Law No. 4523. Production of Medicinal Cannabis end-products and other provisions.

The law consists of 8 articles dealing both with provisions for the use of Cannabis Sativa L. for medicinal purposes and the regulatory provisions associated with prohibited drug use. The law inserts article 2A in the provisions of Law No. 4139/2013 on addictive substances and other provisions, in virtue of which, it is allowed by way of exception, the production, holding, transport, storage and supply of raw materials of the variety of Cannabis Sativa L. containing more than 0,2% of tetrahydrocannabinol (THC) and the establishment and operation of factories processing and producing end-products of medicinal cannabis with the exclusive purpose of either the supply of the State monopoly for medical purposes or export. This approval is non-transferable, excluding the assignment and concession of any activity described above at any stage to third parties, and is granted by (i) joint decision of the Ministers of Economy and Development, Health and Rural Development & Foodstuffs for all activities in accordance with applicable provisions, and (ii) decision of the Deputy Minister for Development, Competitiveness and Shipping, under terms and conditions provided in this article. By decision of the Ministers of Interior, Finance and Development, Justice, Transparency and Human Rights, Health and Agricultural Development further terms and conditions shall be defined, concerning in particular provisions relating to the granting of the authorization, the submission of additional supporting documentation, the safety specifications of production areas, storage places and processing plants, transport procedures, storage time limit which may not be longer than five (5) years, the way in which seed imports are authorized, the procedure for checking compliance with the terms and conditions of authorization, the procedure for regular and extraordinary controls for the continuation of granting approval at any stage of the cultivation and processing process and any other relevant matter.