54 Chimica Oggi - Chemistry Today - vol. 38(4) July/August 2020 REGULATION BARBARA SIEBERTZ*, UTE HEGENER *Corresponding author PharmaLex GmbH, Mannheim, Germany tetrahydrocannabinol (THC) up to 0.2%) does not fall under the definition of an euphoriant substance. Depending on the products manufactured from hemp, rules on medicines, food and food supplements need to be followed. Denmark defines cannabidiol (CBD) as a pharmacological substance, only products with low concentration of CBD might be classified as food supplement. France : In France, cannabis is regulated by the Code of Public Health (2), including “narcotic substances”. Article R. 5132-86 lists the kind of exclusions which are effective for: • “cannabis, plant and resin, products containing it, or those obtained from cannabis, plant or resin”; and, • “tetrahydrocannabinols, except for delta 9-tetrahydrocannabinol, and its esters and ethers, salts and the salts of the aforecited derivatives, and products containing them”. The Code of Public Health also lists exceptions (Article R. 5132- 86-1) to the exclusions, e.g. for delta 9-tetrahydrocannabinol used for the production of Marinol, which is authorized as part of a Temporary Use Exemption by name (Roquette Pflister, M, 2019). After establishing a group of experts, Temporary Specialized Scientific Committee (CST), in September 2018, analyzing the use of medical cannabis in other European countries and results of clinical trials and medical literature, the National Agency for Safety of Medicines and Health Products (ANSM) accepted the proposal of CST to experimentally allow medical use for certain defined indications, e.g. palliative situations or painful spasticity of multiple sclerosis. Follow-up shall be conducted via a patient register. ANSM started to prepare, with the various government departments concerned, technical arrangements necessary to establish the experimental phase. According to information from Franceinfo (3), ANSM announced on January 22nd, 2020, the experiment on medical cannabis will start in September 2020 and will include approximately 3,000 patients; planned time schedule of the experimental phase is two years. Another exception to the Code of Public Health is related to cannabis free of narcotic properties (Article R. 5132-86, II subsection 2) and describes authorization by ministerial order for culture, importation, exportation, industrial, and commercial use. A ministerial order dated August 22, 1990 defines the conditions for cannabis-based non-narcotic requirements and allowed the manufacturing of liquids for electronic cigarettes, cosmetic products, or capsules as legally acceptable (4). Concerning CBD-products, MILDECA (Mission interministérielle de lutte contre les drogues et les THE CURRENT LEGAL AND MARKETING SITUATION IN EUROPE The European Union (EU) is missing a harmonized law on medical and, if appropriate, recreational use of cannabis. A high-level overview of the national legal requirements of some European countries on medical cannabis is provided below, thereby highlighting the differences within the EU, see also Figure 1. Denmark: In December 2017, Denmark adopted its legislation for a four-year medical cannabis pilot project, allowing physicians to prescribe cannabis products which, until then, were not legal in Denmark (1). With the implementation of the medicinal cannabis pilot program, cannabis is legally available. Cultivation and production for medical use started with the introduction of a special development plan, giving companies the ability to apply for a cultivation and handling license to produce cannabis for patients as well as for export. Up to now licenses were given to two companies. Since July 1, 2018, the Executive Order on Euphorizing Substances has been amended. Hemp (content of Successful marketing of medical cannabis and cannabis-derived products A summary of the legal background of some of the European countries which reflects the different national strategies and opportunities for the individual national market for cannabis and cannabis-derived products. This paper shows the legal common basis of European regulation, global treaties, and the different national ways of implementing international and national laws for medicinal cannabis in the respective countries. The different strategies range from a state license for a national competent authority for growing medicinal cannabis, to importing medicinal cannabis for cannabis pilot projects or opening the market by issuing licenses for growing and distribution down to prohibition on use of medicinal cannabis. ABSTRACT KEYWORDS: Medicinal cannabis, cannabis-derived products, narcotic drug, Cannabidiol (CBD), cosmetic, novel food, European regulation. Figure 1. Starting Points of cannabis access programs in different countries. *adapted from Medical Cannabis News - Cannabis & CBD investment News - Green light for medical cannabis in Europe, July 2019.