Cannabis Compliance in Malta – Background Info, Fees & How-to Checklist [FREE LICENSING GUIDE]

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“Being a small island allows us to have more direct access to decision makers and stakeholders” - Marion Zammit, Malta Enterprise.

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The current cannabis situation in Malta

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Malta, the smallest country in the EU became the first one to legalise adult use cannabis when it passed their laws in December 2021. This follows the decision by the UN in December 2020 to remove cannabis from a listing of drugs designated as potentially addictive and dangerous, and having little or no therapeutic use.

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For Malta, already using its limited resources to the fullest with tourism and online gaming, this is a revenue generator for locals as well as plans to promote the legalisation as a tourist attraction. It also aims to remove criminal convictions of cannabis usage after a letter of request has been written.

Added to their big push into the medical cannabis market, which was legalised in March 2018, this marks a huge venture for a traditionally conservative, Catholic country.

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Malta Enterprise, the Maltese government's exclusive agency focused on attracting inward investment and supporting enterprise, seeks to nurture medical cannabis investment by implementing support measures and fostering an environment in which businesses can thrive unimpeded by restrictive regulatory frameworks. Furthermore, it advises the Maltese government on economic policy from its vantage point of being in close and constant communication with the most significant economic powerhouses in the nation.

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The Malta Medicines Authority (MMA) is recognised by both EMA and FDA and has carried out inspections all around the globe. For the pharmaceutical cluster, the MMA is of primary importance, and is pivotal in Malta’s placement as a gateway to both the EU and US markets.

The arrest in March 2022 of a medical doctor on a distribution charge after prescribing cannabis to his patients, have shown that certain laws on adult usage still need to be tweaked. By June 2023 the country still hasn’t licensed any non-commercial cannabis clubs despite having received 26 applications since the application window opened in March 2023.

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When you consider Malta’s trade routes, regulatory infrastructure, favourable tax rates, simplified logistics due to the island’s small size, and generally good climate, it becomes an attractive proposition. Malta’s EU membership, and thus access to the European market, also offers high value growth opportunities for cannabis exporters. The country’s membership means that cannabis has to be produced to EU-GMP standards, adding yet another advantage over products manufactured outside the block.

The process to get a cannabis license in Malta: First phase

What are the rules for growing medical cannabis?

Anyone that wants to grow, harvest, sell, or do anything else with cannabis for medical purposes, must apply for the applicable legal authorisation to do so

Business is open to any person who obtains the correct license. However, getting started will require entities to jump through a few hoops

Download Now: Free Cannabis Licensing Guide for Malta [Get Your Guide]

The application is a two-fold process, starting with a vetting process and, when successfully completed, then moves into the official licensing stage.

Firstly, a letter of intent must be obtained from Malta Enterprise. At this point all aspects of the company must be in full compliance with the ‘Production of Cannabis for Medicinal Use Act, 2018’, as well as any other relevant international obligations. The next phase is to demonstrate that the entity completely observes all regulations relating to the production of medical products.

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Once all of these are satisfied it is possible to apply for the actual license with the regulatory authority. It is possible to apply with Malta Enterprise as a ‘company-in-formation’ and effectively incorporate the company further to a successful outcome of the process. However, it is essential to choose the name under which the company will operate from the outset.

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