How does medical cannabis reach patients in Italy?
Italian patients receive medical cannabis as pharmacy preparations, and Ministry data show that four kilograms in five reach pharmacies through importers.
Through a pharmacy, as a magistral preparation. A doctor writes a non-repeatable prescription and the pharmacist makes it up from a plant-based active substance, a route the Ministry of Health has allowed since 2006. That active substance comes either from the military pharmaceutical plant in Florence, which grows cannabis and is authorised to manufacture the flower under EU GMP, or from imports. The Ministry’s distribution figures show which one carries the market. Of 1,694.8 kg of cannabis flower distributed to Italian pharmacies in 2024, authorised wholesalers supplied 1,356.4 kg, the Florence plant 211.3 kg and local health authorities imported 127.1 kg. For 2026 Florence is authorised to make 400 kg. Four kilograms in five therefore reach Italian patients through wholesalers that import an active substance, and the quality of that flower depends on how those importers qualify their suppliers. I audit suppliers for buyers in this supply chain, and this article follows that part of the system.
What does Italian law allow a doctor to prescribe?
Magistral preparations made from cannabis flower, for uses listed in a 2015 decree. Article 5 of Decree-Law 23/1998 lets doctors prescribe magistral preparations only from active substances described in the pharmacopoeias of EU countries or contained in authorised medicines, and asks them to obtain the patient’s consent and to state in the prescription the need that justifies the preparation. The Ministry decree of 9 November 2015 lists pain in multiple sclerosis and spinal cord injury, chronic pain, nausea and vomiting from chemotherapy, radiotherapy or HIV therapy, appetite loss in cachexia, anorexia and AIDS, glaucoma and Tourette syndrome, in each case where standard treatments have failed.
The pharmacist buys the active substance with the narcotics order form, enters it in the narcotics register and prepares the doses under the Italian Norme di Buona Preparazione, as a decoction or for inhalation with a vaporiser. The national health service pays for pain therapy and the listed uses within its funding, and each Region sets its own reimbursement rules. A doctor can also prescribe for other uses, under Article 5.
Who produces medical cannabis in Italy?
One state plant. The Stabilimento Chimico Farmaceutico Militare in Florence cultivates cannabis and processes it into two active substances, Cannabis FM2 (THC 5 to 8%, CBD 7.5 to 12%) since December 2016 and Cannabis FM1 (THC 13 to 20%, CBD under 1%) since July 2018. The 2015 decree ties that production to an Active Substance Master File deposited with AIFA and to three authorisations, for cultivation, for manufacturing an active substance and for manufacturing a narcotic. The Ministry of Health, as State cannabis agency under the 1961 UN Single Convention, sets the yearly quota from the Regions’ estimates.
The law already allows more growers. Article 18-quater of Decree-Law 148/2017 lets the Minister of Health name other entities or companies by decree to cultivate and process cannabis, with the obligation to work under Good Agricultural and Collecting Practices according to procedures set by the Florence plant, the same GACP whose audits fall to the buyer. The decree fixing production quantities for 2026 lists one manufacturer of cannabis flower, Florence, with 400 kg for Italy and none for export.
Where does the rest of Italy’s medical cannabis come from?
From imports, which have grown faster than domestic production. In 2017 Italian pharmacies received 351.5 kg of flower, and authorised wholesalers supplied 46% of it. In 2024 pharmacies received 1,694.8 kg, and wholesalers supplied 80%. The Florence share fell from 17% to 12.5% over the same years, and the Ministry notes that the Florence figures include flower the plant imports itself.
Two import routes coexist. Local health authorities can ask the Ministry to import unregistered products, such as the varieties of the Dutch Office of Medicinal Cannabis, under a 1997 decree when no registered alternative exists. Pharmacies can also buy imported flower through the normal distribution channels for active substances, from companies that both AIFA and the Ministry have authorised. Trade in narcotic substances between Italy and any other country, EU members included, needs a Ministry import or export permit.
What must an importer of cannabis flower check?
That the active substance was made under GMP and has stayed under control since. The EU guidelines on good distribution practice for active substances apply to importers and distributors, and they draw a line that matters for flower:
Any manufacturing activities in relation to active substances, including re-packaging, re-labelling or dividing up, are subject to Commission Delegated Regulation (EU) No 1252/2014 and EudraLex Volume 4, Part II.
An importer that divides bulk flower into pharmacy packs is therefore doing manufacturing work under Part II, the guide that applies from the point where GMP starts for a herbal active substance. Imports carry the further requirements of Article 46b of Directive 2001/83/EC, and each delivery is checked on receipt, certificate of analysis included. Since 1 July 2024 the Ph. Eur. monograph Cannabis flower (3028) gives that certificate a European specification to report against.
A certificate describes one batch. Qualifying the supplier behind it is a separate job, and it means knowing which site performs which step, under which conditions, with which parameters recorded, and going back on a defined cycle.
What is changing in Italy?
The rules are under review, and supply still leans on imports. According to Farmacia News, the Ministry of Health started work in 2025 with the Regions, the Istituto Superiore di Sanità and the Florence plant to update the 2015 decree, and the report gives no date for a new text.
For a supplier outside Italy the route stays the same, with an Italian importer authorised by AIFA and the Ministry, a Ministry permit for each import, and a buyer that has qualified you before the flower ships.
Written by
Riccardo Longato
GMP Pharmaceutical Quality Systems Lead Auditor
CQI/IRCA certified lead auditor, certificate no. LA113.
Has spoken at PTMC Lisbon, JIHE Tokyo, AIHEF Bangkok and IndicaSativa Trade Bologna.
