At the premises of the Italian Ministry of Health, experts provided a detailed explanation of what it means to build a national medical cannabis control system from the ground up.
Italy did not build its system overnight. From having no domestic production in 2007, the country today records an annual demand of more than 2,400 kg of medical cannabis and has established the institutions, legislation, information systems, and supply chain necessary to support it. This is the story that the Agency’s delegation came to hear firsthand.
The visit was organized under the TAIEX Programme of the European Commission, with Albania participating as the beneficiary country. The delegation was led by Ms. Anila Alliu, Director General of the National Agency for Cannabis Control (NACC).
The cornerstone of the Italian system is a single legal instrument, the Ministerial Decree of 9 November 2015, which established a clear principle: medical cannabis is regulated and managed in the same manner as any other medicinal product.
The national SIUCS platform tracks every gram of controlled substances from the producer to the pharmacy. Every import authorization is accompanied by a certificate of analysis and a batch release certificate. Every quarter, Italy reports to the International Narcotics Control Board (INCB). The system leaves no room for regulatory ambiguity.
However, the visit highlighted not only successes. Italian experts also spoke openly about the challenges they continue to face, including regional fragmentation in reimbursement policies and legal uncertainty arising from Decree No. 48/2025 concerning industrial cannabis flowers, a matter that has reached the Court of Justice of the European Union.
For Albania, which is currently establishing its licensing system under Law No. 61/2023, the lessons are clear: a well-defined state authority, a comprehensive legal framework, GACP and GMP standards as legal requirements, and a traceability system capable of securing the entire chain from cultivation through to export are essential elements for building a credible and sustainable medical cannabis sector.
