October 2021 – On 8 October 2021, an amendment to the Act on Addictive Substances (the “Amendment”) was published. The Amendment is designed to expand the possibilities for cultivating medical use cannabis to a broader range of subjects, including natural person entrepreneurs, thus increasing its availability to Czech patients. It is expected that increased production will lead to a fall in the price of cannabis for medical use.
A new licensing system is being created under the Amendment, enabling entities or natural person entrepreneurs to cultivate plant-based cannabis for medical use, provided that they obtain:
- a licence to cultivate cannabis for medical use issued by the State Institute for Drug Control (the “Institute”); and
- a permit for handling addictive substances issued by the Ministry of Health.
Once medical cannabis is cultivated, it will be treated like any other regulated addictive substance – meaning it will be traded within established distribution systems, or can be exported abroad. Quantities of cannabis harvested for medical use, which have been cultivated based on the abovementioned licencing system, are also subject to reporting to the Institute and Ministry of Health.
The Amendment also introduces a significant change in the definition of industrial hemp in terms of permitted THC concentrations. These have been increased from 0.3% to 1% of dried matter. Industrial hemp, including extraction and tincture that contains up to 1% THC, will therefore no longer be subject to regulation as an addictive substance under Czech law. However, any entities or individuals cultivating industrial hemp on a total land area of more than 100 m2 will also be subject to specific reporting obligations to the locally competent customs authority.
The Amendment further introduces electronic prescriptions for certain medicinal products containing highly addictive substances, including medical cannabis, which will be labelled with a “highly addictive substance” designation.
The Amendment will come into effect on 1 January 2022.
For further information please contact Tomáš Čihula, Partner, at , or Tereza Mašková, Associate, at .