The Life Sciences Law Review: Thailand
The Food and Drug Administration (FDA), established by the Ministry of Public Health (MOPH), is the government administrative and regulatory body governing consumable products in Thailand. Consumable products include foods, drugs, psychotropic substances, narcotics, medical devices, volatile substances, cosmetics and hazardous substances available in the country.2 To ensure the safety, quality and efficacy of consumable products, the FDA controls, regulates and administers the manufacture, distribution, advertisement and other matters in relation to the consumable products through six main divisions: the Bureau of Foods, the Bureau of Drug Control, the Bureau of Import and Export Inspection, the Medical Device Control Division, the Cosmetic and Hazardous Substance Control Division and the Narcotics Control Division.3
The FDA's five main roles and responsibilities are pre-marketing control, post-marketing control, development of a surveillance programme for consumers' safety, consumer education and provision of technical support and cooperation with other agencies.
By law, certain important issues are decided by committees, whose members – all experts in their respective fields – are appointed by the Minister of Public Health. Currently, there are eight committees, for: foods, drugs, psychotropic substances, narcotics, medical devices, cosmetics, hazardous substances and prevention against abuse of volatile substances. In addition, to support the development of drugs, foods and chemical substances, the Cabinet has appointed three additional committees, which are the National Drug Committee, the National Food Committee and the National Chemical Safety Committee.4
The regulatory regime
The consumable products under the responsibility of the FDA are each governed by six specific Acts: (1) the Drug Act BE 2510 (1967); (2) the Food Act BE 2522 (1979); (3) the Act on Promulgating the Narcotics Code BE 2564 (2021) (the Narcotic Code); (4) the Hazardous Substance Act BE 2535 (1992); (5) the Medical Device Act BE 2551 (2008); and (6) the Cosmetic Act BE 2558 (2015) issued specifically for the enforcement, supervision and control over the use, manufacture, distribution, import, export, advertisement, suspension or revocation of required licence, imposition of penalties in case of violation of the act, and determination of governmental fees of the consumable products under the responsibility of the FDA. Each specific Act provides a definition and classification (if any) in its introductory section.
The decisions on classification and categorisation of consumable products into different types or subcategories are undertaken by each responsible bureau or department under the control of the FDA.5 For instance, the classification and categorisation of drugs is undertaken by authorised officers of the Bureau of Drug Control. If a product is considered as a 'drug' under the definition set forth under the Drug Act, it is then further sub-classified into different categories of drugs (e.g., modern drug or traditional drug).
ii Non-clinical studies
Studies of animals are governed by the Animals for Scientific Purposes Act BE 2558 (2015). The implementation and enforcement of this Act is carried out by the Supervisory and Promotional Committee on the Use of Animals for Scientific Purposes. This Act aims to raise awareness about the ethics of, and impose certain ethical standards on, animal testing, as well as to ensure that the testing will be carried out under proper standards, implementation and monitoring.
The Supervisory and Promotional Committee on the Use of Animals for Scientific Purposes issued a notification determining ethics for the use of animals for scientific purposes. The ethics set forth under this notification clearly promote the value of life of animals, and clearly specify that the use of animals for scientific purposes can be undertaken only when the users have thoroughly considered that the experiment in question shall be for the maximum benefits in respect of the development for mankind, academic progress, or both. After the end of a scientific experiment, the animal subjects shall be put to death in a peaceful manner to ensure animal welfare and humane treatment.6
iii Clinical trials
Currently, there is no regulation outlining guidelines for conducting clinical trials. However, according to Section 9 of the National Health Act BE 2550 (2007), if a public health professional practitioner demands to use a service receiver as a subject of an experiment in their research, the written consent of the service receiver shall be granted in advance, and such consent can be revoked by the service receiver at any time.
In addition to the National Health Act, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and Good Clinical Practice (ICH/GCP) which was translated by the FDA in 2000, is used as guidance for conducting clinical trials in Thailand. Although this guidance does not have legal enforceability in Thailand, the criteria for the independent ethics committee or institutional review board for considering clinical trials relating to drugs shall be in line with such guidance.7
On a related matter, recently, the Human Research Ethics Committee has been appointed for considering of clinical research ethic concerning narcotics of Category V with respect to hemp when any applicants wish to apply for a licence to produce, import, export, distribute or possess hemp for the purposes of study, test, research or breeding under the Notification of the Food and Drug Administration Re: List of Names of Human Research Ethics Committees That Consider Clinical Research Projects Concerning Narcotics of Category V with Respect to Hemp BE 2564 (2021).
iv Named-patient and compassionate use procedures
There are no regulations permitting the distribution of medicines or medical devices without prior issuance of a marketing authorisation or other permission for commercial distribution. Thailand does not have exceptions for the registration of named-patient and compassionate use.
v Pre-market clearance
Under the Drug Act, pre-market clearance covers three main steps: licensing, registration and advertising control.
