DISCIPLINE OF CULTIVATION, PROCESSING, TRADE AND USE OF CANNABIS-BASED PRODUCTS INTENDED EXCLUSIVELY FOR MEDICINAL OR THERAPEUTIC USE

The cultivation in technological greenhouses of cannabis seeds and plants is allowed on the territory of San Marino, as well as the processing for the production of medicines or pharmaceuticals of plant origin based on cannabis, substances and vegetable preparations, intended exclusively for medicinal or therapeutic use. 
Cannabis means the Cannabis Sativa L. plant or parts of it including seeds, flowers and inflorescences, resin, separate, raw or purified resin obtained from all parts of the plant, with a percentage of tetrahydrocannabinol (THC) greater than 0.2 percent. 
The cultivation activities of cannabis plants, the processing of the same for the Preparation of medicines and the sale of medicines themselves by qualified subjects are allowed subject to approval by the State Congress, following appropriate authorisation by the Authority for the authorisation, accreditation and quality of health, socio-health and socio-educational services referred to in Law 25 May 2004 n.69, hereinafter briefly referred to as the Health Authority.

Role of the Health Authority

In compliance with articles 23 and 28 of the Single Convention on Narcotics adopted in New York on March 30, 1961, as amended by the Geneva Protocol of March 25, 1972, to which the Republic of San Marino acceded by Decree 18 September 2000 n.89, the Health Authority is attributed the function of San Marino Cannabis Control Agency (ASCC). 

In particular, the ASCC: 

• authorises requests for the cultivation, processing and trade of cannabis, inflorescences, semi-finished products, galenic preparations and derived medicinal products subject to the acctance of the State Congress;
• authorises the import, export, wholesale distribution, stockpile of cannabis-based plants and plant material and stocks held by authorised drug manufacturers;
• authorises the manufacturing quotas of the active substance of plant origin based on cannabis and informs the International Narcotics Control Boards (INCB) of the United Nations;
• monitors and prepares quality controls, in agreement with the Police Forces, so that the activities of cultivation, processing and sale of cannabis, inflorescences, semi-finished products, galenic preparations, and derived medicines take place in compliance with all the conditions imposed and the guarantees required in the authorisation act and the prescriptions subsequently issued by the Health Authority itself.

For the performance of the functions attributed to it, within the ASCC are designated: 

• 1 contact person of the Complex Pharmacy Organisational Unit;
• 1 contact person of the Environmental and Agricultural Resources Management Office;
• 1 representative of the Gendarmerie Corps representing the Police Corps.

The ASCC may, at its discretion, make use of specific professionalism and skills, even external to the Public Administration. 
The Health Authority reports annually to the State Congress and to the IV Permanent Council Commission on its activity as an ASCC.

Permissions

Entities or companies that intend to cultivate, process, wholesale, market cannabis or derived medicinal products following authorisation by the ASCC, which can be granted for each of these activities, both in single form and in cumulative form, must obtain appropriate acknowledgment from the State Congress.

The request for authorisation to carry out the activities must be forwarded to the ASCC, which completes the preliminary investigation activity within thirty days and, having verified the existence of all the necessary requirements, transmits it to the State Congress for obtaining the act, receipt of which, provides for the issuance of the requested authorisation.

By delegated decree, for the purpose of obtaining authorisation for the cultivation and processing and trade of cannabis, semi-finished products, inflorescences and derived medicines are governed by:

• the requirements of commodity tables and ATECO codes that must already be present in the corporate purpose of the entity or company, the structural, technological and organisational characteristics required, the guarantees and requirements that the authorities or companies must comply with in the conduct of the activity, the methods of submitting the application and other elements useful for the investigation;
• the special requirements placed on the owner or legal representative of the entity or company, the technical director, the person in charge of keeping records, as well as the employees, aimed at verifying the existence of professional and honorability requirements.

