Medical cannabis licensing in Malta
A study published in 2018 by market intelligence and strategic consultancy firm Prohibition Partners, has forecasted that the European cannabis market will be valued €115.7 billion by 2028. According to the same study, while patient numbers are currently below 100,000 across the region, their number is set to grow to over 30 million in the next decade. In 2018 Malta introduced a bill to legalize the use of medical marijuana and attract companies willing to produce high-grade medical cannabis for the European market.
Thanks to the expertise of its regulatory team, Grant Thornton can assist entities throughout the process necessary to be recognized as licensed operators in the medical cannabis field in Malta.
The process is broken down into two phases.
Following the completion of Grant Thornton’s on-boarding process, an application with Malta Enterprise is submitted, and an introductory meeting is set up to introduce the promoters and the project to Malta Enterprise officials. Should the outcome be satisfactory, the application is compiled and submitted to Malta Enterprise. The said application is primarily comprised of a thorough due diligence process and the submission of a business plan together with the relevant application forms. Following a satisfactory outcome, Malta Enterprise issue a letter of intent (LOI).
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.
Following the receipt of a LOI from Malta Enterprise, the promoters are required to apply for an authorisation with the Medicines Authority. There are several technical requirements which need to be satisfied, such as the following:
- License holder name indication;
- Appointment of a qualified person who needs to be a pharmacist registered with the Maltese Pharmacy Council and is resident in Malta;
- Evidence of the site (this would typically be the space granted by Malta Enterprise on the LOI);
- Import and export permits, where required (separate processes with customs authorities);
- Details on destruction and waste management;
- Awareness of police report filings in case of loss/theft;
- Compliance with all local laws including occupational health and safety, employment, environmental, sanitary and waste management, electrical safety, tax, and anti-money laundering legislation;
- Security measures and monitoring of the site;
- Where relevant (manufacturing), the site is required to be EU-GMP compliant;
- Further rules on cultivation (however, it should be noted that from experience on this kind of applications, the opportunity for cultivation is limited, mainly only for research and development purposes where it does not make up the main activity of the licensed activity).
Promoters will also have to pass a thorough due diligence procedure by the Medicines Authority. A due diligence report in line with the rules established for this purpose needs to be submitted to the Medicines Authority.
Our role as your medical cannabis licensing consultants in Malta
As your consultants for the whole process, part of our engagement will relate to the collation of all due diligence documents and carrying out of the necessary checks to compile a report which can then be presented to the respective authorities. It should be noted that the Medicines Authority may request further screening.