The Drug Act requires that a person who wishes to sell, produce or import drugs into Thailand obtain a licence from the FDA. The government fee for each licence varies depending on the type of licence and product from between 2,500 and 100,000 baht.8 The approval process will take approximately 30 days depending on type of licence and product.
In addition, a person who wishes to produce or import drugs into Thailand shall also register the drug formulas with the competent official before producing or importing those drugs into Thailand.9 The registration procedure for a drug formula is to ensure efficacy, safety and quality of drugs sold in Thailand. Upon receipt of a drug registration certificate, the drug can be lawfully manufactured or imported. Note that the application shall be submitted to the FDA upon making a reservation for the submission via the FDA's website, phone contact or walk-in contact. The evidence, fee and timeline for the registration of a drug formula varies depending on the types of drugs. For instance, the registration of a drug formula for a new drug will require more evidence and longer time for consideration, compared to the registration of a generic or a new generic drug. The submission of the application and supporting evidence can be made via physical delivery or online. However, the registration of new drug formulas (i.e., pharmacopoeia with new chemical entities) shall be submitted using the eCTD (electronic Common Technical Dossier) only.10 The administrative and product information as well as the documents specifying the quality of the drugs shall be in compliance with the guidelines set forth by the FDA, which follows the rules of the Association of Southeast Asian Nations (ASEAN) Harmonisation on Pharmaceutical Registration. Upon approval, the newly approved drug formulas for new drugs, new generic drugs, whereby the prototype of such drugs is still under the safety monitoring programme (SMP) and new biological products shall still be monitored and are subject to at least a one-year SMP depending on the risk level of the drugs.11 Moreover, advertisement of any drug shall be approved by the FDA before being disseminated. The process will take 15 to 80 days.
Under the Medical Device Act, medical devices are categorised into three subcategories, each with different prerequisite obligations.12 Generally speaking though, any person wishing to import medical devices is required to either obtain a prior licence, notify the relevant authorities, or notify and register the medical device prior to the manufacturing or importation, as the case may be.13
vi Regulatory incentives
The Trade Secrets Act contains a provision governing the duties of the state to maintain trade secrets of drugs, which are in the form of testing results or information on drugs which is prepared, discovered or created by an applicant, and such applicant has requested the state agencies to maintain the information as trade secrets.14 However, under such provision, only one notification has been issued. This notification specifically aimed to protect pharmacopoeia information on modern drugs, which use new chemicals that have never been registered in Thailand.15 The notification provides guidelines on the safekeeping of the approved and registered pharmacopoeia information as trade secrets for five years from the approval date.16
Thailand has no special provisions to encourage the development of products for rare diseases, diseases that are prevalent in developing countries or paediatric use.
vii Post-approval controls
The Post Marketing Bureau of Drug Control, under the control of the Drug Control Bureau, is mainly responsible for the control and supervision of post-approval controls. The Post Marketing Bureau of Drug Control has two main duties: to monitor manufacturing facilities and drug safety and quality after the applicant has obtained the required approval from the FDA. Manufacturing facilities that have been approved are inspected in accordance with the relevant Ministerial Regulations and Notifications. Facilities must be in compliance with the Pharmaceutical Inspection Co-operation Scheme (PIC/S).17 For the monitoring of product safety and quality, officers of the Post Marketing Bureau of Drug Control are vested with the authority provided by the relevant Act, Notifications or Ministerial Regulations to conduct certain actions are to ensure that drugs approved for distribution are safe and comply with the required standards under the law. For instance, a notification issued under the Medical Act allows the officers to order the manufacturer, importer or distributor to recall unsafe drugs, or provide such drugs to the officers for further inspection and disposal.18 In relation to medical devices, the Medical Device Act imposes obligations on manufacturers, distributors and importers.19 Post-market controls on medical devices involve surveillance of medical devices to prevent injury that may be the result of the use of the medical device, as well as to allow the users the opportunity to file a complaint in relation to the medical device for the FDA's further inspection.20 In addition, a notification was issued to provide procedures for the submission of a device defect report or adverse event report as well as the ensuing field safety corrective report.
