THE MINISTER OF HEALTH the Order of the President of the Republic 9 October 1990, n. 309, approving the consolidated text of the laws concerning the regulation of narcotics and psychotropic substances, prevention, treatment and rehabilitation of drug addiction, as amended and supplemented (the Consolidated Law), which, in art. 2, paragraph 1, provides for the responsibility of the Minister of Health, the granting of authorizations for the cultivation, production, manufacture, use, trade, export, import, transit, purchase, the sale and possession of narcotic or psychotropic substances; Vista in particular, the section "B" of the table of medicines attached to Consolidated, which includes plant-based medicinal cannabis (herbal substances and preparations, including extracts and tinctures) from those that can be prescribed with non-repeatable recipe , subject to specific provisions indicated Italian drug Agency (AIFA) as part of any marketing authorization; Having regard to Articles 27, 28, 29 and 30 of the Consolidated Law, governing the authorization of the cultivation; Given the Single Convention on Narcotic Drugs adopted in New York March 30, 1961, as amended by the Geneva Protocol of 25 March 1972, ratified and implemented in Italy under the law June 5, 1974, n. 412; Seen in particular, the combined provisions of Articles 23 and 28 dell'anzidetta convention that, in the event of authorization of the cultivation of the hemp plant, provides for the establishment or maintenance of state bodies for the regulation and related controls; Given the Decree-Law of 17 February 1998. 23, converted into Law 8 April 1998, n. 94, and in particular art. 5 laying down rules on prescription masterful preparations; The Order of the Minister of Health of 18 August 1993 determining the national rate for the sale of medicines to the public, published in the Official Journal of 25 September 1993, n. 226; Having regard to Legislative Decree 24 April 2006, n. 219, and subsequent amendments and additions, implementing Directive 2001/83 / EC on the Community code relating to medicinal products for human use; Having regard to Law 15 March 2010, n. 38 laying down rules to ensure access to palliative care and pain management; The Order of the President of the Council of Ministers February 11, 2014, n. 59 Regulation laying down the organization of the Ministry of Health; The Order of the Minister of Health April 8, 2015 of a non-regulatory nature of the identification of the central and local offices and executive-level features that are not generally published in the Official Gazette of June 11, 2015, n. 133; Having regard to the cooperation agreement signed on 30 March 2012 between the Italian Drug Agency (AIFA) and the Agency of the defense industries - and to which 'entrusted with the management of the Military Chemical pharmaceutical plant in Florence (SCFM) based on decree of the Minister of Defence on 24 April 2001 - which identifies the same military chemical pharmaceutical plant in Florence as a possible site production of medicines lacking on the national or European market, subject to specific agreements, in order to facilitate access to orphan drugs by patients; Having regard to the cooperation agreement between the Minister of Health and the Minister of Defence - signed on September 18, 2014 - aimed at startup of the Pilot Project for the domestic production of substances and herbal preparations made from cannabis, to be implemented by the military chemical pharmaceutical plant in Florence according to the procedures' referred to a protocol to be defined by special working group provided for in paragraph 2 of this agreement; Given the outcome document for the realization of the Pilot Project, produced by the Working Group set up by decree of the Director of the Directorate General of medical devices and pharmaceutical services October 30, 2014, integrated with dd dd December 22, 2014 and June 23, 2015, under by the aforementioned cooperation agreement, and in particular the technical annex prepared by the Group itself for defining the modalities' of national production of substances of vegetable origin and preparations of cannabis; Informed the Board of Health 'at meetings of 10 February and 10 March 2015 on the activities' of the Pilot Project; Deemed it necessary to specify the functions that the Ministry of Health - general management of medical devices and pharmaceutical services - Central Office narcotics, plays, for authorizing the cultivation of plants and determination of the manufacturing units of the active substance of plant origin of cannabis as well as' determination of the requirements and guarantees which make such authorization, in accordance with articles 17, 27 and 31 of the Consolidated Law, also in quality 'of state body identified in accordance with articles 23 and 28 of the single Convention on narcotic drugs of New York; Having obtained the favorable opinion of the autonomous regions and provinces expressed during the meeting of 20 October 2015 of the Permanent Conference for relations between the state, the regions and the autonomous provinces of Trento and Bolzano;
Decrees:
Art. 1
Functions of the Ministry of Health
in quality 'of state body for cannabis 1. The Ministry of Health, General Directorate of medical devices and pharmaceutical services - Central Bureau drugs, in accordance with the powers conferred upon it by the Decree of the President of the Republic 9 October 1990, n. 309, approving the consolidated text of the laws concerning the regulation of narcotics and psychotropic substances, prevention, treatment and rehabilitation of drug addiction, as amended, plays, even in quality 'of state body for cannabis under Articles 23:28 of the single Convention on narcotic drugs adopted in New York March 30, 1961, as amended by the Geneva Protocol of 25 March 1972, ratified and implemented in Italy under the law June 5, 1974, n. 412, the following functions:
a) authorizes the cultivation of cannabis plants to be used for the production of herbal medicines based on cannabis, substances and herbal preparations;
B) identify the areas to be allocated to the cultivation of cannabis plants for the production of related substances of vegetable origin and preparations and the amount of land on which the cultivation and 'permitted;
C) imports, exports and distributes on the national territory, or authorize the import, export, wholesale distribution and maintaining stocks of plants and plant material cannabis, with the exception of stocks held of authorized medicines manufacturers;
D) is responsible for calculating the units of the active substance manufacturing plant-based cannabis based on the demands of the Regions and Autonomous Provinces and inform the International Narcotics Control Board (INCB) at the United Nations. 2. Farmers are authorized pursuant to paragraph 1, letter a), deliver the cannabis plant material, within the timeframe set out in the decision to authorize the cultivation, the Ministry of Health, General Directorate of medical devices and pharmaceutical services - central Office narcotics, which provide for the allocation of the material itself to pharmaceutical authorized workshops for the subsequent transformation into the active substance or plant preparation, within four months from the harvest.