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A regulatory take on cannabis and cannabinoids for medicinal use in the European Union Cover

A regulatory take on cannabis and cannabinoids for medicinal use in the European Union

Open Access
|Apr 2020

Figures & Tables

Figure 1

Different legal status of cannabinoid-based medicinal products
Different legal status of cannabinoid-based medicinal products

Medicinal cannabis cultivation in the EU member states in 2018

EU member stateResponsible authority for medicinal cannabis cultivationResponsibilitiesRef.
AustriaAustrian Agency for Health and Food SafetyIt is responsible for the production of medicinal cannabis, purchases cannabis and ensures its distribution and export.1, 40

Czech RepublicState Agency for Medical Cannabis established within the State Institute of Drug ControlIt is responsible for licensing of medicinal cannabis cultivation, purchases cannabis and ensures its distribution and export.It set rules for e-prescription, pharmacies and so forth; a special registry started operating in November 2014.1, 40

ItalyItalian Ministry of HealthIt 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

GermanyMedical 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

GreeceMinistry of Health, Greek National Organization for MedicinesIt is responsible for licencing of medicinal cannabis cultivation and production (first two licences were granted to private companies Bioprocann SA and Biomecann).38

MaltaMaltese Ministry of HealthIt is responsible for licensing of medicinal cannabis cultivation, monitoring, purchasing, distribution, import, export, and destruction of cannabis.37

NederlandsOffice of Medicinal Cannabis of the Netherlands governmentIt is responsible for controlling of greenhouse cultivation with controlled conditions (GMP); analytical testing; packaging and distribution of cannabis to authorized pharmacies.1, 40

PortugalInstituto 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 FormDescriptionAvailabilityIndications Strength of evidenceReference
Most EU member states except:
Nabiximols Sublingual sprayExtract of cannabis:Δ9-THC and CBDBulgaria Cyprus Greece Hungary Latvia Romania SlovakiaMuscle spasm in multiple sclerosis Moderate1, 24

Dronabinol CapsuleSynthetic Δ9-THCCroatia Denmark France Ireland Poland Slovenia Spain SwedenAIDS related wasting Weak; Little evidence available about stimulation of appetite in people with other conditions1, 25

Nabilone CapsuleSynthetic cannabinoid, similar to Δ9-THCAustria Croatia Denmark Ireland Germany Poland Slovenia Spain United KingdomNausea and vomiting associated with cancer chemotherapy Weak1, 26

Cannabidiol Oral solutionExtract of cannabis: CBDAuthorised for use in all EU member states in 2019 asorphan medicinal productIntractable childhood epilepsy (Lennox-Gastaut syndrome or Dravet syndrome) Moderate22, 23
DOI: https://doi.org/10.2478/aiht-2020-71-3302 | Journal eISSN: 1848-6312 | Journal ISSN: 0004-1254
Language: English, Croatian, Slovenian
Page range: 12 - 18
Submitted on: Jun 1, 2019
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Accepted on: Feb 1, 2020
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Published on: Apr 9, 2020
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2020 Metoda Lipnik-Štangelj, Barbara Razinger, published by Institute for Medical Research and Occupational Health
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.