In 2020, notifications were issued in relation to quality and safety to ensure consumer protection. In this regard, a notification21 was issued to impose an obligation on any person who has registered a place for manufacture of a medical device, authorised person, person who gave notice about the manufacture or importation of a medical device or person who gave notice of and registered the manufacture or importation of a medical device, as the case maybe. The notification requires the preparation of academic documents certifying that such medical device manufactured or imported is up to acceptable standards, has the required capacity, as well as being safe for use. In this regard, the aforementioned persons are required to provide these academic documents to officers when the documents are requested.
To monitor and control medical device quality and to ensure the safety of consumers, a notification22 was issued to govern and regulate medical devices, whereby any person who registered a place for manufacture of a medical device, authorised person, person who gave notice about the manufacture or importation of a medical device or person who gave notice and registered the manufacture or importation of a medical device shall arrange for a channel for customer complaints, recording of such complaints, as well as a system to manage complaints in relation to the medical device manufactured, imported or sold, as the case may be. The summary of the aforesaid information shall be provided to officers for further inspection when such information is requested.
In addition, for the purpose of allowing end-users of any medical device to receive the required information in relation to the usage and maintenance of that medical device, and to ensure safe usage of that medical device, the Notification of the Ministry of Public Health23 was issued to govern the details provided on the device label. In essence, the notification provides specific requirements in relation to the language used and other contents of the label (i.e., name of the product, details of that product, components, method of use, type and kind, objective and purpose, name and place of the manufacturer or importer, licence number, or details on notification receipt, notification or registration receipt, caution, as well as the details for the maintenance of that medical device). The notification also provides details in relation to the medical device documentation and the details required thereto. In this regard, the notification allows the medical device documentation to be presented in a paper or other form, which is included in the packaging of the medical device. The medical device documentation also covers the medical device manual guide. Certain types of medical devices are exempt from having to comply with the labelling and medical device documentation details requirement pursuant to the above-mentioned requirements. Nonetheless, certain details determined under this notification are still required to be presented. The notification also requires any authorised importer of a medical device to present a label in compliance with the details set forth in the notification to the medical device inspection zone, as well as to arrange for a label to be prepared in compliance with the requirement set forth in this notification within 180 days after the officer of the medical device inspection zone has permitted the importation of such medical device, before such product is sold.
viii Manufacturing controls
As mentioned in Section II.v, the Drug Act requires that any person who wishes to manufacture drugs in Thailand obtain a licence from the FDA.24 In this regard, the applicant shall provide the required evidence (i.e., the floor plan of the manufacturing facility, which is approved by the FDA, evidence of ownership over the assets and properties, affidavit if the applicant is a juristic person, and other required evidence, such as factory licence or building construction permit if the facilities fall within the size and manufacturing power as required under the relevant laws). After obtaining a licence for the manufacture of modern drugs, the manufacturer must have at least two pharmacists to manage the operations and to monitor drugs at the premises during business hours.25
In 2020, a guideline for good distribution practices was issued to govern and provide standards for the wholesale distribution of drugs, covering drug manufacturers, distributors and importers. Specifically, the guideline was issued to cover the management of drug quality, personnel, place of business operation and equipment, document system, operation, inspection, delivery, etc.
In this regard, the Ministerial Regulation Re: The Determination of Rules Conditions and Procedures for the Manufacturing of Modern Drugs BE 2563 (2020) was issued to impose additional obligations for the authorised drug manufacturers. In this regard, the obligation to manufacture and distribute drugs in accordance with rules, conditions and procedures for the manufacture and distribution of drugs is determined by the Ministry of Public Health.
Any person wishing to manufacture any category of medical device in Thailand must have its place of business operation registered with the FDA26 and obtain a manufacturing licence.27 A Notification of the Ministry of Public Health28 was issued to categorise medical devices to let the operators know when the manufacture or importation of the medical device requires notification to be sent to the FDA and the device needs to be registered with the FDA. This notification represents a continuation to the amendment of the Medical Device Act made during 2019, specifically for the determination and grouping of medical devices or a group of medical devices into different categories based on the level of risk of harm to health, body, or life of humans or animals or impact on public health in general.
In addition, a notification of the Ministry of Public Health29 was issued to determine the standards of medical devices listed in the notification, requiring the manufacturer or importer to comply with such standards to provide safety for consumers.
ix Advertising and promotion
The Consumer Protection Act generally governs the content of advertisements as well as labelling requirements. However, the Drug Act and Medical Device Act specifically contain chapters governing the advertisement of drugs and medical devices, respectively.30 Both acts set forth two fundamental requirements for advertising drugs and medical devices.
