In the second episode of our Digital Transformation in the Healthcare Industry series, the Healthcare and Life Sciences team at Baker McKenzie brings us up to date with the current laws and regulations relating to telemedicine and telepharmacy in Thailand and associated issues.
Under the current regulation, a Good Manufacturing Practice (GMP) certificate obtained from the Food and Drug Administration (FDA) is a voluntary requirement for local medical device manufacturers. However, manufacturers of licensed medical devices and detailed notification medical devices must provide GMP certificates from the FDA or an ISO 13485 certificate issued by one of the official Certified Bodies as part of the documents for the registration of medical devices. These certificates are not required to manufacture and notify low-risk medical devices unless they are exported and certain certificates are required by the destination countries.
Following the issuance of the notification from the Ministry of Public Health regarding determination of category V narcotics, B.E. 2565 (2022), the Thai Food and Drug Administration has recently provided guidelines.
The Thai Ministry of Public Health issued the ministerial regulation on the application for and the issuance of the license for the manufacturing, import, export, sale or possession of cannabis.
Healthtech gained tremendous attention during the past year or so as a result of the pandemic-driven lockdowns and restrictive circumstances. As we discussed in the past, government agencies around the world had invariably leveraged technology to support healthcare delivery and services over the years, and these efforts have accelerated in response to the pandemic. In the case of Thailand, based on its 10 year national health security plan, the Ministry of Public Health has progressed and implemented its policy by working with relevant government agencies such as the Food and Drug Administration, the Medical Council of Thailand, the Pharmacy Council and the National Broadcasting and Telecommunications Commission to develop and issue guidelines for telehealth services.
In a recent interview Mr. Anutin Charnvirakul, the Minister of Public Health, lauded the many community enterprises all over Thailand which have been growing cannabis for hospitals to extract for medical purposes and the hundreds of medical cannabis clinics all over the country which have proven to be very popular with the Thai people. The Minister was pleased with how Thai people have embraced cannabis and has again stressed his mission to make cannabis both a cash crop, as well as a medicine, for the nation. He also mentioned intended efforts to continue with liberalizing the laws and regulations on cannabis even further to increase access to cannabis.
In the current narcotics and psychotropic substances regulatory regime, there are numerous laws governing narcotics and psychotropic substances which are enforced by different regulatory bodies. The Thai government aims to modernize certain current provisions and to incorporate these laws into the Narcotics Code for ease of reference and consistency in law enforcement.
The Ministry of Public Health 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.
Join the regulatory affairs specialists in our Bangkok office’s Healthcare & Life Sciences Industry Group at this insightful webinar to get an overview of the key issues which you should consider when undertaking a regulatory compliance audit as applicable to pharmaceuticals, medical devices, foods and cosmetics (including considerations based on recent legal updates), as well as the steps that may be taken to ensure you stay compliant and avoid unnecessary pitfalls.
In our previous article in the healthcare transaction series, we highlighted the need to review a target’s supply chain as one of the key areas and issues that one should pay attention to when carrying out a due diligence investigation on a healthcare & life sciences (HLS) target. This exercise in revisiting one’s supply chain in light of the COVID-19 pandemic and emerging industry trends, including (among others) digital transformation, will ensure that the company’s supply chain is resilient, compliant, and ready to meet the challenges and opportunities in the HLS industry.