"Below is the communication from the Marche Region concerning: Clarifications regarding the opportunity to use Cannabis Extract 15% THC.

The Marche Region, with the adoption of law no. 26, introduced provisions on the use of cannabis-based medicines and magisterial preparations for therapeutic purposes by operators and structures of the regional health system. Article 5 of the law highlights how the Regional Council, in order to reduce the cost of cannabis and cannabinoid active ingredients imported from abroad, is authorized to initiate experimental actions or specific pilot projects with the Military Pharmaceutical Chemical Plant of Florence or with other subjects authorized, according to current legislation, for the production of cannabis-based substances and preparations of plant origin.

The Farmalabor company is authorized by the Ministry of Health, pursuant to the Decree of 3 December 2021 - Annual list, updated as of 30 October 2021, of the companies authorized to manufacture, use and wholesale drugs and psychotropic substances integrated with the list of licensed companies for substances classified in category 1 drug precursors. (21A07292) (G.U. General Series, n. 299 of December 17, 2021) - Annex C, as COMPANIES AUTHORIZED FOR THE WHOLESALE OF DRUGS OR PSYCHOTROPS.

Their 15% THC Cannabis extract is classified as a raw material with which the pharmacist can proceed with the masterful preparation based on the doctor's prescription.

When prescribing, in the master's recipe, the doctor specifies that the preparation is prepared from inflorescences or from quantified cannabis extract.

As regards the preparation, since it is an industrial and non-galenic product, the production of which (in terms of quality and quantity) is guaranteed by the fact that it has been authorized by the national authorities in compliance with GMPs, it is not necessary to request titration analysis. which must therefore not be included among the items valued in the tariff.

The tariff must be calculated in accordance with the decree for the update of the national tariff for the sale of medicines to the public Ministerial Decree of 13 December 2017 Amendment and amendment of the decree of 22 September 2017, containing "Update of the national tariff for the sale of medicines to the public" G.U. n. 24 of 30 January 2018 with Substance Price Table and Preparation Cost Table.

The forms and procedures indicated in the Decree of the Manager of the PF Pharmaceutical Assistance No. 13 / ASF of 19 December 2017 are confirmed ".