Cannabis for Medical Use in Malta
Industry success is critically dependent on compliance with medical cannabis production regulations, pharmaceutical law expertise, and experienced risk assessment and management.
Dr Zammit is a pioneer in medical cannabis legislative drafting–acting as one of the first attorneys to provide legal advice, regulatory compliance, and assessment consulting to cannabis producers for medicinal and research use in Europe, enhancing the industry’s international strategic growth and market access. Malta introduced European Union Good Manufacturing Practice (EUGMP) requirements and regulated pharmaceutical formulations of cannabis for medicinal use by patients.
The firm was instrumental in the development and launching of the medical cannabis industry in Malta. Following the enactment of the Production of Cannabis for Medicinal and Research Purposes Act (Chapter 578 of the Laws of Malta), the firm was engaged by the Malta Medicines Authority (Malta’s national competent authority responsible for the regulation of medicinal products and the pharmaceutical industry) to draft the the General Guidelines on the Production of Cannabis for Medicinal and Research Purposes; the Production for Cannabis for Medicinal and Research Purposes (Fees) Regulations 2018; the Application for a Licence in accordance with the Production of Cannabis for Medicinal and Research Purposes Act and the respective memos addressed to the Cabinet of Malta, the collective decision-making body of the Government of Malta.
As the only firm dedicated exclusively to healthcare, pharmaceutical, and life sciences regulatory law, we have the capability to provide our clients with the knowledge and expertise required to understand the regulatory complexity surrounding this unique industry. We have a deep knowledge of the market by working closely with licensed producers and service providers, and advise on the legal and licensing requirements, import and export, strategic alliances, transport and logistics, insurance, security, and risk management required to assist our clients to achieve regulatory compliance.
Dr Anthia A Zammit counsels private and publicly-listed companies on legal and contractual matters including:
- Regulatory compliance;
- International investment and M&A;
- Strategic alliances and joint ventures;
- Due diligence and KYC;
- Employment law and agreements;
- Real estate and turnkey agreements;
- Commercial lease agreements;
- Laboratory set-up and service agreements;
- Management agreements;
- Memorandum and articles of association;
- Shareholder agreements;
- Letters of Intent and agreements between suppliers and buyers;
- Malta Medicines Authority EUGMP license applications;
- Business plans;
- Malta Enterprise letter of intent;
- Malta Enterprise investment cost application;
- Malta Enterprise industrial space application;
- Import and export;
- Marketing and advertising.
Counseled one of the world’s top three indoor cultivators of cannabis for medicinal and research use, a multinational publicly-listed company, on the regulatory EUGMP certification requirements for the import, export, processing, packaging, labeling, batch release, extraction, and distribution of finished dried cannabis flower and finished cannabis oil for medicinal and research use from a non-EU country to a EUGDP licensed facility in the European Union.