Production of Cannabis for Medicinal and Research Purposes Act and Amendments to the Drug Dependence (Treatment not Imprisonment) Act

he Maltese Parliament enacted a new Act which regulates the production of cannabis for medicinal and research purposes under a controlled and supervised environment. The said Act came into force on the 17 April 2018 and succeeded the amendments made by the Maltese Parliament on 26 March 2018 to the Drug Dependence Act (Treatment not Imprisonment) after its third and final reading.

Chapter 578 titled ‘Production of Cannabis for Medicinal and Research Purposes Act’ (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’.

In accordance with the Act the production of cannabis products for medicinal and research purposes requires a licence and the permissible activities include the:

  • Cultivation, importation or processing of cannabis; and/or
  • Production of any products intended for medicinal use deriving from or resulting from the use of cannabis; and/or
  • Trade in cannabis and, or any preparations intended for medicinal use as deriving from cannabis.

To carry out the activities aforementioned, all applicants must:

  • Obtain a letter of intent, from Malta Enterprise, who will ensure that the proposed activity is used solely for production purposes;
  • Obtain a licence from the Medicines Authority; and the applicant must:
    • submit any documents required, including due diligence documentation,
    • any permits, approvals and clearances from other entities as may be required; and
    • possess relevant qualifications in line with the Mutual Recognition of Qualifications Act.
  • Comply with any regulations that are relevant to the production and quality standards of products for medicinal and, or research purposes, as the case may be, as applicable under the Medicines Act and with any other relevant regulations.  

It is strictly prohibited to cultivate, import, process and produce cannabis intended for medicinal and or research purposes before obtaining all necessary approvals, authorisations, licenses and or permits required under Maltese legislation.

An entity who will be opening facilities and operating from Malta, for the purpose of manufacturing cannabis for medical and research purposes, must comply with the Good Manufacturing Practices (GMP). These are the practices required for any entity manufacturing a product, to ensure that their product is consistently of high quality and no harm is caused to the end user.  The entity will self-certify compliance with the GMP requirements.

Malta offers a number of incentives to investors in terms of subsidised rent and tax credits for approved projects in the pharmaceuticals sector together with an attractive fiscal regime.

The Medicines Authority will monitor and review relevant operations by visiting any premises and has the right, at all reasonable times to enter and inspect premises, so that the Authority can ensure that the operation complies with the regulations stipulated in the Act.

Any person who abides by the Act shall be exempt from the provisions of the drug laws insofar as those laws relate to cannabis. However, where a person fails to abide by the provisions of the Act or any other regulation issued in accordance with the Act and such constitutes an offence under the drug laws, then the provisions of the drug laws shall apply.

The Government of Malta and Malta Enterprise are working together not only to produce the product and sell it locally, but also to export the product and in turn, enhance Malta’s economic growth since there appears to be a large demand for export. In fact, foreign investors have already shown their interest in Malta and the Malta Enterprise has already approved production projects by international companies, originating from Canada, Australia and Israel.  

EMD has substantial experience in assisting foreign operators with establishing an operation in Malta including assistance with the preparation of a business plan, financials, application to Malta Enterprise and any legal and financial work required in connection with such projects and acting as liaison with the local authorities.