With the Decree of 7 August 2023 (the “Decree”), which will enter into force on 20 September, the Ministry of Health has introduced significant amendments to the regulation of cannabidiol (“CBD”) in Italy.
These amendments concern the inclusion of compositions for oral administration of CBD obtained from cannabis sativa extracts in the tables of the Decree of the President of the Republic of 9 October 1990, No. 309 (“DPR”), which list narcotic and psychotropic substances.
Definition of cannabidiol
Cannabidiol, or CBD, is a cannabinoid present in cannabis sativa L. (Cannabis). Unlike tetrahydrocannabinol (THC), the main psychoactive component of Cannabis, CBD has no psychoactive effects. This characteristic has led to a growing interest in CBD in recent years in many countries and its inclusion in a wide range of products.
Importantly, CBD is widely regarded as safe for consumption and use. The World Health Organization (WHO) conducted an assessment in 2017, concluding that CBD should not be classified as a controlled substance due to its lack of significant addiction risk or adverse health effects associated with its use. This evaluation has played a pivotal role in fostering the therapeutic utilisation and global trade of CBD in numerous countries.
Likewise, the Court of Justice of the European Union holds a similar standpoint. According to its assessment (C-663/18), based on current scientific knowledge, CBD is distinct from THC in that it does not seem to produce psychotropic effects or pose detrimental risks to human health.
Regulatory framework
Within the existing regulatory framework, the aforementioned DPR, also known as Consolidated Text of the Laws Concerning the Discipline of Narcotic Drugs and Psychotropic Substances, classifies substances based on various criteria. These criteria encompass factors such as their potential for addiction, likelihood of abuse, susceptibility to abuse, and capacity to induce dependence. The Schedule of Medicinal Products, annexed to the DPR, establishes the specific dispensing regulations for each active substance with acknowledged pharmacological properties. This Schedule is organised into five sections denoted by the letters A, B, C, D, and E, each of which pertains to narcotic medicines with recognised therapeutic applications.
Section B of this Schedule is dedicated to medicinal products derived from narcotic substances of plant origin, including those derived from cannabis, such as extracts and tinctures. These medications require a nonrepeatable prescription (RNR) for their dispensation.
However, with the Decree issued on October 1, 2020, the Ministry of Health made amendments to the tables that list narcotic and psychotropic substances. Specifically, it added compositions for the oral administration of cannabidiol obtained from Cannabis extracts to Section B of the Table of Medicinal Products.
However, by a subsequent Decree of the Minister of Health of 28 October 2020, the effectiveness of the abovementioned Decree was suspended, before its entry into force, pending further investigation by the Italian Institute of Health and the Superior Council of Health.
Nonetheless, the Decree dated August 7, 2023, issued by the Ministry of Health, lifted the suspension and reinstated the applicability of the Decree of October 1, 2020, listing CBD as a narcotic substance within Section B.
Implications
Based on the information provided, as of 20 September 2023, orally administered CBD products will be classified as medicinal substances, specifically narcotic medicines, in Italy.
Consequently, as of 20 September 2023:
A) in consideration of the fact that these products are now considered medicinal products, in accordance with Legislative Decree 219/2006:
- these products will only be dispensed through pharmacies and solely with a medical prescription;
- advertising of such products will be prohibited to the general public;
- the manufacture of these products will require prior authorisation for manufacturing medicinal products;
- the storage and distribution of these products will be subject to the prior authorisation for medicinal products.
B) in consideration of the fact that these products are now considered not only medicines, but medicines containing a narcotic substance, in accordance with the Presidential Decree no. 309/1990:
- the manufacturing of these products will also be subject to prior authorisation for the manufacturing and use of narcotic substances (required for companies involved in extracting narcotic substances from natural sources or through synthetic processes, as well as for those engaged in the production of medicinal products containing CBD);
- the storage and distribution of these products will also require a prior marketing authorisation, necessary for warehouse-keepers and wholesalers involved in the wholesale of drugs, now including CBD products.
These authorisations will enable commercial operations at the national, European Union, and non-EU levels.
It is important to note that the effectiveness of this Decree, unless suspended by the Ministry of Health or a competent judicial authority, will bring significant changes in the regulation of CBD in Italy. These changes will impact CBD trade and use in the country across various sectors and levels.
Therefore, it is advisable for entities involved in various aspects of orally administered CBD products to promptly assess their current activities and determine the necessary steps to comply with the provisions outlined in the Decree.
For further information, please contact:
Mauro Turrini, Bird & Bird
mauro.turrini@twobirds.com