First, a party must obtain prior approval for the content of the advertisement before that advertisement can be disseminated.31 In addition, there is also an obligation to obtain an advertising licence for the purposes of advertisements that contain information related to medical devices.32
Second, both acts provide guidelines set forth by the FDA, whereby the content of an advertisement shall not contain information that is false, exaggerated, misleading, or different from the details approved by the FDA.33
In addition to the Drug Act and the Medical Device Act, other rules and Ministerial Regulations issued under both acts provide additional requirements as to the advertisement of drugs and medical devices. For instance, the FDA issued a rule governing presentation of drug names, drug properties, and recommendations for usage and warnings.34 The FDA also issued a notification that provides details regarding prohibited content and other requirements in the advertisement of medical devices, and rules and guidelines for the references to academic studies or research to support information in advertisements related to medical devices.35
In 2020, the notification36 was issued to exempt certain methods of advertisements for medical devices from having to apply for prior approval. In this regard, the advertisement containing only a trade name, a trademark or a trade logo, without specifying the properties, benefits, qualities, standards, components or origin of the medical device to incentivise the viewers to purchase the product shall be exempt from having to apply for prior approval for making advertisements from the FDA.
Another notification37 was issued to exempt advertisements made directly to medical professionals and the public health sector. In this regard, these advertisements shall not contain details or wording that are in violation of the Medical Device Act and shall clearly contain a statement that the advertisement is made only for medical professionals and the public health sector. If so, an application for prior approval for making the advertisement would not be required. Advertisers who are exempt from having to obtain prior approval under this notification shall notify the FDA of the advertisement using the form contained in the notification.
x Distributors and wholesalers
The sale of modern drugs is prohibited unless a licence has been granted by the FDA.38
The Notification Re: Permission and Issuance of a License to Sell Modern Drugs BE 2556 (2013) prescribes the application form and other obligations that an applicant must comply with to receive a distributing licence or a wholesaler licence. Generally, depending on the type of licence, the facilities for distribution or storage of drugs must follow the notification. A distributor or wholesaler is also required to produce purchase reports, as well as to generate sales reports for submission to the FDA as required. There are also other obligations that must be complied with (i.e., the distributor shall have a pharmacist present during business hours to distribute drugs and monitor activities). In addition, the drug distributors and wholesalers shall comply with the guidelines for good distribution practices in relation to the transportation, storage, personnel and document standards and requirements set forth under such guidelines as mentioned in Section II.viii.
Distribution of medical devices is prohibited unless a licence for the distribution of such medical device has been granted.39 The Notification Re: the Permission and the Issuance of Medical Device Distribution Licences BE 2555 (2012) was issued to govern the issuance of licences and imposition of obligations on the applicant.
xi Classification of products
Drugs are categorised as modern, traditional, dangerous, specially controlled, external-use, site-specific, household, packaged and herbal.40 The MOPH, with advice from the Drug Committee, has the authority to classify drugs into one of these categories by making an announcement in the Royal Gazette.41
The Medical Device Act classifies medical devices into different categories each with different restrictions and requirements.42 The MOPH, with advice from the Medical Device Committee, has the authority to classify medical devices based on risk and safety characteristics.
xii Imports and exports
An import licence, granted by the FDA, is required to import drugs into Thailand.
Any person wishing to import medical devices is required to register a place of business operations with the FDA.
In 2020, the Ministerial Regulation No. 30 (BE 2563) (2020) issued under the Drug Act imposed additional obligations on authorised drug importers, such as the obligation to only import drugs that are up to the manufacturing standard as determined by the Ministry of Public Health or equivalent standard as determined by the Secretary of the Food and Drug Administration.
Both the Drug Act and the Medical Device Act do not impose an obligation on an exporter to obtain a licence for the exportation of drugs or medical devices. However, in practice, the Thai Customs Department will request an exporter to provide an export certificate. For example, an export of medical device certificate, issued by the FDA, is evidence specifying that the exporter (or the manufacturer) is the owner of the products. This certificate also indicates the market status and shows that this person has already obtained and complied with the requirements of the law in relation to the medical device.43
In addition, the notification of the Ministry of Public Health,44 as mentioned in Section II.viii, was issued to govern medical device standards for medical devices to be imported into Thailand and must be complied with by the medical device importer.
