The applicant must insert the addresses of the sites from where they plan to operate.

The applicant shall provide the following documentation:

• Relating to the CHRA:
  • A copy of the statute of the CHRA in draft format.
  • Logo.
  • Membership policy including conditions for membership and rules regulating members.
  • An organizational structure including letters of commitment of key function holders.
  • Personal Declaration Form and Source of Wealth for each of the founders, key officer, administrators and/or grantors.
  • Fit and Proper Enquiry – Special Authorization Form for each of the founders, key officer, administrators and/or grantors.
  • Code of Conduct of the CHRA.
• Relating to sites used for operations:
  • A declaration by an architect confirming that each property is covered by all necessary permits and is compliant with the legislation and the binding instruments, accompanied with signed site plans and internal layout plan.
  • Detailed floor plans showing the location of each cannabis plant and each item of equipment. Applicants may initially submit a typical layout for the type and size of the property they intend to find and replace it with a plan of the actual layout when the sites have been found and selected.
• Relating to the operations:
  • Details of the cultivation process.
  • Source of seeds and details about the species and strains that will be used.
  • Numbers of plants that will be cultivated, broken down by strain, and the expected yield from each plant.
  • Declaration that chemical pesticides shall not be used.
  • Details about nutrients, organic pesticides and other natural methods that will be used to cure cannabis plants.
  • Hygiene and sanitation policies.
  • Record-keeping procedure.
  • Product recall procedure.
  • Environmental plan.
  • Pest Control management plan.
  • Operations recovery plan.
  • Transportation policies and procedures.
• Relating to the distribution:
  • Technical specifications and images of the packaging that will be used.
  • Harm Reduction initiatives.
  • Product display policies.
• Relating to human resources:
  • Roles needed and whether any roles will be outsourced.
  • Recruitment policies and procedures.
• Relating to the financial plan:
  • Detailed three-year financial forecasts, including income and expenditure, balance sheet and cash flow statements.
  • Details of workings and key assumptions relevant to the projected financial forecasts.

To trade in cannabis-based products for medicinal use, a wholesale dealer’s license under the Medicines Act and a Notification of Approval are required. The Notification of Approval is a product-specific notification issued by the Superintendent of Public Health, certifying the authorization for licensed wholesale distributors to source finished EU-batch released cannabis-based medicinal products and place them on the market in Malta. Licensees are also required to comply with the relevant sections of the European Union Good Distribution Practice (EU-GDP) Guidelines published by the European Commission.

Information that must be submitted with the application for a wholesale dealer’s license is not limited to:

• Applicant’s name and address.
• Address of the premises that will be used for the purpose of wholesale distribution.
• Equipment and control facilities.
• Proof that the premises are suitable and adequate to ensure proper conservation and distribution of medicinal products.
• Name of at least one responsible or qualified person who will be professionally responsible for the activity.

Before the license is issued, the premises will be inspected by the Superintendent of Public Health.

The Medicines Authority shall establish the period for which the license is valid.

Information that must be submitted with the application for wholesale distributors to place cannabis-based products or synthetic cannabinoid products on the market is not limited to:

• Product details, including:
  • The product’s name.
  • Strain name.
  • Form.
  • Strength of active substances.
  • Mode of use.
  • Active substances and amount of active substances per unit dose.
  • Name of the excipients and quantity per unit dose.
  • Packaging information.
• Applicant company name, address, telephone, contact person and email.
• Name, address, telephone and email of the designated person for safety monitoring and the designated person for quality monitoring.
• Details of the Member State from which the product is being sourced.
• Details of the product manufacturer, wholesale dealer/exporter in the source country and the EU batch release site, if imported from outside the EU.
• Proposed retail price.