Abstract
Current Italian legislation states that the distribution of cannabis for medical use is carried out at pharmacies by preparing magistral preparations on physician’s prescriptions.
Growing, selling, distribution and import of medical cannabis is allowed on the condition that the authorization of the Italian Ministry of Health is obtained through the submission of quality and administrative documentation.
Depending on the type of permits requested, the Central Narcotics Office of the Ministry of Health can issue different authorizations: cultivation licenses, manufacturing authorization for medical cannabis, authorization for use of medical cannabis and distribution authorization.
What is a magistral preparation?
A magistral preparation is prepared by or under the supervision of a pharmacist, specifically according to a detailed medical prescription for the medicinal substances that it contains, applying all technical and pharmaceutical standards.
Medical cannabis pharmaceutical products are obtained by extraction from dried and ground cannabis inflorescences, with standardized tetrahydrocannabinol (THC) and cannabidiol (CBD) contents.
How to obtain the cultivation license for Medical Cannabis products?
The agricultural company can acquire the authorization for cultivation of medical cannabis plants from the Ministry of Health offices. Actually, different pharmaceutical companies have requested approval to produce cannabis flowers in Italy, but due to the workload of the Ministry of Health, the time needed for the approvals is very long.
How to obtain the Manufacturing Authorization for Medical Cannabis products?
According to DPR 309 of 1990, a pharmaceutical company that intends to manufacture and extract the narcotic substance from Cannabis Sativa L. must obtain an appropriate authorization from the Ministry of Health. This authorization allows the substance to be used in all phases relating to manufacturing and the preparation of pilot batches. In order to receive the manufacturing authorization, the company must obtain the GMP certification issued by the Italian Medicines Agency (AIFA) which provides all quality information of the product such as manufacturing processes, quality specifications, quality controls and the stability ensuring efficacy and safety of its product.
On 15 September 2020, the Italian Medicines Agency implemented electronic management of the documentation, as well as requests to be sent to the competent office and the related documents issued. The time to receive authorization is 90 days from the date of arrival of the request. The times are interrupted in the event of a request for additional documentation from the Central Narcotics Office.
How to obtain the Authorization for the use of Medical Cannabis products?
According to DPR 309 of 1990, a pharmaceutical company that intends to use the narcotic substance to obtain a product with a specific pharmaceutical form, suitable for medical application use, must obtain an appropriate authorization from the Ministry of Health. One of the requirements to obtain the authorization is to have a GMP certification issued by the Italian Medicine Agency. If the company dedicates itself exclusively to research, experimentation or laboratory investigations, the GMP certification is not necessary, but the specific authorization issued by the competent authorities (regional or state) to demonstrate the compatibility of the premises is sufficient. The online form is available to require the authorization. The time to receive authorization is 90 days from the date of arrival of the request. The times are interrupted in the event of a request for additional documentation from the Central Narcotics Office.
How to obtain the distribution license for Medical Cannabis products?
This authorization is issued to medicinal product wholesalers which distribute medicinal products based on narcotic or psychotropic substances. This authorization allows commercial operations at national, EU and non-EU levels. Trade authorizations are also issued to companies which, despite holding narcotic drugs or equivalent products, do not come into physical contact with the goods, but carry out wholesale trade using already authorized warehouses or wholesalers.
The online form is available to require the authorization. The time to receive authorization is 90 days from the date of arrival of the request. The times are interrupted in the event of a request for additional documentation from the Central Narcotics Office
