The Decree of the Ministry of Health of 1 October 2020, whereby compositions for oral administration of cannabidiol (CBD) have been included in Section B of the Table of Medicines of Decree of the President of the Italian Republic 309/1990 ("Consolidated text of the laws governing narcotic drugs and psychotropic substances and concerning the prevention and treatment of, and rehabilitation following, drug addiction") was published in the Official Gazette.
Section B of the Table of Medicines includes cannabis-based herbal medicinal products (herbal substances and preparations, including extracts and tinctures) on non-renewable medical prescription (RNR).
The above measure stems from the fact the Italian Medicines Agency (AIFA) is currently assessing a request for authorization to start the marketing of a drug, in an oral solution containing cannabidiol, already authorized by the European Medicines Agency (EMA), and that such drug is controlled under a compassionate use program, notified to AIFA, for patients being treated with DS or LGS 1.
The Decree of the Ministry of Health however hides some pitfalls that are of concern to producers and retailers of the sector.
If indeed, on the one hand, by this measure the therapeutic value of the CBD is acknowledged, on the other hand, the inclusion in Presidential Decree 309/1990 of compositions for oral administration of cannabidiol obtained from Cannabis extracts, without any reference to THC levels, is likely to generate interpretative doubts as to the "narcotic" nature of CBD and the consequent applicability of the sanctions provided by law.
In this situation of absolute uncertainty, the Ministry of Health, "reaffirming the need for health protection that underlies this measure, confirms its willingness to start discussion tables with all those concerned to fully evaluate, from the perspective of safety and effectiveness, the placement of any plant preparation, including extracts and tinctures, related to this composition".
This article is for information purposes only and is not, and cannot be intended as, a professional opinion on the topics dealt with. For further information please contact your counsel.
1 Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients two years of age and older. In Italy, Epidyolex is currently administered under a compassionate use program, notified to AIFA for patients with DS or LGS and, for such use, the General Directorate of Medical Devices and Pharmaceutical Service – Office 7 – Department for Drug Control and Quality, authorised the import in accordance with the guidelines of the UK competent Health Authority.
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