The License Application Procedure for Medical Cannabis Producers

03 January 2019

In 2018, the Maltese government legalised the production of cannabis for medical purposes, subject to acquisition of a license and satisfying a number of applicable criteria. The Bill entitled “The Production of Cannabis for Medicinal Use Act, 2018” stipulates all general provisions and the process by which those that want to grow cannabis for medial use must follow in order to acquire a license.

In order to partake in any stage of the medical cannabis cultivation, processing, or distribution process, the following steps must be followed and satisfied.

  • The individual or entity must comply with every part of the Act as well as all regulations, and international obligations resulting from a treaty which Malta may from time to time be a party, as may be applicable. They must also comply with all regulations relating to the production and quality standards of products for medicinal use as applicable under the Medicines Act and any other relevant regulations.
  • A letter of intent must be issued by Malta Enterprise, accompanied by an application on the prescribed form. Malta Enterprise shall then ensure that the proposed activity is solely an activity for the production process.
  • They must them obtain a license from the regulatory authority that pertains specifically to the work that the entity intends to carry out.

 

The Letter of Intent

The issuing of a license from the authority will be dependent on the following:

  • The applicant’s submission of all required documents, due diligence documentation, and other prescribed information that may be deemed necessary in order to ensure fulfilment of the license requirements.
  • The attainment by the applicant of all the necessary authorisations, approvals, permits, and clearances from other entities as may be applicable under the Act and any other relevant legislation at the time of application.
  • Compliance by the applicant with any relevant terms and conditions, including being in possession of the relevant qualifications in line with the Mutual Recognition Qualifications Act.
  • Compliance with any other additional request from the Authority or Malta Enterprise in order to review and evaluate the application to a satisfactory standard.

The holding of a license, permit, or authorisation does not prevent the Commissioner of Police from taking any action that they deem reasonably necessary if they have evidence of, or suspect that any crime is taking place on the authorised premises. The Authority also reserves the right to halt any activity being carried out under the Act by withdrawing, revoking, cancelling, or noting the expiry of either the license, letter of intent or both.

 

Licensing Appeals

In cases where a license is withdrawn, cancelled, or not accepted, applicants have the means to appeal the decision with the Licensing Appeals Board that includes a Chairperson and three other members, one of which is required to be a practising and qualified scientist with a minimum of seven years’ experience.

Grounds for appeal include a factual error, a material procedural error, an error of law, or some material illegality including unreasonableness or lack of proportionality.

In order to apply for a license under the provisions of this Act, it is advisable to engage the help of professionals to ensure that all of your docuemetation is in order before the application is submitted. BDO Malta can offer you their comprehensive knowledge and experience in the local regulatory environment, and can guide you through every step of the process, including Appeals, should your application be refused.