Import & Export from/to Thailand

Author: Tavatchai Boodin (Page 1 of 2)

Thailand – Recent TFDA updates

Due to the increased hygiene precautions from the COVID-19 pandemic, alcohol-based hand sanitizers and disposable medical face masks are facing severe shortages in Thailand. The Thai government has enacted several regulations to try to abate the shortage. The Ministry of Public Health (MOPH) has relaxed some regulations on the importation and production of these goods. In addition, the Department of Internal Trade of the Ministry of Commerce has acted to control the supply by setting up maximum allowable purchase price of domestic and imported face masks. Other regulations related to these products have been modified to counteract shortages—examples include reclassification of alcohol-based hand sanitizers, implementation of fast-track pathways for the domestic production of alcohol-based hand sanitizers, declaration of alcohol-based hand sanitizers and disposable medical masks as controlled goods, and so on. Regulations such as these will likely continue to change periodically, so healthcare entrepreneurs should check frequently that they are compliant with the latest updates.

Thailand’s Updated Regulations on Alcohol-Based Hand Sanitizers and Disposable Medical Masks

There have been three notable regulations pertaining to alcohol-based hand sanitizers. First, the MOPH has retracted its 2019 reclassification of alcohol-based hand sanitizers as medical devices (Medical Device Act B.E. 2251 (2008)), instead choosing to continue to categorize it as a cosmetics product (Cosmetics Act B.E. 2558 (2015)). The MOPH’s decision to cancel the reclassification serves to alleviate the shortage of alcohol-based hand sanitizers because the more stringent controls of medical devices would cause further delays in restocking. The second regulation enforces a minimum alcohol concentration of 65% w/w in alcohol-based hand sanitizers in order to gain registration as a controlled cosmetic. Finally, the Thai Food and Drug Administration (FDA) has also relaxed regulations to allow domestic pharmaceutical manufacturers, traditional drug manufacturers, and medical device manufacturers to produce and sell alcohol-based sanitizer without first obtaining a cosmetics manufacturing license.

The shortage of disposable face masks is much more acute than sanitizers. Hospitals have run out due to high public demand, low production scale, and consumer hoarding. People have taken advantage of the opportunities to gain additional income by making and selling masks as an alternative to commercial grade face masks. However, these homemade, reusable masks are not classified as medical devices and therefore, cannot be advertised as personal protective equipment against COVID-19. Only disposable medical masks, which are classified as low-risk medical devices, are regulated. Imported masks require product registration with the Thai FDA. Because of the pandemic, the Medical Device Control Division has agreed to facilitate all registration of disposable medical masks.

Price Controls

As both alcohol-based sanitizer and disposable medical masks are currently in high demand, the Thai Central Committee on Prices of Goods and Services (CCP) has published price controls for these goods. The manufacturer, importer, and distributor of alcohol-based hand sanitizer are required to give the CCP their pricing details and may not increase the price without CCP’s permission. For domestically manufactured disposable medical masks, the retail price must not exceed THB 2.50 (approx. USD 0.08) per mask. Currently, the price of imported masks has not been fixed, and the CCP only requires that the importer, distributor, and retailer must not mark up the price more than 10%, 10%, or 23%, respectively. Because only domestic masks are regulated with a fixed price (and because some traders do not obey the law in such a high demand market), the price of masks in the Thai market continues to rise.

Cannabis

On February 19, 2019, by amending its 1979 Narcotics Act, Thailand became the first Asia-Pacific country to legalize medicinal cannabis. While hemp had been approved for use in industry since 2018, the amendment of the Narcotics Act providing for a Thai FDA registration pathway for medicinal cannabis, was largely unexpected.

While the amendments create the foundation for a cannabis industry in Thailand, the true viability and future of the Thai cannabis industry lies in its regulation by both the Thai FDA and the Narcotics Control Board. With the return of an elected government, a new cabinet was sworn in on July 16, 2019, with the Bhumjaithai Party appointed to oversee the Ministry of Public Health (MoPH). The Bhumjaithai Party campaigned on further expansion of liberal cannabis policies, which was well received by the public. With the minister in charge of instituting regulations that further define the scope and use of cannabis for medical purposes, we can only expect further liberalization and clarification.

Some recent clarification was seen by way of helpful MoPH notifications that identified forms of medical cannabis allowed for approved use. These include (i) registered drugs per the Drug Act; (ii) Thai traditional medicines having approved compositions (now 16 formulas); and (iii) drugs approved for Thailand’s Special Access Scheme. Also further clarified were the specific qualifications of Thai traditional practitioners having authority to prescribe traditional cannabis medicines.

Most recently, two additional notifications from the Narcotics Control Board were enacted concerning the labels of medical cannabis products, and the forms for recording inventory movements of medical cannabis.

The exact Thai FDA medical cannabis licensing pathway is to be set out in Implementing Regulations that have been circulated widely for both official and public comment. These are expected to be approved by the MoPH very soon. As the regulations look to move things forward—and the government wants exactly that—no significant change in the regulations is expected before they become law.

As the Narcotics Act and draft Implementing Regulations currently stand, a complex network of who can be licensed for what purposes seeks to ensure control over the process for the beginning stages. There are currently four types of licenses: (1) production, (2) importation/exportation, (3) sale, and (4) possession. There are currently seven entities under both the Narcotics Act and the draft Implementing Regulations who can apply for medical cannabis licenses: (1) public entities, (2) healthcare professionals, (3) private universities, (4) collective farmers, (5) international transportation agencies, (6) traveling patients, and (7) groups to be permitted by further decisions of the MoPH. A further seven entities are set out in the draft Implementing Regulations.

