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Thailand: Updated list of formula of Thai traditional medicine containing cannabis and related requirements issued

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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.

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Peerapan Tungsuwan is a corporate and M&A partner in Bangkok office with specialties in highly regulated industries, including the healthcare industry. She is currently Chair of the AEC Healthcare Harmonization Sub-committee of Baker McKenzie's Asia Pacific Healthcare Industry Group, of which she was head from 2007-2013. Within the Bangkok office, she heads the Healthcare Industry and Natural Resources Groups and co-leads the Mergers & Acquisitions practice group and Japan Advisory Group.

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Panyavith assists major local and multinational clients in a range of heavily regulated industries, such as healthcare & life sciences, chemical and biotech, on large complex mergers and acquisitions, private equity transactions, joint ventures, corporate restructurings, post-acquisition integration projects, commercial agreements and regulatory issues. With his technical and commercial astute, Panyavith has often been involved in a number of pioneering projects, helping clients navigate the challenges of uncharted waters and emerging opportunities with innovative solutions. He is recently recognized as "Up and Coming for Corporate and M&A" in Thailand by Chambers Asia-Pacific 2023.

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Praween Chantanakomes is an associate at Baker & McKenzie’s Bangkok office. He was admitted in 2008. He is currently active in the Corporate & Commercial, Mergers & Acquisitions, Environment, Natural Resources, and Pharmaceuticals practice groups.

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Prim Uditananda is a Regulatory Affairs Manager in Baker McKenzie, Bangkok office.

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