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

The new review published by the Archives of Industrial Hygiene and Toxicology, takes a quick look at the current legal framework in the European Union which regulates cannabis use and cultivation for medicinal purposes. The document was prepared by Slovene Metoda Lipnik-Štangelj from the Faculty of Medicine, Department of Pharmacology and Experimental Toxicology, Ljubljana and Barbara Razinger from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia.

From the abstract

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.

To read/download the review, follow this link>>>.


Legalize or not?

NGO “LEK lekalizuj, which has the mission is to launch initiatives for adoption of law on regulating medical cannabis, organised a public debate on medical cannabis on 24 December 2016 in Ruma, Serbia. The trigger for the debate was the forthcoming draft of the changes to the Law on psychoactive controlled substances.

The room was full of people who experienced different kind of progress in their health conditions claiming that it came from using medicaments based on cannabis oil.

DPNSEE representatives presented different experiences in regulating this item in countries of South East Europe.