The draft Implementing Regulations also address which parties can engage in which activities. Certain licensed activities are available to some entities, but not to others. For example, a healthcare professional is ineligible for a license to possess cannabis for the purpose of addiction treatment, but can be licensed to possess cannabis for R&D purposes. Further clarification will come with promulgation of the draft, Implementing Regulations. The listing of successful Thai FDA license applicants on the Thai FDA website (as is the case with other Thai FDA regulated products such as human and animal pharmaceuticals, medical devices, food, cosmetics, and hazardous substances) will also provide more clarity.

Foreign participation in Thailand’s cannabis industry is severely restricted for the first five years, starting from February 19, 2019. During this period, only state agencies may obtain a license to produce, import or export cannabis. However, a private entity, with an office in Thailand and at least two-thirds of directors, partners, or shareholders having Thai nationality, may act jointly with a state agency to acquire or share these types of commercialization licenses. In this way, certain companies can be involved in the Thai cannabis industry from its inception. There are no restrictions requiring joint participation in R&D efforts (i.e., non-commercialization).

Fortunately, the Narcotics Act’s aforementioned allowance of new categories of entities (category 7 above) to acquire licenses as the MoPH sees fit is open-ended and, with a party that fought for liberal cannabis policies at the reins, promising. With a population currently in need of medicinal cannabis, the facilities established by the government might not be able to supply enough medical grade cannabis for the current need or to supply it quickly enough. This need for assistance may open the door for foreign entities to enter the market and provide access to enough medicinal cannabis to meet demand.

The current state of regulation provides three basic approaches for any foreign entity looking to enter the Thai cannabis industry. For most of the approaches, extensive work with government regulatory agencies and coordinating joint operations with state agencies will be needed.

The first approach is to import materials into Thailand. Getting the materials into Thailand, whether for distribution or for research & development, will be necessary in the near future as there are no materials to source within Thailand at the moment. This could mean as little as importing finished products ready for distribution, or as much as importing seeds, plants, supplies, personnel, facilities, or other necessities for production or research.

The second approach is to establish domestic manufacturing facilities for the production of cannabis and cannabinoid products. Establishing domestic production in Thailand would be beneficial for several reasons. First, Thailand has a long history of agricultural knowledge in cannabis production, and great facilities for R&D exist through research institutes such as universities and pharmaceutical companies. Second, Thai production comes at a low cost and is associated with a record of safe manufacturing practices for ingestible products. This can be done either by sourcing materials and personnel from within Thailand or by using what was imported in the first approach.

The third approach is to use Thailand as a headquarters for expansion into other Asia-Pacific regions, such as Laos, the next prospective country to follow Thailand’s lead in legalizing medicinal cannabis, or China. Depending on the business model, this could include using production facilities in Thailand to export products throughout Asia-Pacific, establishing networks in the region, or acting as an intermediary between producers and consumers.

Ban on trans fats comes into force on January 9, 2019


A vendor removes a (legal) deep-fried chicken from his wok. The ban on ‘partially hydrogenated oils’ has taken effect smoothly, with praise from all parties. (Photo by Pornprom Satrabhaya, Bangkok Post)

Thailand’s ban on artificial trans fats came into effect January 9, 2019, making the country the first in Asean to ban the production, import and sale of partially hydrogenated oils, as well as any food that contains them, said the Public Health Ministry.

Derived from plants through the process of hydrogenation, trans fats have been widely used since the 1950s to fry fast foods. Trans fats are also found in margarine and snacks.

Artificial trans fats have been implicated in health problems, such as heart attacks and other cardiovascular conditions.

“The ban [on artificial trans fats] is aimed primarily at reducing the risk of them causing heart disease and other conditions through food consumption,” he said.

The move has garnered praise from World Health Organisation, according to Dr Piyasakol Sakolsatayadorn, Minister of Public Health.

“The WHO praised the government’s political will, as well as the inclusive process that it applied to prepare for the ban,” he said.

“Instead of telling stakeholders what to do, the ministry listened to to all stakeholders and gave them the opportunity to prepare for the transition.”

Dr Piyasakol said the WHO also praised the ministry for launching an effective public campaign to urge the private sector to take part in the government’s bid to ban trans fats, and communicate its importance…

The Public Health Ministry on July 13 published an announcement of the ban in the Royal Gazette. The ban came into effect 180 days from the publication date, which was Wednesday.

Over the past three months, the Food and Drug Administration (FDA) has been working with education institutions and the food industry to help ensure a smooth transition, he said.

Food and beverage produces have already recalled products containing trans fats before the ban took effect, said Dr Tharet Karatnaiyarawiwong, secretary-general of the FDA.

As of Wednesday, food importers are required to issue a certificate assuring that their products are free of the prohibited trans fats, he said.

Source: Bangkok Post – https://www.bangkokpost.com/news/general/1608342/ban-on-trans-fats-comes-into-force

Thailand Import 2006 – 2015

Imports in Thailand were recorded at 16870 USD Million in November of 2015, down 9.53 percent year-on-year. Imports in Thailand averaged 9569.09 USD Million from 1991 until 2015, reaching an all time high of 24937.81 USD Million in March of 2012 and a record low of 2760 USD Million in February of 1992. Imports in Thailand is reported by the Ministry of Commerce, Thailand.

Thailand Imports

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