Medical Cannabis in Germany: From the BtMG to the Cannabis Act?

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6/7 June 2023

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

According to a draft version for the German Cannabis Law (Cannabisgesetz, CannG), cannabis for medical purposes will no longer fall within the scope of the Narcotics Law (Betäubungsmittelgesetz, BtMG). The working draft provides a separate chapter for this special cannabis. However, this is still under discussion.

What may change

It concerns medicinal cannabis, which is of plant origin, as well as synthetically produced cannabinoids, which correspond to the natural group of active ingredients, the cannabinoids found in the plant (e.g. Dronabinol). With the new law, it is expected that also Dronabinol is to be removed from the scope of the BtMG and then regulated in the CannG. Accordingly, the production of dronabinol (and of preparations / dosage forms containing dronabinol) will no longer be subject to BtMG authorization (a manufacturing authorization according to EU GMP is, of course, still required, e.g. for the manufacture of Dronabinol Capsules).

In addition, the chapter contains regulations around prescription, import and export permission, cultivation and its supervision. However, the cultivation of cannabis for medical purposes in Germany is still expected to take place exclusively under the responsibility of the German Cannabis Agency.

Within terms of operation of a public pharmacy or a hospital pharmacy, cannabis from a state-controlled cultivation for medical purposes may also be imported and exported without a (BtMG) permit.

For more information please see the article (in German) Apotheken dürfen Genusscannabis weder anbauen noch abgeben published by DAZ (Deutsche Apotheker Zeitung) online.