Cannabis for Medicinal and Research Purposes

Legal Framework

In 2018, Malta enacted the Production of Cannabis for Medicinal and Research Purposes Act which provides the legislative measures to permit the production of cannabis for medicinal and research purposes.  This law followed the amendment of the Drug Dependence Act with respect to prescribing of medicinal preparations of cannabis.

The Drug Dependence (Treatment not Imprisonment) Act, is available at: https://legislation.mt/eli/cap/537/eng/pdf

The Production of Cannabis for Medicinal and Research Purposes Act, is available at: https://legislation.mt/eli/cap/578/eng/pdf

The Production of Cannabis for Medicinal and Research Purposes (Fees) Regulations, 2018, as amended, are available at: https://legislation.mt/eli/sl/578.1/eng/pdf

 

Regulatory Framework

The Malta Medicines Authority provides guidance and consultation on scientific matters to support research and development as well as accessibility of quality medicinal cannabis.  The Malta Medicines Authority is responsible to review applications for the importation and wholesale distribution of cannabis based products for medicinal use.  Activities related to the production of cannabis for medicinal and research purposes are regulated through comprehensive evaluation of scientific and technical documentation, security considerations, and good practices.

The list of medicinal cannabis-based products approved for the local market can be accessed here (last updated 13/05/24)


Wholesale distribution of medicinal preparations of cannabis

A licensed wholesale distributor may source to Malta cannabis based products or synthetic cannabinoid products licensed under the Medicines Act (Chapter 458 of the Laws of Malta) or manufactured under EU Good Manufacturing Practice (GMP), subject to the necessary approvals and permits, granted by the Superintendence of Public Health.

The application for wholesale distributors to place cannabis-based products or synthetic cannabinoid products on the market in accordance with the Medicines Act and the Drug Dependence (Treatment not Imprisonment) Act can be downloaded by clicking here.

Requests for tamper-evident labels bearing unique serialisation codes to be affixed on sourced medicinal cannabis-based products that are intended to be marketed locally can be made by downloading and submitting this form.

General Guidelines for wholesale distributors to place cannabis-based products or synthetic cannabinoid products on the market in accordance with the Medicines Act and the Drug Dependence (Treatment not Imprisonment) Act (last updated 14/09/2023)


Production of cannabis for medicinal and research purposes

Operations related to medicinal cannabis production, analysis and research require a Letter of Intent (LOI) from Malta Enterprise, followed by assessment through the regulatory authority.  Inspections of facilities are carried out in accordance with the principles and guidance of EU good practices (GxP).  The Malta Medicines Authority considers applications for EU-GMP certification, both for local and international facilities. 

General Guidelines on the production of cannabis for medicinal and research purposes (last updated 28/07/2022)

The application for a licence in accordance with the Production of Cannabis for Medicinal and Research Purposes Act (Cap. 578 of the Laws of Malta) can be downloaded by clicking here.

The application for a variation to a licence issued in accordance with the Production of Cannabis for Medicinal and Research Purposes Act (Cap. 578 of the Laws of Malta) can be downloaded by clicking here.

Requests for unique serialisation codes to be displayed on produced medicinal cannabis-based products that are intended to be marketed can be made by downloading and submitting this form.

 

Consultation on Scientific Matters

The Malta Medicines Authority shall respond to requests made on scientific matters regarding cannabis for medicinal and research purposes in accordance with Chapter 578 of the Laws of Malta, and any other applicable legislation, as required. Scientific consultation requests shall be considered for prospective applicants intending to submit an application for the grant of a licence for the Production of Cannabis for Medicinal and Research Purposes, as well as other stakeholders who are seeking general guidance in this area. Relevant parties are invited to express interest for scientific consultation through the completion and submission of this form.

 

Research

The Cannabis for Medicinal and Research Purposes Unit welcomes proposals from established organisations for scientific collaboration.  Projects related to advanced research in cultivation, product formulations, analytical developments and clinical trials related to cannabis for medicinal use are invited.  The Medicines Authority collaborates closely with the University of Malta, the Malta Laboratories Network and Malta Enterprise on various specialised studies, including educational initiatives.  The Malta Medicines Authority International Fellowship Programme is available to increase capacity and level of research, innovation and development in the field.

 

Application forms (including supporting documentation) and any queries shall be forwarded to cannabis.medicinesauthority@gov.mt