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

Metoda Lipnik-Štangelj orcid id ; University of Ljubljana, Faculty of Medicine, Department of Pharmacology and Experimental Toxicology, Ljubljana, Slovenia
Barbara Razinger ; Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, Ljubljana, Slovenia

Puni tekst: engleski pdf 217 Kb

str. 12-18

preuzimanja: 490



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.

Ključne riječi

cannabis cultivation, legislation, magistral preparations, officinal preparations, phytocannabinoids, synthetic cannabinoids

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Podaci na drugim jezicima: slovenski

Posjeta: 943 *