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

  • Metoda Lipnik-Štagelj University of Ljubljana, Faculty of Medicine, Department of Pharmacology and Experimental Toxicology, Ljubljana
  • Barbara Razinger Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, Ljubljana
Keywords: cannabis cultivation, legislation, magistral preparations, officinal preparations, phytocannabinoids, synthetic cannabinoids


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.

How to Cite
Lipnik-ŠtageljM, Razinger B. A regulatory take on cannabis and cannabinoids for medicinal use in the European Union. Arh Hig Rada Toksikol [Internet]. 2020Feb.27 [cited 2020Jun.7];71(1). Available from: https://arhiv.imi.hr/index.php/arhiv/article/view/1148