The production of medical cannabis is regulated by the Production of Cannabis for Medicinal and Research Purposes Act, (the "Act"), which became in force on the 17th April 2018. The Act brought along with it the possibility of producing cannabis in Malta however, such production is limited solely to medicinal and research purposes within a regulated and controlled environment. 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.
Cannabis Definition "fresh or dried cannabis; cannabis oil; cannabis plant or seeds; derivatives of cannabis excluding synthetic derivatives; and; or any substance and, or product set out in guidelines issued by the regulatory authority, all of the foregoing to be used exclusively for manufacturing of products for medicinal and, or research purposes.". The Act continues to explain that research within this context, is restricted to research for pharmaceutical, pharmacological and, or clinical purposes.
No form of cultivation, importation or processing of cannabis and no production or trade of any products intended for medicinal and, or research purposes deriving from or resulting from the use of cannabis shall be carried out in Malta unless all the necessary approvals, authorisations, licences and, or permits are granted by the Medicines Authority.
Importation and wholesale distribution of medicinal preparations of cannabis
A licenced 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.
Application to Produce Medical Cannabis
Applicants interested in carrying out any of the foregoing activities shall comply with a comprehensive list of requirements which are set out in the Act. Furthermore, a manufacturing company operating in Malta within the medicinal and research cannabis space, needs to satisfy the Good Manufacturing Practices ("GMP") requirements. These requirements are mainly concerned with production and quality control.
The application fee for a manufacturing site licence for medicinal cannabis has been set out at €35,000, with an annual fee equivalent to the same. An interesting fee which is also noteworthy is that companies carrying out such activities are obliged to pay €1 per unit product transacted, towards research and education to be undertaken by the Medicines Authority.
The validation and processing of the applications submitted shall only start once the respective fees have been paid in full by the applicant to the Medicines Authority unless decided otherwise by the same. Furthermore, the said authority has the power to suspend or revoke licences, certificates, or permits granted or issued, if the fees stipulated in these regulations are not paid fully and in a timely manner.
The Act stipulates the operational requirements for the issuing of a licence by the Medicines Authority. In order to obtain a licence, the applicant shall:
- submit the relevant information, including due diligence documentation and other prescribed information as deemed necessary;
- attain authorisations, permits, approvals and clearances from other entities as may be prescribed and applicable under the Act and any relevant legislation; and
- comply with the terms and conditions as may be prescribed, including the possession of relevant qualifications in line with the Mutual Recognition of Qualifications Act.
Once the applicant has successfully applied, the Malta Enterprise shall then issue a letter of intent. The Malta Enterprise together with the Government of Malta have embraced this regulated opportunity to not only produce the product locally, but to also export the product and in turn, enhance Malta's economic growth. To this effect, there seems to be a large demand with the Malta Enterprise already approving a couple of production projects proposed by international companies.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.