Malta Medical Cannabis Licensing Requirements

Updated: July 30, 2020 | 3 minute read

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 Introduction

The Maltese government legalised the production of cannabis for medical purposes in 2018. Subject to satisfying a number of applicable criteria, and the acquisition of a license, the production of cannabis for medical purposes was possible.

Malta Medical Cannabis Industry

All persons must first obtain a letter of intent from the Malta Enterprise, informing them with the intention to set up operations in Malta for the purpose of undertaking an activity in relation to medicinal cannabis. 

The letter of intent may be obtained by making an application with the Malta Enterprise and would constitute a preliminary approval. 

Any activity that is related or ancillary to cannabis for medicinal and research purposes requires a license under the production of Cannabis for Medicinal and Research Purposes Act. 

The activities which need a license with the regulatory authority (Malta Medicines Authority), are as follows:

  • Cultivation; 

  • Importation;

  • Processing;

  • Production of products intended for medicinal/research purposes deriving from the cannabis;

  • Trade-in cannabis; and

  • Preparations intended for medicinal/research purposes deriving from cannabis.

All necessary approvals, authorisations and permits must be obtained before participating in any of the activities mentioned above. 

Any person, whether licensed or not, seeking to carry out activities ancillary to produce cannabis for medicinal and research purposes, are also required to comply with all regulations and maintain obligations arising from the treaties. 

It is also highly important that any person participating in the production of cannabis for medicinal and research purposes comply with all regulations pertaining to the production and quality standards of the products, according to the Medicines Act.

List of Documents Required for the Production of Cannabis in Malta

In order to obtain a license to operate in the industry, the applicant must submit all the necessary documents in accordance with the Production of Cannabis for Medicinal and Research Purposes Act. The document list is mentioned below:

 

1. Manufacture

  • Manufacturing process;

  • Source(s) of raw materials to be used in manufacture;

  • Copy of EU-GMP certificate for the source(s), as applicable;

  • Copy of EU-GMP certificate for the contractor(s), as applicable; and

  • Research proposal, if applicable.

2. Manufacturing Facility

  • Site Master File in line with EU-GMP guidelines requirements;

  • ERA Permits for unlicensed sites listed on the application;

  • Building site plans;

  • Location survey;

  • Name and contact information of the project’s supervisor (if the building is under construction);

  • Security and Access details;

  • Architect’s report;

  • Floor plan of the site and building;

  • Environmental, waste management and sanitation plan;

  • Proposed work schedule of employees; and

  • Disposal and destruction method(s).

3. Company/Personnel

  • Curriculum vitae of Production Manager;

  • Curriculum vitae of Quality Control Manager;

  • Curriculum vitae of Qualified Person;

  • Copy of Pharmacy Council QP certificate and copy of Pharmacy Council Pharmacist warrant;

  • Qualified Person(s);

  • Organisation chart;

  • Certificate of Registration issued by MFSA (for private & public companies);

  • Memorandum and articles of association;

  • Malta Enterprise Letter of Intent;

  • Notarised identity card/passport copies and due diligence report(s); and

  • Power of attorney to sign on behalf of the licence holder (if applicable).

The Applicant must also have attained all the other documents or authorisations ancillary to the production of medical cannabis and as may be prescribed under the Act before applying for the license.

Conclusion

Thus, as can be seen through this article, the licensing requirements remain applicable throughout the whole process of the production and processing cannabis for medicinal purposes. This results in added protection and oversight of the industry, which will, in turn, also protect against abuse.

Reach out to us to know more about our services by contacting Luke Cann, luke.cann@nexiabt.com.

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