Chapter 578 of the laws of Malta now allows a Maltese company to manufacture or produce cannabis for medicinal or research purposes.
How is cannabis defined in the law?
Cannabis is defined in the law as:
- ‘Fresh or dried cannabis’
- ‘Cannabis oil’
- ‘Cannabis plant or seeds’
- ‘Derivatives of cannabis excluding synthetic derivate’
- ‘Any substance and or product set out in guidelines issued by the regulatory authorities’
The Act allows a person to cultivate, import, process and/or produce products deriving from cannabis as long as such products shall be exclusively used for medicinal and / or research purposes.
Specifically the guidelines issued by the Medicines Authority allow a person to possess, manufacture, provide, ship, sell, deliver, transport, and destroy cannabis (as long as such activities relate to the production of cannabis for medicinal and / or research purposes).
The permitted activities shall only be carried out in a tightly controlled environment under the supervision of the relevant Maltese authorities. An entity who intends to carry any activity relating to the cultivation, importation, processing or production of products derived from cannabis shall be required to obtain a license.
Any person or company who shall be carrying out any of the (permitted) activities from Malta shall be obliged to:
- Comply with all the provisions of the Production of Cannabis for Medicinal and Research Act and other relevant regulations as shall, from time to time, be promulgated under this Act or any other applicable law;
- Obtain a letter of intent from Malta Enterprise after making an application on the prescribed form. Malta Enterprise shall ensure that the proposed activity is solely a production process;
- Comply with all regulations, including international obligations resulting from a treaty to which Malta may from time to time be a party, as may be applicable;
- Comply with all regulations relating 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;
- Obtain a licence from the regulatory authority;
- Comply with any other relevant regulations as shall, from time to time, be promulgated under this Act or any other applicable law
Important Considerations for companies carrying out the production of medicinal cannabis:
Some of the most important considerations set out by the Guidelines on the production of cannabis for medicinal and research purposes published by the Medicines Authority include:
- Production of cannabis at the approved site may only be initiated once the regulatory authority has determined that the application meets the regulatory requirements and the relevant approvals, certificates, licences and permits are issued;
- The licence holder must engage a Qualified Person (QP) who meets the requirements specified in the Medicines Act and its subsidiary legislation, is recognised by the Medicines Authority to act as a QP, is a pharmacist registered with the Maltese Pharmacy Council and is resident in Malta;
- A licence holder must produce, store, package, and label cannabis only inside the designated site;
- A licence holder is responsible for obtaining the import and export documentation and permits required and must comply with Maltese customs laws. The relevant provisions of the United Nations Single Convention on Narcotic Drugs (1961) shall apply;
- Licence holders must provide details on waste management, such as closed incineration or composting, or other waste disposal systems.
- If a licence holder experiences theft, loss, unusual waste, or disappearance of cannabis that cannot be explained to be in the normal course of business, the licence holder must file a police report in accordance with national legislation;
- Due diligence procedures are applicable to company shareholders, ultimate beneficial owners (UBOs), directors, management, qualified person(s), responsible officers and any other persons with a financial interest and persons with decision making powers of influence;
- Access to areas within the licensed site must be physically restricted to persons whose presence is required by their work responsibilities and with adequate managerial supervision. The facility must be designed in such a way that prevents unauthorised access and visitors must be accompanied, at all times;
- The perimeter of a licensed site, and particularly areas within a site where cannabis is present, must at all times be visually monitored by suitable visual recording devices;
- Products must be consistently produced and controlled in accordance with the quality standards appropriate to their intended use and in line with the current good manufacturing practice guidelines published by the European Union Commission;
- A licence holder must keep record of cannabis transactions to ensure traceability.
For more information on the legal framework for the production of medicinal cannabis in Malta, kindly contact:
Franco Falzon C.P.A. LL.M
T: +356 2010 7771 (office)
M: +356 9989 5679 (mobile)
Profile: Franco Falzon
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