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As we approach the end of 2021, a year in which we saw many notable legal developments in the area of cannabis and hemp, the Thai Ministry of Public Health (MOPH) issued the ministerial regulation on the application for and the issuance of the license for the manufacturing, import, export, sale or possession of cannabis (“Ministerial Regulation“). The Ministerial Regulation sets out the implementing framework in relation to the application for licenses required for the manufacturing, import, export, sale and possession of cannabis for medical and research purposes.

The Ministerial Regulation makes clear that holders of a modern drug manufacturing license (among others, if the requirements are met) can apply for a license to manufacture cannabis (that is not growing) and import or export cannabis for medical use. Hospital operators and holders of a modern drug selling license (among others, if the requirements are met) can also apply for a license to sell cannabis for medical use.

Alongside the Ministerial Regulation, the Thai Food and Drug Administration (FDA) also issued guidelines and implementing regulations for the key activities in the cannabis supply chain. These include guidelines and implementing regulations for: the operation of cannabis manufacturing facilities; transportation of cannabis parts; labelling of cannabis parts/extracts; and the manufacturing, dispensing and sale of drugs containing cannabis under the Special Access Scheme.

For more information, please contact our Healthcare & Life Sciences Industry Group and Regulatory Affairs Services Department at Baker McKenzie.

How we can help

Our Healthcare & Life Sciences team in Bangkok comprises over 25 healthcare lawyers and practitioners, including a unique Regulatory Affairs Services Department consisting of five professionals trained in food science, pharmaceutical science, and medical science. This gives us a thorough appreciation of the scientific issues being faced by our clients, as well as complex pricing and reimbursement challenges, compliance pressures, and marketing concerns related to ever changing regulatory regimes. Our knowledge of the industry, combined with our awareness of local legal requirements around the globe, ensures that we can provide you with industry-tailored advice.

Baker McKenzie’s Regulatory Affairs Services Department (RASD) advises clients on how to satisfy regulatory obligations with respect to the launch of products into the Thai market. This initiative was designed to position clients at a comparative strategic advantage and enhance their opportunities for success in Thailand’s growing food, biotech, pharmaceutical and healthcare sectors.

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Author

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.

Author

Panyavith assists major local and multinational clients in a range of heavily regulated industries, such as healthcare & life sciences and petrochemical, on large complex mergers and acquisitions, private equity transactions, joint ventures, corporate restructurings, and post-acquisition integration projects. 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.

Author

Parisa Nontasirichayakul is an Associate in Baker McKenzie Bangkok office.

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