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.
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 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.
New rules for the cultivation and export of medical cannabis and increased limits for THC concentrations in industrial hemp in the Czech Republic
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:
The Amendment will come into effect on 1 January 2022.
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.
For further information please contact Tomáš Čihula, Partner, at , or Tereza Mašková, Associate, at .
EIHA, the European Industrial Hemp Association, is an international organization that seeks to promote the interests of industrial cannabis entrepreneurs in Europe. EIHA proposed to the European Union that the CBD should be added in the European cosmetics database CosIng. The proposal included the removal of restrictions on Cannabis Sativa L. and the addition of three new INCI (International Nomenclature Cosmetic Ingredient) names to the list. Suggestions for names to be added were Cannabis Sativa leaf extract, Cannabis Sativa leaf / stem extract and Cannabis Sativa root extract. EIHA submitted its proposal in late 2019.
CBD can be found in the CosIng database under the name Cannabidiol – Derived from cannabis extract, tincture, or resin. CBD products, such as CBD oil, can be legally marketed with the following properties: antioxidant, anti-sebum, skin protection, and skin care.
The role of the CBD before the changes
The Court notes that the provisions on the free movement of goods within the European Union (Articles 34 and 36 of the Treaty on the Functioning of the European Union) apply because the CBD at issue here cannot be regarded as a ‘drug’ since the CBD does not appear to have psychotropic effects, or otherwise cause adverse effects on human health.
The protection of public health and the assessment of the measures necessary to achieve it are a matter for the national court, but it is for the national court to assess the available scientific information to ensure that the alleged actual risk to public health is not based solely on hypothetical considerations.