By Giorgos Skampoulos, Associate LL.M
Following the recent law 4982/2022, the Greek legislator clarified some basic issues regarding the conditions for the legal production and marketing of products containing medical cannabis. The regulation is not particularly different from the provisions of Law No. 4139/2013, having as its justification the modernization of the legal regime for the production and marketing of the products concerned.
First and foremost, the assignment of any activity for the production of the products concerned to third parties who do not have the guarantees of authorization is expressly prohibited. The law 4982/2022, however, confirms the permissibility of cooperation between pharmaceutical companies for the marketing of products containing medical cannabis, since these companies can obtain the relevant authorization from the EOF and, therefore, the safety conditions of legal production and marketing are not compromised.
Important are the provisions concerning the licensing of companies operating in the relevant market (Articles 50-53 of Law 4982/2022). In particular, the law establishes the exclusive competence of the President of the EOF to grant a license exclusively for the export of medical cannabis products intended for medical purposes in any form and with a tetrahydrocannabinol content of more than 0.2%. It can be, therefore observed that the export license is a specific form of license which is not otherwise included in the licence to produce or have the capacity to produce the products concerned but requires a specific licensing.
In addition, the law specifically regulates the regime of licensing of production exclusively for the export of medical cannabis products in the form of the dry flower in packages of up to 50 gr, providing that the relevant licence is granted only to establishments licensed to produce products containing cannabis in a form other than the dry flower, and establishing the obligation for the relevant operators to submit an application for a marketing authorization for a product other than the dry flower within a period of twelve months from the date of the license. The export licence, as mentioned above, is a more specific form of license.
Finally, the law changes the legal marketing regime for medical cannabis products intended for domestic consumption by clarifying procedural details for the approval, production, and marketing of medical cannabis products of the species “Cannabis Sativa L” for medical purposes.
In conclusion, the clarification of specific issues of licensing and legal production of products containing medical cannabis was the main subject of the recent legislative change.