What is AMRadV?
The regulatory regime overseeing the distribution of a medicinal cannabis in Germany is continuously changing. Cannabis flowers are usually treated with ionizing radiation in order to protect them permanently against bacteria and mold and reduce germ count. However, according to the Medicines Act (AMG), pharmacies are prohibited from selling medicinal products that have undergone ionising radiation unless they have been approved in accordance with the Order on radioactive medicinal products and medicinal products treated with ionising radiation (German designation: AMRAdV, Irradiation Decree)
Since late 2019, this was eventually being enforced on imported cannabis flowers to Germany from the Netherlands and Canada as well. Medicinal Cannabis flowers cultivated under a EU-GMP regime are routinely irradiated with gamma waves to reduce the bacterial and fungi count and increase shelf life. Unless the distribution complies with the Irradiation Decree (AMRadV), German law forbids the distribution of irradiated product. This regulation stipulates that the distributor must hold such a permit when supplying these products to other wholesalers or pharmacies.
The submission for this license is extensive and necessitates elaborate information on the manufacturing process, validation equipment as well as risk evaluation to stability data of the irradiated product.
Other regulatory changes on the horizon for medicinal cannabis products
In the future, we might see a harmonisation process (beyond EU-wide GDP guidelines) on how medicinal cannabis products are treated within the EU. While the regulatory environment is mostly heterogeneous, the European Commission might try to harmonize this market. However, it is not certain when or if real outcome on this may materialize.
One possibility could be that the European Commission could act on the Parliament Parliament’s recommendation, that amongst other things, medicinal cannabis products sold on the market would require a marketing authorization. This would probably have a disruptive effect on the market, requiring that all cannabis products require clinical trials, albeit the exact extent is uncertain.
However, because cannabis products have a broad range of efficacy for different indications, it is unlikely that clinical trials are adequate for specific indications with specific patient portfolios. Nevertheless, if enforced, a marketing authorization would limit the prescription possibilities for medicinal cannabis products to only clinically proven relevant indications.
In the current regulatory regime, a marketing authorization is not required for medicinal cannabis products, neither for oils nor for flowers. While quality control measures are to be complied with, a market authorization is not necessary, and the products do not have to through the price-determination process for pharmaceuticals established in Germany.