The Production of Cannabis for Medicinal and Research Purposes Act (Chapter 578 of the Laws of Malta) placed Malta at the forefront of innovation by promoting it as an attractive investment destination for the cultivation and processing of cannabis for medicinal and research purposes. Moreover, the established reputation of Malta in manufacturing pharmaceuticals certainly provides peace of mind to investors and customers in this sector.

Whilst the recreational use of cannabis remains illegal, in March 2018 the production of cannabis for medicinal and research purposes was legalised.  As a result, a licensed medical practitioner who is duly registered in accordance with the Health Care Professions Act may prescribe to patients’ medical cannabis, if it is considered that there is no viable alternative to such prescription.

The Production of Cannabis for Medicinal and Research Purposes Act, undoubtedly introduces a number of advantages and benefits, including:

• Access to medical cannabis to those who really need it;
• The introduction of a newly regulated cannabis industry;
• Boosting the economy through job creation and taxation.

The involvement of Malta’s highly reputed Medicines Authority as regulator for the sector, gives further comfort to investors, operators and customers in this field.  In fact, the Malta Medicines Authority (MMA) is recognised by both European Medicines Authority and Federal Drugs Agency and has carried out inspections all around the globe.

This new legislation   establishes a robust regulatory structure and strives to maintain quality standards whilst placing patients’ safety and dignity at the forefront, making Malta a key market player in the sector.

The new legislation makes it possible for one to:

• cultivate, import and process cannabis
• produce products deriving from cannabis and
• trade in cannabis

exclusively for medical and research purposes, provided that one complies with all relevant legislation and obtains the necessary licenses, authorizations and permits required by law.

Exportation of cannabis is restricted to finished products (meaning that no further requirement of processing and packaging are pending finalisation of product) intended for medical use. Any person intending on participating in this newly emerging industry must:

• Comply with the provisions of the Production of Cannabis for Medicinal and Research Purposes Act and other regulations and legislation promulgated from time to time;
• Comply with all the regulations and relevant legislation regulating the quality standards of production of any products intended for medicinal and/or research purposes deriving from cannabis, including the Medicine’s Act;
• Comply with international obligations resulting from any treaty which Malta may be a party to;
• Obtain a letter of intent from Malta Enterprise; and
• Obtain a license from the regulatory authority.

EMD can provide the following services:

• Advise and assist with the structuring and setting up of the corporate structure
• Advise and assist with the business plan and financials
• Tax advice and compliance
• Technical assistance with the application to the competent authorities
• Technical expertise