Medical Cannabis in Malta

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5/6 June 2024

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All relevant GMP/GDP/GACP aspects for Medical Cannabis

Malta´s Medicines Authority issued a document which provides general guidance on cannabis production for medical and research purposes. According to the agency applications for the production must be completed and the licence and EU-GMP certificate must be granted before activities related to cannabis production are carried out.

Licence holder

For the granting of permission to produce cannabis for medicinal and / or research purposes a licence holder with the following rights & obligations is needed:

• The licence holder may possess, manufacture, provide, ship, sell, deliver, transport, and destroy cannabis exclusively in relation to the production of cannabis for medicinal and / or research purposes.
• The licence holder must engage a QP and is responsible for obtaining the import and export documentation and permits required.
• Exportation of medical cannabis is restricted to finished products and must comply with the laws & import permits issued by the competent authority of the country of final destination.
• Production has to follow EU GMP. In addition, intermediates, as, for example, oil containing cannabis that shall undergo further manufacturing steps, must have an EU-GMP certificate.

Appendices

The document includes three appendices with detailed information on:

• Quality & Stability (Appendix I)
• Security & Transportation (Appendix II)
• Cultivation, Harvesting & Packaging (Appendix III)
  

Quality & Stability (Appendix I)

Where applicable, the tests and limits provided in the European Pharmacopoeia (Ph. Eur.) apply. Extracts: In case of extraction solvents being used, Residual Solvents (Ph. Eur. 5.4) and Identification and Control of Residual Solvents (Ph. Eur. 2.4.24) have to be considered. For raw materials coming from an outside source, further tests (e.g. fumigant residues, radioactivity) may be required. Malta´s Medicines Authority believes that stability tests must include, as a minimum, assays for Tetrahydrocannabinol (THC), Cannabidiol (CBD), Loss on Drying (LOD), and Microbiology.

*Assay Limits
Cannabis flowers: The average total THC / CBD content must be 90.0 % - 110.0 % of the labelled content.
Cannabis oil or any other dosage form: The average total THC / CBD content must be 95.0 % - 105.0 % of the labelled content.

Security & Transportation (Appendix II)

The level of security during transportation is equivalent to that of the licensed premises. The following applies:

• Any outsourced activity must be audited.
• Agreed Standard Operating Procedures (SOPs) covering responsibility, record keeping, reconciliation, reporting and emergency procedures should be in place.
• Vehicles used for the transportation of cannabis should be tracked and have adequate locking systems and anti-theft systems.
• The vehicle should not contain any visible signs suggesting the presence of cannabis and the products should not be visible from outside the vehicle.
• Tamper-evident containers or packages should be used.
• The details of deliveries should be restricted to personnel that are required to know them.
• A QP is designated to verify and sign out the consignment for delivery.
• Any thefts and losses are to be reported immediately to the Police.

Cultivation, Harvesting & Packaging (Appendix III)

Appendix III relates to the growing, harvesting and primary processing of cannabis plants intended for the production of cannabis for medicinal and research purposes in Malta. Reference is made to Good Agricultural and Collection Practice (GACP) and to EU Good Manufacturing Practice (EU-GMP).

Detailed information is provided on the following:

• Facilities
• Personnel & Training
• Equipment
• Seeds and Propagation material
• Growing
• Harvesting
• Primary processing
• Packaging & Packing material
• Storage & Distribution
• Security
• Documentation

For more information please see Malta´s General Guidelines on the Production of cannabis for medicinal and research purposes.