Cannabis law and legislation in Italy

Growing, selling and importing medical cannabis is allowed on the condition that the authorisation of the Ministry of Health is obtained. Cultivation, sale and import are currently mainly managed by the state through internal production, import from the Netherlands or public tenders for the supply.

Authorisation by the Ministry of Health is mandatory. Such authorisation is personal and cannot be sold or transferred. Moreover, it can be granted only to institutions or companies whose owner or legal representative, if they are companies, is of good behaviour and offers moral and professional guarantees.

As of September 2021, the Ministry of Health has finally provided clarifications for companies that aims to grow Cannabis Sativa L. from certified seeds of varieties permitted under European law for the purpose of supplying pharmaceutical companies authorised by the Italian Medicines Agency (AIFA) to manufacture active pharmaceutical ingredients (API). The grower intending to apply for the authorisation shall enter into an agreement to supply the leaves and inflorescences to a pharmaceutical company authorised to produce API. The grower can in fact sell his product only to that company. The Ministry has specified that the agreement, which is an essential requirement for the authorisation, must be signed by the date of submission of the cultivation and manufacturing applications. The application must also include detailed information on the cultivation activity, such as the species and variety, an estimate of the quantity to be produced annually, an indication of the place of cultivation as well as those used for processing and storage of the product ready for sale to the pharmaceutical company.

Cannabis-based medicines which are already authorised in Italy can be prescribed to patients by physicians using a special form approved by the Ministry of Health. If the medicinal product is not authorised in Italy but duly authorised in a foreign country, the Italian doctor is required to send a request to the Ministry of Health and to the competent customs office for the importation of the medicine in Italy. The request must include the special needs that justify the use of the unauthorised medicine, in the absence of a valid therapeutic alternative. In addition, physicians may also prescribe magistral preparations with cannabis-based plant products, which are generally prepared by specialized pharmacies. Such preparations can be made from legally imported cannabis, or from the domestic production of cannabis for medical use at the Stabilimento Chimico Farmaceutico Militare in Florence.

Anyone who, without the authorisation, imports, exports, purchases, receives or holds medicines containing narcotic or psychotropic substances, which exceed the prescribed quantity, may be sanctioned with imprisonment from six to twenty years and with a fine of EUR 26,000 to EUR 260,000. The aforementioned penalties can be reduced by a third to a half in specific circumstances.

In Italy it is not permitted to sell cannabis for recreational use.

However, some companies have chosen to market a product with low THC content whose sale is permitted based on industrial cannabis legislation only. In short, in the Italian market, “recreational cannabis” is essentially “cannabis for industrial use”, which however, not being a smoke product, is sold with the explicit warning “product not for human use” - “do not smoke”.

Cannabis can be used for industrial purposes on the condition that the THC is lower than 0.2%. However, in accordance with law no. 242 of 2016, if, as a result of a control by the authorities, the total THC content of is more than 0.2% but no more than 0.6%, no liability shall be borne by the grower. 

Industrial cannabis can be used for: (a) foods and cosmetics; (b) semi-finished products, such as fibre, powders, oils or fuels; (c) material intended for use as green manure; (d) organic material for bioengineering works or products useful for green building; (e) material aimed at phytodepuration for the remediation of polluted sites; (f) crops dedicated to teaching and demonstration activities as well as research by public or private institutions; and (g) crops intended for floriculture. 

As of September 2021, the Ministry of Health clarified that, upon authorization, industrial cannabis may be cultivated for the purpose of supplying pharmaceutical companies authorised to manufacture active pharmaceutical ingredients (API).

The only sanctions currently provided by the law on industrial cannabis are the seizure or destruction of the cannabis if the THC content in cultivation is higher than 0.6% . 

The law does not provide for sanctions related to the marketing of industrial cannabis, which must be derived from the general legislation on product safety and consumer protection. 

If, on the other hand, a farmer grows cannabis without authorisation that does not fall within the definition of “industrial cannabis”, they may be punished with imprisonment of six to twenty years and fined from EUR 26,000 to EUR 260,000.

CBD regulation is a topic that is being debated. Indeed, until 2023 there was no proper regulation on the topic and CBD was a substance with recognised pharmacological activity that was not included in the table of drugs. The Ministry of Health had explained that if the CBD was used for the production of medicines, not being present in the tables of narcotic or psychotropic substances, the current legislation on medicinal products should be applied. As a consequence, the rules on medicinal products containing psychotropic substances, which applies to THC, cannot be applied to CBD. 

By Decree of Ministry of Health of 7^th August 2023, which came into force on the 20^thSeptember 2023, CBD to be ingested was included in the list of narcotic and psychotropic substances. Consequently, the sale of these products without a prescription became illegal. 

However, on 24^th October 2023, the Administrative Judge (TAR Lazio) suspended the effectiveness of the aforementioned decree, stating that CBD is not a psychoactive substance and it should not be included in the list of narcotic and psychotropic substances. This suspension by the judge allowed the resumption of the sale of CBD-based to be ingested products in Italy, thus confirming the lawfulness of the sale of light cannabis products. 

Nevertheless, the current government has announced that a new decree to regulate CBD will be presented soon, but no concrete development has been made so far, a part from what  reported in “latest development” below. 

As far as the use of CBD in food and food supplements is concerned, this substance is no longer considered a novel food as clarified by EU Commission on 2^nd June 2023 and therefore no specific authorization by the European Commission according to EU Regulation 2015/2283 is required. 

The Italian regulations do not prevent CBD from being used as an ingredient in cosmetics. Cosmetics with  CBD are marketable in Italy if they are in accordance with the requirements of Regulation (EC) No 1223/2009 on cosmetic products. Therefore, the cosmetic product may not contain narcotics as listed in Table I and II of the UN Single Convention on narcotic drugs (1961).

There is no specific prohibition on patenting a cannabis-based product, provided that the commercial exploitation of the invention does not infringe any law and is not contrary to public order.

On 25^th May 2024, the Italian Government presented an amendment to Italian draft safety bill aiming at prohibiting the cultivation and sale of inflorescences of cannabis even with a THC content lower than 2%, for uses other than the permitted industrial and medical ones. The approval of such proposed amendment would imply the equalisation of so called “light” cannabis with a THC content lower than 0.2% and cannabis with higher THC content, which is illegal, as far as it is included among the narcotic substances. 

Along the same restrictive lines, a sub-amendment was also filed on 29^th May 2024, which even prohibits ‘the use of images or drawings, even in stylised form, reproducing the entire hemp plant or parts thereof on signs, placards, posters and any other means of advertising for the promotion of commercial activities’, in respect of which the failure to comply with would entail a penalty of imprisonment from six months to two years and a fine of up to 20,000 euro. 

The texts are being examined by the Constitutional Affairs and Justice Committees in Parliament and they will be discussed and voted for the first time in the next months.