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...
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Sciendo
2020-03-01
|
| Series: | Arhiv za Higijenu Rada i Toksikologiju |
| Subjects: | |
| Online Access: | https://doi.org/10.2478/aiht-2020-71-3302 |
| _version_ | 1818308758351118336 |
|---|---|
| author | Lipnik-Štangelj Metoda Razinger Barbara |
| author_facet | Lipnik-Štangelj Metoda Razinger Barbara |
| author_sort | Lipnik-Štangelj Metoda |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-13T07:19:22Z |
| format | Article |
| id | doaj.art-e61bbb50b8e24c91aa4d21d4f283284a |
| institution | Directory Open Access Journal |
| issn | 1848-6312 |
| language | English |
| last_indexed | 2024-12-13T07:19:22Z |
| publishDate | 2020-03-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Arhiv za Higijenu Rada i Toksikologiju |
| spelling | doaj.art-e61bbb50b8e24c91aa4d21d4f283284a2022-12-21T23:55:27ZengSciendoArhiv za Higijenu Rada i Toksikologiju1848-63122020-03-01711121810.2478/aiht-2020-71-3302A regulatory take on cannabis and cannabinoids for medicinal use in the European UnionLipnik-Štangelj Metoda0Razinger Barbara1University of Ljubljana, Faculty of Medicine, Department of Pharmacology and Experimental Toxicology, Ljubljana, SloveniaAgency for Medicinal Products and Medical Devices of the Republic of Slovenia,Ljubljana, SloveniaThe 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.https://doi.org/10.2478/aiht-2020-71-3302cannabis cultivationlegislationmagistral preparationsofficinal preparationsphytocannabinoidssynthetic cannabinoidskanabisendokanabinoidisintezni kanbinoidimedicinska uporabagojenje konopljezakonodaja |
| spellingShingle | Lipnik-Štangelj Metoda Razinger Barbara A regulatory take on cannabis and cannabinoids for medicinal use in the European Union Arhiv za Higijenu Rada i Toksikologiju cannabis cultivation legislation magistral preparations officinal preparations phytocannabinoids synthetic cannabinoids kanabis endokanabinoidi sintezni kanbinoidi medicinska uporaba gojenje konoplje zakonodaja |
| 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 | cannabis cultivation legislation magistral preparations officinal preparations phytocannabinoids synthetic cannabinoids kanabis endokanabinoidi sintezni kanbinoidi medicinska uporaba gojenje konoplje zakonodaja |
| url | https://doi.org/10.2478/aiht-2020-71-3302 |
| work_keys_str_mv | AT lipnikstangeljmetoda aregulatorytakeoncannabisandcannabinoidsformedicinaluseintheeuropeanunion AT razingerbarbara aregulatorytakeoncannabisandcannabinoidsformedicinaluseintheeuropeanunion AT lipnikstangeljmetoda regulatorytakeoncannabisandcannabinoidsformedicinaluseintheeuropeanunion AT razingerbarbara regulatorytakeoncannabisandcannabinoidsformedicinaluseintheeuropeanunion |