In the application for authorisation, the bodies and undertakings concerned must indicate the office or office whose holders are responsible for keeping records and complying with the other obligations imposed by the provisions.

The bodies or companies moving must also present a “security plan”, which responds to the characteristics required by the delegated decree indicating the safety systems and systems the adequacy of the resources and means of the private security services commissioned by the entity or company, which must be authorised by the Command of the Gendarmerie in order to guarantee the cultivation, transformation and storage plants from abusive subtraction and other types of violations.

In the act of authorisation of the activity, the ASCC, subject to a positive opinion of the State Congress, may provide for specific conditions and guarantees for the protection of health and public order.

The State Congress, on the recommendation of the ASCC, also sets the maximum annual production quantity of cannabis cultivation in the Republic of San Marino. In accordance with the maximum annual production quantity, the ASCC proceeds to grant the authorisation by public tender, between the entities and companies that meet the requirements, according to the rules in force.

Revocation/Suspensions

The ASCC, subject to clearance by the State Congress, can proceed to revoke the authorisation: 

• in the event of established irregularities during the course of cultivation, harvesting, manufacture, processing, synthesis, use, custody, trade of cannabis, semi-finished products or derived medicinal products;
• in the event that all or part of the defined requirements are missing;
• in case of technical accident, theft, deterioration of substances derived from cannabis;
• in case of theft, only in the event that the judicial authority detects a serious fault or a liability of the entity or company.

The State Congress can proceed to revoke the license in case of serious and/or repeated violations of the requirements given by the ASCC, as well as for the causes provided for in article 29, paragraph 2, of Law 31 March 2014 n.40.

The revocation measure must be motivated and is promptly notified to the interested parties through the Command of the Gendarmerie Corps.

Temporary suspension of the license is provided until the ASCC is ascertained.
In the event that following the investigations the ASCC and the authorised entity reconstruct the contents of the registers themselves, the suspension expires; otherwise the suspension is transformed into revocation of the license.

The State Congress, upon notification of San Marino or foreign judicial authorities, pending the investigations, suspends as a precautionary measure any commercial activity authorised by the entity or company subject to the report. In this case, the ASCC appoints a Commissioner for the management of ordinary business to ensure business continuity.

Subjects acquired or confiscated 

Cannabis plants and seeds, or substances derived from them, lying as a result of revocation of authorisation or otherwise confiscated are acquired by the Ecc.ma Chamber, which can order their use or destruction.

In case of different use or destruction of seized substances, the ASCC supervises the procedure, assisted by the Gendarmerie Corps and the health and territorial offices in charge, according to a guarantee and security protocol established by the ASCC itself.
The costs of disposal or destruction of the confiscated substances are borne by the entity or company.

Vigilance

The ASCC, in collaboration with the Police Forces, carries out periodic checks at the bodies or companies authorised for the cultivation, processing or marketing of cannabis or derived medicines, in order to ascertain compliance with the conditions imposed, the prescriptions issued for the conduct of the activity and the existence of the guarantees placed on the basis of the authorisation order.

The ASCC gives prescriptions to authorised bodies and companies so that the activities are managed by establishing and maintaining an adequate quality and safety system, in reference to the GACP (Good Agricultural Cultivation Practice), GMP (Good Manifacturing Practice) and the international standards that regulate the ISO (International Standardisation Organisation) quality management systems.

The cultivation and production of the active substance are regulated by the ASCC in compliance with and in accordance with the Active Substance Master File. For clinical and care activities, references are to GCP (Good Clinical Practice) and to the indications of International Health Organisations and Scientific Societies.

Any serious incident, whether due to an accidental event or an error, related to the production, collection, control, processing, transformation, storage, distribution and assignment of each product, which is such as to compromise the ordinary activity, must be reported to the Police Forces and the ASCC by the entity or company itself.

Entities or companies authorised to cultivate, process or wholesale market cannabis, semi-finished products, inflorescences or derived medicines, on request, are required to promptly transmit the requested data, information and documents to the ASCC.

