Malta Cannabis Market, Medical
In 2015, Malta decriminalised cannabis. On the 15 January 2018 a Bill for the Production of Cannabis for Medicinal Use was introduced by the Honourable Chris Cardona, M.P., Minister for the Economy, Investment and Small Businesses, to permit the local industrial production of cannabis products for medical use in the context of a controlled and supervised environment. The amendments to the Drug Dependence Act were enacted on 23rd March by Maltese parliament after its third and final reading.
The law permits doctors to prescribe cannabis to patients suffering from chronic pain, spasticity in multiple sclerosis and side effects of chemotherapy. Patients are only permitted to use non-smoking forms of cannabis-derived products once they obtain a card showing they’ve been approved by Malta’s the Superintendent of Public Health.
Products must be consistently produced and controlled in accordance with the quality standards appropriate to their intended use and in line with the current good manufacturing practice guidelines published by the European Union Commission. The licensed site shall be inspected by the regulatory authority, as deemed necessary, to attest European Union Good Manufacturing Practice (EU-GMP) compliance.
Whether local or overseas, cultivation of cannabis to be subsequently manufactured on Malta, must be in accordance with Good Agricultural and Collection Practices (GACP), backed by a documented quality system.
License and Letter of Intent
The issuing of a licence is subject to the submission, by the applicant, of documentation, including that for due diligence, required by the Medicines Authority to ensure fulfillment of licencing requirements as well as the compliance with, and attainment of, any other conditions, licences and authorization required under the relevant legislation. Moreover, a letter of intent will be required from Malta Enterprise.
The government also announced that The Malta Enterprise, the country’s economic development agency, has approved five new projects relating to the production of medical cannabis with a capital investment of over €30 million. Malta cannabis market can include among its medical cannabis partners companies from a diverse range of countries, including Australia, Canada, Israel and more.
Requirements and Fees
Companies producing medicinal cannabis on Malta will be subject to annual fees amounting to a maximum of €63,000 if all related activities are undertaken, and an initial application fee of a maximum of €100,000, according to a Legal Notice.
The application fee for a manufacturing site licence for medicinal cannabis has been set at €35,000, with an annual fee of €35,000.
Such facilities will also be subject to an additional fee per footprint allocated for cultivation purposes. These have been pegged at: €5 per square metre up to 2,000 square metres; €20 per square metre for the part of the footprint exceeding 2,000 square metres up to 4,000 square metres; €40 per square metre for the part of the footprint exceeding 4,000 square metres up to 6,000 square metres; and €100 per square metre for the part of the footprint exceeding 6,000 square metres.
A licence for non-commercial research activities will cost an initial €10,000 and have an annual fee of €8,000.
A Good Manufacturing Practice (GMP) certification related to cannabis for medicinal purposes (involving an inspection in Malta or within the EU/EEA) will cost €15,000 and an annual fee of €5,000.
GMP certificate related to cannabis for medicinal purposes (involving an inspection in a third country outside the EU/EEA) will cost €25,000 plus €600 per day per inspector plus all inspectors’ travel expenses. The annual fee will run at €15,000.
Other initial fees will include additional data integrity, research, and security inspections/audits, at €5,000 per audit consultations of scientific matters (at €200 per man hour).
Companies will also pay €1 per unit product towards research and education to be undertaken by the regulatory authority.
Malta Cannabis Market, Adult-use
In December 2021, Malta cannabis market became the first European market to allow limited cultivation and possession of cannabis for personal use. Adults are allowed to carry up to seven grams of cannabis and grow no more than four plants at home. Smoking it in public or in front of children is illegal.
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