The Malta Medicines Authority
Following the initiation of a legislative framework for the medicinal use of cannabis in early 2018, The Medicines Authority will form part of the review process for incoming applications for the importation and wholesale distribution of cannabis for medicinal use.
The Authority provides guidance and consultation on scientific matters to support research and development as well as accessibility of quality medicinal cannabis. 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.
Early April 2018:
The Drug Dependance Act is amended with respect to the prescription of medicinal preparations of cannabis, the act favours treatment over imprisonment.
The Production of Cannabis for Medicinal and Research Purposes Act, 2018, receives parliamentary approval.
Late April 2018:
Government decides to allow large-scale cultivation of cannabis plants, including the selling of flowers.
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.
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 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.
Eligible candidates for licensing can fill in the form here.
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