Authorised entities or companies are required to inform in advance by communication, including telematics, the ASCC and the Police Forces Operations Centre of any movement of cannabis-based materials entering or leaving the establishment with appropriate notice in order to allow their inspection when they deem it appropriate.

In order to prevent and repress any attempt to violate the security of products, the private security service of the entity or enterprise, in implementation of the security plan, must carry out continuous service (h24).

Excess

Any production surpluses not exceeding 10 percent on the permitted quantities are tolerated provided that they are reported to the ASCC within fifteen days from the moment they are ascertained. 
Surpluses are calculated in the quantities to be produced in the following year.

Quantity

By November of each year, the ASCC, taking into account the indications deriving from the International Conventions on the subject and the Bodies that emanate from them, establishes with its own provision the quantity of cannabis that can be grown, the products that can be processed and the medicines that can be marketed during the following year. 
This measure is promptly communicated to the entities and companies concerned.

Retail 

The retail sale of medicines or pharmaceutical products of plant origin based on cannabis, substances and plant preparations is allowed exclusively at state pharmacies and upon presentation of a medical prescription, as provided for by a special regulation drawn up by the Institute for Social Security.

For the marketing of cannabis-based medicines, the Pharmaceutical Service and the pharmacies of the ISS do not require additional authorisations.

Wholesale 

The wholesale within the Republic of San Marino of cannabis, semi-finished products, inflorescences or derived medicines is allowed exclusively between authorised entities and companies, or by bodies and companies authorised against the State Pharmaceutical Sevizio.

Without prejudice to compliance with the general rules of trade discipline and the distribution network, referred to in Law 26 July 2010 n.130, of any operation of sale or transfer to any wholesale title of cannabis, semi-finished products, inflorescences or derived medicines must be requested prior authorisation from the ASCC and notified to the Police Forces according to the provisions.

The delivery of goods must be carried out in the following ways:

• at the headquarters of the entity or company, or at the state pharmaceutical service;
• personally to the holder of the trade authorisation, subject to verification of his identity or to an employee of the entity or company, duly authorised.

Use of cannabis-based products for therapeutic use

The use of cannabis-based therapeutic products is allowed only upon presentation of a medical prescription, even telematic, issued by a qualified doctor or veterinarian.

The Health Directorate of the ISS, in consultation with the Health Authority, will have to provide guidelines or special protocols for doctors related to the identification of the diseases to be treated, the therapies to be adopted and the methods of administration of the cannabis-based drug.

The therapeutic use of cannabis-based medicinal preparations is allowed, duly prescribed according to the needs of treatment in relation to the particular pathological conditions of the subject.

Any serious undesirable reaction, observed during or after the administration of therapeutic products derived from cannabis must be reported to the ASCC in the manner provided for by the legislation on clinical risk related to these events (near miss), adverse events and sentinel events.

Import, Export and Transit

The import, export and transit of cannabis, semi-finished products, inflorescences or derived medicines may only be carried out by the pharmaceutical service, bodies and companies authorised for the cultivation of plants, the production, manufacture, use and trade of these goods.

Without prejudice to compliance with the general legislation on import and export, to and from the Republic of San Marino, to and from countries of the European Union or outside the European Union, both in relation to the documentation of goods and the fulfilment of tax and customs obligations, each single operation of import, export and transit of cannabis, semi-finished products, inflorescences or derived medicines must be previously authorised by the ASCC.

The import or export of cannabis, semi-finished products, inflorescences or derived medicines through the ordinary public postal service is prohibited.

During transit it is forbidden to tamper with or in any way modify wrappers containing cannabis, inflorescences, semi-finished products or derived medicines, except for customs or police operations, by qualified and authorised personnel.

