, the DMA has recently issued its first report on side effects with medicinal cannabis products included in the pilot programme.
The report presents the possible side effects that have been reported to the DMA during 2018 together with the DMA’s assessment on whether the reported symptoms are connected with the use of medicinal cannabis products under the pilot programme.
A total of 21 cases of possible side effects have been reported, of which five regard presumed serious side effects, whereas the remaining regard presumed non- serious side effects. Conclusively, the DMA has not identified any indications giving rise to safety issues with the medicinal cannabis products, and the DMA has neither found reason to initiate any measures of risk minimization in this regard.