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Since the June 9, 2022, delisting of all parts of the cannabis plant according to the Narcotics Code, there has been an explosion of cannabis dispensaries operating in Thailand. The Department of Thai Traditional and Alternative Medicine (DTTAM) has issued more than 12,000 cannabis dispensary licenses to businesses in Thailand. A license allows a dispensary to sell cannabis flowers legally. In addition, the DTTAM requests the cooperation of dispensaries in submitting monthly reports about the sourcing, selling, and inventory of cannabis flowers. The DTTAM may suspend the selling license of dispensaries that fail to submit these reports.

Apart from the enforcement duties and administrative acts of the DTTAM, the enactment of the laws and regulations pertaining to cannabis seemed to be drastically winding down. One of the reasons was that Thailand had delays in the process of forming a new government following the general election of May 14, 2023. These delays dampened Thailand’s thriving cannabis industry.

In particular, the industry has concerns about the uncertainty of the nascent cannabis law. On August 11, 2023, the Narcotics Control Division of the Thai Food and Drug Administration (FDA) posted the Draft Regulation Re: Application for Approval and Approval for Manufacture, Importation, Exportation, Distribution or Possession of Narcotics under Category 5 (Extracts from Cannabis or Hemp Plants Only). This may be the first regulation that the newly formed government implements with regard to cannabis extracts. Unlike the DTTAM’s enforcement activities, the Thai FDA requests that a domestic manufacturer, importer, exporter, or seller of cannabis extracts apply for a license. The Thai FDA, as the authority, will consider granting a license only in the following cases:

  1. For medical benefits;
  2. For commercial or industrial benefits;
  3. For the benefit of medical or scientific analysis or research; and
  4. For use by the government for preventing and suppressing narcotics-related offenses.

Nonetheless, there is currently a restriction period of five years in place, limiting the importation of cannabis extract to cases 3 and 4 in the above list.

There are also some notable limitations for a legal entity applying for a license:

  • The entity must obtain corporate registration under Thai law;
  • The authorized signatories binding the legal entity (authorized directors) must have Thai nationality with an age of at least 20 years old;
  • If the entity is a limited company, it must have Thai shareholders holding at least 51% of the total number of shares; for legal entities in other categories at least two-thirds of the partners must be Thai nationals; and
  • The entity must have a physical office located in Thailand.

These limitations are likely to impact cannabis business operators engaging in the extraction of cannabis and the preparation of CBD/THC for both domestic and exportation purposes. If the regulation is implemented as written, business operators should review the structure of their legal entities carefully.

WRITTEN BY

Tilleke & Gibbins
For further information, please contact:

Atthachai Homhuan – Director, Regulatory Affairs, Tilleke & Gibbins
atthachai.h@tilleke.com

Dr. Atthachai Homhuan is the director of the regulatory affairs department at Tilleke & Gibbins. Atthachai assists chemical, life sciences, pharmaceutical, and biotechnology companies with regard to the preparation and submission of the healthcare product dossiers for registration, including biological products and vaccines, biosimilar products, new chemical entities, medical devices, food and herbal products, cannabis and hemp, cosmetics, and household chemicals. He assists international companies in developing market entry strategies for countries in Southeast Asia. His broad experience allows him to evaluate the feasibility of product registrations, conduct pharmaceutical and medical device plant audits/due diligence, and coordinate pre-clinical and clinical trials in accordance with international guidelines and standards. Atthachai also reviews healthcare product labeling/claims/advertisements for food products, cosmetics, medical devices, cannabis and hemp, and drug products in Thailand and other Southeast Asian countries.

In addition, he also assists the life sciences industry to draft and review their patent claims and specifications. He advises patent agents on amending claims and providing responses to office actions. Atthachai frequently drafts counterstatements against opposing parties in trademark and patent applications. His practice also includes advising on pre-litigation and litigation matters involving the life sciences, medical devices, and pharmaceuticals. He has presented before the IP&IT Court as a witness in chemistry and life sciences patent litigation.

Prior to joining the firm, Atthachai was a postdoctoral researcher in Japan and Taiwan, focusing on stem cell therapies and vaccine development. He applied his technical expertise to the industry when he became a project manager for a Thai vaccine manufacturing company, where he led the firm’s R&D efforts. His industry background also includes serving as a formulation manager at the subsidiary of a well-known American pharmaceutical innovator, where he was the group leader in charge of the company’s R&D and production functions.

Atthachai holds a PhD in Pharmaceutical Technology from Thailand’s Mahidol University, and he frequently lectures on pharmaceutical and chemical patents at universities across Thailand. He has completed the FICPI South East Asian Drafting Training Course, enabling him to prepare patent applications and claims.

EXPERIENCE

  • Assisted pharmaceutical companies in drafting sale and purchasing agreements and held discussions with the Ministry of Public Health with regard to the purchasing agreements of COVID-19 drug products.
  • Advised pharmaceutical companies about the Thailand Emergency Use Authorization (EUA) approval requirements of COVID-19 drug products and vaccines.
  • Revised guidelines for Thai patent officers examining chemical and pharmaceutical patents.
  • Implemented a quality-control system and addressed GMP-related topics for the manufacturing of vaccines. This involved working closely with the Department of Medical Sciences of the Thai FDA with regard to biohazard manufacturing and audits, in order to obtain approval.
  • Worked with companies in the agricultural and chemicals industries with regard to complaints on substandard products raised by the Ministry of Agriculture.
  • Reviewed clinical trial agreements and bioequivalence studies for new drugs and conventional products, and ensured that the trials/studies and protocols were in accordance with Good Regulatory Practices and Good Clinical Practices.
  • Assisted life sciences and chemical companies to draft a variety of complex patents involving the manufacturing process for creating polymers from waste gas and patents related to biological vaccines, among others.
  • Audited leading pharmaceutical companies to ensure that their product registration dossiers and advertising campaigns comply with Thai legislation.
  • Registered new biological product dossiers at the Thai FDA and received approvals within 1.5 years—a relatively short period of time to obtain approval for a new drug in Thailand.
  • Registered medical devices, food products, and cosmetics with the Thai FDA for domestic and international companies.
  • Worked with the firm’s litigation team and won a disputed patent litigation case for a chemical glass company, in which the opposing party claimed damages exceeding THB 50 million.

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