In recent months, the Ministry of Health has declared to have enforced the provisions governing the authorisation of the cultivation of narcotic substances. The Consolidated Law on Narcotic Drugs (Testo Unico sulle Sostanze Stupefacenti - DPR 309/1900), in fact, expressly allows the cultivation of such substances upon prior authorisation from the Central Narcotics Office (Ufficio Centrale Stupefacenti). The Ministry has provided clarifications for companies that aims to grow Cannabis Sativa L. from certified seeds of varieties permitted under European law. The cultivation of hemp from certified seeds is excluded from the obligation of authorisation when the product is used to produce fibres or for other industrial uses, among which the pharmaceutical one is not included. Cultivation for the purpose of supplying pharmaceutical companies authorised by the Italian Medicines Agency (AIFA) to manufacture active pharmaceutical ingredients (API) must, however, follow the authorisation procedure set out in the Ministry's recent clarifications.
The grower intending to apply for the authorisation shall enter into an agreement to supply the leaves and inflorescences to a pharmaceutical company authorised to produce API. The grower can in fact sell his product only to that company. The Ministry has specified that the agreement, which is an essential requirement for the authorisation, must be signed by the date of submission of the cultivation and manufacturing applications. The application must also include detailed information on the cultivation activity, such as the species and variety, an estimate of the quantity to be produced annually, an indication of the place of cultivation as well as those used for processing and storage of the product ready for sale to the pharmaceutical company.
The application for cultivation authorisation and the application for manufacturing authorisation are two parts of the same procedure and must be received by the Central Narcotics Office simultaneously. The manufacturing authorisation allows the substance to be used in all stages of manufacture, including preliminary stages such as pilot batch preparation and pre-clinical testing for drug development. Pharmaceutical companies authorised to manufacture pharmacologically active substances by AIFA can apply for a manufacturing authorisation. If the activity is limited to manufacturing, the company must provide a copy of AIFA's authorisation for the active substances. If, on the contrary, the substances are used not only for the production of active substances but also for the production of drugs, the company must also submit a copy of AIFA's authorization for the manufacturing of drugs.
The possibility of growing hemp intended for the extraction of cannabinoids to be used in the manufacturing of APIs is clearly an important driver towards a wider use of the plant in the medical sector. Since the use of hemp from certified seeds in the pharmaceutical industry is not explicitly provided for by the legislation on industrial hemp (Law 242/2016), the Ministry's clarification aimed at applying the rules of the Testo Unico Testo Unico sulle Sostanze Stupefacenti (Consolidated Law on Narcotic Drugs), which allow, subject to authorisation, the cultivation of cannabis sativa L., is to be welcomed, thus confirming that the cannabinoids extracted from 'industrial hemp' can be used in the pharmaceutical sector.
The clear authorisation procedure laid down by the Ministry can be an incentive not only for growers, but also for investors interested in starting up production in Italy or in acquiring companies already working in the hemp sector.
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