TAR: Cannabiol available only on a one-off prescription

Cannabiolo is available only on a non-renewable prescription. The Lazio Regional Administrative Court has once again upheld the decree by which the Ministry of Health, on 27 June 2024, updated the tables listing narcotic and psychotropic substances for therapeutic use, included formulations for oral administration of cannabidiol amongst the medicines for which a non-renewable medical prescription is required, i.e. one that must be renewed with every purchase. The administrative judges, in a ruling similar to that of April 2025, deemed the measure lawful.

The appeal lodged by CbWeed Srl, a company active in the sale of products derived from Cannabis sativa, was thus dismissed. The appellant argued, amongst other things, that the conclusions reached by the Ministry were unlawful ‘since it had not been established with regard to CBD (cannabidiol), nor the presumed nature of the substance as a psychotropic drug’.

The Regional Administrative Court, setting out the argument that ‘cannabis in its entirety remains classified as a narcotic substance whose dangerousness is inherent, given that cultivation is permitted only for the purposes defined by the legislator”, and the fact that ‘the scientific considerations and assessments on which the contested measure is based must not address the nature of cannabis as a psychotropic substance or narcotic, but must exclusively assess the condition of ‘dependence’ that may result from the oral intake of CBD-based compounds’, held that, since the Administration, in the exercise of its technical discretion on the basis of scientific literature , had assessed the risks, ‘the measure adopted is appropriate, on the basis of the precautionary principle aimed at averting potential risks to public health and safety without having to wait for the presence of THC in all preparations and the consequent actual situation of dependence to be fully demonstrated’.

In a further ruling – but on virtually identical grounds – the Regional Administrative Court also dismissed an appeal lodged by Crystal Srl, a company specialising in the marketing of natural products, challenging the circular issued by the Ministry of Health in August 2024 regarding the use of CBD in cosmetic products .

The Council of State, which had ‘suspended’ the Regional Administrative Court’s rulings upholding the decree until last May. On 3 August 2026, it referred the matter to the Court of Justice, which is called upon to clarify, in accordance with EU law, whether cannabidiol in oral form is a narcotic-based medicinal product or merely a compound available for sale without prescription. However, the subject of the referral to Luxembourg is not the Meloni decree but the Speranza-Schillaci ministerial decree of 2020. The underlying doubt, however, is the same, and the answer could also be extended to the decree under consideration by the Regional Administrative Court. This is a ruling of no small significance, given that the sector employs around 30,000 people. The president of Canapa Sativa Italia has welcomed the Council of State’s referral to Luxembourg Mattia Cusani “We are awaiting the EU Court’s verdict,” says Cusani, “until which time the decree remains ‘on hold’.” “Following the suspension,” concludes the head of Canapa Sativa Italia, “the Ministry of Health had clarified that, as the decree is no longer in force, the related control measures in pharmacies have ceased.”