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A Regulatory Take on Cannabis and Cannabinoids for Medicinal use in the European Union

The discovery of the endocannabinoid system has raised public interest in the medicinal use of cannabis, phytocannabinoids, and synthetic cannabinoids, which has always been closely regulated due to their psychotropic effects and potential abuse. The review takes a quick look at the current legal fr...

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Detalles Bibliográficos
Autores principales: Lipnik-Štangelj, Metoda, Razinger, Barbara
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Sciendo 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7837236/
https://www.ncbi.nlm.nih.gov/pubmed/32597142
http://dx.doi.org/10.2478/aiht-2020-71-3302
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author Lipnik-Štangelj, Metoda
Razinger, Barbara
author_facet Lipnik-Štangelj, Metoda
Razinger, Barbara
author_sort Lipnik-Štangelj, Metoda
collection PubMed
description The discovery of the endocannabinoid system has raised public interest in the medicinal use of cannabis, phytocannabinoids, and synthetic cannabinoids, which has always been closely regulated due to their psychotropic effects and potential abuse. The review takes a quick look at the current legal framework in the European Union, which regulates cannabis use and cultivation for medicinal purposes in line with the United Nations Conventions on the production, trade, and use of cannabis, phytocannabinoids, and synthetic cannabinoids. And while the EU legislation precisely defines requirements and marketing authorisation procedures for medicinal products for all EU member states, there is no common regulatory framework for magistral and officinal preparations containing cannabinoids, as they are exempt from marketing authorisation. Instead, their regulation is left to each member state, and it is quite uneven at this point, mainly due to cultural and historical differences between the countries, leading to different access to non-authorised medicinal products. Therefore, to meet great public interest, harmonised approaches on cannabinoid-containing products without marketing authorisation would be welcome to level the playing field in the EU.
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spelling pubmed-78372362021-05-25 A Regulatory Take on Cannabis and Cannabinoids for Medicinal use in the European Union Lipnik-Štangelj, Metoda Razinger, Barbara Arh Hig Rada Toksikol Review The discovery of the endocannabinoid system has raised public interest in the medicinal use of cannabis, phytocannabinoids, and synthetic cannabinoids, which has always been closely regulated due to their psychotropic effects and potential abuse. The review takes a quick look at the current legal framework in the European Union, which regulates cannabis use and cultivation for medicinal purposes in line with the United Nations Conventions on the production, trade, and use of cannabis, phytocannabinoids, and synthetic cannabinoids. And while the EU legislation precisely defines requirements and marketing authorisation procedures for medicinal products for all EU member states, there is no common regulatory framework for magistral and officinal preparations containing cannabinoids, as they are exempt from marketing authorisation. Instead, their regulation is left to each member state, and it is quite uneven at this point, mainly due to cultural and historical differences between the countries, leading to different access to non-authorised medicinal products. Therefore, to meet great public interest, harmonised approaches on cannabinoid-containing products without marketing authorisation would be welcome to level the playing field in the EU. Sciendo 2020-04-09 /pmc/articles/PMC7837236/ /pubmed/32597142 http://dx.doi.org/10.2478/aiht-2020-71-3302 Text en © 2020 Metoda Lipnik-Štangelj, Barbara Razinger, published by Sciendo http://creativecommons.org/licenses/by-nc-nd/4.0 This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.
spellingShingle Review
Lipnik-Štangelj, Metoda
Razinger, Barbara
A Regulatory Take on Cannabis and Cannabinoids for Medicinal use in the European Union
title A Regulatory Take on Cannabis and Cannabinoids for Medicinal use in the European Union
title_full A Regulatory Take on Cannabis and Cannabinoids for Medicinal use in the European Union
title_fullStr A Regulatory Take on Cannabis and Cannabinoids for Medicinal use in the European Union
title_full_unstemmed A Regulatory Take on Cannabis and Cannabinoids for Medicinal use in the European Union
title_short A Regulatory Take on Cannabis and Cannabinoids for Medicinal use in the European Union
title_sort regulatory take on cannabis and cannabinoids for medicinal use in the european union
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7837236/
https://www.ncbi.nlm.nih.gov/pubmed/32597142
http://dx.doi.org/10.2478/aiht-2020-71-3302
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