In a similar manner, manufacturing, import and export of Category II Narcotics must be granted license by the FDA. The Ministerial Regulation Re: Application for and Approval of Manufacturing, Import and Export of Category II Narcotic BE 2563 (2020), which came into forth early of 2021, specifies that applicant wishing to manufacture, import or export category II narcotics must obtain a licence before doing so and that the approval is subject only to the use of national medical purpose, scientific or study research, prevention and suppression of narcotic-related crimes and compliance with the resolution of the Commission on Narcotic Drugs (CND) in case of use for treatment in patients for 90 days in Thailand. An example of this qualification is that the export of category II narcotics must be granted an import licence or documents issued by the destination state.
xiii Controlled substances
The Narcotics Control Division has control over the import, export, commercial sale and possession of narcotics and psychotropic substances.45 It is also responsible for the approval, revocation and suspension of licences for import, export, commercial sale, and possession of narcotics and psychotropic substances. For instance, the Narcotics Code provides that no person shall import, export, commence commercial sale of or possess dangerous narcotics such as heroin for the purposes of research, medical use, industry use and science use without the prior approval from the Minister of Public Health as advised by the Narcotic Control Committee.46 The criteria and qualifications of the applicant will be prescribed in the Ministerial Regulation, which is still enacted.
One of the main responsibilities of the FDA involves surveillance of products to maintain product quality and standards, and to prevent violations under the Drug Act and the Medical Device Act. In this regard, FDA officers will, from time to time, initiate random spot checks to ensure that the products (i.e., drugs and medical devices) remain in compliance with the law. If a spot check reveals any failure to comply with the law, or in the case of a complaint made to the FDA, the enforcement phase will commence, which could lead to penalties for the violation as provided in the aforementioned acts.
Pricing and reimbursement
In Thailand, procurement by government agencies, including public hospitals, is subject to the criteria and requirements under the Public Procurement and Management of Supplies Act, BE 2560 (2017). In this regard, drug prices for public hospitals are prescribed by the National Drug System Development Committee. The latest list was announced in the Government Gazette on 22 April 2019.
Regarding reimbursement, Thailand has three types of the public health coverage: the civil service welfare systems for central and local civil officers and their family, social security for eligible employees in the private sector, and the Universal Coverage scheme (UC) for all other Thai nationals.47
The benefits packages, payment systems and funding for each programme are different from one another. The civil service welfare system is funded and regulated by the Comptroller General's Department of the Ministry of Finance or the Ministry of Interior (for local officers), social security is funded by the Social Security Office, while the UC is funded by the National Health Security Office under the National Health Security Act, BE 2545 (2002).
It is notable that all three programmes universally use the National List of Essential Medicines (NLEM) as a guideline for reimbursable drugs. The NLEM is a list of reimbursable drugs announced by the Drug System Development Committee, including the conditions (or lack thereof) for medical professionals to prescribe reimbursable drugs under the coverage. The drugs outside of the NLEM can also be reimbursed; however, only with a prescription by medical professionals in charge as necessary to cure the patient of a sickness.
Administrative and judicial remedies
Under the Drug Act, in the case that a drug licence is not granted or the authority does not renew an existing licence, an applicant has the right to appeal against that decision to the Ministry of Public Health within 30 days from receipt of notice that the licence will not be issued or renewed. If an applicant does not appeal against that decision within 30 days, the licence will be revoked.
Because there is no specific period for consideration of an appeal under the Drug Act, consideration for such an appeal with be as specified in the Administrative Procedure Act, BE 2539 (1996), meaning the consideration process shall be completed within 30 days from the date of receipt of the appeal.
In the case of medical devices, if the authority does not issue an establishment registration certificate, licence or specifications declaration receipt, the applicant has the right to appeal against the authority's order in writing to the Minister of Public Health within 30 days from the date of receipt of notice of the non-issuance of establishment registration certificate, licence or specifications declaration receipt, as the case may be.
When considering an appeal under the Medical Device Act, the Minister of Public Health shall complete the appeal process within 120 days from the date of receipt of the appeal. If, out of necessity, consideration cannot be completed within this time period, written notice shall be sent to the appellant before the expiry of the time period. The period for consideration of an appeal may be extended for not more than 120 days from the expiry of the initial 120-day consideration time period.
Pursuant to both Acts, the judgment of the Minister of Public Health is considered to be final. However, if the appellant is not satisfied with the judgment of the Minister of Public Health, the appellant has right to file a case with the Administrative Court.
Financial relationships with prescribers and payers
Thai law regulates the purchase of medicines and medical devices by the government. For the most part, the organisations that generally make decisions concerning utilisation or reimbursement of medicines and medical devices in Thailand are the Government Pharmaceutical Organisation (GPO), the Thai Red Cross Society and public hospitals.
These organisations need to comply with a set of rules regarding the procurement of these products.48 Thus, there should be no financial relationships between product suppliers or prescribers.
