A regulatory take on cannabis and cannabinoids for medicinal use in the European Union
y | 09 abr 2020
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Article Category: Review
Publicado en línea: 09 abr 2020
Páginas: 12 - 18
Recibido: 01 jun 2019
Aceptado: 01 feb 2020
DOI: https://doi.org/10.2478/aiht-2020-71-3302
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© 2020 Metoda Lipnik-Štangelj, Barbara Razinger, published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Figure 1
Medicinal cannabis cultivation in the EU member states in 2018
| EU member state | Responsible authority for medicinal cannabis cultivation | Responsibilities | Ref. |
|---|---|---|---|
| Austria | Austrian Agency for Health and Food Safety | It is responsible for the production of medicinal cannabis, purchases cannabis and ensures its distribution and export. | 1, 40 |
| Czech Republic | State Agency for Medical Cannabis established within the State Institute of Drug Control | It is responsible for licensing of medicinal cannabis cultivation, purchases cannabis and ensures its distribution and export. |
1, 40 |
| Italy | Italian Ministry of Health | It is the coordinating body for medical cannabis and has the responsibility to issue permits for cultivation, production, possession, and use of cannabis. It supervises the conditions for the cultivation of cannabis for medical purposes and has an exclusive right of redemption and resale cannabis. | 1, 40 |
| Germany | Medical Cannabis Agency, established within the German Federal Institute for Drugs and Medical Devices (BfArM) | It selects breeders who meet the required conditions; contracts with them in which the obligations of the breeders are defined; exercise the control over breeders who, in case of breach of contractual provisions, lose the right to grow; has the exclusive right to buy and sell resin cannabis. | 1, 29, 40 |
| Greece | Ministry of Health, Greek National Organization for Medicines | It is responsible for licencing of medicinal cannabis cultivation and production (first two licences were granted to private companies Bioprocann SA and Biomecann). | 38 |
| Malta | Maltese Ministry of Health | It is responsible for licensing of medicinal cannabis cultivation, monitoring, purchasing, distribution, import, export, and destruction of cannabis. | 37 |
| Nederlands | Office of Medicinal Cannabis of the Netherlands government | It is responsible for controlling of greenhouse cultivation with controlled conditions (GMP); analytical testing; packaging and distribution of cannabis to authorized pharmacies. | 1, 40 |
| Portugal | Instituto Nacional da Farmacia e do Medicament (INFARMED) | It is responsible for licencing of medicinal cannabis cultivation, manufacturing, processing and distribution. | 39 |
Authorised cannabis-based medicines in the EU member states in 2018
| INN Form | Description | Availability | Indications Strength of evidence | Reference |
|---|---|---|---|---|
| Most EU member states except: | ||||
| Nabiximols |
Extract of cannabis: |
Bulgaria |
Muscle spasm in multiple sclerosis |
1, 24 |
| Dronabinol |
Synthetic Δ9-THC | Croatia |
AIDS related wasting |
1, 25 |
| Nabilone |
Synthetic cannabinoid, similar to Δ9-THC | Austria |
Nausea and vomiting associated with cancer chemotherapy |
1, 26 |
| Cannabidiol |
Extract of cannabis: CBD | Authorised for use in all EU member states in 2019 asorphan medicinal product | Intractable childhood epilepsy (Lennox-Gastaut syndrome or Dravet syndrome) |
22, 23 |