Import

In addition to the fulfilment of tax, customs and documentation obligations for the import of goods, the entity or company authorised for the cultivation, processing or marketing of cannabis or derived medicines, interested in importing seeds, plants, semi-finished products, inflorescences or cannabis-based medicines, must submit an application for an import authorisation to the ASCC, in the manner indicated by the ASCC itself through a special regulation, drawn up by the ASCC itself.

The ASCC, issued the import permit in accordance with international conventions, promptly communicates it to the Command of the Rock Guards Corps – Uniformed Nucleus and to the Tax Office, for controls of competence.

The ASCC authorisation measure must bear, on the basis of the application received, the exact indication of the weight, quality and quantity of the goods, the reasonable delivery time frame.
The importer, upon arrival at the destination of the goods, must request from the Uniformed Nucleus of the Guard of the Rock a certificate on the transport documents, which will be issued following verification of the conformity of the documents, the integrity of the casing and the seals of the goods.

The Civil Police, on the advice of the ASCC or on its own initiative, may order the taking of samples of the goods being imported. This operation must be carried out in the presence of the importing entity or its legal representative, who will sign the report of the operations. Any withdrawal must be sent promptly to the ASCC, which will arrange the relevant surveys.

Export

In addition to the fulfilment of customs tax and documentation obligations for the export of goods, and the annotation, the entity or company authorised to the cultivation, processing or marketing of cannabis or derived medicines, interested in exporting seeds, plants, semi-finished products, inflorescences or cannabis-based medicines, must apply for authorisation to the ASCC, according to the procedures indicated by the ASCC itself through the regulation.

The ASCC, having issued the export permit, gives prior notice to the San Marino Gendarmerie Command and to the Foreign Affairs Department for communication to the competent Authorities of the destination country, through diplomatic channels.

On the ASCC export permit, numbered progressively, the weight, quality and quantity of the exported goods must be indicated exactly; as well as the details of the authorisation of the authority of the destination country.

Transit

The authorisation for the transit of seeds, plants, inflorescences, semi-finished products or cannabis-based medicines is granted by the ASCC, upon submission of a specific application by the entity or company that produced the goods, or by the same carrier, according to the procedures indicated by the ASCC regulations.

The application must in any case be accompanied by the import permit issued by the competent authorities of the destination country and the export permit issued by the competent authorities of the country of origin.
The ASCC authorisation measure is promptly transmitted to the police operations centre.

DOCUMENTATION AND CUSTODY

Entry and exit register 

The entity or company authorised to the cultivation, processing or marketing of cannabis or derived medicines, must keep a register in which, without any gap, abrasion or addition, in chronological order, according to a numerical progression unique to each substance or medicine, the movement of entry and exit from the establishment of seeds, plants, semi-finished products, inflorescences or cannabis-based medicines is highlighted.

This register is numbered and signed on each page by the Director of the Health Authority or his delegate, shows on the first page the details of the authorisation and declares on the last page the number
of the pages of which the register is made up. The register is kept by the authorised bodies and companies for a period of five years from the day of the last registration.

The register is prepared by the Secretariat of State for Health, which can provide through its own provision the possibility of registration on computer support according to the methods, procedures and criteria provided for in the same provision, in order to guarantee real-time reporting of each individual entry.

Up to the establishment of the computer register, the company must guarantee at all times access to the Police Forces and the ASCC to the documentation and related media provided.

Register relating to the cultivation of cannabis seeds and plants

Entities or companies authorised to grow seeds, inflorescences and cannabis plants, pursuant to this law, are obliged to note each entry and exit operation or passage in processing on the register.

The records relating to the exit or transition operations into processing must also show the number of the operation with which the substance, which is the subject of it, was recorded as input.
The substance obtained from the working process, even by synthesis, must be entered with the indications that allow the connection with the data contained in the processing register.

Quantitative changes in the stocks of each substance must be accounted for, in a special column to be registered to the substance itself, in correspondence with the entry concerning the operation from which they were determined.