Generally, there are three methods for the procurement of products: the general solicitation method, the selection method and the specific method. The general solicitation method can be made through an e-market, e-bidding or examination of price.49 The e-market method is used when procurement of products will cost more than 500,000 baht, such products do not have complex or specific characteristics and the details and specifications are provided in the e-catalogue system of the Comptroller General's Department.50 The e-bidding method applies to the procurement of products costing more than 500,000 baht and the specifications are not provided in the e-catalogue system in accordance with the methods specified by the Comptroller General's Department.51 The examination of price method must be used in the case of procurement of products costing more than 500,000 baht and there is no internet connection within the area of the relevant government organisations.52 Under the selection method, a government agency will solicit at least three business operators who possess specific qualifications determined by the relevant agency to submit a proposal, unless there are fewer than three business operators who possess such qualifications.53 Under the specific method, a government agency may solicit a single business operator who possesses specific qualifications determined by the relevant agency to submit a proposal, or offers bargain prices where the cost does not exceed 500,000 baht for a single procurement.54
In March 2019, the committee that analysed issues related to public procurement and management of supplies issued guidelines for the purchase of medicines and medical devices for relevant government agencies.55 Under these guidelines, when a government agency intends to purchase medicines or medical supplies under the NLEM that the GPO or the Thai Red Cross Society produces and distributes, that government agency is required to procure such medicines and medical supplies using the specific method. However, the government agency may purchase such products from any other suppliers when the GPO or the Thai Red Cross Society is not able to produce and distribute the products within the specified period according to the annual plan submitted by the relevant government agency.56
On 29 January 2020, the Ministerial Regulation57 was published in the Royal Gazette to determine the products that the state promotes or supports, as well as the procurement method of these products. Certain types of drugs and medical supplies are also listed as supported and promoted products. In this regard, the Ministerial Regulation provides budget allowed for the procurement of the listed drugs or medical supplies, method of procurement or organisation, and list of promoted or supported supplies.
With regard to the purchase of medicines or medical supplies by the private sector, the authorised private sector entity may purchase these products certified by the FDA from any suppliers without restrictions.
Special liability or compensation systems
As there is no specific compensation system for persons injured by medicines or medical devices in Thailand, the general principles of law regarding tort and product liability apply.
Transactional and competition issues
i Competition law
There is no specific rule or law on the settlement of patent disputes between an originator and generic manufacturers provided under intellectual property laws. Also, there is no specific provision targeting drug or medical device markets under the current antitrust law.
ii Transactional issues
There is no specific law governing licensing or strategic collaborations, joint ventures or mergers and acquisitions in relation to medicines and medical devices.
i Drug Act
In order to comply with the current covid-19 situation and ensure the efficiency, rapidity and compliance of Thai drug manufacturing adheres to global guidelines, the FDA Committee thus issued temporary measures regarding the consideration of good manufacturing practice (GMP) certificates. For example, both overseas and domestic GMP certificates that will expire before 31 December 2022 will be automatically valid until 31 December 2022.
ii Narcotic Code
Thailand has reformed laws relating to narcotics to be more systematic and flexible for life sciences industry use by combining 24 existing acts or regulations (some have been endorsed since the 1970s) into the Act on Promulgating the Narcotics Code (the Narcotic Code) on 8 November 2021. In this regard, any sub-laws under the existing acts that had been in force shall remain in force to the extent that they do not conflict with or contradict provisions of the Narcotic Code. The Narcotic Code emphasises revention, suppression and treatment of narcotic-related crimes including enhancement of cooperation between governmental agencies and the private sector with respect to narcotics-related issues; specifically speaking, the Narcotic Code lightens sentences served for each punishment based on the severity of that crime, to ease the situation of overcrowded prisons. The Narcotic Code also ceases any duplicated procedures under repealed acts and provides the licensing system to control the use of narcotics in the areas of research, medical, science and industry.
Over this past year, there have been several sub-laws relating to the relaxation of narcotic use, such as:
- The Notification of the Ministry of Public Health Re: Use of Hemp for Cosmetics BE 2564 (2021) allows the production of cannabis in cosmetics with no more than 0.2 per cent of tetrahydrocannabinol (THC) in each specified product.
- The Notification of the Food and Drug Administration Re: Specification of Forms of Applications for Licences, Replacement of Licences to Produce, Import, Export, Distribute or Possess Narcotics of Category V with Respect to Hemp BE 2564 (2021) governs rules and procedures for a person to obtain a licence to produce, import, export, distribute or possess hemp.
