Thailand Streamlines Renewal of Licenses for Hazardous Substances and Cosmetics

November 4, 2021

Thailand Streamlines Renewal of Licenses for Hazardous Substances and Cosmetics

A new royal decree in Thailand (Royal Decree Re: Licensee to Pay the License Renewal Fee in Lieu of a Grace Period When Submitting a License Renewal Application B.E. 2564) does away with the current red tape associated with renewing certain marketing authorization and business licenses. Under the new royal decree, there is no longer any need to submit renewal applications for eligible licenses or to wait for approval from the relevant authority. Instead, the licenses will be automatically renewed upon payment of renewal fees. There are 31 eligible licenses listed in the royal decree, with a focus on licenses for hazardous substances and cosmetics.

The royal decree on license renewal was published in the Government Gazette in May 2021 and will come into force on November 22, 2021. Although the new royal decree has not yet come into force, Thailand’s Food and Drug Administration (FDA) has already begun renewing licenses for hazardous substance licenses and cosmetics notification receipts via the new procedure. These licenses and notification receipts are detailed below:

(Note: Hazardous substances for household use and public health are classified into four types according to their risk. Products containing type 2 and 3 substances are a higher risk than type 1 and must be registered with the FDA. Type 4 substances are prohibited.)

Procedural Guidance

The licenses for hazardous substances in the table above should be renewed in the two months preceding their expiry date, while the notification receipts for cosmetics should be renewed in the six months before their expiry date. Renewed licenses are valid for another six or three years (i.e., matching the original validity period).

Under the new royal decree on license renewal, eligible licenses for hazardous substances and cosmetics can be renewed by notifying the FDA via its e-submission system. The license holder will then receive a payment order for the renewal fees, which can be paid through various channels (e.g., payment service points, banks, offices of the relevant authorities, and electronic banking). Upon payment, the license will be renewed automatically and the license holder can download a new license for the cosmetic product or a license attachment for the hazardous substance. It can be used instead of or attached to the old license, and there is no need to change the FDA number.

Other Considerations

The new renewal procedure under this royal decree will greatly reduce the time and effort businesses spend seeking license renewal. Nonetheless, this simpler renewal procedure could also be cause for concern due to the lack of verification or approval in the process. The relevant authority may find it difficult to verify and ensure that businesses are operating properly under relevant laws, which could lead to safety issues for consumers and the general public.

For instance, this streamlining of the license renewal process bears some similarity to circumstances surrounding the recent hazardous substance factory explosion in Samut Prakan Province. In the days after the explosion, the latest amendment of the Factory Act B.E. 2562 (2019) was criticized by the public because it removed license renewal requirements, instead stipulating that factory operation permits no longer had an expiry date—a change from the previous requirement to renew the permit every five years. This change meant that factories no longer had to be verified every five years when it was time to renew the permit. Without verification and monitoring from the relevant authority, it is difficult to confirm factory safety and compliance with the relevant laws and regulations.

Similarly, this latest royal decree on license renewal outlines an easy renewal procedure (automatic approval) without verification or approval from the relevant authority. This lack of regulatory verification and approval could lead to heightened safety concerns for employees, consumers, and the general public. It seems that it is now up to businesses themselves to verify their own regulatory compliance and to be aware of any changes that require a license amendment before renewal. It is the responsibility of the business to ensure that its products are safe and in full compliance with laws and regulations. Therefore, this license renewal procedure under the new royal decree eases bureaucratic burdens on businesses but also serves as a reminder of their essential role in protecting consumers and the public interest.

Related Professionals

Thanathon Trakoolpolpruek

Consultant, Regulatory Affairs

Thailand

+66 2056 5555

Email

Sonatree Sehamontree

Consultant, Regulatory Affairs

Thailand

+66 2056 5608

Email

RELATED INSIGHTS

February 14, 2024

New Rules on Drug Importation for Clinical Trials Set to Take Effect in Thailand

Thailand is preparing to implement new rules on drug importation for clinical studies. The Medicines Regulation Department of Thailand’s Food and Drug Administration (Thai FDA) first issued the Notification Re. Detailed Requirements for Drug Importation into Thailand for Clinical Studies almost a year ago, and the notification is expected to come into effect on March 1, 2024. Key Provisions The notification aims at enhancing the efficiency of conducting clinical studies while ensuring the protection of human subjects participating in such studies within Thailand. Some of its key provisions include: Definition of Clinical Study. The notification defines a “clinical study” as a study of a medicine involving human subjects, conducted to provide supporting evidence for the registration of a medicinal product in Thailand or other countries, including for additional indications or variations of a registration dossier. Compliance with ICH GCP. Clinical studies conducted in Thailand must adhere to the current edition of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines. Clinical Trial Application. Sponsors are required to submit a clinical trial application along with supporting documents to the Thai FDA for approval before commencing a clinical study. The permit remains valid for five years and is renewable. Supply of Investigational Drugs. Sponsors must obtain investigational drugs from manufacturers compliant with Good Manufacturing Practice (GMP) standards as recognized by the Thai FDA. Postapproval Obligations. The secretary-general of the Thai FDA may impose postapproval conditions or order investigators to conduct or suspend certain activities to ensure human subject protection and regulatory compliance. Regulatory Oversight. The Thai FDA is responsible for inspecting and overseeing the regulatory compliance of clinical studies, including during prestudy, ongoing, and poststudy phases. The Thai FDA may also conduct inspections of clinical studies conducted overseas. The Thai FDA