Register relating to the use and trade of cannabis products or medicines

The entities or companies authorised to use and trade in cannabis-based products or medicines close the register on December 31 of each year. The closure is carried out by summarising all the data proving the totals of the quality and quantities of the products in charge and the quantities and quality of the products used or marketed during the year, with the indication of any possible difference or residue.

For the processing of cannabis-based products, a processing register is also kept, numbered and signed on each page by the Director of the Health Authority or by an official delegated by them, in which the quantities of raw materials put into processing are recorded, indicating their exact name and the date of entry into the processing department, as well as the products obtained from each processing. This register is kept for five years from the last registration.

The Health Directorate of the Institute for Social Security may establish supplementary procedures for the registration and management of cannabis-based medicines by state pharmacies, or for the discipline of the relative sale.

Data transmission

The entities and companies authorised to the cultivation, processing or marketing of cannabis or derived medicines, transmit to the ASCC, no later than January 31 of each year, the summary data of the previous year and precisely: 

• the closing results of the loading and unloading register;
• the quantity and quality of the substances used for the production of medicines and/or preparations for therapeutic use during the year;
• the quantity and quality of the medicines sold during the year;
• the quantity and quality of existing stocks as of December 31.

In case of loss, misplacement or theft of the registers, parts thereof or related supporting documents, the interested parties, within twenty-four hours of the finding, must report it in writing to the Gendarmerie Corps and notify the ASCC.

ASCC requirements

The ASCC holds at its headquarters, available to the bodies or companies concerned and to the public, all the application forms, prescriptions, guidelines, operating procedures, report or report forms provided. 
These provisions will also be inserted in a special section of the website of the Secretariat of State for Health.

Decriminalisation

Without prejudice to all provisions of punishability contained in the Criminal Code and in Law of November 26, 1997 n.139 and subsequent amendments regarding narcotic substances, without prejudice to cases of production, use, treatment and trade of cannabis and health prescription issued or recognised as effective by the Institute for Social Security, as provided for in Article 1, second paragraph, of Law No. 139/1997 and subsequent amendments.

Tax provisions

By subsequent delegated decree, the “cannabis cultivation” tax is established for the subjects authorised to grow. 
The State Congress is delegated to introduce with a special delegated decree any other taxes related to processing or any other tax provisions.

Sanctions

Anyone, without the prescribed authorisation, carries out activities of cultivation, processing or marketing of cannabis, semi-finished products, inflorescences or derived medicines is subject to the criminal and administrative sanctions provided for the exercise of the same activities of narcotic substances.

Failure to comply with the requirements and guarantees set out in the act of authorisation, unless the fact constitutes a criminal offence, entails an administrative sanction of 15,000.00 euros
(fifteen thousand/00) to 60,000.00 euros (sixty thousand/00), imposed by the Police Forces also on indication/report of the ASCC.

The non-compliance, in whole or in part, with the legitimate requirements of the ASCC, unless the fact constitutes a crime, entails the application of an administrative pecuniary sanction, imposed by the Police Corps also on indication/report of the ASCC itself, from euro 5,000.00 (five thousand/00) to euro 30,000.00 (thirty thousand/00) and may constitute, in the most serious and repeated cases, the title to request the State Congress the revocation of the license.

Cannabis seeds and plants, inflorescences, semi-finished products or cannabis-based medicines illegally or unlawfully held are seized and confiscated by the Gendarmerie Corps, according to a guarantee and safety protocol established by the ASCC.

Anyone through fault or malice produces cannabis-based substances in quantities greater than those allowed or tolerated is punished with imprisonment of up to one year or with a fine of up to 15,000.00 euros (fifteen thousand/00).

Unless the fact constitutes a more serious offence, anyone who does not comply with the rules on the keeping of entry and exit, loading and unloading and processing registers, as well as the obligation to transmit data and report referred to in this Chapter is punished with arrest for up to two years or with a fine of 1,500.00 euros (one thousand five hundred/00) to 25,000.00 euros (twenty-five thousand/00).