- The Notification of the Narcotics Commission Re: Specification of Premises Standards and System for Control of Hemp Cultivation BE 2564 (2021) governs the standard and system of hemp cultivation (e.g., it specifies that areas used for the cultivation of hemp must contain certain qualifications; for instance, the greenhouse must comprise of natural light or light from artificial light bulbs and the preparation of cultivation areas must include convenient access to the cultivation area).
- The Notification of the Narcotics Commission Re: Specification of Rules, Procedures and Conditions on Production of Hemp-based Medicinal Formulae BE 2564 (2021) allows persons to apply for a licence to produce a hemp-based medicine formula for medical purpose. In this regard, the licensee must also arrange to obtain a pharmaceutical practitioner to oversee the production of a hemp-based modern drug or drug that is developed from herbs or must arrange to obtain a practitioner of Thai traditional medicine in case of hemp-based Thai traditional drugs.
- The Notification of the Narcotics Commission Re: Specification of Labels on Containers or Packaging of Produced, Imported, or Exported Hemp and Hemp Extracts that are Narcotics of Category V BE 2564 (2021) imposes duties to a licensee holding a licence to produce, import or export narcotics of category V with respect to hemp and hemp extracts excluding hemp-based medicinal formula products to conclude certain requirements into the labels. For instances, a label for hemp must include the origin of hemp, amount of THC, germination rate of seeds with an indication of the date, month and year of the test.
- The Notification of the Food and Drug Administration Re: Rules, Procedures and Conditions on Application for Amendment to a Plan for the Production, Importation, Exportation, Distribution or Utilisation of Hemp BE 2564 (2021) governs a licensee to apply for the amendment of a plan to produce, import, export, distribute and utilise hemp.
- The Notification of the Narcotics Commission Re: Forms and Procedures for Monitoring the Efficacy and Safety and Reporting Adverse Events Resulting from the use of hemp-based Medicinal Formulae BE 2564 (2021) imposes duties to a licensee holding a licence to produce or import a hemp-based medicinal formula for medical purposes under the special access scheme to constantly monitor and evaluate the efficacy and safety of the use of the medicinal formula though active surveillance procedure.
- The Notification of the Ministry of Public Health Re: Specification of Hemp-based Formulae of Narcotics of Category V that are Consumable for Treatment of Diseases or Research Study BE 2564 (2021) specifies the hemp-based formulas that are consumable for treatment of diseases or research study, e.g., hemp-based traditional Thai medicinal formulas, modern drugs, special access schemes, approved research study projects or Thai tradition that is compounded by a Thai traditional medical practitioner.
1 Jessada Sawatdipong is a managing partner, Pranat Laohapairoj is a partner and Suphakorn Chueabunchai is a senior associate at Chandler MHM Limited.
2 Food and Drug Administration, 'The Roles and Responsibilities of Thai FDA' (Food and Drug Administration 2016), www.fda.moph.go.th/sites/FDA_EN/SitePages/Roles.aspx, accessed 26 November 2021.
3 Ministerial Regulation Re: Determination of Organisation Structure of the Food and Drug Administration, Ministry of Public Health BE 2563 (2010).
5 Ministerial Regulation Re: Determination of Organisation Structure of the Food and Drug Administration, Ministry of Public Health BE 2552 (2009).
6 Chapter 1 of the Notification of the Supervisory and Promotional Committee on the Use of Animals for Scientific Purposes Re: Determining Ethics for the Use of Animals for Scientific Purposes, announced on 29 February 2016.
7 Clause 6.3 of the Notification of the Drug and Food Administration Re: Rule Method and Criteria for Approving the Ethics Committee for Considering the Clinic Trial Project in Relation to Drugs, dated 10 September 2018.
8 Fee rate, Annex to the Drug Act BE 2510 (1967) as amended by the Drug Act (No. 6) BE 2562 (2019).
9 Section 79 of the Drug Act BE 2510 (1967).
10 Clause 8 of the Notification of Ministry of Public Health Re: the Online Submission of Pharmacopoeia Registration BE 2558 (2015).
11 Notification of the Food and Drug Administration Re: the Criteria on the Risk-Based Approach Safety Monitoring Program BE 2560 (2017).
12 Section 6 of the Medical Device Act BE 2551 (2008).
14 Section 15 of the Trade Secrets Act BE 2545 (2002).
15 Clause 3 of the Rule of the Ministry of Public Health Re; the Keeping of Trade Secrets of Pharmacopoeia Registration Information BE 2550 (2007).
16 Clauses 18 and 19 of the Rule of Ministry of Public Health Re: the Keeping of Trade Secrets of Pharmacopoeia Registration Information BE 2550 (2007).