December 15, 2023

Lex Mundi Guide to Doing Business in Thailand 2023

As part of its membership in Lex Mundi, Tilleke & Gibbins has published an updated edition of its Guide to Doing Business in Thailand for 2023. This guide outlines the key factors for starting and operating a business in the Thai market. Issues covered include: Investment incentives Financial facilities Exchange controls Import and export regulations Structures for doing business Requirements for the Establishment of a Business Operation of the Business Cessation or Termination of the Business Labor legislation, relations, and supply Tax Immigration requirements This publication is part of Lex Mundi’s Country Guides series prepared by member firms in more than 100 jurisdictions worldwide. The guides serve as a useful resource for planning international business strategy and researching new markets. The full Guide to Doing Business in Thailand is available through the button below.

December 6, 2023

Laos Implements Medical Device Registration and Notification Requirements

New regulatory requirements for medical device registration and notification in Laos are set to enter into force in the coming weeks under the plan found in Notification No. 9606 to implement Decision No. 1470/MOH on Registration and Notification of Medical Devices (Decision 1470). The notification, issued on October 25, 2023, by the Food and Drug Department (FDD) under the Ministry of Health (MOH), outlines the FDD’s strategic plan for phased-in registration and notification requirements for medical devices. In the first phase, starting January 1, 2024, the FDD will initiate the registration process for class C (moderate-high risk) and D (high risk) medical devices. Meanwhile, operators dealing with class A (low risk) and B (low-moderate risk) devices can continue applying for import permits without having to register the devices or notify the FDD. In the subsequent phase, starting January 1, 2025, operators will have to notify the FDD about class A devices and complete the registration process for class B devices. To prepare for these requirements, import-export companies in the pharmaceutical and medical products sector must submit a list of medical devices, including their classification based on the country of manufacture, to the FDD by December 15, 2023. This measure is aimed at enabling the FDD to streamline the collection, guidance, and preparation processes to ensure efficient registration within the set time frame. While import-export companies can still submit their lists after either December 15, 2023, or January 1, 2024 (the registration commencement date), registration may be delayed since the FDD will prioritize those who submit their lists by the December 15 deadline. The list of medical devices should encompass medical devices imported in the past as well as those intended for future import permission applications. During the initial registration stage (i.e., from January 1, 2024), import-export companies that are

October 25, 2023

Healthcare in Cambodia: Crackdown on Illegal Advertising and Noncompliant Services

Cambodia’s Ministry of Health (MOH) continues to increase awareness among the public and private sector of the need for strict healthcare regulations and strict enforcement to advance the quality of the country’s healthcare sector. In April 2023, the MOH issued a notification letter reminding advertisers of health products that they need to obtain a permit before advertising their products in Cambodia. On October 12, 2023, the MOH issued two press releases on continued noncompliance in the healthcare sector. The two press releases address the illegal advertising of both healthcare products and private healthcare services. The releases also address unlicensed healthcare professionals and general noncompliance by private healthcare services. These releases indicate that the MOH, in cooperation with local authorities, will substantially increase its enforcement efforts across Cambodia. Since October 12, several private healthcare clinics have had their operations closed and licenses suspended or revoked, signaling the ministry’s intent to enforce the legal framework. Noncompliant Advertising of Health Products The first press release focuses on the continued illegal advertising of health products and the advertising of unregistered health products. Health products include modern medicines, traditional medicines, health supplements, medical devices, cosmetics, and other products that prevent or treat diseases. The release highlights that the MOH has noticed ongoing unauthorized and illegal advertising, commenting that these are often found online and on social media. The noncompliant advertising referenced in the release includes advertising of health products without the required advertising permit, advertising products that are not properly registered with the MOH, and advertising by unlicensed companies and individuals. The MOH also states in the release that some advertisements are using inappropriate and noncompliant content that is not based on medical science and exaggerates the qualities of the health products—specifically mentioning skin-whitening cosmetics. The ministry’s press release also informs the public of

You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

Industries

Practices

November 4, 2021