Further to the introduction of the Production of Cannabis for Medicinal and Research Purposes Act (Chapter 578 of the Laws of Malta) in 2018, the Maltese government opened the doors to the production and consumption of medical cannabis, allowing entities wanting to produce for the European market to apply for a licence.
The aim of this article is to provide prospective applicants with a comprehensive guide on how to apply for a medical cannabis licence with the Maltese authorities.
The history of medical cannabis in Malta
The decision to allow pharmaceutical companies to grow high-grade medical cannabis in Malta, was driven by the size of the European market as well as the potential for local investment. Strategic consultancy firm Prohibition Partners has forecasted that the European cannabis market will be valued at €115.7 billion by 2028 and that the number of patients requiring treatment with medical cannabis will grow to over 30 million before 2030. On the Maltese side, the potential for investment is also conspicuous. The pharmaceutical sector employs 15% of the local manufacturing workforce and investments from the medical cannabis sector are estimated to amount to over €100 million and supplement Malta’s export by over €900 million by 2022.
Terms to know
In this article we will frequently make use of technical terms, so we better familiarise ourselves with them before we proceed any further.
LOI: Letter of engagement;
EU-GMP compliance: the Good Manufacturing Practice (GMP) has been established by the European Medicines Agency (EMA) and is the minimum standard that a manufacturer of pharmaceutical products must meet in their production processes.
How to obtain a medical cannabis license in Malta
As your consultants for the whole application process, part of our engagement would 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.
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. Should the outcome be satisfactory, the application is compiled and submitted to Malta Enterprise. It is possible to apply as a ‘company in formation’ and effectively incorporate the company following 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. Promoters would 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 would need to be submitted to the Medicines Authority.
What are the technical requirements which need to be satisfied to obtain a medical cannabis license in Malta?
Upon receiving the 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, including:
- 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.
Q: Have there been any recent amendments to laws governing cannabis in Malta?
A: Yes, there have been recent amendments made to the cultivation and possession of cannabis in Malta (i.e., for recreational purposes). However, these amendments have had no effect on the medical cannabis licensing process in Malta.
Q: Is it possible for someone who already owns land in Malta to carry out medical cannabis business?
A: It may be possible to do so, provided that there are the necessary permits for the land to be used for industrial purposes (as opposed to agricultural). A factory, in line with all applicable standards must also be in place, and the business would need to be of a mixed nature, such as cultivation (which may also include processing) and research. In any such case, the normal process with Malta Enterprise would still need to be undertaken.
Useful resources for medical cannabis licensing in Malta
Further reading to better document yourselves as well as resources are available at these links:
Get in touch with us
Applying for a medical cannabis license requires you to abide to specific technical requirements and present a comprehensive due diligence and business plan to Malta Enterprise.
Our team is ready to assist you with all your queries and to initiate the application process. Get in touch now with one of our experts listed below for a no-obligation meeting.