Malta took a significant decision to regulate its medical cannabis laws and has officially became the first country in the EU to create a regulatory framework for the use of medical cannabis, authorising the use and possession of medical cannabis with a prescription. This means that entities are now allowed to produce or use cannabis for medicinal and research purposes. As the new developments attracted many players to the industry, here is what you need to know about the use and legalisation of Medical Cannabis in Malta.
Regulation of Cannabis in Malta
Although the use of medical cannabis is legal in Malta, recreational use of the product remains an arrestable offense. The Production of Cannabis for Medicinal and Research Purposes Act regulates the production of cannabis in Malta. The Act, which was enacted in April 2018 allowed the production of cannabis in the country for medicinal and research purposes only. The Act also limits the production only in a controlled and regulated environment.
Under the new Cannabis law, entities in Malta are allowed to produce, process, import, and cultivate cannabis for purposes of research and medicine. However, they can only do so after being granted all the necessary authorisations, approval, permits, and licenses by the Medicines Authority. By November 2019, more than 26 projects had been approved in the field of medical cannabis, accumulating a capital investment of €153 million. This is a clear indication of just how the country has progressed in the area within a short period of one year after the law was introduced.
Production of Medicinal Cannabis
For an entity to start any activities related to research, production, and analysis of medical Cannabis, they need to acquire a Letter of Intent from Malta Enterprise. The regulatory authority then assesses the entity and the facilities are inspected based on the guidance and principles of EU good practice. Both local and international entities can apply to the Medicines Authority to be licensed to produce medicinal cannabis.
Importation and Distribution of Medical Cannabis
Once approved and licensed, a wholesale distributor may source cannabis-based products and import them to the country. The imported product must be produced under the EU Good Manufacturing Practice or manufactured under Malta’s Medicine Act.
Applying for Medical Cannabis Production
Any entity interested in the production of medical cannabis in Malta must comply with the Act and satisfy the Good Manufacturing Practices requirements. An application fee of €35,000 is required to acquire a manufacturing site license, with an annual renewal fee of the same amount. In addition to this amount, entities are required to pay €1 for every unit of cannabis product transacted.
Once an application has been lodged and the respective fees paid, the Medicine Authority reviews it for approval. The right to accept, revoke, or suspend licenses and permit lies solely with the authority. Before the approval, applicants are required to submit all necessary information, attain clearance from other entities, and comply with the terms and conditions stipulated in the Act.
Upon approval, the Malta Enterprise issues the applicant a letter of intent. This allows them to start operations related to medical cannabis in the country. However, one is required to conduct all operations and activities within the confines of the Act.
Legalising medical cannabis in Malta not only gave access to government-sanctioned cannabis medication to qualified patients but also created an opportunity to attract foreign investors in its nascent medical cannabis industry and boost its economy. With proper regulations and monitoring, it could downturn the black market, decrease the number of detainees, increase job creation and tax revenue as well as broaden Malta’s healthcare system.
Cannabis for recreational use remains an arrestable offence in Malta.
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