26th February | Christian Farrugia

The Production of Cannabis for Medicinal & Research Purposes in Malta

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26th February | Christian Farrugia

The Production of Cannabis for Medicinal & Research Purposes in Malta

The production of medical cannabis is regulated by the Production of Cannabis for Medicinal and Research Purposes Act, (the “Act”), which became effective 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 Act defines cannabis as ‘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.

The Act commences to set out the prohibitions of the activities which can be carried out in Malta.  It accentuates that 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, authorizations, licenses and, or permits are granted by the Medicines Authority.

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.

Furthermore, applicants are also required to comply with the Production of Cannabis for Medicinal and Research Purposes (Fees) Regulations, (the “Fees Regulation”). The Fees Regulation states that the Medicines Authority shall receive the specified fees, from persons intending to apply to carry out importation, wholesale distribution, cultivation and processing, and/or production of cannabis for medicinal use and/or research purposes.

For instance, the application fee for a manufacturing site license 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 licenses, 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 license by the Medicines Authority.  In order to obtain a license, 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.

Authors;

This article was written by Dr.Franklin Cachia and Dr. Caroline Grech. 

 

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