3 June, 2019
Following our client alert in April 2019 regarding the developments on legalization of cannabis for medical purposes, on 28 May 2019 the Cabinet approved the draft Ministerial Regulation regarding Approval for the Manufacture, Import, Export, Sale, or Possession of Cannabis proposed by the Ministry of Public Health ("MOPH"). Some of the key elements of the draft are outlined below:
- Definitions of the terms "Cannabis"; "Licensee"; and "Government agencies".
- Categorization of seven types of objectives under the manufacture, import, or export of cannabis as follows:
- (i) administration of cannabis for medical use domestically;
- (ii) education, analysis and research for medical, scientific, or pharmacological purposes;
- (iii) for governmental benefit in preventing and suppressing the commission of offenses and for international cooperation
- (iv) manufacture for export and export of cannabis;
- (v) manufacture for specific-patient use by the Thai traditional medical profession;
- (vi) necessary treatment for specific patients;
- (vii) for patients traveling across borders who bring cannabis into or out of the country for personal treatment within 90 days.
- Specification of qualifications of applicants to manufacture, import, export, sell or possess cannabis.
- Requirements for the planting of cannabis to be done only in the areas prescribed in the license; for the use of seeds, tissues and other methods to be in line with the approvals obtained; and for the planting areas to be clearly defined.
- Requirement for the licensee to conduct random tests to verify the concentration of key ingredients, e.g. Cannabidiol (CBD) or Tetrahydrocannabinol (THC), and the presence of contaminants or heavy metals in accordance with the standards prescribed. Records must be kept at the premises for at least three years.
- Requirement for a licensee to manufacture or import a drug that contains cannabis as an ingredient to apply for a product registration license prior to the manufacture or import.
The draft ministerial regulation will be submitted to the Office of the Council of State for review before being published by the MOPH.
We will monitor and keep you informed of further developments.
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