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:

http://www.justiceservices.gov.mt/DownloadDocument.aspx?app=lom&itemid=12289&l=1

The Production of Cannabis for Medicinal and Research Purposes Act, is available at: http://justiceservices.gov.mt/DownloadDocument.aspx?app=lom&itemid=12821&l=1

The Production of Cannabis for Medicinal and Research Purposes (Fees) Regulations, 2018, are available at: http://justiceservices.gov.mt/DownloadDocument.aspx?app=lp&itemid=29382&l=1

Regulatory Framework

The Medicines Authority provides guidance and consultation on scientific matters to support research and development as well as accessibility of quality medicinal cannabis.  The 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.

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

Approved medicinal cannabis-based products (last updated 07/11/22)

Importation and wholesale distribution of medicinal preparations of cannabis

A licensed importer or 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 the importation and/or wholesale distribution of cannabis based products or synthetic cannabinoid products in accordance with the Medicines Act and the Drug Dependence (Treatment not Imprisonment, Act) form is available at:     https://eforms.gov.mt/pdfforms.aspx?fid=HCC075e

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 Medicines Authority considers applications for EU-GMP certification, both for local and international facilities. 

The application for licence in accordance with the Production of Cannabis for Medicinal and Research Purposes Act (Cap. 578 of the Laws of Malta) is available at:

https://servizz.gov.mt/en/Pages/Health-and-Community-Care/Health/Medicines/WEB2427/default.aspx

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) is available at:

https://servizz.gov.mt/en/Pages/Health-and-Community-Care/Health/Medicines/WEB2426/default.aspx

Research

The Advanced Scientific Initiatives Directorate 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.