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Istituto Superiore di Sanità
EpiCentro - Epidemiology for public health
Epidemiology for public health - ISS

About medical cannabis

On 9 November 2015, Italy’s Ministry of Health issued a Decree to regulate national production and cannabis-based herbal preparations. The provisions of the Decree of 9 November 2015 (pdf 430 kb) are summarized below.

 

Production will be in compliance with: international conventions on narcotic drugs or psychotropic substances transposed into national laws; European regulations on active substances for human use; national legislation on magistral prescriptions and related medicinal products prepared in a pharmacy; and provisions aimed at ensuring access to palliative care and pain management.

 

The Decree provides for a 24-month pilot phase, during which up to 100 kg of cannabis inflorescences will be produced based on requests from the Regions and Autonomous Provinces in relation to the number of treated patients.

 

Monitoring of prescriptions

For epidemiological purposes, the Regions and Autonomous Provinces are required to provide the Istituto superiore di sanità (ISS) annually (quarterly for the first 24 months) with age- and sex-aggregated data of patients treated with magistral cannabis-based preparations. To this end, when preparing a prescription, doctors will fill in the relevant form with the following information: age and sex of the patient, dosage in terms of weight of cannabis used, treatment needs as stated on the prescription, and treatment outcomes for the condition. Data should be submitted to the Istituto superiore di sanità by the Local Health Unit or the prescribing doctor (following registration on the dedicated web platform), in compliance with the provisions of the Personal Data Protection Code and the procedures established by each Region or Autonomous Province.

 

Safety monitoring: surveillance system of natural health products

As part of the Surveillance system of suspected adverse reactions to natural health products, coordinated by the Istituto superiore di sanità, safety monitoring will be carried out by collecting reports of suspected adverse reactions associated with the administration of magistral cannabis-based preparations. Healthcare workers should promptly notify the ISS of any suspected adverse reaction using the ad hoc reporting form.

 

Visit also the page listing the periodical reports of the prescription and safety monitoring activities (in Italian).

 

Publication date: 2 January 2021