17 Ministerial Regulation Re: Modern Pharmaceutical Manufacturing BE 2546 (2003) and Notification of the Ministry of Public Health Re: Good Manufacturing Practice Requirements for Modern Medicines and Amendments of Good Manufacturing Practice Requirements for Traditional Medicines in Accordance with the Drug Act BE 2559 (2016).
18 Ministerial Regulation No. 20 (BE 2525) (1982), issued under the Drug Act BE 2510 (1967).
19 Section 41 of the Medical Device Act BE 2551 (2008).
21 Notification of the Food and Drugs Administration Re: Rules Conditions and Procedures for the Arrangement of Academic Documents to Certify the Quality Capacity and Safety for Officer Inspection Upon Request BE 2563 (2020).
22 Notification of Ministry of Public Health Re: Rules Conditions and Procedures for the Provision of Complaint Channel, Recording of Complaint, and System to Manage Complaint to Medical Device Manufactured, Imported or Sold for the Inspection of Officer BE 2563 (2020).
23 Notification of Ministry of Public Health Re: Rules Conditions and Procedures on Labelling and Documents Regulating Medical Device BE 2563 (2020).
24 Section 12 of the Drug Act BE 2510 (1967).
25 Section 20 of the Drug Act BE 2510 (1967).
26 Section 15 of the Medical Device Act BE 2551 (2008).
27 Section 17 of the Medical Device Act BE 2551 (2008).
28 Notification of the Ministry of Public Health Re: Group of Medical Devices or Medical Device where the Manufacturer or Importer shall Notify and make Registration BE 2563 (2020).
29 Notification of the Ministry of Public Health Re: Standards of Medical Device for the Compliance of the Manufacturer or Importer BE 2563 (2020).
30 Chapter 7 of the Medical Device Act BE 2551 (2008) and Chapter 11 of the Drug Act BE 2510 (1967).
31 Section 88 bis of the Drug Act BE 2510 (1967), and Section 57 of the Medical Device Act, BE 2551 (2008).
32 Section 57 of the Medical Device Act BE 2551 (2008).
33 Section 88 of the Drug Act BE 2510 (1967) and Section 59 of the Medical Device Act BE 2551 (2008).
34 Rules of the Food and Drug Administration Re: Rules on Advertisement of Drugs BE 2545 (2002).
35 Notification of the Food and Drug Administration Re: Rules Conditions and Procedures on Advertisement of Medical Device BE 2553 (2010).
36 Notification of the Ministry of Public Health Re: Exemption of Certain Characteristics of Advertisement from Having to Apply for Prior Approval BE 2563 (2020).
37 Notification of Ministry of Public Health Re: Rules Conditions and Procedures for Advertisement Directly to Medical Professional Practitioner and Public Health that is Exempted from Prior Approval BE 2563 (2020).
38 Section 12 of the Drug Act BE 2510 (1967).
39 Section 6 and Section 24 Paragraph 2 of the Medical Device Act BE 2551 (2008).
40 Section 4 of the Drug Act BE 2510 (1967).
41 Section 76 and Section 78 of the Drug Act BE 2510 (1967).
42 Section 6 of the Medical Device Act BE 2551 (2008).
43 Food and Drug Administration, 'The Application for Export of Medical Device Certificate', p. 1.
44 Notification of the Ministry of Public Health Re: Standards of Medical Device for the Compliance of the Manufacturer or Importer BE 2563 (2020).
45 Order of Narcotics Control Division No. 4/2562 Re: Determination of Duties and Power of the Narcotics Controls Division.
46 Section 34 of the Narcotic Code.
47 '10 Things in Health Security' by National Health Security Office.
48 Public Procurement and Management of Supplies Act BE 2560 (2017).
49 Ministerial Regulation re: Public Procurement and Management of Supplies BE 2560 (2017).
50 id. Article 30.
51 id. Article 31.
52 id. Article 32.
53 Section 55(2) of the Public Procurement and Management of Supplies Act BE 2560 (2017).
54 id. Section 55(3).
55 The most urgent letter of the committee on analysing the problems on Public Procurement and Management of Supplies the Comptroller General's Department No. GorKor. (GorWorJor) 0405.2/Wor 119 dated 12 March 2019.
56 Clause 3.1.1 of the Most Urgent Letter of the Committee on analysing the problems on Public Procurement and Management of Supplies the Comptroller General's Department No. GorKor. (GorWorJor) 0405.2/Wor 119 dated 12 March 2019.
57 Ministerial Regulation Re: Determination of the Promoted and Supported Products and the Procurement Methods BE 2563 (2020).