In brief
The Ministry of Public Health (MOPH) has issued notifications to amend the list of formula of Thai traditional medicine containing cannabis under the Herbal Product Act which is allowed for use to treat a disease or for research, and to amend the information, warnings or precautions required to be displayed on the package inserts of Thai traditional medicine containing cannabis.
The key elements of these notifications are summarized below:
- Formula of Thai traditional medicine containing cannabis, which has been registered and approved by the Food and Drug Administration (FDA), will be allowed for use to treat a disease or for research.
- Formula of Thai traditional medicine containing cannabis, which has been approved by the FDA, is classified into three different groups: (i) formula of Thai traditional medicine containing cannabis as specified in the Thai traditional pharmacopoeia; (ii) formula of Thai traditional medicine containing cannabis which is allowed to be manufactured locally under the Special Access Scheme; and (iii) formula of Thai traditional medicine containing cannabis which a licensed Thai traditional medicine doctor, applied Thai traditional medicine doctor, or folk healer compounds based on clear knowledge on Thai traditional medicine (among other requirements).
- Manufacturers, importers or exporters of the Thai traditional medicine containing cannabis must provide labels on the medicine’s container/package as well as package inserts which must include the indications, dosage, warnings and precautions as specified in the notifications, and additional information on the medicine or the disease, as applicable.
For more information, please contact our team at Baker McKenzie.
